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## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06382272 - Study ID: IRB23-2027 - 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 @@
## The Acute Effect of Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes - NCT ID: NCT06382259 - Study ID: H24-Acute-Movement-Breaks - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-07-15 - Lead Sponsor: University of British Columbia ### Study Description To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Movement breaks ### Outcomes Primary Outcomes - Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring Secondary Outcomes - Time in range determined using continuous glucose monitoring - Time above range determined using continuous glucose monitoring - Time below range determined using continuous glucose monitoring - Glycemic variability determined using continuous glucose monitoring - Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Acute Effect of "Exercise Snacks" on Glycemic Responses in Individuals With Type 2 Diabetes - NCT ID: NCT06382246 - Study ID: H24-Acute-ExSnacks - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-07-15 - Lead Sponsor: University of British Columbia ### Study Description To conduct a randomized crossover trial to determine the acute impact of exercise snacks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Exercise snacks ### Outcomes Primary Outcomes - Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring Secondary Outcomes - Time in range determined using continuous glucose monitoring - Time above range determined using continuous glucose monitoring - Time below range determined using continuous glucose monitoring - Glycemic variability determined using continuous glucose monitoring - Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The PRO-FUTURE Project - NCT ID: NCT06382233 - Study ID: PRO-FUTURE project - Status: RECRUITING - Start Date: 2024-01-30 - Completion Date: 2028-01-30 - Lead Sponsor: University of Campania "Luigi Vanvitelli" ### Study Description The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are:* Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies?* Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis? ### Conditions - Ureteropelvic Junction Obstruction - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Identification of Diagnostic Biomarkers ### Outcomes Primary Outcomes - Urine Biomarkers - Blood Biomarkers Secondary Outcomes ### Location - Facility: Univeristà degli Studi della Campania Luigi Vanvitelli, Naples, Campania, 80138, Italy @@
## Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics - NCT ID: NCT06382220 - Study ID: R550 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2024-08-15 - Lead Sponsor: Fayoum University Hospital ### Study Description Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications .Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade.Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration,The aim of this studyTo compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people. ### Conditions - Recruitment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bupivacain ### Outcomes Primary Outcomes - The rate of occurrence of hypotension Secondary Outcomes ### Location - Facility: Fayoum University hospital, Fayoum, Faiyum Governorate, 63514, Egypt @@
## Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs - NCT ID: NCT06382207 - Study ID: HM20029298 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Virginia Commonwealth University ### Study Description When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. ### Conditions - Tachyarrhythmia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Eko Duo electronic stethoscope - CORE 500 electronic stethoscope ### Outcomes Primary Outcomes - Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 - Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500 - Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500 - Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only Secondary Outcomes ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Decision Making Tool for Firearm Storage - NCT ID: NCT06382194 - Study ID: STUDY00014522 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-31 - Lead Sponsor: University of Washington ### Study Description This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage. ### Conditions - Dementia, Mild - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Decision aid ### Outcomes Primary Outcomes - Firearm storage (adapted from the National Firearm Survey) Secondary Outcomes - Low-Literacy Decisional Conflict Scale - Knowledge Questionnaire - Feasibility of intervention delivery - Acceptability of Intervention Measure ### Location - Facility: University of Washington, Seattle, Washington, 98104, United States @@
## A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness - NCT ID: NCT06382181 - Study ID: 2023- ENFPOD-2621979 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-07-31 - Lead Sponsor: University of Valencia ### Study Description The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise). ### Conditions - Loneliness - Mental Health Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Music therapy for community-dwelling individuals with unwanted loneliness - Health education for community-dwelling individuals with unwanted loneliness - Physical exercise for community-dwelling individuals with unwanted loneliness ### Outcomes Primary Outcomes - Score on the Jong Gierveld Loneliness Scale Secondary Outcomes - Score on Goldberg Anxiety and Depression Scale ### Location - Facility: University of Valencia, Valencia, N/A, 46010, Spain @@
## Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia - NCT ID: NCT06382168 - Study ID: D19-11186 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2025-06-30 - Lead Sponsor: Delta-Fly Pharma, Inc. ### Study Description This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants. ### Conditions - Leukemia, Myeloid, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DFP-10917 - Venetoclax ### Outcomes Primary Outcomes - Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. - Number of patients with treatment-related adverse events assessed by CTCAE v5.0. - Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period). Secondary Outcomes - The proportion of patients who achieve complete remission. - The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery. - The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state. - Overall survival. - Progression-free survival. - Maximum concentration of DFP-10917. - Area under the curve of DFP-10917. ### Location - Facility: UCI Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States @@
## A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature - NCT ID: NCT06382155 - Study ID: 111-210 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2036-12 - Lead Sponsor: BioMarin Pharmaceutical ### Study Description The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS). ### Conditions - Idiopathic Short Stature ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vosoritide Injection - Human Growth Hormone - Placebo ### Outcomes Primary Outcomes - Change from baseline in Annualized Growth Velocity (AGV) - Change from baseline in height - Change from baseline in height Z-score Secondary Outcomes - Incidence of treatment-emergent adverse events - Change from baseline in AGV Z-score (average stature reference) - Change from baseline in height - Change from baseline in height Z score - Change from baseline at prespecified timepoints in urine cyclic guanine monophosphate (cGMP) - Change from baseline at pre-specified timepoints in serum collagen X marker (CXM) - Change from baseline in bone age minus chronological age at pre-specified timepoints - Change from baseline in total body (less head) bone mineral density (BMD) Z-score - Change from baseline in lumbar spine BMD Z-score - Change from baseline in total body (less head) bone mineral content (BMC) - Change from baseline in lumbar spine BMC - Maximum concentration (Cmax) of vosoritide in plasma - Area under the plasma vosoritide concentration time-curve from time 0 to infinity (AUC0-∞) - Area under the plasma vosoritide concentration time-curve from time 0 to the last measurable concentration (AUC0-t) - Elimination half-life of vosoritide (t½) - Apparent clearance of vosoritide - Apparent volume of distribution of vosoritide based upon the terminal phase (Vz/F) - Time vosoritide is present at maximum concentration (Tmax) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer - NCT ID: NCT06382142 - Study ID: BL-B01D1-307 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure. ### Conditions - Triple-Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-B01D1 - Eribulin - Vinorelbine - Gemcitabine - Capecitabine ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Anti-drug antibody (ADA) ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, N/A, China @@
## A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer - NCT ID: NCT06382129 - Study ID: BL-B01D1-302 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-B01D1 - Docetaxel ### Outcomes Primary Outcomes - Overall survival (OS) - Progression-free survival (PFS) Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Anti-drug antibody (ADA) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, N/A, China @@
## A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer - NCT ID: NCT06382116 - Study ID: BL-B01D1-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-B01D1 - Pemetrexed+Cisplatin or Carboplatin ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Anti-drug antibody (ADA) ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, N/A, China @@
## Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy - NCT ID: NCT06382103 - Study ID: B2024-108R - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-05-20 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ctDNA monitoring - Plasma proteomic analysis ### Outcomes Primary Outcomes - Correlation between ctDNA level and recurrence-free survival (RFS) - Correlation between specific plasma protein expression level and recurrence-free survival (RFS) Secondary Outcomes - Correlation between tumor mutation numbers and recurrence-free survival (RFS) ### Location - Facility: 180 Fenglin Road, Shanghai, N/A, 200032, China @@
