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## Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability - NCT ID: NCT06390072 - Study ID: 23-X-71 - Status: COMPLETED - Start Date: 2023-09-25 - Completion Date: 2023-11-27 - Lead Sponsor: Ohio University ### Study Description This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance. ### Conditions - Ankle Sprains - Motor Coordination or Function; Developmental Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Self-Hypnosis - Ankle Education ### Outcomes Primary Outcomes - Balance test 1 - Balance test 2 - Heart rate variability Secondary Outcomes - Ankle disability measure 1 - Ankle disability measure 2 - Interoceptive awareness measure 1 - Interoceptive awareness measure 2 - Emotional Distress-Anxiety - Kinesiophobia - Pain self-efficacy ### Location - Facility: Ohio University, Athens, Ohio, 45701, United States @@
## EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06390059 - Study ID: EF-39 - Status: RECRUITING - Start Date: 2023-08-28 - Completion Date: 2026-08 - Lead Sponsor: NovoCure GmbH ### Study Description The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy. ### Conditions - Metastatic Pancreatic Ductal Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tumor Treating Fields - Atezolizumab - Gemcitabine - nab-paclitaxel ### Outcomes Primary Outcomes - Disease control rate (DCR) Secondary Outcomes - Overall survival (OS) - Progression-free survival (PFS) - 1-Year survival rate - Objective response rate (ORR) - Progression free survival at 6 months (PFS6) - Duration of response (DOR) - Rate of of patients with treatment emergent adverse events ### Location - Facility: University Hospital Vall d'Hebron, Barcelona, N/A, 08035, Spain @@
## Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery - NCT ID: NCT06390046 - Study ID: 1072.6120.135.2023 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-12-31 - Lead Sponsor: Jagiellonian University ### Study Description Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient. ### Conditions - Analgesics, Opioid - Anesthesia; Adverse Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intubation - TIVA versus Inhalation ### Outcomes Primary Outcomes - compare the effectiveness of analgesia - determine whether modern technologies such as videolaryngoscopy shorten intubation time. Secondary Outcomes - incidence of postoperative nausea and vomiting ### Location - Facility: Jagiellonian University, Kraków, Malopolskie, 31501, Poland @@
## Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities - NCT ID: NCT06390033 - Study ID: ITS/133/21 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-06-30 - Completion Date: 2024-06-30 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are:1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities?2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market?Participants will be asked to do1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot.2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.3. Participants will be required to perform the Berg Balance Test.4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz.5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis.6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing.7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire. ### Conditions - Amputation - Prosthesis User ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prosthetic foot ### Outcomes Primary Outcomes - Basic mobility function with two prostheses by Berg Balance Test - Basic mobility function with two prostheses by Time to Go Up - Basic mobility function with two prostheses by Four Square Step Test - Basic mobility function with two prostheses by 10-meter Walk Test - Stability index with two prostheses by Eye Close Standing - Stability index with two prostheses by Tandem Test - Functional Reach Test - Gait symmetry analysis of lower limb joint angle - Gait symmetry analysis of lower limb joint power - Gait symmetry analysis of lower limb joint moment - Walking feasibility with two prostheses - Jump feasibility with two prostheses - Subjective evaluation by Locomotion Capabilities Index questionnaire Secondary Outcomes ### Location - Facility: The Hong Kong Polytechnic University, Kowloon, N/A, 999077, Hong Kong @@
## Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study - NCT ID: NCT06390020 - Study ID: NL84880.091.23 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-12 - Lead Sponsor: Radboud University Medical Center ### Study Description This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group.The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores. ### Conditions - Sensory Processing Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MBSR ### Outcomes Primary Outcomes - Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress Secondary Outcomes - Change from Baseline to Post-intervention in self-reported well-being - Change from Baseline to Post-intervention in self-reported burnout symptoms - Change from Baseline to Post-intervention in self-reported physical symptoms - Change from Baseline to Post-intervention in self-reported overstimulation - Change from Baseline to Post-intervention in self-reported mindfulness - Change from Baseline to Post-intervention in self-reported attention regulation - Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation - Change from Baseline to Post-intervention in self-reported body awareness - Change from Baseline to Post-intervention in self-reported self-compassion - Change from Baseline to Post-intervention in self-reported sensory processing sensitivity - Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training ### Location - Facility: The Radboudumc Center for Mindfulness, Nijmegen, Gelderland, 6525 GC, Netherlands @@
## The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital - NCT ID: NCT06390007 - Study ID: 24916 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Indonesia University ### Study Description Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use. ### Conditions - Pain, Postoperative - Pediatric Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sham press needle - Press needle acupuncture ### Outcomes Primary Outcomes - Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale - Numeric Rating Scale (NRS) pain scale Secondary Outcomes ### Location - Facility: RSUPN Dr. Cipto Mangunkusumo, Jakarta Pusat, DKI Jakarta, 10430, Indonesia @@
## Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy - NCT ID: NCT06389994 - Study ID: 23-021041 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-01 - Lead Sponsor: Children's Hospital of Philadelphia ### Study Description Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits. ### Conditions - Eosinophilic Esophagitis (EoE) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Esophageal String Test ### Outcomes Primary Outcomes - Esophageal String Test Secondary Outcomes - Prevalence of Eosinophilic Esophagitis - Eosinophilic Esophagitis Symptoms ### Location - Facility: The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States @@
## Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening - NCT ID: NCT06389981 - Study ID: 1692052 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-30 - Lead Sponsor: VA Boston Healthcare System ### Study Description Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Veterans peer connect Program ### Outcomes Primary Outcomes - Lung Cancer Screening Uptake Secondary Outcomes - Tobacco cessation Treatment - Stigma Related to Smoking - Perceived support from peer - Lung Cancer Screening Knowledge - Lung Cancer Screening Fatalism - Trust in VA - Lung Cancer Self-efficacy - General Cancer Self-efficacy - Intention to engage in shared decision making - Motivation to quit smoking - Intention to undergo lung cancer screening ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis - NCT ID: NCT06389968 - Study ID: 2023-491-S-KH - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-12-31 - Lead Sponsor: Technical University of Munich ### Study Description The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis (pwMS) following optic neuritis (neuritis nervi optici, NNO) by means of a light stimulation.In the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 pwMS following recent NNO (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (n=25), the spontaneous course after NNO will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity (LCVA), the P100 conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography (OCT) and OCT angiography (OCTA). These physiological parameters should help to understand the underlying processes of a potentially altered visual performance. ### Conditions - Multiple Sclerosis, Relapsing-Remitting - Optic Neuritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Light stimulation - Sham light stimulation ### Outcomes Primary Outcomes - High contrast visual sensitivity Secondary Outcomes - Low contrast visual sensitivity - VEP - OCT - OCT Angiography - Color contrast ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654 - NCT ID: NCT06389955 - Study ID: TP-3654-103 - Status: COMPLETED - Start Date: 2023-05-22 - Completion Date: 2023-08-24 - Lead Sponsor: Sumitomo Pharma America, Inc. ### Study Description This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation. ### Conditions - Effect of Drug ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - TP 3654 ### Outcomes Primary Outcomes - Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation - Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation - Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions - Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation Secondary Outcomes - Number of participants with Treatment Emergent Adverse Events (TEAE) ### Location - Facility: Frontage Investigative Site, Secaucus, New Jersey, 07094, United States @@
## Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject - NCT ID: NCT06389942 - Study ID: 9MW3011-2022-CP101 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-10 - Completion Date: 2024-04 - Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. ### Study Description The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 9MW3011 - 9MW3011 placebo ### Outcomes Primary Outcomes - Adverse Event(including serious adverse event) Secondary Outcomes - Number of subjects with abnormal vital signs - Number of subjects with abnormal clinically significant results from physical examination - Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters - Number of subjects with abnormal clinically significant clinical laboratory results - Cmax - AUC0-t - AUC0-∞ - Tmax - λz - t1/2z - Vz - CL - MRT - Pharmacodynamic(PD)parameters-hepcidin - PD parameters-serum iron - PD parameters-TSAT - Anti-drug antibodies(ADA) ### Location - Facility: PKUcare Luzhong Hospital, Zibo, Shandong, N/A, China @@
## Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs? - NCT ID: NCT06389929 - Study ID: IU-HB-RK-02 - Status: COMPLETED - Start Date: 2023-10-30 - Completion Date: 2024-01-28 - Lead Sponsor: Inonu University ### Study Description Purpose: This study aimed to examine the effect of health education material developed by nursing students in gynecological health and disease nursing on students' teaching material motivation and material design self-efficacy belief.Method: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control.In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data. ### Conditions - Nursing Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Education ### Outcomes Primary Outcomes - Instructional Material Motivation Scale Secondary Outcomes - Material Design Self-Efficacy Belief Scale ### Location - Facility: Simge OZTURK, Bartin, None Selected, 74100, Turkey @@
## Euclid Phoenix Lens Design Trial - NCT ID: NCT06389916 - Study ID: EU-PHX-RCT-001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-04 - Lead Sponsor: Euclid Systems Corporation ### Study Description The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children. ### Conditions - Myopia - Cornea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Euclid orthokeratology MAX (current design) - Euclid orthokeratology MAX Phoenix (new design) ### Outcomes Primary Outcomes - First fit success rate Secondary Outcomes ### Location - Facility: Insight Vision Center Optometry, Costa Mesa, California, 92626, United States @@
## Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease - NCT ID: NCT06389903 - Study ID: 2018-A00185-50 - Status: COMPLETED - Start Date: 2019-06-04 - Completion Date: 2021-10-05 - Lead Sponsor: Centre Hospitalier du Rouvray ### Study Description This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21). ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - assessment ### Outcomes Primary Outcomes - Assessment of change of mania symptoms Secondary Outcomes - Assessment of change of depressive symptoms - Assessment of change of Behavior - Assessment of change of Impulsivity - Assessment of change of Apathy - Assessment of personality - Assessment of executive functions - Assessment of confusion ### Location - Facility: Marie Desbordes, MD, Sotteville Les Rouen, N/A, 76300, France @@
## Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy - NCT ID: NCT06389890 - Study ID: PaSuTE - Status: COMPLETED - Start Date: 2010-01-01 - Completion Date: 2019-12-31 - Lead Sponsor: Richard Hunger ### Study Description The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed. ### Conditions - Volume-Outcome Relationship in Pancreatic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pancreatic resection procedure ### Outcomes Primary Outcomes - In-hospital mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD) - NCT ID: NCT06389877 - Study ID: BTX-302-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-08 - Lead Sponsor: Beam Therapeutics Inc. ### Study Description This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD). ### Conditions - Alpha 1-Antitrypsin Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BEAM-302 ### Outcomes Primary Outcomes - Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) - Phase 2 Dose Expansion: Absolute blood levels of total AAT Secondary Outcomes - Phase 1 Dose Exploration: Absolute blood levels of total AAT - Phase 2 Dose Expansion: Rates of TEAEs and SAEs ### Location - Facility: Clinical Study Center, London, N/A, N/A, United Kingdom @@
## rTMS in Children and Adolescents With ADHD: - NCT ID: NCT06389864 - Study ID: rTMS in ADHD - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: Assiut University ### Study Description Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - rTMS (repetitive transcranial magnetic stimulation) ### Outcomes Primary Outcomes - The resting motor threshold (RMT) - Arabic version Conners' Parent Rating Scale - Revised Long form - Clinical Global Impression CGI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD - NCT ID: NCT06389851 - Study ID: NAFLD-LYCOPENE - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2025-05-20 - Lead Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis ### Study Description The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;* intestinal barrier;* body composition;* intestinal microbiota;* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. ### Conditions - NAFLD - IBS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Case Group - Tomato-free diet - Experimental: Case group - Diet enriched with tomatoes ### Outcomes Primary Outcomes - The effect of intervention on CAP value (Controlled Attenuation Parameter) - The effect of intervention on FLI value (fatty liver index) - The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis - The effect of the intervention on the integrity of the intestinal barrier - The effect of the intervention on the microbiota Secondary Outcomes ### Location - Facility: Irccs Saverio de Bellis, Castellana Grotte, Bari, 70013, Italy @@
## RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application - NCT ID: NCT06389838 - Study ID: DINKS01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2024-12-01 - Lead Sponsor: Kranus Health GmbH ### Study Description This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes. ### Conditions - Urinary Incontinence,Stress - Urinary Incontinence, Urge - Urinary Incontinence - Overactive Bladder Syndrome - Female Urinary Stress Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kranus Mictera ### Outcomes Primary Outcomes - Incontinence episodes Secondary Outcomes - ICIQ-SF - I-QoL - PAM-13 - PGI-I - Cured patients - Urinary frequency day - Urinary frequency night - Pad use - Urge incontinence - Functional bladder capacity - Body weight - Treatment Failure ### Location - Facility: Kranus Health Gmbh, München, N/A, 80331, Germany @@
## Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia. - NCT ID: NCT06389825 - Study ID: FH-Diet-RX - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: Laval University ### Study Description The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome. ### Conditions - Familial Hypercholesterolemia - Nutrition, Healthy - Cholesterol, Elevated ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Healthy diet ### Outcomes Primary Outcomes - Post-diet differences in LDL-C levels. Secondary Outcomes - Post-diet differences in plasma metabolomics profiles ### Location - Facility: INAF-NUTRISS Université Laval, Québec, N/A, G1V0a6, Canada @@
## Dual-task Exercise in People With Cognitive Impairment - NCT ID: NCT06389812 - Study ID: LoughboroughUni - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-30 - Completion Date: 2024-09-30 - Lead Sponsor: Loughborough University ### Study Description The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\<10) will be removed from the study. ### Conditions - Dementia - Mild Cognitive Impairment - Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dual-task exercise traning ### Outcomes Primary Outcomes - BDNF serum level Secondary Outcomes - Visual screening ### Location - Facility: Loughborough University, Loughborough, Leicestershire, LE11 3TU, United Kingdom @@
## A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) - NCT ID: NCT06389799 - Study ID: PERELI - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2028-12-31 - Lead Sponsor: Lund University Hospital ### Study Description Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment. ### Conditions - Dedifferentiated Liposarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pemigatinib - Retifanlimab ### Outcomes Primary Outcomes - To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS Secondary Outcomes - To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS - To evaluate the safety and tolerability of pemigatinib and retifanlimab - To evaluate impact of treatment and disease status on quality of life - To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity ### Location - Facility: Oslo University Hospital HF, Oslo, N/A, N/A, Norway @@
## Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer - NCT ID: NCT06389786 - Study ID: MC230504 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2026-05 - Lead Sponsor: Mayo Clinic ### Study Description This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy. ### Conditions - Localized Prostate Carcinoma - Oligometastatic Prostate Carcinoma - Stage I Prostate Cancer AJCC v8 - Stage II Prostate Cancer AJCC v8 - Stage III Prostate Cancer AJCC v8 - Stage IVA Prostate Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Bilateral Pelvic Lymph Node Dissection - Biospecimen Collection - Bone Scan - Computed Tomography - Electronic Health Record Review - Flotufolastat F-18 Gallium - Laparoscopic Radical Prostatectomy with Robotics - Magnetic Resonance Imaging - Positron Emission Tomography ### Outcomes Primary Outcomes - Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis Secondary Outcomes - Specificity - Positive/negative predictive value - Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20 - Gleason score - Digital rectal examination - Number of patients where management has changed - Rates of biochemical recurrent disease (BCR) ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States @@
