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## Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy - NCT ID: NCT06366659 - Study ID: M2024049 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-08-20 - Lead Sponsor: Peking University ### Study Description This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP. ### Conditions - Intrahepatic Cholestasis of Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Progesterone metabolites (levels in plasma) - Itch intensity Secondary Outcomes - Total bile acids (levels in plasma) ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100000, China @@
## Competency-based Intervention for Head Nurses - NCT ID: NCT06366646 - Study ID: 035901 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-04-30 - Lead Sponsor: Matrouh University ### Study Description Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness. ### Conditions - Intervention - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Competency-based intervention ### Outcomes Primary Outcomes - Questionnaire to measure head nurses' knowledge of leadership competency - Questionnaire to measure head nurses' ability to use leadership competency - Questionnaire to measure leadership effectiveness Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use - NCT ID: NCT06366633 - Study ID: 2024P000713 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-03-31 - Lead Sponsor: Jafar Bakhshaie ### Study Description The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use.Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT.Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations. ### Conditions - Orthopedic Disorder - Nontraumatic Injury - Substance Use - Upper Extremity Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Web-TIRELESS ### Outcomes Primary Outcomes - Credibility and Expectancy Questionnaire (CEQ) - Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment - The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery - The percent of patients that agree to participate to assess feasibility of recruitment - Rate at which program was accepted, measured by attendance to assess acceptability of treatment - Adherence to homework - Rate of participant's completion of self-report measures to assess feasibility of assessments - Adverse Events Secondary Outcomes - Graded Chronic Pain Scale (GCPS) - Disabilities of the Arm, Shoulder and Hand (DASH) - Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0 - PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0 - Pain Catastrophizing Scale (PCS) - Pain Anxiety Symptoms Scale - Short Form (PASS-20) - Pain Vigilance and Awareness Questionnaire (PVAQ) - Brief Experiential Avoidance Questionnaire (BEAQ) - Current Opioid Misuse Measure (COMM) - The Timeline Follow Back (TLFB) - Numerical Rating Scale (NRS) ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02129, United States @@
## Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports - NCT ID: NCT06366620 - Study ID: STUDY00003416 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-19 - Lead Sponsor: Seattle Children's Hospital ### Study Description Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports. ### Conditions - Child Disruptive Behavior Disorders - Parent Child Relationship - Parent Management Training - Peer Support - Child Behavior Problems - Challenging Behavior - Positive Parenting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - FAST-B PEERS - FAST-B (First Approach Skills Training - Behavior) ### Outcomes Primary Outcomes - Acceptability of FAST-B PEERS - Acceptability of FAST-B - FAST-B PEERS support calls attended Secondary Outcomes - Weekly Assessment of Child Behavior - P - Coping with Child Negative Emotions Scale - Strengths and Difficulties Questionnaire ### Location - Facility: Seattle Children's, Seattle, Washington, 98115, United States @@
## Managing High-alert Medication Administration and Errors - NCT ID: NCT06366607 - Study ID: 0306066 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2023-05-31 - Lead Sponsor: Matrouh University ### Study Description High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. ### Conditions - Knowledge - Practice Nurse's Scope - Competence - Nurse's Role - Error Disclosure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - high-alert medication administration ### Outcomes Primary Outcomes - Questionnaire to measure nurses' knowledge about high-alert medication administration - Questionnaire to measure medication safety climate - Questionnaire to measure nurses' competency - observational check list to measure nurses' practice during administration of high-alert medications - Questionnaire to measure errors associated with administering high-alert medications Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## First-line Nurse Manager Authentic Leadership Training Program - NCT ID: NCT06366594 - Study ID: 0305897 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-04-30 - Lead Sponsor: Matrouh University ### Study Description Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes. ### Conditions - Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Authentic leadership training program ### Outcomes Primary Outcomes - Questionnaire to measure first-line nurse managers' knowledge about authentic leadership - questionnaire to measure authentic leadership behavior among first-line nurse managers - Questionnaire to measure nursing care self-efficacy - Questionnaire to measure nurses' trust in their workplace Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Mersa Matruh, N/A, 002, Egypt @@
## Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology - NCT ID: NCT06366581 - Study ID: HD20240307 - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2024-03-01 - Lead Sponsor: Fudan University ### Study Description This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix. ### Conditions - Incisional Hernia - Extracellular Matrix Alteration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcriptomic analysis ### Outcomes Primary Outcomes - the gene expression list Secondary Outcomes ### Location - Facility: Hua Dong Hospital Affiliated to Fu Dan University, Shanghai, N/A, N/A, China @@
## Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas - NCT ID: NCT06366568 - Study ID: CRO-2022-10-PG-MER-MW-JG - Status: COMPLETED - Start Date: 2024-02-19 - Completion Date: 2024-03-06 - Lead Sponsor: Colgate Palmolive ### Study Description The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial. ### Conditions - Plaque, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product - fluoride toothpaste containing 1450 ppm of MFP in a PCC base ### Outcomes Primary Outcomes - Turesky Modification of the Quigley & Hein Plaque Index Secondary Outcomes - questionnaire ### Location - Facility: Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras, Dresden, N/A, 01307, Germany @@
## The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals - NCT ID: NCT06366555 - Study ID: 24-02-0268 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06-22 - Lead Sponsor: Indonesia University ### Study Description Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training ### Conditions - Muscle Soreness - Stiffness of Elbow, Not Elsewhere Classified ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Manual Acupuncture Twirling, - Manual Acupuncture Sham ### Outcomes Primary Outcomes - Visual Analog Scale Secondary Outcomes - Pain Pressure Threshold ### Location - Facility: Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower, Jakarta, DKI Jakarta, 10430, Indonesia @@
## Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT - NCT ID: NCT06366542 - Study ID: 2/2024 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Jordan ### Study Description This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life. ### Conditions - Vestibular Dizziness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vestibular rehabilitation therapy - Virtual reality exercises - Optokinetic Stimulation exercises ### Outcomes Primary Outcomes - The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) - The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) - The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) - Dizziness Handicap Inventory (DHI) - Dizziness Handicap Inventory (DHI) - Falls Efficacy Scale International (FES-I) - Falls Efficacy Scale International (FES-I) - Dynamic Gait Index (DGI) - Dynamic Gait Index (DGI) Secondary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - Pittsburgh Sleep Quality Index (PSQI) - Hospital Anxiety and Depression Scale (HADS) - Hospital Anxiety and Depression Scale (HADS) - Medical Outcomes Study Short Form 12 (SF-12) - Medical Outcomes Study Short Form 12 (SF-12) ### Location - Facility: Royal Medical Services, Amman, N/A, N/A, Jordan @@
## Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction - NCT ID: NCT06366529 - Study ID: TJ-IRB202308123 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2030-09 - Lead Sponsor: Zhen Li ### Study Description Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved.With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney.In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis. ### Conditions - Renal Insufficiency, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - ESKD Secondary Outcomes ### Location - Facility: Tongji hospital, NO.1095 jiefang avenue, Wuhan, Hubei, 430074, China @@
## Role of Methylation Test Triage in HPV Positive Women - NCT ID: NCT06366516 - Study ID: FUOBGY2024-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-02 - Lead Sponsor: Obstetrics & Gynecology Hospital of Fudan University ### Study Description The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening. ### Conditions - Precancerous Cervical Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Methylation Test ### Outcomes Primary Outcomes - The sensitivity and specificity of methylation test in detecting CIN2+. Secondary Outcomes - KAPPA value of methylation test. ### Location - Facility: Obstetrics and Gynecology Hospital of Fudan University, Shanghai, Shanghai, 200011, China @@
## Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation - NCT ID: NCT06366503 - Study ID: RS-2023-05 - Status: COMPLETED - Start Date: 2023-10-03 - Completion Date: 2023-12-29 - Lead Sponsor: Revision Skincare ### Study Description This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device.A total of 22 healthy female subjects completed the study. ### Conditions - Photoaging - Wrinkle - Skin Laxity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Fractional Ablative CO2 Laser - Facial Cleanser - Facial Moisturizer - Sunscreen - Basic Ointment ### Outcomes Primary Outcomes - Investigator Tolerability - Incidence of Adverse Events - Subject Tolerability Secondary Outcomes - Self-Assessment Questionnaire ### Location - Facility: The Dermatology Group, Blue Ash, Ohio, 45242, United States @@
## Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer - NCT ID: NCT06366490 - Study ID: CIP2023-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-03-01 - Lead Sponsor: PhotonPharma, Inc. ### Study Description Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer ### Conditions - Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Innocell Autologous Cellular Immunotherapy ### Outcomes Primary Outcomes - Saferty and Immunogenicity of Innocell in Ovarian Cancer Patients - Safety of Innocell in Ovarian Cancer Patients - Immunogenicity of Innocell in Ovarian Cancer Patients - Immunogemicity in Ovarian Cancer Patients - Immunogenicity of Innocell Vaccine in Ovarian Cancer Patients Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke - NCT ID: NCT06366477 - Study ID: B-ER-103-417 - Status: COMPLETED - Start Date: 2017-01-01 - Completion Date: 2019-11-15 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores. ### Conditions - Rehabilitation - Stroke - Hand Grasp ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vibration stimulation combined with task-oriented training ### Outcomes Primary Outcomes - Fugl-Meyer assessment - wrist and hand - Box and Blocks Test - Motor Activity Log - Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Pitolisant in Patients With Prader-Willi Syndrome - NCT ID: NCT06366464 - Study ID: HBS-101-CL-312 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-07 - Lead Sponsor: Harmony Biosciences, LLC ### Study Description This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.Secondary objectives include assessing the impact of pitolisant on:* Irritable and disruptive behaviors* Hyperphagia* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech ### Conditions - Prader-Willi Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pitolisant tablet - Placebo tablet ### Outcomes Primary Outcomes - Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score Secondary Outcomes - Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain - Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS) - Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS) - Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors - Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ) - Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score - Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains - Percentage of patients reporting TEAEs ### Location - Facility: Santa Monica Clinical Trials, Los Angeles, California, 90025, United States @@
## PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC - NCT ID: NCT06366451 - Study ID: MST01-AZN-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Presage Biosciences ### Study Description This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Rilvegostomig - Volrustomig - Sabestomig - Pembrolizumab ### Outcomes Primary Outcomes - Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab Secondary Outcomes - Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability] ### Location - Facility: UC Davis, Sacramento, California, 95817, United States @@
## A Trial of Two Universal Programs for Parents of Teenagers - NCT ID: NCT06366438 - Study ID: ABC vs Parentweb - Status: COMPLETED - Start Date: 2021-12-11 - Completion Date: 2024-03-24 - Lead Sponsor: Karolinska Institutet ### Study Description Parent training programs in groups and over internet can help parents improve their interaction and communication with their children. There is however a lack knowledge of how programs work for parents of teenagers, as most studies have concerned younger children. Furthermore, most studies have been conducted on programs for selective populations with elevated risk. The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers: The group-based program 'ABC-teen' and the online-based 'ParentWeb'. Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication. The programs are developed in Sweden with content based on other established parenting programs (e.g., Comet, Incredible Years, the Triple P). The aim of the present study was to evaluate the effects of the the two programs, with adolescent mental health as primary outcome. Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected. Parents were randomized to ABC-teen, ParentWeb or a 6 months Wait-List control. Parent- and adolescent ratings were collected at baseline, after 4 and after 12 months. All data collection has now been completed and the next step is to process and analyze the data. ### Conditions - Mental Health Issue - Mental Disorder - Adolescent Behavior - Adolescent Development - Parent-Child Relations - Parenting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ABC-teen - ParentWeb ### Outcomes Primary Outcomes - The Strength and Difficulties Questionnaire (SDQ) - Patient Health Questionnaire (PHQ-9) - Parental stress scale (PSS) - General Anxiety Disorder Scale (GAD-7) Secondary Outcomes - Conflict scale - Adult Child Relationship Scale (ACRS) - Adolescents' openness scale - Brief Family Relationship Scale - Positive and Negative Parenting Behaviors - Me as a Parent - Conflict Resolution Efficacy - School Adjustment Scale - Stockholmsenkaten - Satisfaction Questionnaire - Attendance and engagement measures ### Location - Facility: Bromma stadsdel, Bromma, N/A, 16867, Sweden @@
## Screening for Chronic Liver Diseases in General Population - NCT ID: NCT06366425 - Study ID: RECHMPL23_0272 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03 - Lead Sponsor: University Hospital, Montpellier ### Study Description Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care. ### Conditions - Fibrosis, Liver ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Blood sample then fibroscan ### Outcomes Primary Outcomes - Evaluation of the liver fibrosis screening acceptability (FIB-4) - Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan) Secondary Outcomes - Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67 - Prevalence of excessive consumption of alcohol - Prevalence of a history or drug use - The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders) - prevalence of viral hepatitis - Description of socio-demographic characteristics of participants ### Location - Facility: CHU de Montpellier, Montpellier, N/A, 34295, France @@
## Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein. - NCT ID: NCT06366412 - Study ID: serum Tau-217 in elderly - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: Minia University Hospital ### Study Description To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia. ### Conditions - Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Dexmedetomidine Hydrochloride - normal saline ### Outcomes Primary Outcomes - the effect of dexmedetomidine on serum Tau-217 protein value. Secondary Outcomes - to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group. ### Location - Facility: Arwa Essam, Minya, N/A, 61111, Egypt @@
## The Acute T-Rex (Timing of Resistance Exercise) Study - NCT ID: NCT06366399 - Study ID: 00156659 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-12-31 - Lead Sponsor: University of Utah ### Study Description The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus. ### Conditions - Diabetes Mellitus, Type 2 - Insulin Resistance - Glucose Intolerance - Sleep Disturbance - Overweight or Obesity - Insulin Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Resistance Exercise Timing ### Outcomes Primary Outcomes - Insulin sensitivity Secondary Outcomes - Sleep Duration ### Location - Facility: University of Utah HPER E Buildling, Salt Lake City, Utah, 84112, United States @@
## Integrating Hypertension Management in DSD for HIV - NCT ID: NCT06366386 - Study ID: 5K43TW011963-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-30 - Lead Sponsor: Infectious Diseases Research Collaboration, Uganda ### Study Description The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are:1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care?2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care?3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda?4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda?5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda?6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda. ### Conditions - Hypertension - HIV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Screening and treatment of hypertension among PLHIV in DSD models for HIV ### Outcomes Primary Outcomes - Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) - % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) Secondary Outcomes - Mean blood pressure (both systolic and diastolic blood pressure) - Number and % of hypertensive PLHIV with suppressed Viral load - Number and % of patients retained in care - Number and % of PLHIV screened for HTN at least once in six months - Implementation costs ### Location - Facility: Infectious Diseases Research Collaborations (IDRCUganda), Kampala, Central, +256, Uganda @@
## An Evaluation on a Mental Health Art Exhibition's Impact on Reducing Stigma - NCT ID: NCT06366373 - Study ID: 531118232022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: Hunan University ### Study Description Mental health art exhibitions, as an intervention strategy integrating artistic expression and social contact, have the potential to positively impact the elimination of stigma and discrimination associated with mental health problems. This study will utilize a real-world quasi-randomized controlled trial design and a 6-month follow-up questionnaire survey to evaluate the intervention's impact on stigma/discrimination and related outcomes, such as mental health literacy. The evaluation will encompass four categories of people: those with lived experience of mental disorders, family members and friends of those with lived experience, health professionals, and the general public. Additionally, the cost-effectiveness of the art exhibition intervention will be analyzed. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - A mental health art exhibition - printed or online education materials ### Outcomes Primary Outcomes - Stigma/discrimination regarding mental disorders Secondary Outcomes - mental health literacy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immersive Virtual Reality Treatment for Unilateral Spatial Neglect - NCT ID: NCT06366360 - Study ID: Piano-Neglect - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2027-09 - Lead Sponsor: Hopitaux de Saint-Maurice ### Study Description Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided. ### Conditions - Stroke - Unilateral Spatial Neglect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Immersive Virtual Reality Intervention - Conventional rehabilitation ### Outcomes Primary Outcomes - Bells Test - Mesulam cancellation Task - Bisection Test - Copying Test - Scene description Task - Ecological scale of daily life activities - Piano bisection Task - Identifying the keys at the ends of the piano - Virtual reality Bells Test - Auditory Stimuli Localization Task in virtual reality - Ecological virtual reality bisection task - Virtual reality Baking Tray test Secondary Outcomes - Mood assessment - Situational motivation questionnaire ### Location - Facility: Hôpitaux de Saint-Maurice, Saint-Maurice, N/A, 94410, France @@
## ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab - NCT ID: NCT06366347 - Study ID: 23-695 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2029-03-01 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.The names of the study drugs involved in this study are:* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)* Letrozole (a type of aromatase inhibitor)* Pembrolizumab (a type of monoclonal antibody) ### Conditions - Endometrial Cancer - Recurrent Endometrial Cancer - TP53 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abemaciclib - Letrozole - Pembrolizumab ### Outcomes Primary Outcomes - Median Progression Free Survival (PFS) Secondary Outcomes - Grade 3-5 Adverse Events (AE) Rate - Median Overall Survival (OS) - Objective Response Rate (ORR) ### Location - Facility: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States @@
## Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation - NCT ID: NCT06366334 - Study ID: 23/02E - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-09-30 - Lead Sponsor: Children's Hospital of Eastern Ontario ### Study Description Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond. ### Conditions - Suicidal Ideation - Suicidal Ideas ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketamine Hydrochloride - Normal saline ### Outcomes Primary Outcomes - Proportion of eligible participants who complete the study protocol Secondary Outcomes - Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5) - Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) - Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9). - Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9). - Assessment of blinding - Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5) - Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) - Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) - Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5) - Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) - Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) - Admission to Hospital - Length of Stay in Hospital - ED revisits ### Location - Facility: Children's Hospital Of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada @@
## Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture - NCT ID: NCT06366321 - Study ID: 23-067 - Status: COMPLETED - Start Date: 2024-01-01 - Completion Date: 2024-02-01 - Lead Sponsor: British University In Egypt ### Study Description This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues. ### Conditions - Dental Diseases - Dental Trauma - Bone Remodeling Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - relining technique - CAD/CAM milling technique ### Outcomes Primary Outcomes - patient satisfaction using questionnaire - denture retention - denture adaptation to oral tissues Secondary Outcomes ### Location - Facility: British University in Egypt, El Shorouk, Cairo, 4914085, Egypt @@
## Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population - NCT ID: NCT06366308 - Study ID: ProBiox - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-06-01 - Lead Sponsor: West China Hospital ### Study Description Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations. ### Conditions - Prostate Cancer - Pathology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transperineal Prostate Biopsy ### Outcomes Primary Outcomes - Positive rate of prostate biopsy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial - NCT ID: NCT06366295 - Study ID: WUM.Perio.05 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-11 - Lead Sponsor: Medical University of Warsaw ### Study Description The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - subgingival mechanotherapy with perioscopy - classical subgingival mechanotherapy ### Outcomes Primary Outcomes - Probing pocket depth (PPD) - Clinical attachment level (CAL) - Bleeding on probing (BoP) - Plaque index (PI) Secondary Outcomes - Width of keratinized tissue (KTW) - Gingival thickness (GT) ### Location - Facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw, Mazowieckie, 02-097, Poland @@
## Pediatric and Caregiver Traumatic Stress Intervention (PACTS) - NCT ID: NCT06366282 - Study ID: IRB00110030 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-03 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression. ### Conditions - Traumatic Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Caregiver Counseling for Childhood Traumatic Injury - Standard of Care for Childhood Traumatic Injury ### Outcomes Primary Outcomes - Change in Kessler 6 Scores - Change in Patient Health Questionnaire - 9 (PHQ-9) Scores - Change in Child and Adolescent Trauma Screen (CATS) Scores Secondary Outcomes ### Location - Facility: Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States @@
## Acupuncture First for IC/BPS - NCT ID: NCT06366269 - Study ID: STUDY20240374 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: David Sheyn ### Study Description The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.Participants will* complete surveys about their bladder pain symptoms* make behavioral changes that have been shown to improve bladder pain symptoms* attend six (6) weekly acupuncture sessions* attend six (6) weekly physical therapy sessions after finishing acupuncture ### Conditions - Bladder Pain Syndrome - Interstitial Cystitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture - Behavioral management - Physical therapy ### Outcomes Primary Outcomes - O'Leary-Sant Interstitial Cystitis Index (OLSICI) Secondary Outcomes - Patient Global Impression of Improvement (PGI-I) - Short Form (SF-36) - Genitourinary Pain Index (GUPI) - Number of additional treatments used during study period - Number of unscheduled interactions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Simplified Ultrasound Feedback for Speech Remediation - NCT ID: NCT06366256 - Study ID: 1R01DC017301-01 - Status: RECRUITING - Start Date: 2023-10-24 - Completion Date: 2025-08 - Lead Sponsor: University of Cincinnati ### Study Description Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic. ### Conditions - Speech Sound Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Traditional ultrasound biofeedback - Simplified ultrasound biofeedback ### Outcomes Primary Outcomes - Change in percent accurate words in probe list at beginning and midpoint of study - Change in percent accurate words in probe list at beginning and end of study Secondary Outcomes ### Location - Facility: University of Cincinnati, Cincinnati, Ohio, 45220, United States @@
## A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants - NCT ID: NCT06366243 - Study ID: CVL-231-HV-1012 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2024-06-24 - Lead Sponsor: Cerevel Therapeutics, LLC ### Study Description The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Emraclidine - Esomeprazole ### Outcomes Primary Outcomes - Maximum Observed Plasma Concentration (Cmax) of Emraclidine - Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine - Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine Secondary Outcomes - Number of Participants With Treatment-emergent Adverse Events (TEAEs) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values - Number of Participants With Clinically Significant Changes in Vital Sign Parameters - Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments - Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results - Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adding Urea to the Final Dialysis Fluid - NCT ID: NCT06366230 - Study ID: 24-41450 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-06-30 - Lead Sponsor: University of California, San Francisco ### Study Description At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis. ### Conditions - Dysequilibrium Syndrome - ESRD - Hyperkalemia - Metabolic Acidosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Urea in the dialysate ### Outcomes Primary Outcomes - Disequilibrium - Serum potassium concentration - Serum CO2 concentration Secondary Outcomes - Serum BUN concentration ### Location - Facility: Zuckerberg San Francisco General Hospital, San Francisco, California, 94110, United States @@
## Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients - NCT ID: NCT06366217 - Study ID: 20-32530A - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: University of California, San Francisco ### Study Description To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops. ### Conditions - Dilation - Pupil Reaction Absent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - MydCombi Device - MydCombi Drug ### Outcomes Primary Outcomes - Percent change in Spherical equivalent - Percent Change in maximum pupil diameter - Percent Change in pupil constriction percentage Secondary Outcomes - Percent Change in Intraocular Pressure ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## Lysine Requirements During Lactation - NCT ID: NCT06366204 - Study ID: H23-03119 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of British Columbia ### Study Description The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations. ### Conditions - Lactation - Breastfeeding, Exclusive - Breastfeeding ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary Lysine Intakes ### Outcomes Primary Outcomes - Carbon 13 Oxidation Secondary Outcomes ### Location - Facility: BC Children's Hospital Research Institute, Vancouver, British Columbia, V5Z 4H4, Canada @@
## Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study - NCT ID: NCT06366191 - Study ID: 2023/CHU/08 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2025-07 - Lead Sponsor: Centre Hospitalier Universitaire de la Réunion ### Study Description A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system. ### Conditions - Psychological Trauma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - prevention algorithm - Standard care ### Outcomes Primary Outcomes - study acceptability rate Secondary Outcomes - Adherence of patient to the watch - Adherence of patient to the health watch - Patient satisfaction (quantitatif) - Patient satisfaction (qualitatif) - Strong points of the health watch - Evolution of the patient journey in experimental arm - Occurrence of post-traumatic stress disorder - Complications associated with post-traumatic stress disorder - Complications associated with post-traumatic stress disorder - Complications associated with post-traumatic stress disorder - Complications associated with post-traumatic stress disorder ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses - NCT ID: NCT06366178 - Study ID: 2024/864 - Status: NOT_YET_RECRUITING - Start Date: 2024-12-01 - Completion Date: 2026-12-01 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment.A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF. ### Conditions - Craniosynostoses ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BONFIX system ### Outcomes Primary Outcomes - Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. - Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. - Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Linking Special Care Dentistry Curriculum to Seemingly Irrelevant Comedy - NCT ID: NCT06366165 - Study ID: ACU-Med3 - Status: RECRUITING - Start Date: 2021-10-01 - Completion Date: 2024-08-30 - Lead Sponsor: Cairo University ### Study Description As Special care dentistry curriculum is very complicated and has a lot of details. Upon teaching it, the investigator will include memes and videos of movies and cartoons and will test the degree of retention of the information after years of passing the subject's exam. ### Conditions - Learning Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - seemingly irrelevant funny videos and memes in teaching ### Outcomes Primary Outcomes - degree of retention of information Secondary Outcomes ### Location - Facility: Ahram Candian University, Giza, N/A, N/A, Egypt @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06366152 - Study ID: 43N2US2105 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia - NCT ID: NCT06366139 - Study ID: Trigeminal RFT vs max/mand PRF - Status: COMPLETED - Start Date: 2023-01-11 - Completion Date: 2024-03-07 - Lead Sponsor: Diskapi Teaching and Research Hospital ### Study Description Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared. ### Conditions - Trigeminal Neuralgia - Headache Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiofrequency thermocoagulation of the trigeminal ganglion - Maxillary/Mandibular nerve pulsed radiofrequency ### Outcomes Primary Outcomes - Numerical rating scale (NRS) Secondary Outcomes - The Medication Quantification Scale III (MQS III) ### Location - Facility: Diskapi Training and Research Hospital, Ankara, N/A, N/A, Turkey @@