## Premenstrual Syndrome and Laughter Yoga - NCT ID: NCT06382090 - Study ID: PamukkaleU-SBE-BB-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2025-05-24 - Lead Sponsor: Pamukkale University ### Study Description In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined. ### Conditions - Premenstrual Syndrome - Laughter ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Laughter yoga ### Outcomes Primary Outcomes - Premenstrual Symptom Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chronic Post Surgical Pain-Cardiac - NCT ID: NCT06382077 - Study ID: CPSP5502 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-10-25 - Lead Sponsor: Ondokuz Mayıs University ### Study Description The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors. ### Conditions - Chronic Post-surgical Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The incidence of chronic postsurgical pain Secondary Outcomes - Postoperative opioid consumption in the first 24 hours - Postoperative pain scores - The incidences of postoperative nausea and vomiting - The number of patients with side effects and complications - Time to extubation - Length of stay in the intensive care unit - Length of stay in the hospital - Chronic pain status at 3 and 6 months - Psychological assessment - Quality of life assessment - Postoperative complications at 3 and 6 months ### Location - Facility: Ondokuz Mayis University, Samsun, Atakum, 55139, Turkey @@
## Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers - NCT ID: NCT06382064 - Study ID: 2024H0089 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2025-05 - Lead Sponsor: Ohio State University ### Study Description This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biweekly replacement contact lenses - One week replacement contact lenses ### Outcomes Primary Outcomes - Subjective assessment of lens wear experience Secondary Outcomes ### Location - Facility: The Ohio State University College of Optometry, Columbus, Ohio, 43210, United States @@
## Modifying PEST for Psoriatic Arthritis Screening - NCT ID: NCT06382051 - Study ID: CAIN457ACA06 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-28 - Completion Date: 2025-04-30 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status. ### Conditions - Plaque Psoriasis - Psoriatic Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - PEST Screening group ### Outcomes Primary Outcomes - Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs Secondary Outcomes - Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist - Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist - Proportion of patients with a false positive score between each group - Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests - Patient acceptability/user experience of the PEST+2 questionnaire - Administration of dermatologist quantitative surveys - Qualitative interview with selected dermatologists - Intervention Appropriateness Measure (IAM) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism - NCT ID: NCT06382038 - Study ID: HZKY-PJ-2024-19 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-31 - Lead Sponsor: Navy General Hospital, Beijing ### Study Description Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE. ### Conditions - Venous Thromboembolism - Pulmonary Thromboembolisms - Clinical Decision Support Systems - Digital Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - mobile venous thromboembolism application (mVTEA) ### Outcomes Primary Outcomes - VTE-related composite event Secondary Outcomes - Patient satisfaction with anticoagulant treatment - Generic quality of life - Recurrent VTE - Chronic thromboembolic pulmonary hypertension (CTEPH) - Major bleeding - VTE-related hospitalization - Death ### Location - Facility: Sixth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, 100048, China @@
## Preoperative Information With Storybook for Pediatric Anesthesia - NCT ID: NCT06382025 - Study ID: Alkinstorybook - Status: COMPLETED - Start Date: 2018-03-09 - Completion Date: 2020-05-29 - Lead Sponsor: Trakya University ### Study Description Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period. ### Conditions - Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - showing cartoons -storybook - showing cartoons - standard ### Outcomes Primary Outcomes - preoperative anxiety scale - State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents - Children's Hospital of Eastern Ontario Pain (CHEOP) Scale - Pediatric Anesthesia Emergence Delirium (PAED) scale Secondary Outcomes ### Location - Facility: Trakya University, Edirne, Edi̇rne, 22030, Turkey @@
## Antiemetic Fosaprepitant To Remedy Nausea and Vomiting - NCT ID: NCT06382012 - Study ID: 2024-15703 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: Montefiore Medical Center ### Study Description The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration. ### Conditions - Nausea and Vomiting - Nausea - Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fosaprepitant 150 mg - Ondansetron 4 mg ### Outcomes Primary Outcomes - Sustained Relief from NV Secondary Outcomes - Severity of Nausea - Need for rescue antiemetic medication - Medication Preference - Functional disability - Vomiting - Hospitalization - Fluid Treatment - Mean Fluid Volume - Length of Stay - QTc Interval (QT interval corrected for heart rate) - Revisit Rate ### Location - Facility: Montefiore Medical Center (Montefiore and Weiler EDs), Bronx, New York, 10467, United States @@
## Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool - NCT ID: NCT06381999 - Study ID: M602011083 - Status: COMPLETED - Start Date: 2023-10-27 - Completion Date: 2024-02-26 - Lead Sponsor: Merz Therapeutics GmbH ### Study Description The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool. ### Conditions - Post-stroke Spasticity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral Secondary Outcomes - Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral ### Location - Facility: Gailtal-Klinik, Hermagor, N/A, 9620, Austria @@
## Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients - NCT ID: NCT06381986 - Study ID: SHJ002-SJP2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-02 - Lead Sponsor: Sunhawk Vision Biotech, Inc. ### Study Description The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. ### Conditions - Corneal Erosion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SHJ002 - Vehicle ### Outcomes Primary Outcomes - To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score Secondary Outcomes - To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score - To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) - To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) ### Location - Facility: Kaohsiung Medical Chung-Ho Memorial Hospital, Kaohsiung, N/A, 807, Taiwan @@
## Ventilation Distribution in COPD Patients During Breathing Exercises - NCT ID: NCT06381973 - Study ID: ELTGOL - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-01 - Lead Sponsor: William Poncin, PT, PhD ### Study Description ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution. ### Conditions - Chronic Obstructive Pulmonary Disease - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - ELTGOL_Physio - ELTGOL_Auto - PEP - 1L-Tidal-Breathing - Spontaneous Breathing ### Outcomes Primary Outcomes - Impedance variation using Electrical Impedance Tomography Secondary Outcomes ### Location - Facility: Cliniques universitaires Saint-Luc, Brussels, Brussels Capital, 1200, Belgium @@
## Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe - NCT ID: NCT06381960 - Study ID: 2022LJ014 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Jianhui Tian ### Study Description To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fuzheng Quxie Recipe ### Outcomes Primary Outcomes - Disease-free survival, DFS Secondary Outcomes - Overall survival,OS - Minimal residual disease, MRD - Circulating Tumour Cell Assay - Chinese Medicine Symptom Score - Quality of life assessment - Immunological indicators - Tumour marker - Peripheral blood systemic immunoinflammatory index ### Location - Facility: Shanghai Chest Hospital, Changning, Shanghai, N/A, China @@
## Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients - NCT ID: NCT06381947 - Study ID: 19092023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: University of Salerno ### Study Description Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels.The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients. ### Conditions - Dyslipidemias - Statin Adverse Reaction - Cardiovascular Diseases - Lipid Metabolism Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe - Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe ### Outcomes Primary Outcomes - Mean percentage change in LDL-C after 12 weeks of treatment Secondary Outcomes - Mean absolute change from baseline to week 12 in low-density lipoprotein cholesterol - Percentage of patients reaching the recommended LDL-C target - Changes in plasmatic levels of total cholesterol after 12 weeks of treatment - Changes in plasmatic levels of HDL cholesterol after 12 weeks of treatment - Changes in plasmatic levels of non-HDL cholesterol after 12 weeks of treatment - Changes in plasmatic levels of fasting glucose after 12 weeks of treatment - Changes in plasmatic levels of glycated haemoglobin after 12 weeks of treatment - Changes in plasmatic levels of fasting insulinemia after 12 weeks of treatment - Changes in plasmatic levels of HOMA index after 12 weeks of treatment - Changes in plasmatic levels of hs-CRP after 12 weeks of treatment - Changes in plasmatic levels of lipoprotein(a) after 12 weeks of treatment - Changes in plasmatic levels of apolipoprotein B after 12 weeks of treatment - Changes in PCSK9 serum levels before starting the treatment and after 12 weeks of treatment - Number of participants with abnormal uric acid level, abnormal AST/ALT level, ALT or AST >3x ULN, and/or unexplained creatine kinase (CK) >3x ULN - The number and type of adverse events - MACE at 12 and 28 weeks - Rehospitalization at 12 and 28 weeks - Death at 12 and 28 weeks ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics - NCT ID: NCT06381934 - Study ID: 2024-00335; kt23ChristCrain4 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-04 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments. ### Conditions - Thiazide Associated Hyponatremia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standard Care - aSID/ChU Guided Therapy ### Outcomes Primary Outcomes - Serum Sodium Level Secondary Outcomes - Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels - Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels - Diagnostic performance analyses of: aSID and ChU - Diagnostic performance analyses of: aSID measured