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## Regulation of Affect and Physiology in Depression - NCT ID: NCT06345859 - Study ID: UP-23-00467 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2029-06-30 - Lead Sponsor: University of Southern California ### Study Description Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Heart rate variability biofeedback ### Outcomes Primary Outcomes - Physiological regulation success - Average level of heart rate variability Secondary Outcomes - Perceived regulation success ### Location - Facility: University of Southern California, Los Angeles, California, 90089, United States @@
## Stability of Secondary Intraocular Lenses With no Capsular Support - NCT ID: NCT06345846 - Study ID: Secondary IOL - Status: ENROLLING_BY_INVITATION - Start Date: 2022-12-30 - Completion Date: 2025-12 - Lead Sponsor: Vienna Institute for Research in Ocular Surgery ### Study Description Assessment and differences in the centration, tilt and wobble of two secondary IOLs without capsular support. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - IFIOL - SFIOL ### Outcomes Primary Outcomes - Centration of the IOL Secondary Outcomes - Tilt of the IOL ### Location - Facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, Vienna, N/A, 1140, Austria @@
## Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study - NCT ID: NCT06345833 - Study ID: ENT-2024-32847 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-07-01 - Lead Sponsor: University of Minnesota ### Study Description Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face.Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date. ### Conditions - Hemophilia - Hemorrhage - Facelift Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 1%Tranexamic acid with standard local - 3% TXA - 1% TXA with local plus 3% TXA-soaked pledgets ### Outcomes Primary Outcomes - Blood loss Secondary Outcomes - adverse effects of TXA rates ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses - NCT ID: NCT06345820 - Study ID: Evolux - Status: RECRUITING - Start Date: 2023-06-28 - Completion Date: 2025-06 - Lead Sponsor: Vienna Institute for Research in Ocular Surgery ### Study Description Comparison of the clinical performance of two enhanced monofocal IOLs with similar design. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Evolux - Tecnis Eyhance ### Outcomes Primary Outcomes - Monocular intermediate visual acuity Secondary Outcomes - Monocular distance visual acuity - Monocular near visual acuity ### Location - Facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital, Vienna, Vienna, N/A, 1140, Austria @@
## Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation - NCT ID: NCT06345807 - Study ID: 2023-A02617-38 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-11 - Lead Sponsor: Elsan ### Study Description The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient. ### Conditions - Individualised Physical Activity Program - Coronary Patient ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Individuals activity programs - activity program - no Physical Activity program ### Outcomes Primary Outcomes - 6 minutes walk test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants - NCT ID: NCT06345794 - Study ID: 27111 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-06-17 - Lead Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company ### Study Description The main purpose of this study is to assess the effect of multiple doses of itraconazole, fluconazole, and carbamazepine on single dose pharmacokinetic of LY4100511 (DICE-853) in healthy participants. The study will also evaluate the safety and tolerability of LY4100511 (DICE-853) with itraconazole, fluconazole, and carbamazepine. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - LY4100511 (DC-853) - Itraconazole - Fluconazole - Carbamazepine ### Outcomes Primary Outcomes - Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4100511 (DC-853) - PK: PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-t]) of LY4100511 (DC-853) - PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY4100511 (DC-853) Secondary Outcomes ### Location - Facility: ICON San Antonio Clinical Research Unit, San Antonio, Texas, 78209, United States @@
## Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury - NCT ID: NCT06345781 - Study ID: 2174433-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Craig Hospital ### Study Description The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device. ### Conditions - Spinal Cord Injuries - Neurogenic Bowel ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Abdominal Functional Electrical Stimulation ### Outcomes Primary Outcomes - Bowel Management Time (BMT) Secondary Outcomes - Bowel Management Strategy - Stimulation Dose - EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - International Spinal Cord Society's (ISCoS) International SCI Bowel Function Basic Data Set Questionnaire - Visual Analog Scale (VAS) - Neurogenic Bladder Symptom Score (NBSS) - Intervention Acceptability - Intervention Safety ### Location - Facility: Craig Hospital, Englewood, Colorado, 80113, United States @@
## The Effect of the Stress Ball Applied Before Colocystectomy Surgery on Patients' Fear, Stress and Comfort. - NCT ID: NCT06345768 - Study ID: 147258369 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Akdeniz University ### Study Description Cholecystectomy is the most common major abdominal surgical procedure in western countries. Patients may experience fear and anxiety before surgery.Stress ball, one of the distraction methods, is an effective method in providing cognitive focus. It is seen that the stress ball method is used to reduce patients' anxiety and pain. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing their sense of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure.In this study, it is aimed to evaluate the effect of preoperative use of stress ball on patients' fear, stress and comfort in order to determine the effect of stress ball applied before cholecystectomy surgery on patients' surgical fear, stress and comfort. It is thought that the data obtained as a result of the research will provide evidence for the effect of the stress ball, which is a non-pharmacological method used before the procedure, on fear, stress and comfort. ### Conditions - Cholecystitis - Stress - Fear - Comfort ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Stress Ball ### Outcomes Primary Outcomes - Fear of surgery - Fear of surgery - Comfort - Comfort - Stress - Stress Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants - NCT ID: NCT06345755 - Study ID: VX23-407-001 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Vertex Pharmaceuticals Incorporated ### Study Description The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants. ### Conditions - Autosomal Dominant Polycystic Kidney Disease (ADPKD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VX-407 - Placebo - Midazolam ### Outcomes Primary Outcomes - Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407 - Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407 Secondary Outcomes - Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407 - Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407 - Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407 - Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407 - Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) ### Location - Facility: ICON Lenexa, Lenexa, Kansas, 66219, United States @@
## The Effect of Parental Participation on Newborn Comfort During Diaper Care - NCT ID: NCT06345742 - Study ID: ATADEK-2023-10/396 - Status: RECRUITING - Start Date: 2023-12-19 - Completion Date: 2025-02-01 - Lead Sponsor: Acibadem University ### Study Description It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants. ### Conditions - Preterm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - No parental participation - Mother participation - Father participation ### Outcomes Primary Outcomes - Level of Parental Stress - Change in Level of Comfort Secondary Outcomes ### Location - Facility: Acıbadem University, İstanbul, Ataşehir, 34750, Turkey @@
## A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004) - NCT ID: NCT06345729 - Study ID: 1084-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2031-02-18 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS). ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MK-1084 - Placebo - Pembrolizumab ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) - Overall Survival (OS) Secondary Outcomes - Objective Response Rate (ORR) - Duration of Response (DOR) - Number of Participants Who Experience One or More Adverse Event (AEs) - Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score - Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic - NCT ID: NCT06345716 - Study ID: renal colic 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-11-30 - Lead Sponsor: University of Monastir ### Study Description This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group. ### Conditions - Renal Colic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - paracétamol tramadol - Paracétamol cafeine - Placebo ### Outcomes Primary Outcomes - Pain recurrence Secondary Outcomes - Painful recurrence - number of patient who revist the ED for residual pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## First-into-human Study of NS-136 in Healthy Subjects - NCT ID: NCT06345703 - Study ID: NeuShen Therapeutics - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-02 - Lead Sponsor: NeuShen Therapeutics ### Study Description The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen? ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Placebo - NS-136 tablet ### Outcomes Primary Outcomes - Number of Participants with Treatment-Related Adverse Events - Main pharmacokinetic parameters - Main pharmacokinetic parameters - Main pharmacokinetic parameters - Main pharmacokinetic parameters - Main pharmacokinetic parameters - Main pharmacokinetic parameters Secondary Outcomes ### Location - Facility: CMAX Clinical Research Pty Ltd, Adelaide, South Australia, 5000, Australia @@
## VIA Disc NP Registry 3.0 - NCT ID: NCT06345690 - Study ID: VIA-2023-003 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2027-01-01 - Lead Sponsor: VIVEX Biologics, Inc. ### Study Description Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP. ### Conditions - Discogenic Pain - Back Pain - Back Pain, Low ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VIA Disc NP ### Outcomes Primary Outcomes - Numeric Pain Rating Scale (NPRS) - Oswestry Disability Index (ODI) - Patient Satisfaction - Pain Medication Secondary Outcomes ### Location - Facility: The Denver Spine & Pain Institute, Greenwood Village, Colorado, 80111, United States @@
## Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects - NCT ID: NCT06345677 - Study ID: ViXe-CLP-0002 - Status: COMPLETED - Start Date: 2023-06-09 - Completion Date: 2024-02-01 - Lead Sponsor: Vensica Therapeutics Ltd. ### Study Description The goal of this interventional clinical trial is to assess the safety, usability and initial efficacy of Xeomin and Vibe combination (ViXe) compared to placebo + sham in female subjects with idiopathic Overactive Bladder. The main question\[s\] it aims to answer are: • The rate of device and drug related serious adverse events during treatment and throughout the follow up period • Investigator, subject and technician satisfaction from treatment, and • Assess the initial efficacy of the drug-device combination compared to placebo-sham combination. Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks, during which they will visit the clinic after 2, 6 and 12 weeks. Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit. ### Conditions - Overactive Bladder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ViXe Xombination - Placebo + Sham ### Outcomes Primary Outcomes - Adverse Events Rate - Usability and ease-of-use perception by investigator, subject and technician Secondary Outcomes - Daily Urgency Urinary Incontinence - Total Daily Episodes - Urinary Urgency - Voiding Leaks - Quality of Life Queationnsaire - Nocturia ### Location - Facility: CHUC, Coimbra, N/A, N/A, Portugal @@