## Long Term Impact of Child Abuse in University Students - NCT ID: NCT06366126 - Study ID: Child Abuse - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-08-31 - Lead Sponsor: Delta University for Science and Technology ### Study Description Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified.This study aimed too evaluate the psychological and social long-term effects of different types of child abuse. ### Conditions - Child Abuse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - tailored questionnaire Secondary Outcomes ### Location - Facility: Amira Hussin Mohammed, Gamasa, N/A, 35712, Egypt @@
## Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD) - NCT ID: NCT06366113 - Study ID: 2023-A00363-42 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-07-01 - Lead Sponsor: Michaël RACODON ### Study Description Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.The program should not be improved by introducing new subjects such as circadian rhythm. ### Conditions - Respiratory Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Pulmonary rehabilitation ### Outcomes Primary Outcomes - 6-minute walk test (6MWT) Secondary Outcomes - Time limit test (Time-lim) - Sit to stand test (STT) - Single arm curl Test (SAC) - Single-leg stance test (SLT) - Hospital Anxiety and Depression Scale (HAD) - Pittsburgh Sleep Quality Index ### Location - Facility: Clinique la Mitterie, Lille, N/A, 59130, France @@
## Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction - NCT ID: NCT06366100 - Study ID: 2023I060 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-12-31 - Lead Sponsor: Universidad de Zaragoza ### Study Description The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions (Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP) to treat alcohol addiction by mental health practitioners in the Spanish National Health System. The main questions this study aims to answer are:Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments (EBPTs), level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction?What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training (DBT-SUD and UP)?In what degree the implementation outcomes (adoption, reach, appropriateness, feasibility, fidelity, sustainability) will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice?What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice?What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes?The study comprises two phases. In the first phase, mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other (DBT-SUD and UP) and will be evaluated before and after each training. In the second phase, participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation. Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design. ### Conditions - Implementation Science ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) - Unified Protocol (UP) ### Outcomes Primary Outcomes - Acceptability and Intention to Use Survey - Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM) - Normalization MeAsure Development Questionnaire (NoMAD) Secondary Outcomes - Copenhagen Burnout Inventory (CBI) - Brief Scale of Understanding Substance Abuse (SUSS) - Implementation Climate Scale (ICS) - Organizational Readiness for Implementing Change (ORIC) - Evidence-Based Practice Attitudes Scale (EBPAS) - Program sustainability assessment tool (PASAT) - Barriers to Implementation Inventory (BTI) ### Location - Facility: University of Zaragoza, Teruel, Aragón, C/ Ciudad Escolar S/N44003, Spain @@
## Sublingual Atropine Bioequivalence by Route of Administration (SABER) - NCT ID: NCT06366087 - Study ID: BP-C-24-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-24 - Lead Sponsor: Biomedical Advanced Research and Development Authority ### Study Description A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers. ### Conditions - Atropine Bioequivalence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Atropine Sulfate Ophthalmic Solution USP, 1% - Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) ### Outcomes Primary Outcomes - The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf). - The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt). Secondary Outcomes - The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F) - The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka) ### Location - Facility: Johnson County Clin-Trials (JCCT), Lenexa, Kansas, 66219, United States @@
## Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device - NCT ID: NCT06366074 - Study ID: HUM00252120 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: University of Michigan ### Study Description This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Watch-TEA group - Tethered TEA device ### Outcomes Primary Outcomes - Usability of the device for both groups day 3 - Number of adverse events related to the device noted on the safety questionnaire - Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days - Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level - Number of non-treatment TEA adverse events for both groups Secondary Outcomes ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING - NCT ID: NCT06366061 - Study ID: 2020-02868 - Status: RECRUITING - Start Date: 2022-05-14 - Completion Date: 2024-12-01 - Lead Sponsor: Eckhard Mauermann ### Study Description This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning. ### Conditions - Cardiac Functional Disturbances During Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine Secondary Outcomes - Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function? ### Location - Facility: University Hospital Basel, Basel, Basel Stadt, 4000, Switzerland @@
## A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) - NCT ID: NCT06366048 - Study ID: EHBHKY2022-K-025 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-01 - Completion Date: 2024-12-31 - Lead Sponsor: National Natural Science Foundation of China ### Study Description The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice. ### Conditions - Liver Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - the different definitions of PHLF according to 50-50 criteria and ISGLS criteria ### Outcomes Primary Outcomes - Probability of PHLF was predicted with our individual model based on RNLV. Secondary Outcomes ### Location - Facility: The Third Affiliated Hospital of Naval Medical University, Shanhai, Shanghai, 201800, China @@
## LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression - NCT ID: NCT06366035 - Study ID: NMRR ID-24-00924-HPO - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-10-01 - Lead Sponsor: National Institutes of Health, Ministry of Health Malaysia ### Study Description Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions. ### Conditions - Postpartum Depression - Maternal Behavior - mHealth Intervention - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - LoVE4MUM mobile application ### Outcomes Primary Outcomes - Postpartum Depression Secondary Outcomes - Postpartum Mental Health Literacy - Automatic Negative Frequency ### Location - Facility: Hospital Tengku Ampuan Rahimah, Klang, Selangor, 41586, Malaysia @@
## Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft - NCT ID: NCT06366022 - Study ID: Warsaw.06 - Status: RECRUITING - Start Date: 2023-05-30 - Completion Date: 2024-05-30 - Lead Sponsor: Medical University of Warsaw ### Study Description Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft. ### Conditions - Gingival Recession ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The tunnel technique for root coverage with CTG with inner side of the graft - The tunnel technique for root coverage with CTG with outer side of the graft ### Outcomes Primary Outcomes - Clinical attachment level (CAL) - Recession height (RH) - Recession width (RW) - Width of keratinized tissue (KTW) - Thickness of keratinized tissue (GT - Average recession coverage (ARC) - Complete recession coverage Secondary Outcomes - Probing pocket depth (PPD) - Root coverage esthetic score (RES) - Post surgical pain and swelling - Patient's satisfaction with treatment ### Location - Facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw, MAzowsze, 00-246, Poland @@
## Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes - NCT ID: NCT06366009 - Study ID: Warsaw Study - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-07-31 - Lead Sponsor: Przemyslaw Kunert ### Study Description The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE). ### Conditions - Epilepsy - Focal Epilepsy - Drug Resistant Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NaoX in-ear EEG system ### Outcomes Primary Outcomes - determination of the starting point of focal temporal epileptic seizures Secondary Outcomes - Identification of subgroups of epileptic patterns - Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician ### Location - Facility: Kliniki Neurochirurgii CSK UCK WUM, Warsaw, N/A, N/A, Poland @@