in blood gas analysis - Diagnostic performance analyses of: clinical volume status assessment - Diagnostic performance analyses of: not-invasive instrumental volume status assessment - Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain - NCT ID: NCT06381921 - Study ID: B2023-0046 - Status: NOT_YET_RECRUITING - Start Date: 2025-05-01 - Completion Date: 2029-02-28 - Lead Sponsor: University of Connecticut ### Study Description The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial. ### Conditions - Abdominal Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - IBS-PPSM intervention ### Outcomes Primary Outcomes - Pain intensity and interference - IBS-related symptoms - Electrodermal activity (EDA) - Electrocardiogram (ECG) - Electromyogram (EMG) - Objective integrated multimodal electrophysiological index Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity - NCT ID: NCT06381908 - Study ID: 1-10-72-19-24 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-15 - Lead Sponsor: University of Aarhus ### Study Description The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Calorie-restriction with low carbohydrate - Calorie-restriction with moderate carbohydrate ### Outcomes Primary Outcomes - Time to exhaustion - Sprint performance - Exercise tolerance - Muscle glycogen levels Secondary Outcomes - Physical activity level - Maximal fat oxidation capacity - Muscle metabolic enzyme activity - Blood lipid profile - Continuous glucose levels - Fasting blood glucose and insulin - Long-term glycemic control (HbAc1) ### Location - Facility: Section for Sport Science, Department of Public Health, Aarhus University, Aarhus C, N/A, 8000, Denmark @@
## The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer - NCT ID: NCT06381895 - Study ID: SYSKY-2023-467-01 - Status: COMPLETED - Start Date: 2023-05-30 - Completion Date: 2024-02-20 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated. ### Conditions - Bladder Cancer - Radiomics - Immunotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Tumour-infiltrating lymphocytes (TIL) Secondary Outcomes - overall survival - cancer-specific survival ### Location - Facility: Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, N/A, China @@
## The Role of the Human Microbiome in Patients After Pancreatic Resection. - NCT ID: NCT06381882 - Study ID: MiPac - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-01 - Lead Sponsor: St. Antonius Hospital ### Study Description The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients. ### Conditions - Pancreas Cancer - Pancreas Neoplasm - Pancreas Adenocarcinoma - Periampullary Cancer - Periampullary Carcinoma - Microbial Colonization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pancreatic resection ### Outcomes Primary Outcomes - Risk stratification postoperative complications Secondary Outcomes - Long time oncological outcomes - site of recurrence - Long time oncological outcomes - disease free survival - Long time oncological outcomes - overall survival - Complications neoadjuvant chemotherapy - Complications adjuvant chemotherapy - Response to neoadjuvant chemotherapy - Complications bile duct drainage - Postoperative endocrine insufficiency - Postoperative exocrine insufficiency ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioavailability of Pea Protein in Young and Old Volunteers - NCT ID: NCT06381869 - Study ID: CRNHA 2018-2 - Status: COMPLETED - Start Date: 2019-01-10 - Completion Date: 2019-06-13 - Lead Sponsor: Roquette Freres ### Study Description The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal. ### Conditions - Healthy Male Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Pea protein (NUTRALYS ® S85 plus) in water - Pea protein (NUTRALYS ® S85 plus) within meal - Whey protein in water - Whey protein within meal ### Outcomes Primary Outcomes - Leucine blood concentration Secondary Outcomes - Essential amino acids blood concentration (µmol/L) - Non essential amino acid blood concentration (µmol/L) - Blood glucose concentration (g/L) - Blood insulin concentration (μIU/ml) - Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l) - Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml) ### Location - Facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne, Clermont-Ferrand, N/A, 63009, France @@
## Improving Participation of Autistic Children and Adolescents in the Habilitation Process - NCT ID: NCT06381856 - Study ID: EPM_2024-00227-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-12 - Lead Sponsor: Region Örebro County ### Study Description This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre. ### Conditions - Autism Spectrum Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The child's involvement Secondary Outcomes - The Mental Health Continuum - Short Form - The "Your child's strengths, abilities and special needs"-questionnaire. - The collaboration with the neuropsychiatric team questionnaire - Cantril ladder ### Location - Facility: University Health Care Research Center, Örebro, N/A, 70182, Sweden @@
## A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster - NCT ID: NCT06381843 - Study ID: WSKCT004 - Status: COMPLETED - Start Date: 2022-08-02 - Completion Date: 2023-12-30 - Lead Sponsor: WestVac Biopharma Co., Ltd. ### Study Description A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated. ### Conditions - COVID-19 - SARS-CoV-2 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Recombinant COVID-19 Vaccine (Sf9 Cell) - COVID-19 Vaccine (Vero Cell), Inactivated ### Outcomes Primary Outcomes - Incidence of adverse drug reactions (ADRs) - Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain - Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant Secondary Outcomes - Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain - Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant - GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain - GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant - GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD ### Location - Facility: West China Hospital of Sichuan University, Chengdu, Sichuan, N/A, China @@
## Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma - NCT ID: NCT06381830 - Study ID: ASCT+CART - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-01-01 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma. ### Conditions - Lymphoma, B-Cell - Autologous Stem Cell Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Apheresis - Autologous Stem Cell Transplantation - CAR-T Cell Therapy ### Outcomes Primary Outcomes - Overall Response Rate (ORR) - Progression-free Survival（PFS） Secondary Outcomes - Duration of Response(DOR) - Complete Response Rate - Overall Survival（OS） - Adverse events profile ### Location - Facility: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China @@
## Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients - NCT ID: NCT06381817 - Study ID: 2024112 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03-31 - Lead Sponsor: The First Affiliated Hospital of Soochow University ### Study Description The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion. ### Conditions - Acute T Cell Lymphoblastic Leukemia - Haploidentical Hematopoietic Stem Cell Transplantation - Cord Blood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Haplo-cord HCT - Haplo-HCT ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall survival - Cumulative incidence of relapse - Non-relapse mortality - Adverse events ### Location - Facility: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China @@
## Effect of Shotblocker and Palm Stimulator - NCT ID: NCT06381804 - Study ID: 24YL9001 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2024-05 - Lead Sponsor: Necmettin Erbakan University ### Study Description This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - shotblocker - palm stimulator ### Outcomes Primary Outcomes - Visual analog scale (VAS) pain Scale score Secondary Outcomes ### Location - Facility: Necmettin Erbakan University, Meram, N/A, N/A, Turkey @@
## CBD for Pain Following Orthopedic Shoulder Surgery - NCT ID: NCT06381791 - Study ID: PRO00036811 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-30 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.Participants will:* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.* Complete two short surveys. Once before surgery and once after.* Have bloodwork tested after surgery ### Conditions - Shoulder Osteoarthritis - Rotator Cuff Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Epidiolex - Placebo oral solution ### Outcomes Primary Outcomes - Primary - Pain Journal Secondary Outcomes - Survey Data - Pain Disability Index (PDI) - Pain, Enjoyment, General Activity (PEG) Scale - Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety - Pittsburgh Sleep Quality Index (PSQI) ### Location - Facility: Houston Methodist Hospital, Houston, Texas, 77030, United States @@
## Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis - NCT ID: NCT06381778 - Study ID: 112006-E - Status: RECRUITING - Start Date: 2023-02-06 - Completion Date: 2027-12-01 - Lead Sponsor: Far Eastern Memorial Hospital ### Study Description Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan. ### Conditions - Hypertrophic Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Death Secondary Outcomes - CV death ### Location - Facility: Far Eastern Memorial Hospital, New Taipei City, N/A, 220, Taiwan @@