## Interdisciplinary E-health Based Follow-up of Preterm Born Children - NCT ID: NCT06345664 - Study ID: 548/2022BO1 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-12 - Lead Sponsor: University Hospital Tuebingen ### Study Description The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children. ### Conditions - Preterm Birth ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Diagnostics and intervention recommendations ### Outcomes Primary Outcomes - Bayley Scales of Infant and Toddler Development - Wechsler Intelligence Scale for Children (WISC-V) - Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) - Sleep Self Report (SSR) - Somatics - Child Behavior Checklist (CBCL) - Youth Self Report (YSR) - Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) - KIDSCREEN-27 (The KIDSCREEN) - Parent's Stress Inventory (EBI) - App-questions - Postexperimental questionnaire Secondary Outcomes - Demographic data - Actigraphy measurement - Video of a sleeping sequence - Sleep cartoon for children - Kiddie-Sads-Present and Lifetime Version (K-SADS PL) - Self efficacy dealing with social situations (WIRKSOZ) - Group interviews ### Location - Facility: University Hospital Tuebingen, Tuebingen, N/A, 72076, Germany @@
## Brain Oscillation-synchronized Stimulation of the Frontal Cortex in Major Depressive Disorder - NCT ID: NCT06345651 - Study ID: 2023-03, Version 7 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-08 - Lead Sponsor: University Hospital Tuebingen ### Study Description Major depressive disorder (MDD) is a common severe psychiatric disease with enormous socioeconomic costs for the patient and society alike. Current pharmacological treatments are ineffective in a substantial fraction of patients and are accompanied by unwanted side effects. Using a novel non-invasive brain stimulation method to specifically target and modulate dysfunctional brain oscillations with high spatial and temporal precision this study will investigate the efficacy of EEG-triggered transcranial magnetic stimulation to alleviate de-pressive symptomatology in patients with MDD in a double-blind randomized controlled pilot clinical trial. ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial Magnetic Stimulation ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) Secondary Outcomes - MADRS (Montgomery-Åsberg Depression Rating Scale) 4 weeks after intervention - HDRS-17 (Hamilton Depression Rating Scale-17) - BDI-2 (Beck Depression Inventory-2) - IDS-30 (Inventory of depressive symptoms-30) - Response Rate - Remission Rate ### Location - Facility: University Hospital Tuebingen, Tuebingen, Baden-Wuerttemberg, 72076, Germany @@
## Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease - NCT ID: NCT06345638 - Study ID: 854343 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2025-05-31 - Lead Sponsor: University of Pennsylvania ### Study Description This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood. ### Conditions - Sickle Cell Disease - Vaso-occlusive Crisis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - C-reactive protein level Secondary Outcomes ### Location - Facility: Penn Medicine University City, Philadelphia, Pennsylvania, 19104, United States @@
## Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - NCT ID: NCT06345625 - Study ID: 6012 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2028-01 - Lead Sponsor: Universiteit Antwerpen ### Study Description The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing. ### Conditions - Aged - Accidental Fall - Postural Balance - Gait ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cognition - Sensory function - Frailty - Biomechanical movement analysis - Screening - Follow up ### Outcomes Primary Outcomes - Spatio-temporal parameters of gait - Foot placement estimator - Onset latency - Peak amplitude - Fixation duration - Gain - Latency - Fall characteristics Secondary Outcomes - Multisensory integration - Digit symbol substitution test - Trail making test - Go/No Go test - Head Repositioning Accuracy - Fly test - Fly test - vHIT - fHIT - Frailty ### Location - Facility: University of Antwerp, Antwerp, N/A, 2160, Belgium @@
## Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes - NCT ID: NCT06345612 - Study ID: Hypoxia-Exercise-DiabetesT1 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2025-07 - Lead Sponsor: Silesian Centre for Heart Diseases ### Study Description Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters ### Conditions - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - hypoxia - normoxia - creatine supplementation - no creatine supplementation ### Outcomes Primary Outcomes - Metabolic control of diabetes - Time in range - Time below range - Maximum oxygen consumption (VO2max) Secondary Outcomes ### Location - Facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland, Zabrze, Silesia, 41-800, Poland @@
## PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study) - NCT ID: NCT06345599 - Study ID: LK2023100 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-01-10 - Lead Sponsor: Second Affiliated Hospital of Soochow University ### Study Description The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer. ### Conditions - Pancreatic Ductal Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy - Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab - Chemotherapy:Albumin-bound paclitaxel、Gemcitabine ### Outcomes Primary Outcomes - Adverse events - Serious adverse events - 1-year overall survival Secondary Outcomes - Objective response rate - Disease control rate - Overall survival - R0 resection rate - Progression free survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study - NCT ID: NCT06345586 - Study ID: 078066 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Chulalongkorn University ### Study Description The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery ### Conditions - Contraception ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Drospirenone ### Outcomes Primary Outcomes - Cervical mucus by modified Insler score Secondary Outcomes - Estrogen and progesterone levels versus time - Number of Participants With Treatment-Related Adverse Events ### Location - Facility: Chulalongkorn University, Bangkok, N/A, 10330, Thailand @@
## Heart-brain-axis and Psychosocial Stress - NCT ID: NCT06345573 - Study ID: BASEC 2020-02922 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-10-11 - Completion Date: 2024-11 - Lead Sponsor: University of Zurich ### Study Description The main study objective is to prospectively determine the influence of sex-related risk factors and psychosocial variables on neuronal stress responses and myocardial perfusion in a population of 64 female and male individuals 50-75 years of age and free of cardiovascular disease. ### Conditions - Mental Stress - Myocardial Ischemia - Sex Role - Gender ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mental stress ### Outcomes Primary Outcomes - Amygdala-to-cerebellum ratio of glycolytic metabolic activities (SUV/SUV) - Difference between the rest and stress amygdala-to-cerebellum perfusion ratios (kBq/kBq) - Myocardial flow reserve (MFR, no unit) Secondary Outcomes - Amygdala-to-vmPFC ratio of glycolytic metabolic activities (SUV/SUV) - Difference between the rest and stress amygdala-to-vmPFC perfusion ratios (kBq/kBq) - Myocardial blood flow (MBF) at rest (mL/g/min) - Myocardial blood flow (MBF) at stress (mL/g/min) - Heart-rate response (HRR, no unit) - Salivary cortisol (mol/L) - Noradrenaline (mL/min) - Adrenaline (mL/min) - Dopamine (mL/min) - Spleen metabolic activity (SUV) - Bone marrow metabolic activity (SUV) - Aorta metabolic activity (SUV) - Left ventricular ejection fraction (LVEF, %) - C-reactive protein (CRP, mg/L) - Interleukin-2 (IL-2, pg/mL) - Interleukin-4 (IL-4, pg/mL) - Interleukin-6 (IL-6, pg/mL) - Interleukin-8 (IL-8, pg/mL) - Interleukin-10 (IL-10, pg/mL) - Tumor necrosis factor (TNF, pg/mL) - Matrix metalloproteinase-9 (MMP9, pg/mL) - Monocyte Chemoattractant Protein-1 (MCP1, pg/mL) - Vascular Cell Adhesion Molecule (VCAM) - Gender score questionnaire ### Location - Facility: University Hospital Zurich, Zürich, N/A, 8091, Switzerland @@
## Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study - NCT ID: NCT06345560 - Study ID: 077766 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Chulalongkorn University ### Study Description The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption ### Conditions - Contraception ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Drospirenone ### Outcomes Primary Outcomes - Plasma concentration versus Time of Drospirenone Secondary Outcomes - Number of Participants With Treatment-Related Adverse Events ### Location - Facility: Chulalongkorn University, Bangkok, N/A, 10330, Thailand @@
## Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE) - NCT ID: NCT06345547 - Study ID: EDGE 003539 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2027-05-31 - Lead Sponsor: University Hospital, Antwerp ### Study Description The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question\[s\] it aims to answer are:* what is the prevalence and development of sarcopenia in cirrhosis?* what is the role of malnutrition? Participants will * undergo a muscle ultrasound of the lower and upper limb muscles * handgrip strength will be measured * malnutrition screening and assessment * complete a questionnaire to assess quality of life ### Conditions - Sarcopenia - Cirrhosis - Malnutrition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound ### Outcomes Primary Outcomes - Prevalence of sarcopenia: muscle mass - Prevalence of sarcopenia: muscle strength - Development of sarcopenia: changes in muscle mass - Development of sarcopenia: changes in muscle strength - Development of sarcopenia: changes in muscle quality Secondary Outcomes - Decompensation events: MELD score • MELD evolution - Decompensation events: mortality • MELD evolution - Decompensation events: transplantation • MELD evolution - Malnutrition - Quality of life in cirrhosis ### Location - Facility: University Hospital Antwerp, Edegem, Antwerpen, 2650, Belgium @@
## FAST-FORWARD vs HAI5 - NCT ID: NCT06345534 - Study ID: ONZ-2023-0255 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2033-12-31 - Lead Sponsor: University Hospital, Ghent ### Study Description Randomized comparison between the FAST-FORWARD schedule and the HAI5 schedule for breast cancer radiotherapy in 5 fractions. ### Conditions - Cancer, Breast ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Early side effects Secondary Outcomes ### Location - Facility: Universitary Hospital, Ghent, N/A, 9000, Belgium @@
## The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry - NCT ID: NCT06345521 - Study ID: 2022-1-4032-3 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: China National Center for Cardiovascular Diseases ### Study Description Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure ### Conditions - Heart Failure - Congenital - End-stage Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - the recurrence rate of heart failure Secondary Outcomes - NT-proBNP level - Incidence rate of drug adverse reactions - Readmission rate for heart failure ### Location - Facility: Fuwai hospital, Beijing, N/A, N/A, China @@
## Early Detection of Liver Cancer by QUS - NCT ID: NCT06345508 - Study ID: 2024-12161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-12 - Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) ### Study Description Worldwide, liver cancers are the third most common cause of cancer mortality. Even when liver cancer is suspected by blood tests, imaging is required to determine the location, size, and extent of disease. Medical societies therefore recommend surveillance with ultrasound every 6 months in at-risk patients. However, a key challenge to improving the survival is that ultrasound may miss half of early-stage liver cancers, thus diagnosis must rely on additional tests such as computed tomography (CT), magnetic resonance imaging (MRI), or biopsy. Hence, there is a clear need to improve the ability to detect liver cancers, especially with ultrasound. The investigator's team proposes novel ultrasound approaches to detect cancer nodules invisible on conventional ultrasound based on differences in mechanical and structural properties between liver and tumor. Improving detection is critical because liver cancer can be cured only if detected at an early stage, as shown by improvements in survival rates in patients enrolled in surveillance programs. The investigator's multi-disciplinary, national, and international team includes experts in clinical fields (hepatology, oncology, radiology, pathology), basic sciences (engineering, medical physics, machine learning, biostatistics), and patient partnership. The investirgator will apply the methodology of patient partner recruitment and collaborate with the Centre of Excellence on Partnership with Patients and the Public to select potential new collaborators. This will permit this project to be informed at every stage by patient and family perspectives, ensuring that the results of this project will be more robust, impactful, and aligned with the priorities, needs and experiences of those who live with liver cancer. The investigator submits a research proposal focused on advanced imaging techniques because imaging constitutes a foundation for surveillance, diagnosis, staging, treatment selection and assessment of treatment response in patients with liver cancer. ### Conditions - Hepatocellular Carcinoma - Liver Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quantitative Ultrasound - B-mode Ultrasound - Magnetic Resonance Imaging - Liver Biopsy ### Outcomes Primary Outcomes - Compare the sensitivity of QUS + B-mode US vs B-mode US alone for lesion detection, using MRI as the reference standard for detection Secondary Outcomes - Compare the specificity of QUS + B-mode US vs B-mode US alone for diagnosis of HCC, using MRI or biopsy as the composite reference standard for classification - Determine the lesion-to-liver contrast of investigational QUS techniques for detection of HCC ### Location - Facility: Centre Hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec, H2X 0A9, Canada @@
## High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly - NCT ID: NCT06345495 - Study ID: 2023-0899 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2029-01-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed. ### Conditions - Splenomegaly - Myelofibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ruxolitinib - Allogeneic Stem Cell Transplantation - Levetiracetam - Eltrombopag - Busulfan - Romiplostim - Fludarabine phosphate - Cyclophosphamide - Mesna - Tacrolimus ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## A Study of MHB039A for Advanced Solid Tumor - NCT ID: NCT06345482 - Study ID: MHB039A-A-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-06-01 - Lead Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd ### Study Description Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MHB039A ### Outcomes Primary Outcomes - Incidence of participants with adverse events (AE) - Number of participants with dose-limiting toxicity (DLT) Secondary Outcomes - Maximum Plasma Concentration (Cmax) of MHB039A - The area under the plasma concentration-time curve (AUC) of MHB039A - To detectable anti-drug antibodies with treated subjects - Objective response rate (ORR) ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China @@
## Cost Analysis of Therapies for Severe Anemia - NCT ID: NCT06345469 - Study ID: O-PBM2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-05-01 - Lead Sponsor: Helios Klinik Gotha/Ohrdruf ### Study Description The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses.The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia? ### Conditions - Severe Anemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient blood management (PBM) - Allogeneic transfusion ### Outcomes Primary Outcomes - cost-effectiveness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Value of End-tidal Capnography in Gastrointestinal Bleeding - NCT ID: NCT06345456 - Study ID: izmirkatip - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2021-01-01 - Lead Sponsor: Izmir Katip Celebi University ### Study Description Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding. ### Conditions - Gastro Intestinal Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - End-tidal capnography ### Outcomes Primary Outcomes - The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated. Secondary Outcomes ### Location - Facility: Katip Çelebi Üniversitesi, İzmir, N/A, N/A, Turkey @@
## NRM on Vascular Perfusion in Heathy Adults - NCT ID: NCT06345443 - Study ID: 23-005288 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-05-31 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to better understand the effects of nicotinamide riboside supplement in overall cardiovascular health in healthy adults. ### Conditions - Vascular Stiffness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nicotinamide Riboside Malate - Placebo ### Outcomes Primary Outcomes - Reduction of Endothelial stiffness Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Wearable Technological Device Applied to Patients With Chronic Pain - NCT ID: NCT06345430 - Study ID: 2023-14 - Status: COMPLETED - Start Date: 2023-11-18 - Completion Date: 2024-01-30 - Lead Sponsor: Hacettepe University ### Study Description Within the scope of this research, a single session of Wearable Technological Device (Exopulse Molli-Suit) will be applied to patients with chronic back and neck pain. The results will be evaluated acutely, after 24 hours, after 1 week and after 1 month. ### Conditions - Neck Pain - Low Back Pain - Chronic Pain - Musculoskeletal Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exopulse Molli-Suit (Wearable Technological Device) ### Outcomes Primary Outcomes - Pain Severity Secondary Outcomes - Sleep Qaulity - Disability Level - Repetitive Reach Test - Body Composition Analysis - Lifting object overhead test - Sustained Overhead Work Test - back performance test ### Location - Facility: Yasemin Özel Aslıyüce, Yeni̇mahalle, Ankara, 06100, Turkey @@
## Outcomes of Patient Blood Management in Severely Anemic Patients - NCT ID: NCT06345417 - Study ID: O-PBM1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Helios Klinik Gotha/Ohrdruf ### Study Description The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question\[s\] it aims to answer are:* Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions?* Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both. ### Conditions - Severe Anemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient Blood Management (PBM) - Allogeneic transfusion ### Outcomes Primary Outcomes - Number of dead participants at the end of hospitalization (inhospital mortality) Secondary Outcomes - Number of participants with surgical wound complications - Number of participants with a documented acute myocardial infarction - Number of participants suffering renal injury - Number of days spent in hospital (Length of stay in hospital) - Number of participants readmitted to the studied hospital - Number of participants with a documented transfusion reaction - Number of participants receiving an allogeneic transfusion - Number of participants treated in an intensive care ward - Number of participants with documented respiratory complications ### Location - Facility: Helios Klinikum, Erfurt, Thuringia, N/A, Germany @@
## Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD - NCT ID: NCT06345404 - Study ID: CPI-818-003 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Corvus Pharmaceuticals, Inc. ### Study Description Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Soquelitinib - Placebo ### Outcomes Primary Outcomes - Incidence of adverse events, changes in laboratory values, vital signs, and electrocardiograms Secondary Outcomes - To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by percent change in Eczema and Severity Index (EASI) - To determine the efficacy of soquelitinib in participants with atopic dermatitis as measured by change in percent reaching validated Investigator Global Assessment (vIGA) of 0 or 1 ### Location - Facility: Corvus Clinical Trials Information, Burlingame, California, 94010, United States @@
## Co-creation of Pain Science Education for Children Living Beyond Cancer - NCT ID: NCT06345391 - Study ID: PANACEA_CO-CREATION_2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Vrije Universiteit Brussel ### Study Description A pain science education (PSE) intervention for children (8-12y) living beyond cancer (CBC) will be developed through a co-creational approach with CBC, their parents and pediatric oncology clinicians. The study will be guided by the Intervention Mapping Protocol. ### Conditions - Children Living Beyond Cancer (i.e. Child Cancer Survivor) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Co-creation - Concept Mapping ### Outcomes Primary Outcomes - Satisfaction with the co-created intervention Secondary Outcomes - Understandability of the co-created intervention - Empowerment with regard to the co-created intervention - Ownership of the intervention development ### Location - Facility: Vrije Universiteit Brussel, Jette, Brussels, 1090, Belgium @@
## Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII) - NCT ID: NCT06345378 - Study ID: IRFMN_PapaGio - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-11-25 - Completion Date: 2027-12 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. ### Conditions - Quality of Care - Evaluation - Emergency Departments - Appropriateness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Algorithm creation - Algorithm validation - Algorithm application - Appropriateness estimation Secondary Outcomes ### Location - Facility: ASST Papa Giovanni XXIII, Bergamo, BG, 24127, Italy @@
## MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) - NCT ID: NCT06345365 - Study ID: 09 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2028-12-31 - Lead Sponsor: Zhongnan Hospital ### Study Description Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine). ### Conditions - Acute Myeloid Leukaemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mitoxantrone liposome, Ara-Cytarabine and azacitidine - Daunorubicin,Ara-Cytarabine, azacitidine ### Outcomes Primary Outcomes - Complete remission rate Secondary Outcomes - Incidence of adverse events - Compound CR rate - Objective remission rate - No remission rate - Event-free survival - Disease-free survival - Overall survival - Mortality rate ### Location - Facility: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China @@
## Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico) - NCT ID: NCT06345352 - Study ID: IRFMN_7520_PoliMI - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-09-15 - Completion Date: 2027-12 - Lead Sponsor: Mario Negri Institute for Pharmacological Research ### Study Description The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. ### Conditions - Quality of Care - Evaluation - Emergency Department - Appropriateness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Algorithm creation - Algorithm validation - Algorithm application - Appropriateness estimation Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milano, MI, 20122, Italy @@
## A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants - NCT ID: NCT06345339 - Study ID: M21-341 - Status: RECRUITING - Start Date: 2024-04-26 - Completion Date: 2028-06-03 - Lead Sponsor: AbbVie ### Study Description This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. ### Conditions - Hypothyroidism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Armour Thyroid - Levothyroxine ### Outcomes Primary Outcomes - Percentage of Participants who Achieve Thyroid-Stimulating Hormone (TSH) Response - Number of Participants with Adverse Events (AEs) Secondary Outcomes - Percentage of Participants who Achieve TSH Response - Number of Participants Needing Altered Dose Conversion from Synthetic T4 to Armour Thyroid - Frequency of Dose Titrations During the Double-Blind (DB) Period Among Participants who Achieved TSH Response at the End of the DB Period ### Location - Facility: Diagnamics Inc. /ID# 262680, Encinitas, California, 92024, United States @@
## Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine - NCT ID: NCT06345326 - Study ID: E1-22-3155 - Status: RECRUITING - Start Date: 2023-01-15 - Completion Date: 2024-04-30 - Lead Sponsor: Adiyaman University Research Hospital ### Study Description The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF) ### Conditions - Migraine ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Greater occipital nerve block ### Outcomes Primary Outcomes - NRS Secondary Outcomes - Complications - the frequency of headhache ### Location - Facility: Ankara City Hospital Bilkent, Ankara, N/A, 06680, Turkey @@
## EFFECT OF CIRCADIAN RHYTHM ON INFLAMMATORY PARAMETERS IN UNILATERAL INGUINAL HERNIORRAHIES - NCT ID: NCT06345313 - Study ID: CIRCADIAN RHYTHM - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-10-15 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description To evaluate the inflammatory response of participants who will undergo unilateral inguinal hernia surgery at two different times of the day (08.00-12.00 during the day and 18.00-22.00 at night). The main question it aims to answer is; Is the inflammation response higher in participants who undergo surgery later in the day? Serum inflammatory parameters will be measured in both groups at the preoperative 1st hour and the postoperative 24th hour. ### Conditions - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Day Group - Night Group ### Outcomes Primary Outcomes - Change of IL6 (interleukin) (ng/ml) Secondary Outcomes - Quality of recovery from anesthesia according to difference in circadian rhythm - Change of NLR ( Neutrophil/ Lymphocyte Ratio ) - Change of PLR ( Platelet / Lymphocyte Ratio ) - Change of SII (Systemic immune-inflammation index ) - Change of CRP (C Reactive Protein) (mg/dl) - Change of Fibrinogen (mg) - Change of Sedimentation (mm/hour) - Change of Procalcitonin (µg/l) - Change of Ferritin (ml/ng) ### Location - Facility: Ankara Bilkent City Hospital, Ankara, Cankaya, 06800, Turkey @@
## NALIRIFOX in Combination With Camrelizumab for BRPC: a Prospective, Exploratory Study - NCT ID: NCT06345300 - Study ID: NCC4309 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-12-24 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description The aim of this study is to assess the efficacy and safety of Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab for patients with borderline resectable pancreatic cancer ### Conditions - Borderline Resectable Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate in combination with Camrelizumab - Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate ### Outcomes Primary Outcomes - R0 resection rate Secondary Outcomes - Event free survival (EFS) - Overall survival (OS) - Objective Response Rate(ORR) - Disease Control Rate（DCR） - Safety and tolerability by incidence, severity and outcome of adverse events ### Location - Facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijin, N/A, N/A, China @@
## Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC - NCT ID: NCT06345287 - Study ID: 24/018-4298 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description The aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients. ### Conditions - Head and Neck Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - radical radiotherapy (60Gy) - radical radiotherapy (66Gy) - radical radiotherapy (70Gy) - anti-PD-1 or PD-L1 antibody ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall survival - Deep partial response - Local-Regional failure survival - Toxicity Adverse events ### Location - Facility: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC, Beijing, N/A, N/A, China @@
## MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs) - NCT ID: NCT06345274 - Study ID: SP0077172 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-02 - Lead Sponsor: Northwestern University ### Study Description The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Measurement Based Care Training and Monthly Consultation ### Outcomes Primary Outcomes - Patient treatment attendance (effectiveness outcome) - Patient treatment attendance (effectiveness outcome) - Treatment provider measurement based care exposure (implementation outcome) Secondary Outcomes - Patient opioid abstinence (effectiveness outcome) - Treatment provider measurement based care fidelity (implementation outcome) ### Location - Facility: Family Guidance Centers, Inc., Aurora, Illinois, 60505, United States @@
## Diphenhydramine in Catheter Related Bladder Discomfort - NCT ID: NCT06345261 - Study ID: 2024-872 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Cairo University ### Study Description Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action . ### Conditions - Catheter Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - DiphenhydrAMINE 50 Mg/mL Injectable Solution - Saline ### Outcomes Primary Outcomes - incidence of catheter related bladder discomfort postoperative Secondary Outcomes - visual analog scale (VAS) ### Location - Facility: Cairo university, Cairo, N/A, 11562, Egypt @@
## Laparoscopic-assisted Versus Ultrasonography-guided Transversus Abdominis Plane Block in Laparoscopic Sleeve Gastrectomy - NCT ID: NCT06345248 - Study ID: 2024-854 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Cairo University ### Study Description The transversus abdominis plane (TAP) block, whereby local anesthetic is injected between the internal oblique and transversus abdominis fascia to facilitate blockade of somatic afferents nerves, is an effective, non-narcotic adjunct incorporated into many ERAS protocols. We hypothesized that surgeon delivered LAP-TAPs would be non-inferior to anesthesia-delivered US-TAPs in terms of post-operative pain control ### Conditions - Transversus Abdominis Plane ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - US-TAP - LAPTAP ### Outcomes Primary Outcomes - morphine needed Secondary Outcomes - first analgesic request time - patients' satisfaction - opioid-associated side effects ### Location - Facility: Cairo university, Cairo, N/A, 11562, Egypt @@
## New Biomarkers and Plasma Prothrombotic Potential in Cardiac Transthyretin Amyloidosis - NCT ID: NCT06345235 - Study ID: ID DEC-2023/07/X/NZ5/00141 - Status: RECRUITING - Start Date: 2023-07-11 - Completion Date: 2024-07-11 - Lead Sponsor: John Paul II Hospital, Krakow ### Study Description The development of cardiac amyloidosis is caused by the deposition of misfolded, insoluble proteins in the extracellular matrix of tissues. An important element of the clinical picture of the disease is the increased risk of thromboembolic complications, independent of the occurrence of atrial fibrillation, and the presence of intracardiac thrombi. The pathomechanism may be related to an increase in filling pressure or amyloid infiltration leading to myocardial damage and endothelial dysfunction, which may activate the prothrombotic inflammatory cascade, resulting in increased thrombogenic potential. Currently, there is limited published data on the potential role of new heart failure biomarkers in the assessment of ATTR cardiomyopathy, particularly in the assessment of asymptomatic carriers of pathogenic TTR variants. Moreover, there are few literature reports on the direct assessment of the coagulation system in this group of patients, and the pathomechanism of the increased thromboembolic risk is unexplored.Purpose of the study: To assess the diagnostic value of biomarkers related to heart failure (growth differentiation factor-15 (GDF15), soluble suppression of tumorigenicity-2 (ST2), galectin-3), amyloidosis ( TTR, tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-9 (MMP-9, matrix metalloproteinase-9), neurofilament light chain (NfL)) and the generation potential thrombin as a marker of the prothrombotic state in the course of ATTR.Methods: This prospective, single-center study will include consecutive patients diagnosed with ATTR cardiomyopathy (GROUP 1, n=30), asymptomatic carriers of pathogenic TTR variants (GROUP 2, n=30), and a matched control group of healthy volunteers (GROUP 3 , n=20). Material for research was collected and secured from all study participants. After giving informed consent, all patients will be tested using the ELISA method from peripheral blood (enzyme-linked immunosorbent assay) GDF15, ST2, TTR, TIMP-1, MMP-9, galectin-3, NfL. The values of these biomarkers will be compared in subgroups and correlated with clinical data, laboratory test results, echocardiography including analysis of left ventricular global strain (GLS), and scintigraphy. Additionally, the prothrombotic potential of plasma will be tested in both groups of patients using the calibrated automatic thrombogram (CAT) method, in accordance with the protocol previously used in the laboratory Expected results: The project will provide information on the value of biomarkers in the assessment of ATTR cardiomyopathy, especially in the assessment of asymptomatic carriers of pathogenic TTR variants, which may translate into the creation of a diagnostic algorithm for early identification of the development of the disease. Moreover, it will allow us to determine whether patients with cardiac ATTR are characterized by a prothrombotic state, which has not yet been described in the literature and may have potential clinical implications. ### Conditions - Transthyretin Amyloidosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - blood test ### Outcomes Primary Outcomes - Biomarkers - Thrombin as a marker - Biomarkers - Biomarkers - Biomarkers - Biomarkers - Biomarkers - Biomarkers Secondary Outcomes ### Location - Facility: John Paul II Hospital, Kraków, N/A, 31-202, Poland @@
## Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain - NCT ID: NCT06345222 - Study ID: GETAT 23/05 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2023-07-31 - Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital ### Study Description 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month. ### Conditions - The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prolotherapy ### Outcomes Primary Outcomes - change in knee pain with prolotherapy application - change in quality of life Secondary Outcomes ### Location - Facility: Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Türkiye, 16310, Turkey @@
## Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels - NCT ID: NCT06345209 - Study ID: BM-D19 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: BrosMed Medical Co., Ltd ### Study Description To evaluate the safety and efficacy of a sirolimus-coated coronary balloon dilatation catheter for the treatment of small vessel lesions of primary coronary arteries. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sirolimus-coated Coronary Balloon Dilatation Catheter - Drug-coated Coronary Balloon Dilatation Catheter ### Outcomes Primary Outcomes - Late luminal loss (LLL) Secondary Outcomes - Device success rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Motivational Interviewing Applied to Individuals With Diabetes - NCT ID: NCT06345196 - Study ID: BozokUni - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-10-15 - Lead Sponsor: Bozok University ### Study Description This study will be conducted using a randomized controlled trial design to evaluate the effect of online individual motivational interviewing on well-being, stress and difficulties in individuals with diabetes. The study will be conducted between March 2024 and March 2025 with individuals with Type 2 Diabetes who are followed up in Yozgat Bozok University Health Practice and Research Center Internal Medicine Polyclinic. The motivational interview group will receive a motivational interview once a week, lasting a maximum of 40 minutes, consisting of a total of four sessions. Chi-square (X2), t-test, repeated measures analysis of variance, Pearson correlation coefficient, partial eta-square and linear regression analysis will be used to evaluate the data. ### Conditions - Motivational Interviewing - Stress - Well-Being, Psychological - Diabetes Mellitus - Type2diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - motivational interview ### Outcomes Primary Outcomes - Change in coping with stress Secondary Outcomes - State of Well-Being Change ### Location - Facility: Akdağmadeni School of Health, Yozgat, N/A, N/A, Turkey @@
## Real-World Outcomes of Nivolumab+Ipilimumab and Pembrolizumab+Lenvatinib Among US Advanced Renal Cell Carcinoma (aRCC) Patients - NCT ID: NCT06345183 - Study ID: CA209-1275 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12-31 - Lead Sponsor: Bristol-Myers Squibb ### Study Description This observational study aims to describe demographic, clinical characteristics, treatment patterns outcomes of participants with advanced Renal Cell Carcinoma (aRCC) receiving either Nivolumab + Ipilimumab, or Pembrolizumab + Lenvatinib combination therapy ### Conditions - Advanced Renal Cell Carcinoma (aRCC) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nivolumab + Ipilimumab combination therapy - Pembrolizumab + Lenvatinib combination therapy ### Outcomes Primary Outcomes - Participant year of birth - Participant sex at birth - Participant primary payer - Participant race - Participant ethnicity - Participant U.S. state of residence - Participant initial Renal Cell Carcinoma (RCC) diagnoses - American Joint Committee on Cancer (AJCC) TNM stage - Participant advanced/metastatic Renal Cell Carcinoma (RCC) diagnosis - Participant renal cell carcinoma (RCC) histology results - Participant tumor grade - Participant biomarker or genetic testing method - Participant molecular and/or genetic mutations reported - Participant site of metastatic disease - Participant Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) - Participant Karnofsky score (KPS) - Participant comorbidities and/or chronic conditions - Participant blood test results - Participant Memorial Sloan Kettering Cancer Center (MSKCC) score - Participant International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) score - Participant smoking status - Participant COVID-19 status - Participant surgical history - Participant radiation treatment history - Participant treatment regimen received - Participant treatment initiation and discontinuation dates - Participant rationale for discontinuation of treatment - Participant radiation therapy prescribed - Participant total number of radiotherapy cycles - Participant initial dose and frequency/schedule of index therapy - Participant index treatment dose modifications - Participant rationale for dose modifications of index therapy - Participant date of dose modifications of index therapy - Participant last dose and frequency/schedule of index therapy Secondary Outcomes ### Location - Facility: Cardinal Health, Dublin, Ohio, 43017, United States @@
## Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children With Developmental Risk - NCT ID: NCT06345170 - Study ID: buhucgun05 - Status: RECRUITING - Start Date: 2023-01-03 - Completion Date: 2024-04-10 - Lead Sponsor: Biruni University ### Study Description The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study. ### Conditions - Children With Developmental Risk ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The DIR/Floortime™ Therapy Program - The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) Training Program ### Outcomes Primary Outcomes - The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) - Age and Stages Questionnarie (ASQ) - Age and Stages Questionnaires: Social-Emotional (ASQ-SE) - Brief Infant and Toddler Social Emotional Assessment (BITSEA) Secondary Outcomes ### Location - Facility: Biruni University, Istanbul, N/A, 34015, Turkey @@
## ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients - NCT ID: NCT06345157 - Study ID: COMB157GIT02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-04-30 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting. ### Conditions - Multiple Sclerosis, Relapsing-Remitting ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ofatumumab ### Outcomes Primary Outcomes - Annualized relapse rate (ARR) Secondary Outcomes - Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test) - Fatigue Severity Scale [FSS] - Quality of life parameters assessed by EQ-5D-3L - Treatment satisfaction assessed by TSQM-9 - Expanded Disability Status Scale (EDSS) - Variation of NfL in plasma - Adverse Events (AEs) - Discontinuation rates due to AE and/or other reasons ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Learning Experience of Undergraduate Nursing Students in Pediatric Oncology Ward - NCT ID: NCT06345144 - Study ID: 202307211RINC - Status: RECRUITING - Start Date: 2023-08-22 - Completion Date: 2024-03-29 - Lead Sponsor: National Taiwan University Hospital ### Study Description Clinical practices are crucial experiences for nursing students as they prepare themselves for future nursing work. Despite some research having been studied among Taiwanese nursing students in the past, there has been limited research into the experiences within pediatric oncology wards, where diseases are complex and frequently involve life-and-death issues. Therefore, the purpose of this study is to explore the experiences of undergraduate nursing students in pediatric oncology wards. ### Conditions - Pediatric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Explore the experiences of undergraduate nursing students practicing in pediatric oncology wards. Secondary Outcomes ### Location - Facility: Wei-En Li, New Taipei City, N/A, N/A, Taiwan @@
## Clinical Research Plan for the Safety and Accuracy of Ultrasound-guided Radial Artery Puncture Catheterization - NCT ID: NCT06345131 - Study ID: KY20230829-06 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-09 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description By observing the anatomical relationship and influencing factors of the radial artery through ultrasound, the optimal puncture location is selected, and puncture catheterization