## Development and Validation of the Polish Geriatric Core Set. - NCT ID: NCT06365996 - Study ID: Core set geriatric ICF - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-12-15 - Lead Sponsor: University of Rzeszow ### Study Description Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people. ### Conditions - Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - ICF Geriatric core set Secondary Outcomes - Sociodemographic data of the sample - Disability - WHODAS 2.0 v 36 item ### Location - Facility: University of Rzeszow, Rzeszów, Podkarpacie, 35-959, Poland @@
## Comparison of Free Gingival Graft and Linear Incision for Connective Tissue - NCT ID: NCT06365983 - Study ID: UFRGS-Cassio - Status: RECRUITING - Start Date: 2023-04-28 - Completion Date: 2026-04-28 - Lead Sponsor: Federal University of Rio Grande do Sul ### Study Description A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.EXCLUSION CRITERIAIndividuals will not be considered eligible if they:* Present any form of immunological compromise;* Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;* Present active periodontitis, defined by presence of \>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \>4mm (Tonetti et al. 2018);* Are current or ex-smokers;* Have allergies to ibuprofen and chlorhexidine digluconate.Research Objective:PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.SECONDARY OBJECTIVECompare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes. ### Conditions - Connective Tissue - Gingiva - Gingival Recession - Humans ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Connective Tissue with Free Gingival Graft - Connective Tissue with Linear Incision ### Outcomes Primary Outcomes - Percentage of root coverage Secondary Outcomes - Recession depth ### Location - Facility: Alex Nogueira Haas, Porto Alegre, RS, 95780000, Brazil @@
## Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers - NCT ID: NCT06365970 - Study ID: HCC 23-056 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-05-31 - Lead Sponsor: Ibrahim Halil Sahin ### Study Description The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC. ### Conditions - MMR-D/MSI-H Colorectal Cancers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Niraparib - Dostarlimab ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Adverse Events Related to Treatment - Progression-free Survival (PFS) - Duration of Response (DoR) - Overall Survival (OS) ### Location - Facility: UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States @@
## Acute Effects of Exercise Combined With Ketone Ester Supplement - NCT ID: NCT06365957 - Study ID: BSERE24-APP001-FED - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Macau ### Study Description To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults. ### Conditions - Overweight and Obesity - Cognitive Change - Ketoses, Metabolic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ketone monoester supplementation - High-intensity interval exercise - Moderate-intensity continuous exercise - Placebo ### Outcomes Primary Outcomes - Maximal Oxygen Uptake - Systolic Blood Pressure - Diastolic Blood Pressure - Concentration of Blood Lipid - Concentration of Blood Glucose - Concentration of Blood Beta-Hydroxybutyrate - Concentration of Blood Lactic Acid - Concentration of Blood Insulin - Reaction Time of Stroop Task - Accuracy of Stroop Task - Reaction Time of N-back Task - Accuracy of N-back Task - Cerebral Hemoglobin Concentration Secondary Outcomes - Arousal Level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process - NCT ID: NCT06365944 - Study ID: CHUBX 2023/73 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-04-20 - Lead Sponsor: University Hospital, Bordeaux ### Study Description Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol. ### Conditions - Brain Concussion - Cerebral Concussion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire) Secondary Outcomes ### Location - Facility: Bordeaux University Hospital, Bordeaux, N/A, N/A, France @@
## Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation - NCT ID: NCT06365931 - Study ID: 160224 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-04-30 - Lead Sponsor: University of Extremadura ### Study Description INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot.OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients.METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle.The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed. ### Conditions - Stroke/Brain Attack ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Percutaneous neuromodulation - Transcutaneous neuromodulation - Placebo-percutaneous - Placebo-transcutaneous - Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) ### Outcomes Primary Outcomes - Muscle activity - Displacement of the center of pressures (CoP) - Articular amplitude - Balance - Balance - Gait - Tissue oxygen in muscle - Muscular strength - Functionality - quality of life index - Spasticity Secondary Outcomes ### Location - Facility: Mª Dolores Apolo Arenas, Badajoz, N/A, N/A, Spain @@
## Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis - NCT ID: NCT06365918 - Study ID: 2023-0836 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2030-03-22 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors. ### Conditions - Advanced Solid Tumor - Carcinomatosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - VG2025 ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding - NCT ID: NCT06365905 - Study ID: 23-011680 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-30 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions. ### Conditions - Endometrial Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) Secondary Outcomes ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis - NCT ID: NCT06365892 - Study ID: 22-36548 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-01-01 - Lead Sponsor: University of California, San Francisco ### Study Description This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years. ### Conditions - Adolescent Idiopathic Scoliosis (AIS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - open-label placebo - Treatment as usual ### Outcomes Primary Outcomes - The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery Secondary Outcomes - Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6. - Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6. - Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6. - The duration of time in days following surgery until patients establish Independence with Physical Therapy - The length of time in days following surgery until discharge from the hospital - The length of time in days following surgery until participant returns to school - Whether participants experience urinary retention following surgery. - Whether participants experience constipation measured by the number of days between surgery and first bowel movement - Whether participants experience an oxygen requirement and the duration of the requirement following surgery. ### Location - Facility: University of California, San Francisco, San Francisco, California, 94158, United States @@
## To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria - NCT ID: NCT06365879 - Study ID: CMAB007-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd ### Study Description This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria ### Conditions - Chronic Spontaneous Urticaria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CMAB007 - Xolair ### Outcomes Primary Outcomes - Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12 Secondary Outcomes - Change From Baseline of Urticaria Activity Score (UAS7) At Week 12 - Change From Baseline of Number of Hives Score (NHS7) At Week 12 - Time to ISS7 MID Response by Week 12 - Percentage of Patients With UAS7≤6 at Week 12 - Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12 - Change From Baseline of Urticaria Control Test (UCT) at Week 12 - Percentage of Patients With UCT≥12 at Week 12 - Percentage of Complete Controls (UCT=16) at Week 12 - Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12 - Percentage of Complete Responders (UAS7=0) at Week 12 - Percentage of Angioedema-free Days From Week 4 to Week 12 - Incidence of adverse events - Immunogenicity - AUC0-t - AUC0-inf - Half time - Cmax - Tmax - Clearance Rate - Apparent Volume of Distribution - Level of Total IgE and Free IgE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer. - NCT ID: NCT06365866 - Study ID: 2022-06-008B - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer. ### Conditions - Esophageal Neoplasms - Head and Neck Neoplasms - Gastrointestinal Neoplasms - Digestive System Diseases - Digestive System Neoplasms - Esophageal Diseases - Neoplasms by Site - Gastrointestinal Diseases - Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - "BRAXX" Esophageal Brachytherapy Applicator. - Add-on of intraluminal brachytherapy ### Outcomes Primary Outcomes - To estimate the local control rate at primary tumor site. Secondary Outcomes - To estimate overall response rate. - To estimate distant metastasis rate. - To estimate progression-free survival rate. - To estimate overall survival status. - To estimate toxicity analysis. - To estimate adverse event. ### Location - Facility: Taipei Veterans General Hospital, Taipei, N/A, 11217, Taiwan @@
## A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression - NCT ID: NCT06365853 - Study ID: IMGN853-0424 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2027-05-26 - Lead Sponsor: ImmunoGen, Inc. ### Study Description The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression. ### Conditions - Recurrent Ovarian Cancer - Folate Receptor-Alpha Positive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mirvetuximab Soravtansine - Lubricating Eye Drops - Prednisolone acetate ophthalmic suspension 1% eye drops - Brimonidine tartrate ophthalmic solution eye drops ### Outcomes Primary Outcomes - Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants Secondary Outcomes - Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis - Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants - Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis - National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score - Area Under the Curve (AUC) of MIRV - Maximum Serum Concentration (Cmax) of MIRV - Trough Concentration (Ctrough) of MIRV ### Location - Facility: University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP), Aurora, Colorado, 80045, United States @@
## A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor - NCT ID: NCT06365840 - Study ID: IMC-001-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-12 - Lead Sponsor: ImmuneOncia Therapeutics Inc. ### Study Description The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients. ### Conditions - TMB-H - Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IMC-001 ### Outcomes Primary Outcomes - ORR Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI) - NCT ID: NCT06365827 - Study ID: AZ293/20 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-01 - Completion Date: 2024-07-31 - Lead Sponsor: University of Giessen ### Study Description Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis. ### Conditions - Cardiac Surgery With Cardiopulmonary Bypass - Acute Mesenteric Ischemia - Acute Kidney Injury - Non-Occlusive Mesenteric Ischaemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational study ### Outcomes Primary Outcomes - Concentration of I-FABP values with/and without acute mesenteric ischemia Secondary Outcomes - Time interval to mesenteric ischemia - Overall mortality rate - Correlation of I-FABP with biomarkers of acute kidney injury - Association of mesenteric ischemia with hypercoagulable states ### Location - Facility: University Hospital Giessen, Cardiovascular surgery, Giessen, Hessen, 35392, Germany @@
## ERAS for Gastric Cancer Patients After NACT - NCT ID: NCT06365814 - Study ID: ERASforNACT - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-04-01 - Lead Sponsor: The Affiliated Hospital of Qingdao University ### Study Description Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - enhanced recovery after surgery - conventional perioperative management ### Outcomes Primary Outcomes - postoperative infectious complications