## Serratus Plane Block and Pectointercostal Block - NCT ID: NCT06381765 - Study ID: Serratus-Pectointercostal - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-01 - Lead Sponsor: Cukurova University ### Study Description ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Serratus plane bock and pectointercostal block ### Outcomes Primary Outcomes - postoperative morphine consumption - postoperative visual analog scale scores Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement - NCT ID: NCT06381752 - Study ID: CPMvsPT - Status: COMPLETED - Start Date: 2019-06-25 - Completion Date: 2020-03-31 - Lead Sponsor: Johannes Gutenberg University Mainz ### Study Description Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes. ### Conditions - Total Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Continuous passive motion - standard rehabilitation ### Outcomes Primary Outcomes - Staffelstein Score Secondary Outcomes - Oxford Knee Score (OKS) - Range of motion (ROM) - Visual Analogue Scale (VAS) - Return to work ### Location - Facility: Universitaetsmedizin der JGU Mainz, Mainz, Rheinland-Pfalz, 55131, Germany @@
## A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol - NCT ID: NCT06381739 - Study ID: M011 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-07 - Lead Sponsor: McMaster University ### Study Description The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine).To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs.During follow-up participants will:* visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination* report their symptoms for 24 weeks after getting the vaccine.In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy). ### Conditions - COVID-19 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - ChAd-triCoV/Mac - Control ### Outcomes Primary Outcomes - Antigen specific T cell responses in blood. - Antigen specific T cell responses in bronchoalveolar lavage (BAL). - Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine. Secondary Outcomes - Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR) - CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood. - Neutralizing and total antibody levels in BAL and blood - Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely. - Tissue-resident memory surface marker expression airway T cells ### Location - Facility: Health Sciences Centre, Hamilton, Ontario, L8S 4K1, Canada @@
## Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life - NCT ID: NCT06381726 - Study ID: Progetto AIRC IG-2022 ID 27184 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2028-02-28 - Lead Sponsor: University of Milan ### Study Description Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR.Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity.Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.Expected Results1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.2. Identify demographic, clinical and imaging variables associated with functional reorganization.3. Describe the gain induced by up-front treatment.4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment.Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history. ### Conditions - Glioma - Glioma, Malignant ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Resting State Functional Magnetic Resonance Imaging (rs-fMRI) - Up-front Motor Rehabilitation - Up-front Chemotherapy ### Outcomes Primary Outcomes - Muscle power - Motor praxia Secondary Outcomes - Comprehensive neuropsychological assessment ### Location - Facility: IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Lombardy, 20157, Italy @@
## Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate - NCT ID: NCT06381713 - Study ID: ONZ-2024-0158 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-12 - Lead Sponsor: University Ghent ### Study Description Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders. ### Conditions - Cleft Palate Children - Speech Therapy - Speech Disorders in Children - Cleft Lip and Palate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High intensive combined phonetic-phonological intervention - Low intensive combined phonetic-phonological intervention ### Outcomes Primary Outcomes - Consonant proficiency - Incremental cost-utility ratio - Incremental cost-effectiveness ratio Secondary Outcomes - Intelligibility in Context - Health-related quality of life - Speech Function - Speech Distress - Communication attitudes of children aged 4 and 5 years - Communication attitudes of children aged 6 years and older ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: - NCT ID: NCT06381700 - Study ID: DF CO2405/0014 (P) - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: University of Malaya ### Study Description The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?3. Is the MySmile app easy to use by secondary school children?4. Is the MySmile app acceptable to use from the perspective of secondary school children?Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours. ### Conditions - Oral Disease - Gingival Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MySmile app - Control ### Outcomes Primary Outcomes - The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972 - The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963 Secondary Outcomes - The mean increment of oral health knowledge, attitude and practice using validated questionnaires. ### Location - Facility: Muhammad Hamidie bin Saari, Kuala Lumpur, Wilayah Persukutuan Kuala Lumpur, 50480, Malaysia @@
## A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol) - NCT ID: NCT06381687 - Study ID: 2023-3118978 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-07-31 - Lead Sponsor: University of Valencia ### Study Description The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education. ### Conditions - Fundamental Motor Skills - Physical Activity - Music Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - A multi-component, multi-level programme (MoviMusi) ### Outcomes Primary Outcomes - Physical activity - Sleep time - Motor skills - Musical skills - Sedentary time Secondary Outcomes - For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities. - For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play. - For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution. - For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program. - For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children. - For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home. - For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm - For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment. - For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children. ### Location - Facility: University of Valencia, Valencia, Comunidad Valenciana, 46021, Spain @@
## Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation - NCT ID: NCT06381674 - Study ID: OHSU: 25890 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2028-09-30 - Lead Sponsor: Oregon Health and Science University ### Study Description Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy. ### Conditions - Mild Traumatic Brain Injury, Concussion - Rehabilitation - Balance Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback - Vestibular therapy for mTBI ### Outcomes Primary Outcomes - Patient Global Impression of Change (PGIC) Secondary Outcomes - Concussion Clinical Profiles Screening (CP Screening) - Dizziness Handicap Index (DHI) - Quality of Life After Brain Injury (QOLIBRI) - The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a - Hospital Anxiety and Depression Scale (HADS) - Headache Impact Test (HIT-6) - Insomnia Severity Index (ISI) - Neck Disability Index (NDI) - Convergence Insufficiency Symptom Survey (CISS) - Vertigo Symptom Scale (VSS) - Concussion Symptom Subtypes Inventory (CSSI) - Automated Neuropsychological Assessment Metric (ANAM) - Dynamic Visual Acuity ( DVA-Clinical) - Ocular Motor Function Tests - Video Head Impulse Test (vHIT) - Functional Gait Assessment (FGA) - Complex Turning Course (CTC) - Modified Balance Error Scoring System (mBESS) - Modified Clinical Test for Sensory Integration on Balance (mCTSIB) - Instrumented One Minute Walk (Single and Dual Task) - Hybrid Assessment of Mobility (HAM-4) - Tandem Gait (Single and Dual Task) - Vestibular Ocular Motor Screening (VOMS) - Central Sensorimotor Integration Testing (CSMI) ### Location - Facility: Oregon Health & Science University, Portland, Oregon, 97239-3098, United States @@
## Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial - NCT ID: NCT06381661 - Study ID: APHP240385 - Status: NOT_YET_RECRUITING - Start Date: 2026-04-01 - Completion Date: 2032-04-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context. ### Conditions - Sepsis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tocilizumab - Baricitinib - Anakinra - Hydrocortisone - Hydrocortisone and fludrocortisone - Heparin - Low molecular weight heparin - Recombinant humanThrombomodulin( rhTM) - Sivelestat - Fresh frozen plasma - Usual care ### Outcomes Primary Outcomes - All-cause mortality - Number of patients with persistent life-supportive therapies Secondary Outcomes - Composite of the two primary outcomes - Overall Survival - Overall Survival - Overall Survival - Number of hospital free days - Number of hospital free days - Time to recover walking - Time to resume previous social and professional activities - Quality of life score for adults assessed by SF-36 - Quality of life score for adults assessed by EQ-5D-5L - Quality of life score for children assessed by FFS - Quality of life score for adults assessed by SF-36 - Quality of life score for adults assessed by EQ-5D-5L - Quality of life score for children assessed by FFS - Quality of life score for adults assessed by SF-36 - Quality of life score for adults assessed by EQ-5D-5L - Quality of life score for children assessed by FFS - Number of adverse events - Incidence of new sepsis episodes - Incidence of new sepsis episodes - Incidence of new sepsis episodes - Incidence of new unscheduled hospitalizations - Incidence of new unscheduled hospitalizations - Incidence of new unscheduled hospitalizations - Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC) - NCT ID: NCT06381648 - Study ID: 23228/LyMIC - Status: RECRUITING - Start Date: 2023-04-15 - Completion Date: 2026-06-18 - Lead Sponsor: City of Hope Medical Center ### Study Description Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients. ### Conditions - Cholangiocarcinoma - Cholangiocarcinoma, Intrahepatic - Cholangiocarcinoma Resectable - Cholangiocarcinoma; Liver ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91016, United States @@
## Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis - NCT ID: NCT06381635 - Study ID: FD-BUE-REC: IRB000124920 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-01 - Lead Sponsor: Ain Shams University ### Study Description The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients.The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis?2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy. ### Conditions - Radiation Mucositis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Manuka honey mixed with aloe vera gel ### Outcomes Primary Outcomes - Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis Secondary Outcomes - the level of salivary transforming growth factor beta 1 - the level of salivary Epidermal Growth factor (EGF) ### Location - Facility: ain shams University, Cairo, N/A, 11565, Egypt @@
## Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block - NCT ID: NCT06381622 - Study ID: CTA no: 2023-510028-63-00 - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2024-09-03 - Lead Sponsor: Nordsjaellands Hospital ### Study Description The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery. ### Conditions - Nerve Block - Anesthesia, Local - Forearm Fracture - Surgery - Brachial Plexus Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropivacaine 0.5% Injectable Solution - Lidocaine epinephrine - Ropivacaine 0.75% Injectable Solution ### Outcomes Primary Outcomes - Total time to breakthrough pain Secondary Outcomes - The onset of sensory block - Total duration of sensory blockade - Total duration of motor blockade - Degree of motor blockade ### Location - Facility: Nordsjælland Hospital, Hillerød, N/A, 3400, Denmark @@
## Peer Support in Alcohol Dependence - NCT ID: NCT06381609 - Study ID: 69HCL22_0901 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-11-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Quality life questionnaire AQoLS - Quality life questionnaire Euroqol EQ-5D-5L - Peer support consultations ### Outcomes Primary Outcomes - Unplanned cessation of care at 6 months Secondary Outcomes - Number of unfulfilled consultations - Euroqol-5D-5L questionnaire score - Difference in costs (in euros) - Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) - Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score - average number of standard drinks declared per week - Alcohol Quality of Life Scale (AQoLS) score - State-Trait Anxiety Inventory (STAI-Y) score - Montgomery-Åsberg Depression Rating Scale (MADRS) score - Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score - type of opioid use - frequency of opioid use - type of psychostimulant use - frequency of psychostimulant use - Fagerström test score - Health Care Satisfaction Questionnaire (HCSQ) score - Number of hospitalisations - Service organization description - Description of type of support and missions performed by Peer Support - Acceptability of Intervention Measure (AIM) score - AIM score - Adoption of intervention - Intervention fidelity ### Location - Facility: CH Le Vinatier, Bron, N/A, 69500, France @@
## Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration - NCT ID: NCT06381596 - Study ID: 2023-1715 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophyParticipants will undergo FPF imaging using the OcuMet Beacon system. ### Conditions - Geographic Atrophy - Age-Related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - OcuMet Beacon ### Outcomes Primary Outcomes - Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon Secondary Outcomes - Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement - Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement ### Location - Facility: Department of Ophthalmology and Visual Sciences, Madison, Wisconsin, 53705, United States @@
## A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma - NCT ID: NCT06381583 - Study ID: 23228/EMERALD - Status: RECRUITING - Start Date: 2023-04-15 - Completion Date: 2026-06-18 - Lead Sponsor: City of Hope Medical Center ### Study Description This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses. ### Conditions - Esophagus Cancer - Esophageal Cancer Stage - Esophageal Cancer - Esophageal Neoplasms - Esophagus Adenocarcinoma - Esophagus, Barrett - Barrett Esophagus - Barrett Adenocarcinoma - Barrett Epithelium - Barretts Esophagus With Dysplasia - Barrett's Esophagus Without Dysplasia - Barretts Esophagus With High Grade Dysplasia - Barretts Esophagus With Low Grade Dysplasia - Barrett Esophagus, Long-Segment - Barrett's Esophagus With Dysplasia, Unspecified - Barrett's Esophagus With Esophagitis - Gastroesophageal Reflux - Reflux Disease - Esophageal Adenocarcinoma - Esophageal Dysplasia - Esophageal Neoplasms Malignant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91016, United States @@
## Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas - NCT ID: NCT06381570 - Study ID: VICTORY/OZM-138 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2029-03-21 - Lead Sponsor: Daniel Morgenstern ### Study Description This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.The study will be conducted in two sequential phases:Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later ### Conditions - Low-grade Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tovorafenib ### Outcomes Primary Outcomes - MTD/RP2D - Safety and Tolerability - Overall response rate Secondary Outcomes - Pharmacokinetics (Cmax vinblastine and tovorafenib) - Pharmacokinetics (AUC of vinblastine and tovorafenib) - Progression free survival - Duration of response - Clinical Benefit rate ### Location - Facility: The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada @@
## Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules - NCT ID: NCT06381557 - Study ID: YRPG-PMS-ZYJN-RCT-2022-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-03-01 - Lead Sponsor: Qiang Fu ### Study Description Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer. ### Conditions - Cancer-related Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Zhengyuan Capsules - Placebo contains 5%-10% Zhengyuan Capsule total mixed powder ### Outcomes Primary Outcomes - Fatigue degree with the Brief Fatigue Inventory（BFI） Secondary Outcomes - Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R） - Fatigue degree with the MD Anderson Symptom Inventory（MDASI） - Change of patients' functional status with Karnofsky performance status (KPS) - Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23） ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Aromatherapy Use in Nursing Skills Training - NCT ID: NCT06381544 - Study ID: fbu_nurs_elmali_002 - Status: COMPLETED - Start Date: 2024-02-12 - Completion Date: 2024-03-06 - Lead Sponsor: Fenerbahce University ### Study Description Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.RESEARCH HYPOTHESES:H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.H1: Aromatherapy reduces the anxiety experienced by students during skills training.H2: Aromatherapy has a positive effect on students' learning nursing skills. ### Conditions - Nursing Students ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Aromatherapy application ### Outcomes Primary Outcomes - Difference between skill learning of students in the aromatherapy group and the control group Secondary Outcomes - Difference between anxiety levels of students in the aromatherapy group and the control group ### Location - Facility: Fenerbahce University, Istanbul, Atasehir, 34758, Turkey @@
## Tracing Brain Tumors Through Deep Time - NCT ID: NCT06381531 - Study ID: 4410 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-10 - Completion Date: 2027-06-10 - Lead Sponsor: Tata Memorial Centre ### Study Description Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology. ### Conditions - Brain Tumor - Oncology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Imaging with CT and MRI ### Outcomes Primary Outcomes - Age-based density maps of brain tumor location Secondary Outcomes - Anthropometric analysis of skulls ### Location - Facility: Tata Memorial Hospital, Mumbai, Maharashtra, 400012, India @@
## Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease - NCT ID: NCT06381518 - Study ID: Z2023165 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-12 - Completion Date: 2025-05-01 - Lead Sponsor: Zuyderland Medisch Centrum ### Study Description The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch. ### Conditions - IBD - Infliximab - Crohn Disease - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Switch to SC CT-P13. ### Outcomes Primary Outcomes - Area under the curve (AUC) at steady state Secondary Outcomes - Quality of life score - Patient satisfaction - Time expenditure ### Location - Facility: Zuyderland Medical Centre, Sittard, N/A, N/A, Netherlands @@
## RetracTOR/ Retractor for Image Guided Trans-Oral Surgery - NCT ID: NCT06381505 - Study ID: STUDY02002103 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-12-31 - Lead Sponsor: Ryan J. Halter ### Study Description This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients. ### Conditions - Oral Cavity Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. Secondary Outcomes ### Location - Facility: Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States @@
## Quantifying Patellar Tendon Microstructure Using DTI - NCT ID: NCT06381492 - Study ID: 2024-0057 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.Participants will:* undergo MRI and ultrasound imaging* perform knee function test* complete questionnaires ### Conditions - Patellar Tendinopathy - Anterior Cruciate Ligament Reconstruction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI - Ultrasound (US) ### Outcomes Primary Outcomes - Compare scalar parameters of known patellar tendon pathology to the contralateral tendon - Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon Secondary Outcomes ### Location - Facility: University of Wisconsin - Madison, Madison, Wisconsin, 53705, United States @@
## Exploring the Effects of Probiotics on Workplace Related Stress Symptoms - NCT ID: NCT06381479 - Study ID: B031 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-03-31 - Lead Sponsor: National Taiwan Sport University ### Study Description There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. ### Conditions - Stress - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - probiotics - placebo ### Outcomes Primary Outcomes - Cortisol Secondary Outcomes - Perceived Stress Scale (PSS) - Job Stress Scale - Overwork Survey - Insomnia Severity index (ISI) - The State Trait Anxiety Inventory (STAI) - Depression Anxiety Stress Scales (DASS-42) - The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 - VAS-GI - Patient Global Impression scales of Improvement rated by patient, PGI-C - Serotonin - GABA - Norepinephrine - Immunoglobulin A, IgA - adrenocorticotropic hormone, ACTH - Total Antioxidant Capacity , TAC ### Location - Facility: Graduate Institute of Sports Science, National Taiwan Sport University, Taoyuan, N/A, 33301, Taiwan @@
## A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants. - NCT ID: NCT06381466 - Study ID: D7250C00001 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-20 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants. ### Conditions - Dilated Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AZD0233 - AZD0233 Placebo ### Outcomes Primary Outcomes - Number of participants with adverse events (AEs) and serious adverse events (SAEs) Secondary Outcomes - Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233 - Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233 - Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233 - Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233 - Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233 - Terminal elimination half-life (t1/2) of AZD0233 - Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233 - Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233 - Terminal rate constant (λz) of AZD0233 - Accumulation ratio for Cmax (Rac Cmax) of AZD0233 - Accumulation ratio for AUC (Rac AUC) of AZD0233 - Renal clearance (CLR) of AZD0233 - Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233 - Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233 - Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233 ### Location - Facility: Research Site, Glendale, California, 91206, United States @@
## Belimumab in Autoimmune Hepatitis - NCT ID: NCT06381453 - Study ID: 23-5037 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2029-04-30 - Lead Sponsor: University Health Network, Toronto ### Study Description Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\<2x ULN \& corticosteroids at a dose of \</= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH. ### Conditions - Autoimmune Hepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Belimumab Auto-Injector [Benlysta] ### Outcomes Primary Outcomes - To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH Secondary Outcomes - To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden - To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden - To see the effects of treatment with Belimumab on AIH disease activity and treatment burden - To measure the effects of Belimumab on markers of AIH disease activity - To evaluate the effects of Belimumab on markers of AIH disease activity - To outline the effects of Belimumab on Patient Reported Outcomes (PRO) - To assess the effects of Belimumab on Patient Reported Outcomes (PRO) - To measure the effects of Belimumab on Patient Reported Outcomes (PRO) - To evaluate the safety of Belimumab in patients with autoimmune hepatitis - To assess the safety of Belimumab in patients with autoimmune hepatitis - Safety and Tolerability - To report the safety of Belimumab in patients with autoimmune hepatitis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability - NCT ID: NCT06381440 - Study ID: PROGR-EX_MNESYS - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-11-30 - Lead Sponsor: University Hospital of Ferrara ### Study Description Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lokomat device (Hocoma AG, Volketswil, Switzerland). - Conventional walking training ### Outcomes Primary Outcomes - Walking function Secondary Outcomes - Mobility - Walking endurance - Balance - Spasticity - Perceived quality of life - Perceived walking ability - Fatigue - Anxiety - Depression - Kinesiophobia - Adaptation to medical condition - Coping strategies - Muscle oxygen consumption - Hemodynamic cortical activation - Electrical brain activity - miRNA expression - Acceptability of robot intervention ### Location - Facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Emilia Romagna, 44124, Italy @@
## Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure - NCT ID: NCT06381427 - Study ID: 01NVF22109 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2027-03-01 - Lead Sponsor: University of Giessen ### Study Description Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Interdisciplinary decision-making for perioperative care ### Outcomes Primary Outcomes - combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation Secondary Outcomes - Incidence of acute kidney injury - Incidence of any, treatable, suspected, or confirmed bacterial infection - Incidence of cardiac decompensation - Incidence of re-hospitalization - Mortality - Incidence of myocardial infarction (STEMI, NSTEMI) - Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS) - Quality of life assessed using PHQ-9 - Quality of life assessed using GAD-7 ### Location - Facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg, Gießen, N/A, 35390, Germany @@
## Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion - NCT ID: NCT06381414 - Study ID: ChildhoodEarlyOralAging - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-20 - Lead Sponsor: University of Nove de Julho ### Study Description The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05. ### Conditions - Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - Assessment of Tooth Wear and Dental Management - Presence of Enamel Defects - Vertical Dimension of Occlusion Secondary Outcomes ### Location - Facility: Nove de Julho University, São Paulo, SP, 03155-000, Brazil @@
## Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries - NCT ID: NCT06381401 - Study ID: MS-492-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-07-05 - Lead Sponsor: Cairo University ### Study Description Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious complications.The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). ### Conditions - Surgical Field Visualization, Acute Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - bupivacaine 0.25% - bupivacaine 0.125% ### Outcomes Primary Outcomes - The total consumption of IV glyceryl trinitrate (GTN) Secondary Outcomes - Fentanyl consumption - Postoperative pain - Postoperative hospital stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke - NCT ID: NCT06381388 - Study ID: NL86587.041.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-30 - Lead Sponsor: Jord Vink ### Study Description Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.Study design: A prospective, open-label within-subject intervention studyStudy population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - cTBS ### Outcomes Primary Outcomes - Interhemispheric inhibition (IHI) Secondary Outcomes - Ipsilesional resting motor threshold (RMT) - Contralesional resting motor threshold (RMT) - TMS interference - Intracortical inhibition (ICI) ### Location - Facility: De Hoogstraat Revalidatie, Utrecht, N/A, N/A, Netherlands @@
## Drug-drug Interactions With Anti-tuberculous Drugs - NCT ID: NCT06381375 - Study ID: 24-2-2024 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-02-15 - Lead Sponsor: Cairo University ### Study Description This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients. ### Conditions - Drug-drug Interaction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anti Tuberculosis Drug ### Outcomes Primary Outcomes - Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients - 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events). Secondary Outcomes ### Location - Facility: Omnia Azmy Nabeh, Cairo, N/A, 11562, Egypt @@
## Italian Registry of Minimally Invasive Pancreatic Surgery - NCT ID: NCT06381362 - Study ID: IGOMIPS - Status: RECRUITING - Start Date: 2019-02-28 - Completion Date: 2029-02-28 - Lead Sponsor: Associazione Italiana per lo Studio del Pancreas ### Study Description Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes ### Conditions - Pancreatic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Minimally invasive pancreatic surgery ### Outcomes Primary Outcomes - Postoperative short-term outcomes - Long-term oncological outcomes Secondary Outcomes - Rate of cases that after a minimally invasive approach had to be converted to and open approach - Surgeon learning curve - Surgeon learning curve - Surgeon learning curve - Surgeon learning curve ### Location - Facility: Giovanni Capretti, Milan, N/A, N/A, Italy @@
## Predicting Outcomes of GPOEM Using Gastric Electrical Mapping - NCT ID: NCT06381349 - Study ID: GPOEM-GEMS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-01 - Lead Sponsor: Chris Varghese ### Study Description Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months. ### Conditions - Gastroparesis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gastric Alimetry test ### Outcomes Primary Outcomes - Gastroparesis Cardinal Symptom Index (GCSI) Secondary Outcomes - Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) - EQ-5D scores - Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) - Patient Health Questionnaire - 8 (PHQ-8) - Generalized Anxiety Disorder 7-item (GAD-7) - Perceived Stress Scale 4 (PSS-4) - Brief Illness Perception Questionnaire-Revised - Alimetry® Gut-Brain Wellbeing (AGBW) - Work Productivity and Activity Impairment (WPAI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Digital Home-Based Physiotherapy Program for Active Aging - NCT ID: NCT06381336 - Study ID: TRAKSILVER2022 - Status: COMPLETED - Start Date: 2022-03-23 - Completion Date: 2022-11-07 - Lead Sponsor: Trak Health Solutions S.L. ### Study Description This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity. ### Conditions - Frail Elderly Syndrome - Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TRAK-SILVER platform ### Outcomes Primary Outcomes - Short Physical Performance Battery (SPPB - Gait Speed - Timed Up and Go Test - 6-minute walk test (6MWT) - Berg Balance Scale - Number of steps count - Geriatric Depression Scale-15 (GDS) - De Jong Gierveld Loneliness Scale (JGLS) - Quality of life (QoL) questionnaire Secondary Outcomes ### Location - Facility: Social Center of Orio (Zahartzaroa), Orio, Basque Country, 20810, Spain @@
## The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism - NCT ID: NCT06381323 - Study ID: PA2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-04-01 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism. ### Conditions - Primary Aldosteronism - Finerenone - Mineralocorticoid Receptor Antagonist ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Finerenone ### Outcomes Primary Outcomes - 24h systolic BP drop value Secondary Outcomes - The change of diastolic BP from the baseline level after Finerenone treatment - Hypertension remission rate - Change of serum potassium level - Change of plasma renin activity - Change of ARR - Change of UACR - Change of eGFR ### Location - Facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School, Nanjing, Jiangsu, 210008, China @@
## Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access - NCT ID: NCT06381310 - Study ID: 202310077DINB - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-10-30 - Lead Sponsor: National Taiwan University Hospital ### Study Description Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care. ### Conditions - Successful Cannulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - asus-handheld-ultrasound LU710L ### Outcomes Primary Outcomes - cannulation success rate Secondary Outcomes - cannulation satisfaction ### Location - Facility: National Taiwan University Hospital Bei-Hu Branch, Taipei City, N/A, N/A, Taiwan @@