is guided to reduce the number of punctures, reduce complications, and improve safety and accuracy. ### Conditions - Surgical Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non invasive blood pressure monitoring ### Outcomes Primary Outcomes - Measure the transverse diameter of the radial artery at each anatomical point Secondary Outcomes ### Location - Facility: Nanjing First Hospital, Nanjing, Jiangsu, 210006, China @@
## Evaluate the Results of Fall Prevention in Older Adults With Type 2 Diabetes Mellitus - NCT ID: NCT06345118 - Study ID: FallpreventT2DMelderly - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: National Geriatric Hospital ### Study Description .This randomized controlled clinical trial aims to evaluate the effects of fall prevention in older adults with type 2 diabetes mellitus. The main questions it aims to answer are:* Describe the current situation of falls, the risk of falls, and some related factors in elderly type 2 diabetic patients* Evaluate the results of fall prevention and related factors in the study population.Participants will be randomly divided into control and intervention groups. The intervention group will be trained to follow the Otago Training Program as the primary fall prevention method. On the other hand, the control group will receive the standard care following the treatment guidelines for type 2 diabetes mellitus and other comorbidities.At the end of the intervention, the study will mainly compare the rate of fall incidents after 6 months of intervention as well as other physical performance tests. ### Conditions - Diabetes Mellitus, Type 2 - Fall - Elderly Patient ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Otago exercise program ### Outcomes Primary Outcomes - Physical performance 1 - Timed Up and Go (TUG) - Physical performance 2 -Berg Balance Scale (BBS) Secondary Outcomes - Activities of Daily Living (ADLs) - Health-related Quality of Life - Functional Reach Test (FRT) - Instrumental Activities of Daily Living (IADLs) ### Location - Facility: National Geriatric Hospital, Hanoi, N/A, 100000, Vietnam @@
## Real Time Effective Withdrawal Time and Adenoma Detection Rate - NCT ID: NCT06345105 - Study ID: AIeffectiveV4 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-31 - Lead Sponsor: The University of Hong Kong ### Study Description The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI ### Conditions - Colon Polyp - Colon Adenoma - Artificial Intelligence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endoscreener QC ### Outcomes Primary Outcomes - Adenoma detection rates of the endoscopists Secondary Outcomes - Adenoma detection rate - Polyp detection rate ### Location - Facility: Queen Mary Hospital, the University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Comparison Between IPRF With Vit. C and IPRF Alone in Management of ID'Pain - NCT ID: NCT06345092 - Study ID: Omfs.3-3-3 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-09-01 - Lead Sponsor: Cairo University ### Study Description Randomized clinical trial between 2groups,the study group to be injected in the TMJ with injectable platelet rich fibrin with vitamin C and the control group to be injected in the TMJ with injectable platelet rich fibrin alone in management of internal Temporomandibular joint derangement ### Conditions - TMJ Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin C - Injectable platelet rich fibrin ### Outcomes Primary Outcomes - Pain management Secondary Outcomes - disc position using MRI ### Location - Facility: Faculty of Dentistry cairo university, Cairo, N/A, +2, Egypt @@
## Cessation of Somatostatin Analogues After PRRT in Mid-Gut Neuroendocrine Tumours - NCT ID: NCT06345079 - Study ID: AG0219NET - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-06 - Lead Sponsor: Australasian Gastro-Intestinal Trials Group ### Study Description Neuroendocrine tumours (NETs) are slow growing cancers, which commonly present as metastatic incurable disease. Some neuroendocrine tumours, termed functional NETs, overproduce hormones which result in a variety of symptoms. However, approximately 75% of NETs are considered non-functional meaning that they do not result in hormone overproduction. The main treatment for both functional and non-functional NETs is somatostatin analogues (SSA, a type of inhibitory hormone). These drugs slow tumour growth and reduce hormone production. Over time, the majority of patients will experience tumour growth despite treatment with SSA therapy. When this occurs, the addition of Peptide Receptor Radionuclide Therapy (PRRT, a type of targeted radiotherapy) in combination with ongoing SSA therapy is given. However, it is not known if continuing SSA therapy after commencement of PRRT is beneficial or not.The aim of this study is to estimate the outcomes of patients with grade 1 and 2 well differentiated mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA. ### Conditions - Neuroendocrine Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cessation of somatostatin analogues - Continuation of somatostatin analogues ### Outcomes Primary Outcomes - 20-month progression free survival rate after PRRT - Assess the barriers which would impede the feasibility of a subsequent phase 3 trial Secondary Outcomes - Measure Quality of life using the European Organisation For Research And Treatment Of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) scales - Measure Quality of life using the EORTC QLQ-GINET21 scales - Cost-effectiveness of SSA therapy cessation - Psycho-oncological impacts of SSA therapy cessation: Decision Regret - Psycho-oncological impacts of SSA therapy cessation: Fear of Cancer Progression - Psycho-oncological impacts of SSA therapy cessation: Decisional Conflict - Time to commencement of subsequent therapy - Overall survival - Rates of SSA being recommenced over time ### Location - Facility: Royal Brisbane Women's Hospital, Brisbane, Queensland, 4006, Australia @@
## A Study of LY3841136 in Overweight and Obese Participants - NCT ID: NCT06345066 - Study ID: 18834 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-03 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks. ### Conditions - Obesity - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Tirzepatide - LY3841136 - Placebo ### Outcomes Primary Outcomes - Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration Secondary Outcomes - Percent Change from Baseline in Body Weight - Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136 - Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 ### Location - Facility: Fortrea CRU, Inc., Daytona Beach, Florida, 32117, United States @@
## Presence of PTSD and Emotion Dysregulation Among Inpatients With Substance Use Disorder - NCT ID: NCT06345053 - Study ID: 203428 - Status: RECRUITING - Start Date: 2021-05-01 - Completion Date: 2025-10-01 - Lead Sponsor: Norwegian University of Science and Technology ### Study Description There are high rates of co-occurring posttraumatic stress disorder (PTSD) among patients receiving treatment for substance use disorder (SUD). PTSD and SUD should be treated simultaneously, but adults in SUD treatment are often not assessed for PTSD nor offered PTSD-based interventions. One of the reasons for reluctance in offering trauma focused treatment is increased risk of drop out. PTSD and related emotion dysregulation are related to elevated psychological burden, higher dropout rates and increased risk of relapse. this is a feasibility study, where the plan is to integrate a combination of Dialectical Behaviour Therapy for Substance Use Disorder (DBT-SUD skills) a therapy targeting difficulties in emotion regulation and Narrative Exposure Therapy (NET) a trauma focused therapy, for patients with co-occurring PTSD symptoms into standard SUD treatment . The plan is to assess its potential benefits by assessing whether adding this combination to standard SUD treatment is relevant, feasible, acceptable, and safe. Treatment outcomes are 1) Prevalence of PTSD, suicidal behaviour, and self-harm, as well as the severity of difficulties in emotion regulation and emotional avoidance among patients (N approx. = 100) in inpatient treatment for SUD. 2) Change post-treatment and at 3 and 12 months follow up, from baseline in PTSD symptom severity, depressive symptoms, emotion regulation, emotion avoidance, and experience of shame. 3) Rates of dropout and relapse compared to previous rates.This project can increase knowledge about psychological mechanisms in co-occurring PTSD and SUD and improve the quality of treatment for this vulnerable patient population. ### Conditions - Post Traumatic Stress Disorder - Substance Use Disorders - Emotion Regulation - Suicide - Self-harm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Narrative Exposure Therapy ### Outcomes Primary Outcomes - The intervention is relevant - prevalence of PTSD /SUP PTSD. - The intervention is relevant - prevalence of traumatic experiences. - The intervention is relevant - The severitiy of difficulties in emotion regulation. - The intervention is feasible, accepted and safe - The dropout rate from treatment. - The intervention is safe - Suicide behaviour while in treatment. - The intervention is safe - Self-harm behaviour while in treatment. - The intervention is accepted - participation in DBT-SUD skills sessions. - The intervention is feasible and accepted - Objective experience of treatment. Secondary Outcomes - The potential benefits of the intervention - Change in PTSD symptoms from base line to 3-and 12 month follow up. - The potential benefits of the intervention - Change in Difficulties in emotion regulation from baseline to 3- to 12- month follow up. - The potential benefits of the intervention - Relapse to alcohol abuse at 3- and 12-months follow up. - The potential benefits of the intervention - Relapse to substance abuse at 3- and 12-month follow up. ### Location - Facility: Molde Treatment Center, Møre and Romsdal Hospital Trust, Molde, Møre And Romsdal, 6410, Norway @@
## The Dialogue Study: A Virtual-reality Based Treatment for Eating Disorders - NCT ID: NCT06345040 - Study ID: H-22067692 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-06 - Lead Sponsor: Mental Health Services in the Capital Region, Denmark ### Study Description The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles. ### Conditions - Eating Disorders - Anorexia Nervosa - Bulimia Nervosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual-reality intervention - TAU - specialized treatment ### Outcomes Primary Outcomes - Eating disorder symptoms post treatment measured with the Eating Disorder Examination Questionnaire Secondary Outcomes - Level of depressive symptoms post treatment - Motivation for change post treatment - Level of identification with the eating disorder and level of embodiment post treatment - Experience of the eating disorder voice post treatment - Beliefs about the power and benevolence of the eating disorder voice post treatment - engagement scale ### Location - Facility: Copenhagen Research Center for Mental Health - CORE, Hellerup, Copenhagen, 2900, Denmark @@
## CHIMERIC ANTIGEN RECEPTOR TREATMENT TARGETING CD70 (SEVENTY) - NCT ID: NCT06345027 - Study ID: H-53163 CASEY - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2042-04-01 - Lead Sponsor: Baylor College of Medicine ### Study Description This study is for patients that have lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease and the patients condition has come back or has not gone away after treatment, including the best treatment we know for these diseases.Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV). This virus causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma. This suggests that the EBV plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction.T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in blood and affect the tumor. We have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses (meaning the cancer could no longer be detected).We think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study we will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. We know that T cells need substances called cytokines (substances such as proteins released by specific cells of the immune system) to survive and that the cells may not get enough cytokines after the cells are infused into the body. We have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time.The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on the cancer. ### Conditions - Leukemia, Myeloid, Acute - Leukemia, B-cell - Leukemia, T-Cell - Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Treatment Arm A ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) rate Secondary Outcomes - Overall Response Rate ### Location - Facility: Texas Children's Hospital, Houston, Texas, 77030, United States @@
## The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome - NCT ID: NCT06345014 - Study ID: 23CP40803 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2026-03-30 - Lead Sponsor: AJU Pharm Co., Ltd. ### Study Description This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) ### Conditions - Chronic Prostatitis With Chronic Pelvic Pain Syndrome - Chronic Prostatitis - Chronic Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OM-89 [Uro-Vaxom® Capsule] - OM-89 Placebo [Uro-Vaxom® Capsule Placebo] ### Outcomes Primary Outcomes - NIH-CPSI total score Secondary Outcomes - NIH-CPSI domain score - Subject and Investigator's Global Assessment ### Location - Facility: AJU Pharm Co., Ltd., Seoul, N/A, N/A, Korea, Republic of @@
## A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer - NCT ID: NCT06345001 - Study ID: 22261 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-08-30 - Lead Sponsor: Bayer ### Study Description Researchers are studying a new potential treatment for liver cancer.To do this, researchers have developed a protein, called a monoclonal antibody, which can find and attach itself to another protein present on the surface of liver cancer cells. This can help the new treatment to specifically target cancer cells in the liver.In this study, researchers want to understand the distribution and processing of this monoclonal antibody in people with liver cancer.Researchers will use the following two forms of monoclonal antibody as study interventions during this study:* BAY3630942: This is the monoclonal antibody attached to a tracer. A tracer emits radiation that can help researchers track the monoclonal antibody in the body using imaging tests like PET/CT (positron emission tomography / computed tomography). All participants will receive a fixed dose of BAY3630942 during the study.