Secondary Outcomes - postoperative recovery parameter - blood test result - 3-year overall survival - 3-years recurrence-free survival ### Location - Facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital, Qingdao, Shandong, 266000, China @@
## Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics - NCT ID: NCT06365801 - Study ID: 2022YFC3500401-IBS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University ### Study Description Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pain sensitivity - Thermal radiation characteristics - Microcirculation characteristics - Electrical characteristics - Biological ultra-weak luminescence Secondary Outcomes - Intestinal flora - Tryptophan metabolites - Bristol Fecal Traits Grading Scale - Severity of IBS (IBS-SSS) - IBS Quality of Life (IBS-QOL ) - TCM Constitution Survey - Gastrointestinal Symptoms Rating Scale (GSRS) - Self-Rating Anxiety Scale (SAS) - Self-Rating Depression Scale (SDS) - Pittsburgh Sleep Quality Index (PSQI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer - NCT ID: NCT06365788 - Study ID: S66466 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2027-12 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer. ### Conditions - Triple Negative Breast Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Abemaciclib - Bicalutamide ### Outcomes Primary Outcomes - Number of participants with disease control at 16 weeks Secondary Outcomes - Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 - HRQoL change from baseline as measured by EORTC QLQ-C30 - Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells. - Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate - Number of participants with disease control at 24 weeks - Number of participants with partial or complete response at 16 weeks - Duration of response - Months of progression free survival - Months of overall survival ### Location - Facility: Antwerp University Hospital, Antwerp, N/A, N/A, Belgium @@
## Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss - NCT ID: NCT06365775 - Study ID: TJ-IRB20221229 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2026-11-23 - Lead Sponsor: Dan Bing ### Study Description The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls* to find out which factor from multi-omics data relates to outcomes of SSNHL* to develop the best prognostics model based on the multi-omics data.Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model. ### Conditions - Sudden Sensorineural Hearing Loss - Hearing Loss, Sensorineural - Hearing Loss, Sudden ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pure tone audiometry (PTA) Secondary Outcomes - Speech reception thresholds - Speech discrimination scores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract - NCT ID: NCT06365762 - Study ID: CK-0103 - Status: COMPLETED - Start Date: 2006-01-01 - Completion Date: 2007-04-30 - Lead Sponsor: Livionex Inc. ### Study Description The study objectives were:* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s). ### Conditions - Age Related Cataracts ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EDTA Ophthalmic Solution 2.6% - EDTA Ophthalmic Solution 1.3% - Saline Solution (Placebo) ### Outcomes Primary Outcomes - Contrast Sensitivity (Mesopic) Responder Analysis Secondary Outcomes - Cumulative Improvement in Contrast Sensitivity (Mesopic) ### Location - Facility: St Mary's Eye Specialists, Inc., San Francisco, California, 94117, United States @@
## Genetic Feature of Congenital Hearing Loss in Chinese Population - NCT ID: NCT06365749 - Study ID: TJ-IRB20221228 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2026-11-23 - Lead Sponsor: Dan Bing ### Study Description Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:* to present the genetic characteristics of the infant with hearing loss in the Chinese population* to build up a prognostic model base on diverse data.Participants will be asked to receive audiological tests and collection of the peripheral blood sample. ### Conditions - Congenital Hearing Loss - Congenital Deafness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Whole exome sequencing data Secondary Outcomes - TEOAE-based otoacoustic emissions test outcome measure - Auditory brainstem response testing - Acoustic impedance - Audiogram ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being - NCT ID: NCT06365736 - Study ID: 240310 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2024-09-04 - Lead Sponsor: University of Twente ### Study Description The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is:Does a 2-week contemplative nature intervention improve spiritual well-being?Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality.Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes.Participants in the active control condition will walk for 30 minutes without further instruction. ### Conditions - Spiritual Well-being - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Contemplating in nature - Walking in nature ### Outcomes Primary Outcomes - Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) - Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) - Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) - Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) - Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) - Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) Secondary Outcomes ### Location - Facility: University of Twente, Enschede, Overijssel, 7522NB, Netherlands @@
## Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial - NCT ID: NCT06365723 - Study ID: SPH-2023-32410 - Status: NOT_YET_RECRUITING - Start Date: 2025-01-15 - Completion Date: 2032-06-15 - Lead Sponsor: University of Minnesota ### Study Description Approximately 92 million U.S. adults (\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD. ### Conditions - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Green Walk - Gray Walk ### Outcomes Primary Outcomes - Measure of Anxiety - Perceived stress assessment - Mood assessment Secondary Outcomes - Heart Rate variability - Salivary cortisol levels - Ambient Particulate Matter - Black Carbon levels - CMD risk - State and Trait anxiety ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture - NCT ID: NCT06365710 - Study ID: HUS/206/2022 - Status: RECRUITING - Start Date: 2022-11-24 - Completion Date: 2026-01-31 - Lead Sponsor: Töölö Hospital ### Study Description Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE). ### Conditions - Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation - Traditional physiotherapy ### Outcomes Primary Outcomes - Patient-Rated Wrist Evaluation (PRWE) Secondary Outcomes - Grip strength - Quick Disabilities of the arm, shoulder, and hand - Pain (Visual Analogue Scale) - Wrist range of motion (ROM) - Adverse events - Global improvement - Patient-rated Quality of Life (EQ-5D) - Cost-utility analysis ### Location - Facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital, Helsinki, Uusimaa, 00029, Finland @@
## Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis - NCT ID: NCT06365697 - Study ID: ZHTQ202301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd. ### Study Description The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis. ### Conditions - Carotid Artery Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ton-bridge carotid stent - WALLSTENT carotid stent ### Outcomes Primary Outcomes - Incidence of non-MAE(major adverse events) within 30 days post-procedure Secondary Outcomes - Technical success - Procedural success - Target lesion revascularization (TLR) - Ipsilateral stroke between 31 days and 1 year post-procedure - In-stent restenosis - mRS score - Device deficiency - Incidence of MAE - Incidence of Adverse events (AE) - Incidence of Serious adverse events (SAE) ### Location - Facility: The People's Hospital of Liaoning Province, Shenyang, Liaoning, N/A, China @@
## Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 - NCT ID: NCT06365684 - Study ID: 133548 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-05-01 - Lead Sponsor: Leiden University Medical Center ### Study Description Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed ### Conditions - Hyperkalemia - Diet Modification - Chronic Kidney Disease - Sodium Zirconium Cyclosilicate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Sodium zirconium cyclosilicate ### Outcomes Primary Outcomes - The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis. Secondary Outcomes - Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours) - 24 hours albuminuria - urinary potassium (mmol/l) - Plasma bicarbonate - Quality of life, using SF36 questionnaire - Effect on stool (assessed with Bristol Stool Chart) - Difference in serum potassium one week after start of study (SCZ free period) - Per protocol analysis of difference in serum potassium after six week (end of study) - Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia) - Incidence of hyperkalemia (serum potassium above 5.5 mmol/l) - Necessity for treatment of hyperkalemia - urinary sodium (mmol/l) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors - NCT ID: NCT06365671 - Study ID: ASCT-CART - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Ruijin Hospital ### Study Description Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors ### Conditions - B-NHL, Extranodal, TP53 Alterations, Bulky Mass ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel) ### Outcomes Primary Outcomes - Best Complete Response (CR) Rate in 3 months Secondary Outcomes - Objective remission rate (ORR) in 3months - Duration of Response (DOR) - Progression-Free Survival (PFS) - Overall Survival (OS) - Adverse Events rate as assessed by CTCAE version 5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective - NCT ID: NCT06365658 - Study ID: 2024/PTPiP/1 - Status: RECRUITING - Start Date: 2023-07-03 - Completion Date: 2025-12 - Lead Sponsor: Bartosz M. Radtke ### Study Description The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.The main questions it aims to answer are:1. What is the profile of memory and learning among polish adults?2. Do gender and age moderates patterns of memory and learning functioning among polish adults?3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?Researchers will compare the following groups of adults:1. general population/control group2. with neurologically recognized aphasic syndromes3. seniors (over 60 y.o.) ### Conditions - Aphasia - Development, Human - Neuropathology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Psychological assessment ### Outcomes Primary Outcomes - Memory and learning - Language - Socio-demographic data Secondary Outcomes - General mental state - Health related data - Education data ### Location - Facility: Laboratory of Psychological and Educational Tests, Gdansk, Pomerania, 80-239, Poland @@
## Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention - NCT ID: NCT06365645 - Study ID: 2138752 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Women and Infants Hospital of Rhode Island ### Study Description Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention. ### Conditions - Postpartum Depression - Postpartum Anxiety - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - M.Bapp - App-based parenting education ### Outcomes Primary Outcomes - Feasibility - Acceptability Secondary Outcomes - Edinburgh Postnatal Depression Scale - General Anxiety Disorder-7 - Perceived Stress-Scale 4 - Dyadic Adjustment Scale - UCLA Loneliness Scale - Frequency of Mothers and Babies Skills Use ### Location - Facility: Women & Infants Hospital of Rhode Island, Providence, Rhode Island, 02905, United States @@
## Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis - NCT ID: NCT06365632 - Study ID: OLTOSPAN-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-12 - Lead Sponsor: Research Institute for Physical Chemical Problems of the Belarusian State University ### Study Description The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions. ### Conditions - Abdominal Adhesions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus - antegrade appendectomy ### Outcomes Primary Outcomes - Number of patients with acute phlegmonous appendicitis cured Secondary Outcomes - absence of signs of adhesions ### Location - Facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk, Minsk, N/A, 220024, Belarus @@
## Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma - NCT ID: NCT06365619 - Study ID: HCI168525 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2029-08 - Lead Sponsor: University of Utah ### Study Description The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response. ### Conditions - Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ipilimumab - Nivolumab ### Outcomes Primary Outcomes - Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery. Secondary Outcomes - Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment. - Rate of adverse events that occur within 30 days post-surgery. - Rate of Event Free Survival (EFS). - Rate of Overall Survival (OS). - Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection. ### Location - Facility: Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States @@
## Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites - NCT ID: NCT06365606 - Study ID: CLS-015A - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-05-29 - Lead Sponsor: bioLytical Laboratories ### Study Description This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at ### Conditions - Syphilis Infection - Syphilis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - iStatis Syphilis Ab Test ### Outcomes Primary Outcomes - Sensitivity and specificity of the iStatis Syphilis Ab Test Secondary Outcomes ### Location - Facility: Epicentre Health Research, Hillcrest, KwaZulu Natal, 3650, South Africa @@
## hATTR Polyneuropathy in Russia - NCT ID: NCT06365593 - Study ID: D8450R00005 - Status: RECRUITING - Start Date: 2023-12-29 - Completion Date: 2024-05-31 - Lead Sponsor: AstraZeneca ### Study Description A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients. ### Conditions - Hereditary Transthyretin Amyloidosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Mean age at the hATTR-PN or CIAP diagnosis information will be collected - In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of women and men will be collected - In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with each race and ethnicity will be collected - to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIA, information on Proportion of patients from each federal district of the Russian Federation will be collected - in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, tha following Anthropometric characteristics will be collected: - In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with underweight will be collected - in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with negative lifestyle factors will be collected: - in order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with positive family history in close relatives will be collected - to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from the first symptoms of neuropathy to the diagnosis of PN will be collected - to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, Proportion of patients with different firstly suspected etiology of PN will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from first PN manifestation/diagnosis to the hATTR-PN or CIAP diagnosis will be collected - To describe the baseline electrophysiological and clinical characteristics of patients, Proportion of patients with chronic sensory or sensorimotor polyneuropathy and progressive chronic polyneuropathy among patients with CIAP will be calculated - To describe the baseline clinical characteristics of patients with hATTR-PN and CIAP, Proportion of patients with each result of TTR gene testing will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each clinical manifestation will be calculated: - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each PND score will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each score by each parameter of neurological examination will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by MRS will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by INCAT scale (total score, arm disability, leg disability) will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean left ventricular ejection fraction (LVEF) will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean wall thickness of the left ventricular (LV) will be collected - To describe the baseline electrophysiological characteristics of patients with hATTR-PN and CIAP, information Mean variables based on the results of electrophysiological investigation, including the following (on both extremities) will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with diagnosis of HFpEF will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean NT-proBNP level will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean estimated glomerular filtration rate (eGFR) will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean urine albumin-to-creatinine ratio (UACR) in a spot urine sample will be collected - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with a positive paraprotein blood test result will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean blood pressure (BP) (systolic and diastolic) and Mean heart rate (HR) - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each concomitant disease will be calculated - To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients underwent surgery for CTS to the moment of diagnosis will be calculated Secondary Outcomes - To arrange a score to select patients with axonal neuropathy who deserve screening for TTR mutation. ### Location - Facility: Research Site, Kazan, N/A, N/A, Russian Federation @@
## Dose Escalation Study of Kylo-0603 in Healthy Subjects - NCT ID: NCT06365580 - Study ID: Kylo-0603-I-C01 - Status: RECRUITING - Start Date: 2023-05-23 - Completion Date: 2024-06-30 - Lead Sponsor: Kylonova (Xiamen) Biopharma co., LTD. ### Study Description This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects. ### Conditions - Nonalcoholic Steatohepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kylo-0603 capsule - Placebo ### Outcomes Primary Outcomes - incidence of adverse events Secondary Outcomes - Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) - PK parameter of time of maximum observed concentration (Tmax) - PK parameter of area under the concentration time curve (AUC) ### Location - Facility: The first affiliated hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease. - NCT ID: NCT06365567 - Study ID: CE209/2023 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-03-02 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week.Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition.The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children. ### Conditions - Pediatric Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - assessment of fructose intake with questionnaires - correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis - Correlation of fructose consumption with bone metabolism, detected through QUS Secondary Outcomes - Characterization of the concentration of intestinal microorganisms - Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers) ### Location - Facility: SCDU Pediatria, AOU Ospedale Maggiore della Carità, Novara, N/A, 28100, Italy @@
## On-Premise and Remote Robotic Neurointervention - NCT ID: NCT06365554 - Study ID: 2 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Remedy Robotics, Inc. ### Study Description This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention. ### Conditions - Cerebrovascular Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Remedy Robot ### Outcomes Primary Outcomes - Procedural safety - Procedural Technical Success Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients - NCT ID: NCT06365541 - Study ID: GYLLPJ-2024006 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-31 - Lead Sponsor: The People's Hospital of Gaozhou ### Study Description Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance. ### Conditions - The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin ### Outcomes Primary Outcomes - N-terminal B-type natriuretic peptide precursor (NT-proBNP) - Left ventricular ejection fraction (LVEF) Secondary Outcomes ### Location - Facility: The People's Hospital of Gaozhou, Maoming, Guangdong, 525200, China @@
## Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes - NCT ID: NCT06365528 - Study ID: 2023-0232 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2026-07-31 - Lead Sponsor: Hospital de Clinicas de Porto Alegre ### Study Description The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days. ### Conditions - CLABSI - Central Line Associated Bloodstream Infection - Deep Vein Thrombosis - Dislodged Catheter - Occlusion - Catheter Rupture - Catheter (Other); Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Subcutaneous tunnelling - Non-tunnelling ### Outcomes Primary Outcomes - End of therapy or catheter removal free from complications Secondary Outcomes ### Location - Facility: Hospital de Clínicas de Porto Alegre, Porto Alegre, N/A, N/A, Brazil @@