## Speech in Noise Discrimination Skills in Multiple Sclerosis Patients. - NCT ID: NCT06381297 - Study ID: OndokusMU - Status: COMPLETED - Start Date: 2020-10-09 - Completion Date: 2023-04-23 - Lead Sponsor: Asuman Kucukoner ### Study Description The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.The main questions it aims to answer are:Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated. ### Conditions - Multiple Sclerosis-Relapsing-Remitting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - Hearing test - Speech in noise discrimination test - Montreal Cognitive Assessment Scale - Symbol Number Modalities Test (SDMT) ### Outcomes Primary Outcomes - Pure tone Audiometry Test - Speech Audiometry - Speech Discrimination in Noise Test - Otoacoustic Emission Test - Contralateral Suppression Test Secondary Outcomes - Montreal Cognitive Assessment Scale - Symbol Digit Modalities Test ### Location - Facility: Ondokuz Mayıs University, Samsun, N/A, 55300, Turkey @@
## Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment - NCT ID: NCT06381284 - Study ID: MG-001 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-05-27 - Lead Sponsor: ZS Associates ### Study Description This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG). ### Conditions - Myasthenia Gravis - Neuromuscular Manifestations - Neuromuscular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Social media recruitment - Self-Assessment - Follow-up ### Outcomes Primary Outcomes - Social media recruitment feasibility Secondary Outcomes - MG Exercise Assessment Tool validity ### Location - Facility: ZS Associates, Evanston, Illinois, 60201, United States @@
## Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation - NCT ID: NCT06381271 - Study ID: TRUST TAVR Registry - Status: RECRUITING - Start Date: 2018-10-30 - Completion Date: 2034-10 - Lead Sponsor: Xijing Hospital ### Study Description The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected ### Conditions - Aortic Valve Regurgitation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcatheter aortic valve replacement ### Outcomes Primary Outcomes - Combined clinical efficacy outcomes Secondary Outcomes - Combined early safety and clinical efficacy outcomes - Rate of technical success - Rate of device success - Combined clinical efficacy outcomes - Rate of all-cause mortality - Valve-related long-term clinical efficacy ### Location - Facility: Xijing Hospital, Xi'an, Shannxi, 710032, China @@
## Fetal Cardiac Function - NCT ID: NCT06381258 - Study ID: SDF - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-11 - Lead Sponsor: Assiut University ### Study Description The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies. ### Conditions - Fetal Growth Retardation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Cardiac systolic function Secondary Outcomes - Cardiac diastolic function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## First-time Ablation of Atrial Fibrillation Registry - NCT ID: NCT06381245 - Study ID: KB/265/2023 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-03-31 - Lead Sponsor: Medical University of Warsaw ### Study Description Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. ### Conditions - Atrial Fibrillation - Arrhythmia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PPG-based remote heart rhythm/rate monitoring - ECG-based remote heart rhythm/rate monitoring - Transthoracic and transesophageal echocardiography examination - Liver ultrasound examination - Rotational angiography with three-dimensional reconstruction - Blood-derived biomarker analysis - Mobile health-based spirometry ### Outcomes Primary Outcomes - Late AF recurrence Secondary Outcomes - Late recurrence of AF or atrial tachycardia or atrial flutter - Early recurrence of AF - Early recurrence of AF or atrial tachycardia or atrial flutter - Time to AF recurrence and the impact of early recurrence on late AF recurrence - The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring - Progression or regression of AF - Modification of treatment, including antiarrhythmic treatment - AF-related quality of life and symptoms - Periprocedural complications - Heart rate variability and rate - Blood biomarker levels - Ablation procedure parameters - Cardiac remodelling ### Location - Facility: Medical University of Warsaw, Warsaw, N/A, N/A, Poland @@
## Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population - NCT ID: NCT06381232 - Study ID: VIOME-001 - Status: RECRUITING - Start Date: 2018-07-23 - Completion Date: 2028-07-23 - Lead Sponsor: Viome ### Study Description The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease. ### Conditions - General Health - Wellness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Molecular Determinants of Health and Disease Secondary Outcomes ### Location - Facility: Viome Life Sciences, Bothell, Washington, 98011, United States @@
## Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial - NCT ID: NCT06381219 - Study ID: s67001 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2028-12-31 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE. ### Conditions - Eosinophilic Esophagitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Implementation of cow's milk in decreasingly heated forms - Implementation of hen's egg in decreasingly heated forms ### Outcomes Primary Outcomes - Maintained remission of EoE Secondary Outcomes - Maintained remission only in step 1 of the diet - Association of remission with circulating IgG4 levels - Association of remission with IgG4 levels on biopsy - In vitro B cell test to mimic B cell activation after stimulation - Correlation between QoL and remission - Associated atopy - Associated food allergies ### Location - Facility: UZ Leuven Gasthuisberg, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Silodosin in Management of Lower Ureteral Stones - NCT ID: NCT06381206 - Study ID: No 475 - Status: COMPLETED - Start Date: 2022-10-20 - Completion Date: 2023-10-25 - Lead Sponsor: Syrian Private University ### Study Description This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin. ### Conditions - Stone, Kidney ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Silodosin ### Outcomes Primary Outcomes - Stone expulsion (yes) - Stone expulsion (no) Secondary Outcomes ### Location - Facility: Damascus university, Damascus, N/A, 1, Syrian Arab Republic @@
## Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics - NCT ID: NCT06381193 - Study ID: ESTR-01-2022 - Status: COMPLETED - Start Date: 2023-03-03 - Completion Date: 2023-07-10 - Lead Sponsor: Centros de Investigación de Nutrición y Salud ### Study Description The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.* To evaluate the stool consistency after 8 weeks (Bristol scale).* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.Participants are randomized into the following groups:* Group A: 20 assigned to probiotic + placebo* Group B: 20 assigned to prebiotic + placebo* Group C: 20 assigned to probiotic + prebiotic* Group D: 20 assigned to the placebo + placeboParticipants took 4 units of product per day (2 of each assigned product) for 2 months. ### Conditions - Functional Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic - Prebiotic - Probiotic + Prebiotic - Placebo ### Outcomes Primary Outcomes - 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. Secondary Outcomes - To evaluate the stool consistency (Bristol scale). - To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20) - To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale). ### Location - Facility: Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA), Madrid, N/A, 28036, Spain @@
## Warrior CARE: Cannabis Behavioral Health - NCT ID: NCT06381180 - Study ID: Warrior CARE: CBH - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-12-31 - Lead Sponsor: Wayne State University ### Study Description This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. ### Conditions - Post Traumatic Stress Disorder - Cannabis Use - Suicide - Veterans - Marijuana ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tetrahydrocannabinol - Cannabidiol - Placebo ### Outcomes Primary Outcomes - Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. - Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment - Assessing Suicidality over time using the C-SSRS assessment. - Assessing Suicidality throughout the study using the SBQ-R assessment. - Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. Secondary Outcomes - Assess emotional state pre- and post-treatment using the PANAS questionnaire. - Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment. - Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires. - Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments. - Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales. - Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires. - Assess demographics using a self-report assessment - Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments. - Assess smoking habits and history using the FTND assessment - Assess general health and history pre- and post-treatment using the SF-36 assessment. - Assess healthcare utilization throughout the study. - Assess pain pre- and post-treatment using the BPI assessment. - Assess sleepiness pre- and post-treatment using the ESS questionnaire. - Assess overall quality of life pre- and post-treatment using the QOL questionnaire. - Assess substance use throughout the study using the TLFB assessment. - Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks - Assess physiological measures throughout the study as a safety check - Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD. ### Location - Facility: Wayne State University, Detroit, Michigan, 48201, United States @@
## Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis - NCT ID: NCT06381167 - Study ID: Endoscopic decompression - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-10 - Lead Sponsor: Assiut University ### Study Description To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis. ### Conditions - Lumbar Spinal Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Endoscopic Decompressive Laminectomy ### Outcomes Primary Outcomes - Oswestry Disability Index ODI scores for low back pain and neuropathic pain Secondary Outcomes - visual analog scale (VAS) score for low back and lower extremity radiating pain - European Quality of Life-5 Dimensions (EQ-5D) score - painDETECT