* BAY3547922: This is the monoclonal antibody without the tracer. Participants may receive different amounts of BAY3547922 during the study.In this study, participants will not derive therapeutic benefit from receiving BAY3630942 or BAY3547922. However, this study may help researchers develop a new treatment for people with liver cancer and find a dose to be tested in future studies.The main purpose of this first-in-human study is to check how BAY3630942 distributes among different organs in the body and how much of the radiation it emits is absorbed by the organs based on the total dose of BAY3630942 and BAY3547922 given. For this, the researchers will:* measure the amount of BAY3630942 radiation found in different organs over time.* measure the amount of BAY3630942 radiation absorbed by different organs.* use the above information to estimate the amount of radiation that would be absorbed by the same organs from the new potential treatment.Researchers will also monitor the number and severity of medical problems participants have after receiving BAY3630942 and BAY3547922. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study interventions.The study participants will first receive BAY3547922 as an infusion into a vein followed by BAY3630942 as an injection into the same vein. Both interventions will be administered only once, on the same day.Each participant will be in the study for around 44 days with up to 7 visits to the study clinic which includes:* a visit up to 14 days before the start of the study to confirm if the participant can take part in the study.* up to 5 visits during the imaging intervention period. During this period, participants: * will receive the study interventions and have blood tests on the first visit, * will have imaging and blood tests on the next 3 visits. The tests scheduled for the second visit may be performed during the first visit. * may have blood tests on the last visit.* a follow-up visit to check their health after 30 days of receiving the study interventions.During the study, the doctors and their study team will:* check participants' health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)* track and study BAY3630942 using PET/CT imaging testsAs the study interventions are not yet treatments for liver cancer, access to BAY3630942 and BAY3547922 after the end of the study will not be required. ### Conditions - Hepatocellular Carcinoma (HCC) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - BAY3630942 - BAY3547922 ### Outcomes Primary Outcomes - Radioactivity concentration (SUVmean, %ID/g) of BAY3630942 in normal organs (including but not limited to kidney, spleen, liver, and bone marrow) as a function of time using 3 post-administration PET/CT scans - Zirconium-89 absorbed doses (mGy/MBq) in normal organs - Absorbed doses (mGy/MBq) from actinium-225 and daughter radionuclides in critical organs estimated Secondary Outcomes - Proportion and severity of adverse events (AEs) after administration of BAY3630942 and BAY3547922 - Cmax (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) - AUC (from zirconium-89 radioactivity concentration (Bq/g and %ID/kg) as a function of time in blood) - Cmax (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) - AUC (from plasma concentration of total antibody (mg/L and %ID/L) as a function of time) ### Location - Facility: HonorHealth, Scottsdale, Arizona, 85258, United States @@
## Physical and Functional Effects of Online Exercise Program on Musicians Playing Stringed Instruments - NCT ID: NCT06344988 - Study ID: 2023/41-10 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-01 - Lead Sponsor: Bandırma Onyedi Eylül University ### Study Description Musculoskeletal problems related to instrument playing or performance are frequently seen in musicians. Different interventions such as strength training, endurance training and yoga have been used in the management of these problems. The first specific exercise program for professional orchestra musicians was developed by Chan et al. However, it has been stated that it is difficult to encourage musicians' participation in exercise due to their constantly changing work schedules, and at this point, the use of digital media such as DVDs, USBs, and educational exercise videos may have a potential role.On the other hand, it has been stated that smart wearable devices with mobile applications (such as smart watches, smart band) as digital health interventions are an interesting, interactive and efficient psychological strategy to promote physical activity and can be used as an intervention to promote a healthy lifestyle. Based on the literature, in our study, the exercise program developed by Chan et al., will be done online via "Google Meet" and symptoms can be evaluated with objective evaluation methods. Unlike other studies using digital media, exercises will be performed synchronously and feedback will be given to the musicians simultaneously, as in face-to-face exercises. In addition, all participants will be given a smart band, they will be encouraged to use it until the end of the study, and the change in their physical activity levels will be evaluated. ### Conditions - Musculoskeletal Diseases or Conditions - Musculoskeletal Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The exercise program - Online education presentation - Smart band ### Outcomes Primary Outcomes - Musculoskeletal problems - Muscle oxygenation - Pressure pain threshold - Reaction time - Grip strength Secondary Outcomes - Upper extremity function - Physical activity level ### Location - Facility: Bursa Regional State Symphony Orchestra, Bursa, N/A, 16000, Turkey @@
## A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults - NCT ID: NCT06344975 - Study ID: Starna Therapeutics - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Starna Therapeutics ### Study Description This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B. ### Conditions - Respiratory Syncytial Virus Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - STR-V003/Placebo ### Outcomes Primary Outcomes - Immediate unsolicited AEs for 30 minutes post-vaccination - Solicited injection site (local) and systemic reactions for 7 days postvaccination. - Unsolicited AEs for 28 days postvaccination - Medically attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) for the entire study duration Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Effects of Absorbable and Non-absorbable Suture in Bronchial Sleeve Resection - NCT ID: NCT06344962 - Study ID: QYFYKYLL930611921 - Status: RECRUITING - Start Date: 2023-02-28 - Completion Date: 2025-12 - Lead Sponsor: The Affiliated Hospital of Qingdao University ### Study Description Bronchial sleeve resection is performed as an alternative to pneumonectomy for lung cancer patients with centrally located lesions and limited cardiopulmonary reserve. Intraoperative bronchial anastomosis is very complex and difficult, mainly due to the difficulty of suturing and knotting in limited space. There are currently few studies comparing the clinical effects of absorbable and non-absorbable suture in bronchial sleeve resection. So the investigator wants to conduct a prospective study, trying to figure out this problem. ### Conditions - Suture, Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Absorbable Suture - Non-absorbable Suture ### Outcomes Primary Outcomes - Incidence rate of anastomotic complications Secondary Outcomes - Time of bronchial anastomosis - Number of stitches - 5-year survival rate ### Location - Facility: the Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China @@
## Ciprofol Versus Propofol for Tracheal Intubation in ICU - NCT ID: NCT06344949 - Study ID: B2024-074 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients. ### Conditions - Emergency Tracheal Intubation in Critically Ill Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ciprofol - Propofol ### Outcomes Primary Outcomes - cardiovascular collapse within 30minutes from the start of the intubation procedure Secondary Outcomes - Success rate of sedation - Successful intubation on the first attempt - Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes) - The incidence of cardiac arrest within 30 minutes after tracheal intubation - The incidence of bradycardia within 30 minutes after tracheal intubation - The incidence of hypoxemia within 30 minutes after tracheal intubation - new requirement or increase of vasopressors - new requirement or increase of antiarrhythmic drugs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects - NCT ID: NCT06344936 - Study ID: HRS-1780-103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Shandong Suncadia Medicine Co., Ltd. ### Study Description The study was designed to evaluate the pharmacokinetic effects of itraconazole and rifampicin on HRS-1780 after oral administration of HRS-1780 tablets in healthy subjects ### Conditions - Chronic Kidney Disease(CKD) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HRS-1780 tablets; Itraconazole capsules; Rifampicin capsules ### Outcomes Primary Outcomes - Assess the Cmax of HRS-1780 in plasma. - Assess the Tmax of HRS-1780 in plasma. - Assess the t1/2 of HRS-1780 in plasma. - Assess the AUC0-t of HRS-1780 in plasma. - Assess the AUC0-inf of HRS-1780 in plasma. Secondary Outcomes - Assess the incidence and severity of adverse events in healthy subjects after administration of HRS-1780 tablets. ### Location - Facility: Beijing Hospital, Beijing, Beijing, 100730, China @@
## Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy - NCT ID: NCT06344923 - Study ID: KYLL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-09-01 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated. ### Conditions - Ileostomy - Stoma - Rectal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing - Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing ### Outcomes Primary Outcomes - postoperative complications related to ileostomy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC - NCT ID: NCT06344910 - Study ID: 20230416-C1_v2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description This is a prospective cohort study, where we aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands. ### Conditions - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies ### Outcomes Primary Outcomes - Use of guideline-directed medical therapy (GDMT) Secondary Outcomes - All-cause mortality - Hospitalisation for Heart Failure - other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) - renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Kinesio Taping in Pediatric Surgery - NCT ID: NCT06344897 - Study ID: mac1 - Status: COMPLETED - Start Date: 2024-02-25 - Completion Date: 2024-04-01 - Lead Sponsor: KTO Karatay University ### Study Description This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery. ### Conditions - Appendicitis - Surgery - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Kinesio taping ### Outcomes Primary Outcomes - Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery. - Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery. Secondary Outcomes - Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery ### Location - Facility: University of Health Sciences Konya Health Application and Research Center, Konya, Karatay, 42020, Turkey @@