## Dopamine, Reward Learning and Sex Hormones - NCT ID: NCT06365515 - Study ID: TUE010_IRTG_P5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: University Hospital Tuebingen ### Study Description Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, we aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, we are testing the effects of hormonal status on metabolic indices and its effects on mood fluctuations in a period of a month.The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. We have exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explore if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase. ### Conditions - Hormonal Changes - Menstrual Cycle ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Levodopa administration - Placebo administration ### Outcomes Primary Outcomes - Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making - Reward-related brain responses in the reward network during effort-based decision-making - Reward anticipation on a neural level - Execution of effort on a neural level Secondary Outcomes - Resting-state functional connectivity - Changes in reinforcement learning - Menstrual cycle induced changes in mood and food cravings - Changes in resting energy expenditure - Changes in metabolic hormone levels during the menstrual cycle ### Location - Facility: Department of Psychiatry & Psychotherapy, University of Tübingen, Tübingen, BW, 72076, Germany @@
## Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial) - NCT ID: NCT06365502 - Study ID: KY2023-156 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-12 - Lead Sponsor: Harbin Medical University ### Study Description The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome. ### Conditions - Acute Coronary Syndrome (ACS) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Drug-coated balloon - Guideline-directed medical treatment ### Outcomes Primary Outcomes - Target lesion failure (TLF) Secondary Outcomes - Target lesion failure (TLF) - Target lesion failure (TLF) - Target lesion failure (TLF) - Major cardiac adverse event (MACE) - Major cardiac adverse event (MACE) - Major cardiac adverse event (MACE) - Major cardiac adverse event (MACE) - All-cause death - All-cause death - All-cause death - All-cause death - Cardiac death and target lesion MI - Cardiac death and target lesion MI - Cardiac death and target lesion MI - Cardiac death and target lesion MI - Cardiac death - Cardiac death - Cardiac death - Cardiac death - Target lesion myocardial infarction - Target lesion myocardial infarction - Target lesion myocardial infarction - Target lesion myocardial infarction - Periprocedural myocardial infarction - Periprocedural myocardial infarction - Periprocedural myocardial infarction - Periprocedural myocardial infarction - Periprocedural and non-periprocedural myocardial infarction - Periprocedural and non-periprocedural myocardial infarction - Periprocedural and non-periprocedural myocardial infarction - Periprocedural and non-periprocedural myocardial infarction - Target vessel failure (TVF) - Target vessel failure (TVF) - Target vessel failure (TVF) - Target vessel failure (TVF) - Minimal lumen area after DCB treatment - Plaque burden after DCB treatment - FCT after DCB treatment - Lipid arc after DCB treatment - FCT <75 μm after DCB treatment - PB >65% after DCB treatment - PB >70% after DCB treatment - MLA <3.5 mm^2 after DCB treatment - Maximal lipid arc >180° after DCB treatment - Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc. ### Location - Facility: Affiliated Beijing Luhe Hospital of Capital Medical University, Beijin, Beijing, 101149, China @@
## Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery - NCT ID: NCT06365489 - Study ID: 113293 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-11 - Completion Date: 2024-09 - Lead Sponsor: Golestan University of Medical sciences ### Study Description Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated. ### Conditions - Vascular Access Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Early post operative WBI changes following AVF implantation - Two-week post operative WBI changes following AVF implantation - Three-month post operative WBI changes following AVF implantation Secondary Outcomes - Correlation between WBI changes following AVF implantation with age - Correlation between WBI changes following AVF implantation with sex - Correlation between WBI changes following AVF implantation with co-morbidities - Correlation between WBI changes following AVF implantation with steal syndrome ### Location - Facility: Pezhman Kharazm, MD, Gorgan, Golestan, 4917956808, Iran, Islamic Republic of @@
## FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity - NCT ID: NCT06365476 - Study ID: 202309126RIND - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04-15 - Lead Sponsor: National Taiwan University Hospital ### Study Description Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity. ### Conditions - Stroke - Spasticity, Muscle ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - focused extracorporeal shock wave therapy (ESWT) ### Outcomes Primary Outcomes - passive range of motion for the wrist and finger joints - hand grip strength - Visual Analogue Scale (VAS) - modified Ashworth scale (MAS) - modified Tardieu scale (MTS) Secondary Outcomes - Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) - Action Research Arm Test (ARAT) - Barthel index - Functional Independence Measure (FIM) - ultrasound assessment - Box and Block Test - Wolf Motor Function Test ### Location - Facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## Telerehabilitation to Improve Balance and Mobility in Patients After Stroke - NCT ID: NCT06365463 - Study ID: URIS202401 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-05-31 - Lead Sponsor: University Rehabilitation Institute, Republic of Slovenia ### Study Description Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions. ### Conditions - Hemorrhagic Stroke - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation ### Outcomes Primary Outcomes - Change in balance - Change in limits of stability - Change in weight-bearing symmetry Secondary Outcomes - Change in mobility - Change in walking speed ### Location - Facility: University Rehabilitation Institute, Republic of Slovenia, Ljubljana, N/A, 1000, Slovenia @@
## Breast and Cervical Cancer Education Program - NCT ID: NCT06365450 - Study ID: IRB00315481 - Status: COMPLETED - Start Date: 2022-09-22 - Completion Date: 2024-04-05 - Lead Sponsor: Johns Hopkins University ### Study Description The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference. ### Conditions - Cervical Cancer - Breast Cancer - Health Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Educational Intervention ### Outcomes Primary Outcomes - Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool. Secondary Outcomes - Number of participants recruited from each community partner - Number of participants who preferred virtual or in person sessions - Number of participants who were lost of follow up - Number of participants who needed help redeeming their gift codes ### Location - Facility: Johns Hopkins University School of Nursing, Baltimore, Maryland, 21205, United States @@
## A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation - NCT ID: NCT06365437 - Study ID: TCD601B101 - Status: RECRUITING - Start Date: 2021-06-06 - Completion Date: 2025-08 - Lead Sponsor: ITB-Med LLC ### Study Description The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients. ### Conditions - Kidney Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - TCD601 - Tacrolimus (TAC) - Corticosteroids (CS) - Mycophenolate Mofetil (MMF) - ATG ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. - Measure Peak Plasma Concentration (Cmax) over time. - Measure the Area under the plasma concentration versus time curve (AUC). Secondary Outcomes - Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time. - Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time. - Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation. ### Location - Facility: Innsbruck Medical University, Innsbruck, N/A, A-6020, Austria @@
## Fenofibrate in Patients With Primary Biliary Cholangitis (PBC) - NCT ID: NCT06365424 - Study ID: KY20151230-5-1 - Status: RECRUITING - Start Date: 2017-04-08 - Completion Date: 2027-04 - Lead Sponsor: Xijing Hospital of Digestive Diseases ### Study Description An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC) ### Conditions - Primary Biliary Cholangitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fenofibrate - UDCA ### Outcomes Primary Outcomes - Treatment emergent adverse events (TEAEs) - Percentage of patients with biochemical response Secondary Outcomes ### Location - Facility: Xijing Hospital, Xi'an, Shaanxi, N/A, China @@
## GEnomic Medicine in Kidney Transplantation Study - NCT ID: NCT06365411 - Study ID: GEM-KiT - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2035-01-01 - Lead Sponsor: Western Sydney Local Health District ### Study Description Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction ### Conditions - Transplant Complication - Kidney Transplant Rejection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biomarker discovery and validation - with focus on genomic biomarkers ### Outcomes Primary Outcomes - Death censored graft loss (DCGL) - Biopsy proven rejection (BPAR) Secondary Outcomes - All cause graft loss - Death - Treatment resistant rejection - Hospital admission or emergency attendance - Delayed Graft Function (DGF) - Kidney function - Albuminuria - Surrogate end-point markers - Borderline rejeciton - chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores - Recurrent disease - BK virus complications - Major cardiovascular complications - Major infectious complications - Malignancy post transplantation - Kidney biopsy transcriptomic signature - Kidney cell type composition - Proteinomic signature ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy - NCT ID: NCT06365398 - Study ID: SELECT - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2022-01-01 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients. ### Conditions - Cerebral Angiography - Heparinization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Heparin - Heparin Sodium Injection - No heparinization ### Outcomes Primary Outcomes - postoperative cerebral infarction Secondary Outcomes - Numerical Rating Scale (NRS) for back pain - the incidence of paralysis of surgical limb - the incidence of pain of surgical limb - the incidence of postoperative urethral catheterization ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, N/A, China @@
## Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes - NCT ID: NCT06365385 - Study ID: FOODSEQ-MARS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Universidade do Porto ### Study Description Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021).However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017).Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state. ### Conditions - Healthy - Nutrition, Healthy - Postprandial Hyperglycemia - Hunger - Craving ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Carbohydrate-last meal pattern - Carbohydrate-first meal pattern ### Outcomes Primary Outcomes - Postprandial blood glucose concentrations Secondary Outcomes - Postprandial subjective appetite ratings - Prospective ad libitum energy intake - Prospective ad libitum nutritional intake - Postprandial serum insulin concentrations - Postprandial plasma total GLP-1 concentrations - Postprandial plasma total GIP concentrations - Postprandial serum total ghrelin concentrations - Postprandial plasma total PYY concentrations - Postprandial serum triglyceride concentrations - Postprandial serum NEFA concentrations ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Circulating MrgD in Pulmonary Hypertension - NCT ID: NCT06365372 - Study ID: MrgD and PAH - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-01 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension. ### Conditions - Pulmonary Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Western blot ### Outcomes Primary Outcomes - Circulating MrgD level Secondary Outcomes ### Location - Facility: Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China @@

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