score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer - NCT ID: NCT06381154 - Study ID: MC230404 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2029-07-04 - Lead Sponsor: Mayo Clinic ### Study Description This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer. ### Conditions - Locally Advanced Pancreatic Adenocarcinoma - Metastatic Pancreatic Adenocarcinoma - Stage II Pancreatic Cancer AJCC v8 - Stage III Pancreatic Cancer AJCC v8 - Stage IV Pancreatic Cancer AJCC v8 - Unresectable Pancreatic Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Computed Tomography - Endoscopic Ultrasound - Fluorouracil - Irinotecan - Leucovorin - Lymph Node Biopsy - Magnetic Resonance Imaging - Oxaliplatin - Pembrolizumab - Photodynamic Therapy - Positron Emission Tomography - Questionnaire Administration - Verteporfin ### Outcomes Primary Outcomes - Overall response rate (ORR) Secondary Outcomes - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Incidence of adverse events (AEs) ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma - NCT ID: NCT06381141 - Study ID: CLN-619-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-03 - Lead Sponsor: Cullinan Therapeutics Inc. ### Study Description A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CLN-619 ### Outcomes Primary Outcomes - Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) - Changes in Eastern Cooperative Oncology Group (ECOG) performance - Incidence of Dose-Limiting toxicity (DLTs) - Best Overall Response (BOR) per patient - Overall Response Rate (ORR) - Duration of Response (DoR) - Clinical Benefit Rate (CBR) - Progression Free Survival (PFS) - Overall Survival (OS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Coronary Arteries Anomalies by CT in Children With CHD - NCT ID: NCT06381128 - Study ID: CAA by CT in children with CHD - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2029-12-31 - Lead Sponsor: Assiut University ### Study Description Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction. ### Conditions - Cardiac Congenital Defects ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiac CT ### Outcomes Primary Outcomes - Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## App-Based Optimization of Long-Term CPAP Adherence and Quality of Life - NCT ID: NCT06381115 - Study ID: 23-006685 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SleepWell24 Application ### Outcomes Primary Outcomes - CPAP Adoption - Change in Quality of Life Secondary Outcomes - Change in sleep time - Change in physical activity - Change in sedentary time ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1 - NCT ID: NCT06381102 - Study ID: 20240134 - Status: RECRUITING - Start Date: 2024-04-13 - Completion Date: 2024-10-01 - Lead Sponsor: University of Miami ### Study Description The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - transcutaneous auricular vagus nerve stimulation 30/30 - transcutaneous auricular vagus nerve stimulation 10/10 ### Outcomes Primary Outcomes - Tolerability measured by tolerability questionnaire - Tolerability measured by self-report Secondary Outcomes - Change in heart rate variability (HRV) ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients - NCT ID: NCT06381089 - Study ID: VNS004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2024-08-10 - Lead Sponsor: SEFA HAKTAN HATIK ### Study Description This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p\<0.05 level. ### Conditions - Ischemic Stroke - Vagus Nerve Stimulation - Robotic Rehabilitation - Autonomic Nervous System ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Robotic Rehabilitation - Transcutaneous Auricular Vagal Nerve Stimulation ### Outcomes Primary Outcomes - Numerical Pain Rating Scale - Stroke Specific Quality of Life Scale - 10 Meter Walk Test - Fugl-Meyer Assessment Lower Extremity - Modified Ashworth Scale - Electromyography - Autonomic Nervous System Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis. - NCT ID: NCT06381076 - Study ID: IRB202400087 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-12 - Lead Sponsor: University of Florida ### Study Description A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey. ### Conditions - Chronic Kidney Disease 5D ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Liposomal curcumin - Food colorant ### Outcomes Primary Outcomes - high-sensitivity C-reactive protein Secondary Outcomes - Advanced glycation end products - fatty acid byproduct - 4-hydroxynon-enal - fatty acid byproduct - malondialdehyde - fatty acid byproduct - 8-F2 isoprostanes - Klotho ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-steroidal Anti-inflammatory in Cardiac Surgery - NCT ID: NCT06381063 - Study ID: PI2023_843_0152 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2027-07 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication. ### Conditions - Acute Postoperative Pain - Non-steroidal Anti-inflammatory Drugs - Cardiac Surgery - Pain Intensity - Multimodal Pain Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - pain management - ketoprofen - PLacebo ### Outcomes Primary Outcomes - reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery - NSAIDs reduce postoperative at rest at 24 hours from the end of surgery Secondary Outcomes - Change in pain trajectory during the first 7 days after cardiac surgery - Change in cumulative opioid within 48 hours after surgery - Change in pulmonary postoperative complications within 7 days after surgery ### Location - Facility: CHU Amiens Picardie, Amiens, N/A, N/A, France @@
## The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors - NCT ID: NCT06381050 - Study ID: SHR-7631-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. ### Study Description This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR-7631 ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) or maximum administered dose (MAD) - Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) Secondary Outcomes - PK parameter: Tmax - PK parameter: Cmax - PK parameter: AUC0-t - PK parameter: AUC0-∞ - PK parameter: t1/2 - PK parameter: MRT (mean residence time) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Quality of Life and Psychological Strengths of Older People - NCT ID: NCT06381037 - Study ID: PID2021-127986OB-I00 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2026-08-31 - Lead Sponsor: CEU San Pablo University ### Study Description As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors. ### Conditions - Quality of Life - Skills, Coping ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "How to improve your strengths and quality of life". ### Outcomes Primary Outcomes - Quality of life - Psychological wellbeing - Loneliness - Anxiety and depression Anxiety and depression - Gratitude - Experiential acceptance - Resilience - Family functioning Secondary Outcomes ### Location - Facility: San Pablo CEU University (Campus Montepríncipe), Alcorcón, Madrid, 28925, Spain @@
## A Study of Telemonitoring in Cancer Patients - NCT ID: NCT06381024 - Study ID: 2022 A02702-41 - Status: RECRUITING - Start Date: 2023-04-04 - Completion Date: 2024-12-30 - Lead Sponsor: Centre Hospitalier de Bligny ### Study Description The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:* In-person care alone (Standard of care group).* In-person care with Cureety telemonitoring (Standard of care with Cureety group).Participants will:* be monitored with digital application Cureety (Standard of care with Cureety group)* fill out quality of life questionnaire (baseline, 2 months, 4 months)* fill out satisfaction questionnaire (2 months, 4 months)* have the ongoing and incoming phone calls logged (duration and type) ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - remote patient monitoring ### Outcomes Primary Outcomes - Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment Secondary Outcomes - Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment - Numbers of telephone calls during the first 4 months of cancer treatment in subgroups - Hospital-free survival rate - Quality of life at 2 and 4 months after initiation of cancer treatment. - Patient satisfaction with the healthcare provided - CH Bligny staff satisfaction with the healthcare provided ### Location - Facility: Centre Hospitalier de Bligny, Briis-sous-Forges, N/A, 91640, France @@
## Local Vibration in Cervical Radiculopathy - NCT ID: NCT06381011 - Study ID: BEUFTR-4 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-01 - Lead Sponsor: Bitlis Eren University ### Study Description The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy. ### Conditions - Cervical Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Local Vibration ### Outcomes Primary Outcomes - Neck Pain - Upper Limb Pain - Paresthesia Secondary Outcomes - Cervical Range of Motion - The Change in the Pressure Pain Threshold of the Upper Trapezius - The Change in the Viscoelastic Properties of the Upper Trapezius ### Location - Facility: Bitlis Eren University, Bitlis, Merkez, 13000, Turkey @@
## Effects of Petroleum Compounds on Psychological Health and Cognitive Functions - NCT ID: NCT06380998 - Study ID: EPCPHCFAPAEWPSPSWAG - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2027-10-01 - Lead Sponsor: Assiut University ### Study Description Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity. ### Conditions - Cognitive Deterioration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - whey protien ### Outcomes Primary Outcomes - Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut - To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers - To explore the role of supplements with whey protein in ameliorating these effects Secondary Outcomes - To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers ### Location - Facility: Faculty of medicine, Assiut, Assiut University, 71515, Egypt @@
## Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury - NCT ID: NCT06380985 - Study ID: NURA-009-23F - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-12-31 - Lead Sponsor: VA Office of Research and Development ### Study Description The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI. ### Conditions - Alcohol Use Disorder - Mild-Moderate Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized VR Alcohol Approach Bias Modification (ApBM) Condition - Sham Condition ### Outcomes Primary Outcomes - Percent of Heavy Drinking Days Secondary Outcomes - Cue-induced fMRI BOLD-signal craving activation contrasts ### Location - Facility: San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, 94121-1563, United States @@