## Early Patient Removal of Urinary Catheters After Urogynecologic Surgery - NCT ID: NCT06344884 - Study ID: 23-2619 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description Management of postoperative urinary retention often requires the use of indwelling catheters. In a previous study, the investigators determined that patient removal of catheters at home is non-inferior to standard office removal on postoperative day three or four (POD3-4). The purpose of this study is to determine whether patient removal of catheters at home on postoperative day one (POD1) is noninferior to removal on POD 3-4. ### Conditions - Urinary Retention Postoperative - Postoperative Urinary Tract Infection - Catheter Site Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Early catheter removal ### Outcomes Primary Outcomes - Number of patients with ongoing urinary retention (noninferiority) Secondary Outcomes - Number of patient contacts for voiding dysfunction by Type - Total patient contacts for voiding dysfunction Combined - Number of patients treated for postoperative UTI. - Number of patients with ongoing urinary retention - Patient Satisfaction Survey Score-Pain - Patient Satisfaction Survey Score-Ease of Use - Patient Satisfaction Survey Score-Satisfaction - Patient Satisfaction Survey Score-Likelihood to Use Again ### Location - Facility: UNC Health Rex, Raleigh, North Carolina, 27607, United States @@
## Exploratory Study Using a New Head-only PET Scanner / ExploreNeuroLF - NCT ID: NCT06344871 - Study ID: 002 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-11-30 - Lead Sponsor: Positrigo AG ### Study Description The "NeuroLF prototype" is a small aperture PET scanner. The NeuroLF prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the NeuroLF prototype without the need for an additional radioactive tracer dose.The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the NeuroLF prototype. ### Conditions - Brain Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - NeuroLF - Conventional PET scan ### Outcomes Primary Outcomes - PET Image of the Brain Secondary Outcomes - Ease of Placement (Usability) - Usage of accessories for patient placement (Usability) ### Location - Facility: University Hospital Leipzig, Leipzig, N/A, N/A, Germany @@
## Characterization of the Temporal Profile of the Anti-nociceptive Effect of Ketamine Bolus Measured With ANI - NCT ID: NCT06344858 - Study ID: 124/2021 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-12-31 - Lead Sponsor: Pontificia Universidad Catolica de Chile ### Study Description Ketamine, an intravenous anesthetic, and analgesic agent has experienced a resurgence in its clinical application, particularly in subanesthetic doses. The aim of this observational study is to characterize the changes in the Nociception Analgesia Index (ANI) associated with the administration of an intravenous ketamine bolus using a Pharmacokinetic-Pharmacodynamic (PKPD) modeling approach. The pharmacokinetic parameters of the Domino model will be used to predict ketamine plasma concentrations after the bolus dose. An Emax model and a link model assuming a first order rate constant (ke0) will be used to fit the data. Modeling analysis will use the program NONMEM. It is expected to recruit a total of 20 patients between 40 and 80 years, ASA I, II or III, programmed for elective surgery with general anesthesia. ANI values will be recorded every 6 seconds for 5 minutes from the bolus dose. ### Conditions - Analgesia - Ketamine - Pharmacokinetic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ketamine ### Outcomes Primary Outcomes - To measure ANI values after ketamine bolus dose administration. - To determine the time maximum predicted concentrations in each patient - To determine the time to maximum effect of a bolus dose of ketamine - To predict ketamine plasma concentrations values after ketamine bolus - To calculate the difference between the time of maximum ANI effect Secondary Outcomes - Patient weight ### Location - Facility: Pontificia Universidad Catolica de Chile, Santiago, Metropolitana, 450881, Chile @@
## Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases - NCT ID: NCT06344845 - Study ID: PUMCH-NM-PBB3 - Status: RECRUITING - Start Date: 2022-11-01 - Completion Date: 2025-11 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through \[18F\]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of \[11C\]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications. ### Conditions - Neurodegenerative Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 18F-PBB3 PET/CT scan ### Outcomes Primary Outcomes - Diagnostic Performance Secondary Outcomes - Clinical Stage ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## SSTR PET/CT for Preoperative N Stage Evaluation in GEP-NETs - NCT ID: NCT06344832 - Study ID: K5098 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-03-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description The research aims to prospectively include patients with GEP-NENs, undergo preoperative imaging assessment (including PET/CT and contrast-enhanced CT), and accurately delineate lymph node regions. Through postoperative pathological reports, the diagnostic performance of lymph node metastasis (LNM) in GEP-NENs is evaluated. Factors influencing the diagnostic accuracy of SSTR-PET/CT and contrast-enhanced CT are also investigated. ### Conditions - Gastro-entero-pancreatic Neuroendocrine Tumor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - lymph node metastasis status Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Acupuncture Study for People At High Risk for Sepsis - NCT ID: NCT06344819 - Study ID: 24-062 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2028-03-20 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture. ### Conditions - Sepsis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture - Sham Acupuncture ### Outcomes Primary Outcomes - Number of participants recruited compared to the number of participants who complete study treatment. Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States @@
## The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women - NCT ID: NCT06344806 - Study ID: oyunlastirmabeslenme - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-05-30 - Lead Sponsor: Lokman Hekim Üniversitesi ### Study Description Objective: This study was conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.Method: This study is a randomized controlled pretest-posttest parallel group experimental study, and 28 women included in the experimental group and 28 women in the control group. In the study, "Sociodemographic Information Form", "Breastfeeding Self-Efficacy Scale Short Form-Antenatal Form (BSES-SF), ", "Infant Nutrition Attitude Scale (IOWA)" Form was used. The data analyzed in SPSS program.Breastfeeding education content integrated into the game program designed with the gamification technique. A training program was applied to the women in the experimental group in the last trimester. Women in the control group received the standard breastfeeding training in the hospital. Measurement tools was applied to all participants before and after the training.Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. In this study, it is found that breastfeeding education given through gamification have a positive effect on breastfeeding self-efficacy and infant feeding attitudes of pregnant women. ### Conditions - Breastfeeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Gamified Breastfeeding Education ### Outcomes Primary Outcomes - breastfeeding self-efficacy - infant feeding attitudes Secondary Outcomes ### Location - Facility: Lokman Hekim University, Ankara, N/A, N/A, Turkey @@
## Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer - NCT ID: NCT06344793 - Study ID: YOUNGBC-30 - Status: RECRUITING - Start Date: 2023-05-20 - Completion Date: 2024-11-01 - Lead Sponsor: Fudan University ### Study Description A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PFS Secondary Outcomes - OS ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Abemaciclib, Palbociclib or Dalpiciclib Combined With Endocrine Therapy as First-line Treatment in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer - NCT ID: NCT06344780 - Study ID: YOUNGBC-28 - Status: RECRUITING - Start Date: 2023-05-20 - Completion Date: 2024-11-01 - Lead Sponsor: Fudan University ### Study Description A multi-center, real world study to evaluate the clinical outcomes and safety of Abemaciclib, Palbociclib or Dalpiciclib combined with endocrine therapy as first-line treatment in HR Positive, HER2 Negative unresectable or metastatic Breast Cancer. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PFS Secondary Outcomes - OS ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Positive ER Expression Assessed by 18F-FES PET/CT in the MBC With ER-negative Primary Tumor - NCT ID: NCT06344767 - Study ID: YOUNGBC-27 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-05-05 - Lead Sponsor: Fudan University ### Study Description To investigate the treatment pattern and efficacy of patients with negative primary ER lesion but positive ER expression in MBC using a novel convenient way of 18F-fluoroestradiol positron emission tomography/computed tomography (18F-FES PET/CT). ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Adverse events ### Location - Facility: China,Shanghai, Shanghai, Shanghai, 200032, China @@
## Gamification in Family Planning Education: Impact on University Students - NCT ID: NCT06344754 - Study ID: gamifiedfamilyplanning - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-04-15 - Lead Sponsor: Lokman Hekim Üniversitesi ### Study Description More than 3 billion of the worlds population are young people under the age of 25. According to WHO data, one million girls under the age of 15 give birth each year, mostly in low- and middle-income countries, and 3 million adolescent girls between the ages of 15 and 19 are exposed to unsafe abortions. Failure to meet the family planning needs of young people in a timely, adequate and appropriate manner can have significant public health impacts. According to World Health Statistics, the global birth rate for girls between 15 and 19 years of age is 49 out of 1000, and early pregnancy and childbirth can lead to serious health and social problems. In addition, this age group does not have sufficient information about pregnancy and its complications, and their access to and utilization of health services is low. Inadequacies in the education of adolescents on sexual issues and sociocultural differences further increase the sexual and reproductive health risks of young people in the university period. Information and services that will enable individuals to understand their sexuality and help them protect themselves from sexual risks should be provided specifically for that age. Therefore, it is important for young people to know family planning methods. In this study, it was aimed to examine the effect of family planning education to be given with gamification method, which is different from the classical method in the literature, on the knowledge and attitudes of university students. ### Conditions - Gamification - Reproductive Health - Family Planning - Students ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Gamified education ### Outcomes Primary Outcomes - Knowledge and attitude towards family planning Secondary Outcomes ### Location - Facility: Lokman Hekim University, Ankara, N/A, 06300, Turkey @@
## Consequences of Admission to the Delivery Room in the Early and Late Phases - NCT ID: NCT06344741 - Study ID: sdilek6 - Status: RECRUITING - Start Date: 2023-11-13 - Completion Date: 2024-05-31 - Lead Sponsor: Kocaeli University ### Study Description This study will be conducted to compare maternal and neonatal outcomes of pregnant women who applied to the delivery room in the early (latent) and late (active) phase. The population of the research will consist of participants who applied to Darıca Farabi Training and Research Hospital for birth. To determine the sample size of the study, first, those who meet the inclusion criteria and are admitted to the delivery room in the latent phase and those who are accepted in the active phase will be numbered and recruited sequentially. When the number of participants in the 100 latent and 100 active acceptance groups is reached, the effect size will be calculated using the STAI score averages and the G\Power program, and the exact sample number will be determined, taking into account possible data losses. If necessary, data collection will continue until the target number is reached. Randomization will not be applied in the study. Data will be collected with the maternal and neonatal information form, State and Trait Anxiety Scale (STAI), Fear of Birth Scale, Neonatal Pain and Stress Assessment Scale (ALPS-Neo) and Visual analog scale for birth satisfaction. Data will be collected by the assistant researcher. Statistical analysis will be performed using IBM SPSS Statistic. Descriptive statistical methods will be used to evaluate socio-demographic data, and parametric/nonparametric tests will be used for comparative analyses. ### Conditions - Fear of Childbirth - Neonatal - Pain - Maternal Distress (During Labor) - Satisfaction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Accepted in latent phase - Accepted in active phase ### Outcomes Primary Outcomes* - Neonatal pain and stress - Birth satisfaction Secondary Outcomes - Maternal Anxiety - Fear of Birth ### Location - Facility: Kocaeli University, Kocaeli, N/A, 41380, Turkey @@
## A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants - NCT ID: NCT06344728 - Study ID: INS1007-110 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-05-21 - Lead Sponsor: Insmed Incorporated ### Study Description The primary purpose of this study is to determine the relative bioavailability of brensocatib between the pediatric oral solution and oral tablets in healthy participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Brensocatib Oral Solution - Brensocatib Oral Tablet ### Outcomes Primary Outcomes - Relative Bioavailability Between Brensocatib Pediatric Oral Solution and Oral Tablets for Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC∞) of Brensocatib in Plasma Secondary Outcomes - Number of Participants who Experienced at Least one Adverse Event (AE) - Concentration of Brensocatib in Plasma ### Location - Facility: USA001, Dallas, Texas, 75230, United States @@
## Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. - NCT ID: NCT06344715 - Study ID: SL-T10-001_P1 - Status: RECRUITING - Start Date: 2022-10-17 - Completion Date: 2024-10-31 - Lead Sponsor: SL VAXiGEN ### Study Description The purpose of this study is to evaluate the efficacy and safety of SL-T10 and GX-I7 or SL-T10, GX-I7 and pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC). ### Conditions - Metastatic Castration-resistant Prostate Cancer (mCRPC) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SL-T10 - GX-I7 - Pembrolizumab ### Outcomes Primary Outcomes - Number of participants with treatment-emergent adverse events (TEAEs) - Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 Secondary Outcomes - PSA response rate - PSA progression free survival - Radiographic progression free survival - Change of induced T-cell responses for SL-T10 vaccine ### Location - Facility: Seoul National University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## The Effect of CPAP on Maternal and Infant Outcomes in Pregnant Women With OSAS - NCT ID: NCT06344702 - Study ID: 2024PHB065-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Peking University People's Hospital ### Study Description The goal of this clinical trial is to learn about the impact of CPAP on the maternal and infant outcomes of women with obstructive sleep apnea syndrome. The main questions aim to answer are:\[question 1\]Explore the impact of different CPAP treatment times on the maternal and infant outcomes of pregnant women with combined OSAS; \[question 2\]Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women.The CPAP treatment group received standardized CPAP treatment and routine prenatal care, while the non CPAP treatment group and non OSAS group only received routine prenatal care. ### Conditions - Maternal Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CPAP ### Outcomes Primary Outcomes - Explore the effects of CPAP on placental weight and birth weight/placental weight ratio in OSAS pregnant women. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Surgical Correction of Cicatricial Ectropion - NCT ID: NCT06344689 - Study ID: SH9H-2023-T477 - Status: COMPLETED - Start Date: 2023-12-12 - Completion Date: 2024-03-27 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description The main purpose of this study is to verify and compare the treatment effects of scarred ectropion surgery, perform statistical descriptions, compare patients undergoing tarsal strip and skin flap procedures with those undergoing simple skin flap treatment, and compare their pre- and post-operative Ectropion Grading Scale (EGS) and subjective and objective symptom changes.Secondary Objective: To observe the incidence and resolution of complications after lower eyelid ectropion surgery. Compare postoperative effects among patients of different ages undergoing the same surgery. ### Conditions - Patients With Cicatricial Ectropion - Over 18-year-old - With Complete Clinical Record ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgical treatment ### Outcomes Primary Outcomes - Ectropion Grading Scale Secondary Outcomes ### Location - Facility: Shanghai ninth people's hospital, Shanghai, N/A, 200011, China @@
## Study of the Impact of a Social Robot on Unwanted Loneliness in Elderly People Living in Nursing Homes - NCT ID: NCT06344676 - Study ID: FSIE2024Robot - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-30 - Lead Sponsor: Sara Domenech ### Study Description The goal of this clinical trial is to assess the usefulness of social robots reducing unwanted loneliness in persons over 65 living in nursing homes. The main questions it aims to answer are:* Can social robots reduce unwanted loneliness?* Can social robots improve quality of live and well-being? The selected centers are organized in several classes of living units. Living units are independent physical spaces with their own common facilities for the persons living in (usually around 15). Living units of the same class gather persons with similar characteristics.To compare the added value of the robots half of the living units will be allocated to a control group, and the other half to the intervention group.The persons in living units allocated to the control group will receive the same attentions and care which were receiving before the enrollment in the study, whereas the persons allocated to the intervention group will add a social robot to their usual therapies and activities. Namely participants will do three weekly individual cognitive stimulation sessions of 10 minutes each one, two weekly group mobility sessions of 30 minutes, one monthly conversational group about customs and traditions of 60 minutes, one 10 minutes videoconference per month with their relatives. Furthermore, participants will be able to interact freely with the robot to obtain information about the center (for instance, what is for dinner) and its activities.The intervention will last 8 weeks. To assess the effectivity, the investigators will assess both groups, before the intervention, at the end of the intervention and 4 weeks after finishing the intervention. ### Conditions - Elderly People - Nursing Home Residents - Loneliness - Quality of Life - Wellbeing - Social Interaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Cognitive - Mobility - Social - Relational - Usual Care ### Outcomes Primary Outcomes - Loneliness Secondary Outcomes - Well-being - Quality of life, irrespective of the disease - Satisfaction with life - Depressive symptoms - Social Support - Communication ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Motivational Interviewing Inadequate Milk and Cortisol - NCT ID: NCT06344663 - Study ID: KSIU-SBF-ES-02 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-12-25 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description Motivational interviewing is a technique used in many fields. No study has been found in national and international databases investigating the effect of motivational interviewing on the perception of insufficient milk, breastfeeding motivation and cortisol level. The study aimed to evaluate the effect of motivational interviews on the perception of insufficient milk, breastfeeding motivation and cortisol level. ### Conditions - Motivation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - motivational interview ### Outcomes Primary Outcomes - Insufficient Milk Perception Scale (ANN) Secondary Outcomes - Breastfeeding Motivation Scale (EMS) ### Location - Facility: Eda Sever, Kahramanmaraş, Onikişubat, 46370, Turkey @@
## Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study - NCT ID: NCT06344650 - Study ID: RF-2021-12373584 - Status: RECRUITING - Start Date: 2023-09-28 - Completion Date: 2024-07 - Lead Sponsor: IRCCS San Raffaele ### Study Description Prospective observational clinical, molecular, translational and basic study aimed at identifying the main determinants and predictive factors of risk of bone damage in acromegaly patients ### Conditions - Acromegaly - Bone Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample ### Outcomes Primary Outcomes - Identify the rate of morphometric vertebral fractures in acromegalic patients Secondary Outcomes ### Location - Facility: Andrea Giustina, Milan, N/A, 20132, Italy @@
## Effects of Cervical Lidocaine Spray on Pain Relief During Manual Vacuum Aspiration - NCT ID: NCT06344637 - Study ID: 2566/081 I - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-14 - Completion Date: 2024-07-30 - Lead Sponsor: UdonThani Hospital ### Study Description This randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration ### Conditions - Pain, Procedural - Lidocaine - Obstetric Surgical Procedures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 10 % lidocaine spray without adrenaline - Placebo ### Outcomes Primary Outcomes - pain score during manual vauum aspiration - pain score after manual vauum aspiration Secondary Outcomes ### Location - Facility: UdonThani Hospital, Udon Thani, UdonThani, 41000, Thailand @@
## The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students - NCT ID: NCT06344624 - Study ID: Mersin_U - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-02-01 - Lead Sponsor: Mersin University ### Study Description The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - CBT group - Laughter group ### Outcomes Primary Outcomes - The change in mental symptoms will be assessed using the Brief Symptom Inventory. Secondary Outcomes - Psychological resilience will be assessed using the Psychological Resilience Scale. - Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale. ### Location - Facility: Turkey, Mersin University, Mersin, N/A, 33180, Turkey @@
## Incidence & Predictive Factors of Recompensation in Children With Decompensated Cirrhosis as Per the Baveno VII Criteria - NCT ID: NCT06344611 - Study ID: ILBS-DCLD-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-07 - Completion Date: 2026-03-31 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description Cirrhosis is a leading cause of morbidity and mortality world- wide and can develop on the basis of repetitive and/or chronic liver injury due to toxic, infectious, metabolic and genetic pathogenic factors. Traditionally, the natural history of cirrhosis has often been considered a one-way street, with a definite and irreversible progression from a compensated to a decompensated disease stage. But recent data has shown that if the underlying etiology can be successfully treated, cirrhosis can regress and recompensation of liver disease can occur. Hence, in this study we want to evaluate the incidence and predictive factors of recompensation in pediatric subjects with decompensated cirrhosis as per the Baveno VII criteria. We would also evaluate the predictive factors of recompensation in pediatric decompensated chronic liver disase (DCLD) subjects and would explore systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in pediatric subjects with decompensated cirrhosis. ### Conditions - Decompensated Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Other ### Outcomes Primary Outcomes - To determine the incidence of recompensation in pediatric subjects with decompensated cirrhosis as per Baveno VII criteria Secondary Outcomes - To evaluate the predictive factors of recompensation in pediatric DCLD subjects - To investigate the systemic and intestinal inflammatory markers as possible biomarkers for predicting recompensation in in pediatric subjects with decompensated cirrhosis. - To assess incidence of re-decompensation in patients with recompensation. ### Location - Facility: Institute of Liver and Biliary Sciences, New Delhi, Delhi, 110070, India @@
## Identification and Assessment of Risk Factors for the Development of Osteoporosis in Adults and Children Living in the Abay Region of the Republic of Kazakhstan Using the Method of Dual-energy X-ray Absorptiometry and Clinical and Epidemiological Research - NCT ID: NCT06344598 - Study ID: 0123РК00314 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-12-31 - Lead Sponsor: Semey State Medical University ### Study Description A survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. Diagnosis of osteoporosis by dual-energy X-ray absorptiometry. Conducting a correlation analysis of the relationship of the data obtained. ### Conditions - Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults - to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination - to assess the state of BMD in adults using X-ray absorptiometry (DXA) - To carry out a correlation analysis of the relationship between the obtained data in adults of the Abay region of of the Republic of Kazakhstan Secondary Outcomes ### Location - Facility: Semey Medical University, Semey, N/A, 071400, Kazakhstan @@
## Drop-out of Infertile Couples: a Large Single Center Experience Over 10 Years - NCT ID: NCT06344585 - Study ID: DROPOUT - Status: COMPLETED - Start Date: 2012-01-01 - Completion Date: 2023-07-31 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description Conducted at a single-center, this prospective-retrospective study focused on all couples who initiated their journey at the Fertility Center of Humanitas Research Hospital, Rozzano (Milan), Italy.The prospective study focused on the couples whose first consultation occurred in 2021. A tailored questionnaire was administered via telephone by staff members to gather insights into the personal reasons for treatment discontinuation among non-returning patients.Conversely, the retrospective study included all infertile couples initiating treatment between January 2012 and December 2021 at the Fertility Center. Data encompassing personal history and demographic details were extracted from the internal database of Humanitas Fertility Center to assess the factors involved in a treatment discontinuation. ### Conditions - Infertility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Drop out patients who had their first access in 2021 were additionally asked to answer to a phone -call questionnaire to assess their motivation of discontinuation ### Outcomes Primary Outcomes - Dropout rate Secondary Outcomes - Reasons for dropout collected by a phone call questionnaire ### Location - Facility: Istituto Clinico Humanitas, Rozzano, Milano, 20089, Italy @@
## Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia - NCT ID: NCT06344572 - Study ID: SAT001-KP-002 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2025-09-30 - Lead Sponsor: S-Alpha Therapeutics, Inc. ### Study Description The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SAT-001 - Single vision spectacles ### Outcomes Primary Outcomes - Change in Cycloplegic Spherical Equivalent Refractive Error Secondary Outcomes - Change in Cycloplegic Spherical Equivalent Refractive Error - Change in Axial Length - Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia) - Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia) ### Location - Facility: Gachon University Gil Hospital, Incheon, N/A, N/A, Korea, Republic of @@

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