## Teamwork for Resilient Staff and Safe Care in ICU - NCT ID: NCT06389773 - Study ID: 302958 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-02 - Completion Date: 2025-09-30 - Lead Sponsor: King's College London ### Study Description The goal of this ethnographic study is to observe how healthcare professionals work together in an intensive care unit (ICU). The main questions it aims to answer are* How do healthcare staff work together in everyday ICU settings?* What helps people work together in ICUs?* What challenges do staff face in working together in ICUs?* How have teamwork practices changed since the COVID-19 pandemic?Researchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork. ### Conditions - Teamwork ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Examine the changing nature of teamwork in ICUs in the post-pandemic context Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer - NCT ID: NCT06389760 - Study ID: IST-Nim-PC-16 - Status: RECRUITING - Start Date: 2023-10-18 - Completion Date: 2026-09-30 - Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School ### Study Description This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nimotuzumab - mFOLFIRINOX ### Outcomes Primary Outcomes - disease-free survival (DFS) Secondary Outcomes - distant metastasis-free survival (DMFS) - overall survival (OS) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire pancreatic cancer 29 (EORTC-QLQ-PAN26) - tumor-related markers - adverse events ### Location - Facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210008, China @@
## Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness - NCT ID: NCT06389747 - Study ID: OU - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-06-15 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned. ### Conditions - Pain Intensity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BFR technique ### Outcomes Primary Outcomes - Visual analog scale - myoton - dynamometer - dolorimeter Secondary Outcomes ### Location - Facility: Gamze Aydın, Istanbul, N/A, 34940, Turkey @@
## Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF - NCT ID: NCT06389734 - Study ID: B-ER-111-470 - Status: COMPLETED - Start Date: 2023-03-02 - Completion Date: 2024-02-02 - Lead Sponsor: National Cheng Kung University ### Study Description The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated. ### Conditions - Chronic Obstructive Pulmonary Disease - Manual Soft Tissue Release - Exercise Training - Lung Function - Exercise Capacity - Cardiac Autonomic Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Manual soft tissue release - Myofascial release - Exercise training ### Outcomes Primary Outcomes - Forced expiratory volume in 1 s (FEV1) - forced vital capacity (FVC) - FEV1/FVC ratio - expiratory reserve volume (ERV) - functional residual capacity (FRC) - inspiratory capacity (IC) - inspiratory reserve volume (IRV), - residual volume (RV) - total lung capacity (TLC) - tidal volume (TV) - vital capacity (VC) Secondary Outcomes - Rate of perceived exertion (RPE) - Oxygen consumption (VO2) - oxygen saturation - heart rate (HR) - blood pressure (BP) - Diaphragmatic mobility - Cardiac Autonomic Function - six minute walk test (6-MWT) - maximal expiratory pressure (MEP) - maximal inspiratory pressure (MIP) - St. George's Respiratory Questionnaire (SGRQ) - fatigue severity scale (FSS) - Modified Medical Research Council (mMRC) - 36-Item Short Form Health Survey (SF-36) ### Location - Facility: National Cheng Kung University, Tainan, N/A, 701, Taiwan @@
## Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy - NCT ID: NCT06389721 - Study ID: 2024-0145 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2027-01-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN. ### Conditions - Chemotherapy-induced Peripheral Neuropathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Electroencephalogram (EEG) ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit. - NCT ID: NCT06389708 - Study ID: VEVUS-HF - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-01-15 - Lead Sponsor: Inonu University ### Study Description Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3). Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4). Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. ### Conditions - Heart Failure - Acute Kidney Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - VEXUS - MORTALİTY - AKI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients - NCT ID: NCT06389695 - Study ID: CP-2023-03 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Norroy Bioscience Co., LTD ### Study Description 68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-NYM032 injection ### Outcomes Primary Outcomes - Incidence of Adverse Events Secondary Outcomes ### Location - Facility: Affliated Hospital of Jiangnan University, Wuxi, Jiangsu, 214000, China @@
## Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients - NCT ID: NCT06389682 - Study ID: CP-2023-02 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Norroy Bioscience Co., LTD ### Study Description 68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma ### Conditions - Clear Cell Renal Cell Carcinoma Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-NYM005 injection ### Outcomes Primary Outcomes - Incidence of Adverse Events Secondary Outcomes ### Location - Facility: Affliated Hospital of Jiangnan University, Wuxi, Jiangsu, 214000, China @@
## Is Low Flow Anaesthesia Feasible? - NCT ID: NCT06389669 - Study ID: Inonu LTI - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-09-15 - Lead Sponsor: Inonu University ### Study Description Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA. ### Conditions - Feasibility of Low Flow Anaesthesia in Clinical Use - Factors Affecting Oxygen Consumption ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Feasibility of Low Flow Anaesthesia Secondary Outcomes - Factors affecting oxygen consumption ### Location - Facility: Inonu Univercity, Malatya, N/A, 44280, Turkey @@
## Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes - NCT ID: NCT06389656 - Study ID: 1K23DK135791-01 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-02 - Lead Sponsor: The Miriam Hospital ### Study Description Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention. ### Conditions - Body Weight - Weight Bias - Weight Stigma - Weight ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioral Weight Management - Weight Bias Internalization ### Outcomes Primary Outcomes - Total score on an adapted version of the Acceptability of Intervention Measure (AIM) - In depth qualitative feedback from teens regarding intervention acceptability and feasibility - Attendance rates at intervention sessions - Retention rate for intervention sessions Secondary Outcomes - Total score on the Modified Weight Bias Internalization Scale (WBIS-M) - Total score on the Weight Self-Stigma Questionnaire (WSSQ) - Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS) - Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS) - Anthropometrics ### Location - Facility: The Miriam Hospital, Providence, Rhode Island, 02903, United States @@
## Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques - NCT ID: NCT06389643 - Study ID: 11/WIM/2021 - Status: COMPLETED - Start Date: 2021-03-19 - Completion Date: 2023-09-19 - Lead Sponsor: Military Institute od Medicine National Research Institute ### Study Description Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC) ### Conditions - Aphakia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Four-point scleral fixation of Akreos AO60 IOL - Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique ### Outcomes Primary Outcomes - BCVA - RE - ECC Secondary Outcomes - Number of complications ### Location - Facility: Military Institute of Medicine - National Research Institute, Warsaw, N/A, 04-141, Poland @@
## Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills - NCT ID: NCT06389630 - Study ID: 0012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-01-20 - Lead Sponsor: Kocaeli Sağlık ve Teknoloji Üniversitesi ### Study Description Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.Purpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.Design: A pretest-posttest two-group, quasi-experimental design will be used in the study. ### Conditions - Complication of Injection ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - video-assisted training group - low fidelity simulation model group ### Outcomes Primary Outcomes - subcutaneous injection skills - ecchymosis - hematoma - lipoarthrrophy - lipohypertrophy - pain - blood glucose level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block - NCT ID: NCT06389617 - Study ID: USM/JEPeM/KK/24010061 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: Hospital Universiti Sains Malaysia ### Study Description To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant ### Conditions - End Stage Renal Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone ### Outcomes Primary Outcomes - To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg - To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg Secondary Outcomes - To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience - NCT ID: NCT06389604 - Study ID: NL86367.068.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Maastricht University Medical Center ### Study Description As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast. ### Conditions - Body Temperature Changes - Heat Exposure - Heat Stress - Hyperthermia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Heat acclimation ### Outcomes Primary Outcomes - Core temperature Secondary Outcomes - Skin temperature - Sweat rate - Heart rate - Blood pressure - Skin blood flow - Energy expenditure - Substrate oxidation - Plasma metabolites - Brain blood flow - Flow-mediated dilation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM) - NCT ID: NCT06389591 - Study ID: OCR44973 - Status: NOT_YET_RECRUITING - Start Date: 2024-12 - Completion Date: 2028-12 - Lead Sponsor: University of Florida ### Study Description This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma. ### Conditions - Recurrent Glioblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) - RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2) ### Outcomes Primary Outcomes - Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines - Incidence of investigational treatment related toxicities Secondary Outcomes ### Location - Facility: UF Health, Gainesville, Florida, 32608, United States @@
## A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease - NCT ID: NCT06389578 - Study ID: HZNP-TEP-103 - Status: COMPLETED - Start Date: 2022-07-14 - Completion Date: 2023-09-12 - Lead Sponsor: Horizon Therapeutics USA, Inc. ### Study Description The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease. ### Conditions - Thyroid Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Teprotumumab ### Outcomes Primary Outcomes - Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab - PK: Maximum Serum Concentration (Cmax) of Teprotumumab - Number of Participants With Adverse Events (AE) Secondary Outcomes ### Location - Facility: Bascom Palmer Eye Institute - University of Miami, Miami, Florida, 33136, United States @@
## Pilot Randomized Clinical Trial of Change My Story - NCT ID: NCT06389565 - Study ID: 2024p000857 - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2026-06-30 - Lead Sponsor: Massachusetts General Hospital ### Study Description Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress. ### Conditions - Hiv - Depression - Psychological Distress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Problem Solving Therapy - Change My Story ### Outcomes Primary Outcomes - Engagement - Satisfaction - Feasibility 1 - Feasibility 2 - Feasibility 3 - Feasibility 4 - Feasibility 5 - Feasibility 6 - Feasibility 7 - Acceptability 1 - Acceptability 2 - Acceptability 3 - Acceptability 4 - Acceptability 5 Secondary Outcomes - Remission of depression. - Remission of psychological distress. - ART adherence - Viral suppression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients - NCT ID: NCT06389552 - Study ID: IN_CTP_N01 - Status: RECRUITING - Start Date: 2023-09-25 - Completion Date: 2027-12 - Lead Sponsor: HK inno.N Corporation ### Study Description This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery. ### Conditions - Adjuvant Chemotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Disease-free survival Secondary Outcomes - Overall survival ### Location - Facility: Seoul ST. Mary's Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Synbiotic to Attenuate Resorption of the Skeleton - NCT ID: NCT06389539 - Study ID: Pro00070958 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-04 - Lead Sponsor: Hebrew SeniorLife ### Study Description This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women. ### Conditions - Osteoporosis - Inflammation - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - SBD111 medical food - Placebo ### Outcomes Primary Outcomes - Lumbar spine BMD (g/cm2) Secondary Outcomes - Vertebral compressive strength (N) - volumetric BMD - C-terminal cross-linked telopeptide of type I collagen (β-CTX) - Procollagen Type I Intact N-terminal Propeptide (P1NP) ### Location - Facility: Hebrew SeniorLife, Roslindale, Massachusetts, 02131, United States @@
## A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors - NCT ID: NCT06389526 - Study ID: CHS-1000-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2028-01-30 - Lead Sponsor: Coherus Biosciences, Inc. ### Study Description The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors. ### Conditions - Advanced or Metastatic Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - CHS-1000 - Toripalimab ### Outcomes Primary Outcomes - Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Secondary Outcomes - Maximum Observed Concentration (Cmax) - Area Under the Concentration-time Curve (AUC) - Terminal Half-life (t1/2) - Number of Participants with Antidrug Antibodies - Investigator-assessed Objective Response Rate (ORR) - Duration of Response (DoR) - Disease Control Rate (DCR) - Time to Response (TTP) - Progression-free Survival (PFS) - Landmark PFS Rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants - NCT ID: NCT06389513 - Study ID: CTP-MCVF-005 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-04 - Lead Sponsor: CanSino Biologics Inc. ### Study Description This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age. ### Conditions - Epidemic Meningitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - MCV4 ### Outcomes Primary Outcomes - Incidence of localized adverse reactions in subjects - Incidence of systemic adverse reactions in subjects Secondary Outcomes - Incidence of adverse reactions in subjects - Incidence of adverse events in subjects - Incidence of severe adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer - NCT ID: NCT06389500 - Study ID: SHR-1316-HLJ-006 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: Harbin Medical University ### Study Description This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer. ### Conditions - Biliary Tract Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab - Lenvatinib - Hepatic Arterial Infusion Chemotherapy ### Outcomes Primary Outcomes - R0 resection rate - Surgery conversion rate Secondary Outcomes - Objective response rate - pathological complete response rate - Major pathological response rate - Recurrence-free survival - Overall survival - AEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above - NCT ID: NCT06389487 - Study ID: 222253 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2025-04-28 - Lead Sponsor: GlaxoSmithKline ### Study Description The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above ### Conditions - Respiratory Syncytial Virus Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - RSVPreF3 OA investigational vaccine ### Outcomes Primary Outcomes - RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR) - Seroresponse rate (SRR) in RSV-A neutralizing titers - RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) - SRR in RSV-B neutralizing titers Secondary Outcomes - Percentage of participants reporting solicited administration site events - Percentage of participants reporting solicited systemic events - Percentage of participants reporting unsolicited adverse events (AEs) - Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs - Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF) - RSV-A neutralizing titers expressed as GMTs - RSV-B neutralizing titers expressed as GMTs ### Location - Facility: GSK Investigational Site, Phoenix, Arizona, 85023, United States @@
## A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS - NCT ID: NCT06389474 - Study ID: CT-INM004-04 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-16 - Completion Date: 2025-09-28 - Lead Sponsor: Inmunova S.A. ### Study Description The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS). ### Conditions - Hemolytic-Uremic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INM004 - Placebo ### Outcomes Primary Outcomes - Time to recovery of renal function during the acute phase Secondary Outcomes - Short-term recovery of renal function - MAKE 90 - Dialysis longer than 10 days - Dialysis requirement - Mortality ### Location - Facility: Hospital El Cruce - Néstor Kirchner, Florencio Varela, Buenos Aires, N/A, Argentina @@
## 4th Ventricular Compression Technique on Anxiety - NCT ID: NCT06389461 - Study ID: OST1_012 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-16 - Completion Date: 2024-12-31 - Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto ### Study Description Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 4th Ventricular Compression Technique - "Sham" Therapy ### Outcomes Primary Outcomes - Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention. Secondary Outcomes - Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention ### Location - Facility: Escola Superior da Saúde do Porto, Porto, N/A, 4200-072, Portugal @@
## Comparison of pCLE and EB in Gastric Lesion Diagnosis - NCT ID: NCT06389448 - Study ID: pCLE vs EB 2024tj - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2026-10 - Lead Sponsor: Huazhong University of Science and Technology ### Study Description This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research. ### Conditions - Low Grade Intraepithelial Neoplasia - High Grade Intraepithelial Neoplasia - Early Gastric Cancer - Gastric Intraepithelial Neoplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - pCLE-gastr ### Outcomes Primary Outcomes - Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion Secondary Outcomes - The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion ### Location - Facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques - NCT ID: NCT06389435 - Study ID: 2024DS - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2028-01 - Lead Sponsor: Danderyd Hospital ### Study Description Rationale for conducting the study:The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.Study design:Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.Study population:Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.Number of patients:400Inclusion criteria:Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.Exclusion criteria:Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.Primary outcome variables:The Forgotten Joint Score (FJS) at 2 years after surgery ### Conditions - Knee Arthroplasty, Total - Robotic-assisted - Osteoarthritis of the Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Patients will be randomized to undergo TKR or RTKR ### Outcomes Primary Outcomes - The Forgotten Joint Score (FJS) Secondary Outcomes - KOOS - ADLS knee instability - The Forgotten Joint Score (FJS) - EQ-5D - Knee alignment - Adverse events ### Location - Facility: Danderyds Sjukhus, Stockholm, N/A, 18288, Sweden @@
## Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis - NCT ID: NCT06389422 - Study ID: NCC4620 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity. ### Conditions - Hepatocellular Carcinoma - Radiotherapy - Pembrolizumab - Tumor Thrombosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Moderate-dose Hypofractionated Intensity-modulated Radiotherapy - Pembrolizumab ### Outcomes Primary Outcomes - Median Overall Survival Secondary Outcomes - Objective Response Rate - Progression-free Survival - Toxicity ### Location - Facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, Beijing, Beijing, N/A, China @@
## Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients - NCT ID: NCT06389409 - Study ID: Protocollo N.2009 Testicolo - Status: RECRUITING - Start Date: 2010-08-24 - Completion Date: 2040-08-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient. ### Conditions - Testicular Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation of testicular cancer patients ### Outcomes Primary Outcomes - Clinical data - Adjuvant therapy - lactate dehydrogenase - Testicular objective examination - Testicular objective examination - cysts - Testicular objective examination - nodules - Testicular objective examination - varicocele - Testicular objective examination - hydrocele - α-feto protein - β human Chorionic Gonadotropin - carcinoembryonic antigen Secondary Outcomes ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy @@
## Investigation of a New Rectal Catheter for Users of Transanal Irrigation - NCT ID: NCT06389396 - Study ID: CP362 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-06-30 - Lead Sponsor: Coloplast A/S ### Study Description The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark. ### Conditions - Bowel Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - CP362 Test Catheter ### Outcomes Primary Outcomes - The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2) Secondary Outcomes ### Location - Facility: Århus Universitetshospital, Århus, Jutland, 8200, Denmark @@
## Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy. - NCT ID: NCT06389383 - Study ID: 22-0182 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-21 - Completion Date: 2024-12 - Lead Sponsor: University Hospital, Caen ### Study Description The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns. ### Conditions - Newborn; Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Nasal Swab ### Outcomes Primary Outcomes - rate of viral infections Secondary Outcomes ### Location - Facility: CAEN University Hospital, Caen, N/A, N/A, France @@
## ASSESSMENT OF ORAL HEALTH KNOWLEDGE, ATTITUDE AND BEHAVIOUR AND ITS ASSOCIATION WITH SOCIODEMOGRAPHIC FACTORS OF PRECLINICAL AND CLINICAL DENTAL STUDENTS IN CAIRO UNIVERSITY: A CROSS-SECTIONAL STUDY - NCT ID: NCT06389370 - Study ID: knowledge, Attitude, Behaviour - Status: NOT_YET_RECRUITING - Start Date: 2024-11-04 - Completion Date: 2024-12-03 - Lead Sponsor: Cairo University ### Study Description The knowledge, behaviour and attitude of oral health professionals reflects their awareness and understanding of oral preventive measures, which will have significant impact on their delivery of public oral health promotion in the future. They are expected to set an example for positive oral health behaviour among other college students, family members and their patients. Various external factors like sociodemographic factors like age, gender, marital state, occupation, and number of family members play a major role in oral hygiene. The relationships between various modifiable factors needs to be assesses in a vast manner.There were some researches about oral health knowledge, behaviour and attitude in correlation to socio-demographic data, of dental students in other countries, but little was known in Egypt. Dental students are expected to play a critical role in instructing public oral health for improving their patient's, families, and friends. In addition, it may pave the way to develop new programs to encourage needful oral health practices. ### Conditions - Oral Health Knowledge, Attitude and Behaviour of Dental Students ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HU-DBI questionnaire ### Outcomes Primary Outcomes - Increase of dental students KAB by preceding through higher academic levels Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Return to School Adaptation Programme for Children With Cancer - NCT ID: NCT06389357 - Study ID: 1305G2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2024-11-30 - Lead Sponsor: Gazi University ### Study Description This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer.H1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme? ### Conditions - Childhood Cancer - ALL, Childhood - AML, Childhood - Lymphoma - Solid Tumor, Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - training and counselling ### Outcomes Primary Outcomes - social anxiety - coping - back to school readiness Secondary Outcomes - process evaluation ### Location - Facility: Gizem Cakir, Ankara, Cankaya, 06490, Turkey @@
## Effect of Esketamine on Conscious State in Patients With pDoC - NCT ID: NCT06389344 - Study ID: lk20240401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia.Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated. ### Conditions - Esketamine - Consciousness Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esketamine - normal saline ### Outcomes Primary Outcomes - Coma recovery scale-revised(CRS-R) Secondary Outcomes - Coma recovery scale-revised(CRS-R) - Full Outline of UnResponsiveness(FOUR) - Glasgow coma scale(GCS) - Original EEG - Patient state index(PSI) - Power spectral density - Burst-suppression ratio - Spectral edge frequency - The incidence of perioperative adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia - NCT ID: NCT06389331 - Study ID: IRC/1971/020 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2021-08-31 - Lead Sponsor: B.P. Koirala Institute of Health Sciences ### Study Description The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested. ### Conditions - Hernia - Direct Inguinal Hernia - Seroma Following Procedure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - closed the defect with barbed suture ### Outcomes Primary Outcomes - seroma Secondary Outcomes ### Location - Facility: Vijay Pratap Sah, Malangwa, Madhesh Pradesh, N/A, Nepal @@
## Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair - NCT ID: NCT06389318 - Study ID: RC 29-11-2023 - Status: COMPLETED - Start Date: 2023-03-26 - Completion Date: 2024-04-24 - Lead Sponsor: Benha University ### Study Description Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients ### Conditions - Inguinal Hernia Repair ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - buccal midazolam +oral placebo syrup - oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline ### Outcomes Primary Outcomes - Ramsay sedation score Secondary Outcomes - Parental separation anxiety scale ### Location - Facility: Benha University, Banha, N/A, 13511, Egypt @@
## CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction - NCT ID: NCT06389305 - Study ID: BJGBYY-IIT-LCYJ-2024-012 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: Beijing GoBroad Hospital ### Study Description This is a single-center, double-blind, randomized trial. Patients with r/r B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the mRNA-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled. ### Conditions - B-cell Acute Lymphoblastic Leukemia - Acute Lymphoblastic Leukemia, in Relapse - Refractory Acute Lymphoid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - peripheral blood lymphocytes - CIK cell ### Outcomes Primary Outcomes - EFS in CIK infusion group Secondary Outcomes - PFS in CIK infusion group - DOR in CIK infusion group - OS in CIK infusion group - EFS in mRNA-CIK infusion group ### Location - Facility: Beijing GoBroad Hospital, Beijing, Beijing, 102206, China @@
## A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia - NCT ID: NCT06389292 - Study ID: APG2575AG301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-03-26 - Lead Sponsor: Ascentage Pharma Group Inc. ### Study Description An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lisaftoclax (APG-2575) - Placebo - Azacitidine Injection ### Outcomes Primary Outcomes - Overall Survival（OS） Secondary Outcomes - Percentage of Participants with Objective Response Rate (ORR) - Safety evaluation based on the adverse event concurrence ### Location - Facility: Hematology Hospital of the Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300020, China @@
## The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery - NCT ID: NCT06389279 - Study ID: 2023-18/11 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-10-24 - Lead Sponsor: Antalya Training and Research Hospital ### Study Description The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia. ### Conditions - Hip Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PENG block group - FIC block group - Femoral block group - Control group ### Outcomes Primary Outcomes - recovery quality Secondary Outcomes - postoperative Numeric Rating Scale (NRS) pain score - postoperative opioid consumption ### Location - Facility: University of Health Sciences, Antalya Training and Researh Hospital, Antalya, N/A, N/A, Turkey @@
## Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia - NCT ID: NCT06389266 - Study ID: 221550 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2029-01-10 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are:1. Can rTMS change functional connectivity in brain circuits associated with nicotine use?2. Are those rTMS-induced changes in functional connectivity related to craving?Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving. ### Conditions - Schizophrenia - Nicotine Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Repetitive Transcranial Magnetic Stimulation (rTMS) ### Outcomes Primary Outcomes - Resting-state functional connectivity - Cue-induced craving - Tiffany Brief Questionnaire of Smoking Urges (QSU) - Self-reported craving Secondary Outcomes - Wisconsin Smoking Withdrawal Scale (WSWS) - Fagerstrom Test for Nicotine Dependence (FTND) - Self-reported nicotine use ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States @@
## Subtalar Extra-articular Screw Arthroereisis - NCT ID: NCT06389253 - Study ID: HTSW1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Università Vita-Salute San Raffaele ### Study Description The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi. ### Conditions - Flatfoot, Flexible - Ankle Proprioception ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Histological Analysis ### Outcomes Primary Outcomes - Primary Endpoint (%) Secondary Outcomes - Secondary Endpoint ### Location - Facility: Ircss Ospedale San Raffaele, Milan, Lombardy, 20149, Italy @@
## Early Weight Bearing in Unicondylar Tibial Plateau Fractures - NCT ID: NCT06389240 - Study ID: 160848 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-21 - Completion Date: 2025-12 - Lead Sponsor: University of Utah ### Study Description The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome ### Conditions - Early Mobilization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 6 weeks post-operatively early weight bearing - 10 weeks post-operatively weight bearing (standard of care) ### Outcomes Primary Outcomes - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) - Average peak load (Newtons (N)) Secondary Outcomes ### Location - Facility: University of Utah Orthopedics, Salt Lake City, Utah, 84108, United States @@
## Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial - NCT ID: NCT06389227 - Study ID: 0433611 - Status: COMPLETED - Start Date: 2023-10-15 - Completion Date: 2024-02-15 - Lead Sponsor: University of Turin, Italy ### Study Description Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination. ### Conditions - Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - dynamic ecological approach (DEA) - traditional training group ### Outcomes Primary Outcomes - Number of participants evaluated on physical efficiency Secondary Outcomes ### Location - Facility: Cit Turin LDE, Turin, N/A, 10100, Italy @@
## A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease - NCT ID: NCT06389214 - Study ID: ADX-102-DED-030 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-12-31 - Lead Sponsor: Aldeyra Therapeutics, Inc. ### Study Description A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease ### Conditions - Dry Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reproxalap Ophthalmic Solution (0.25%) - Vehicle Ophthalmic Solution ### Outcomes Primary Outcomes - Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4 Secondary Outcomes ### Location - Facility: Cliantha Research, Mississauga, Ontario, N/A, Canada @@
## Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients - NCT ID: NCT06389201 - Study ID: 2024HCQ - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Affiliated Hospital of Nantong University ### Study Description Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HCQ - Placebo ### Outcomes Primary Outcomes - Recurrence and metastasis Secondary Outcomes ### Location - Facility: Bo You, Nantong, Jiangsu, 226000, China @@
## Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash - NCT ID: NCT06389188 - Study ID: JVT003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-10-01 - Lead Sponsor: Universidad Miguel Hernandez de Elche ### Study Description To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program. ### Conditions - Whiplash ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RHB Group ### Outcomes Primary Outcomes - Subjective pain intensity - Neck specific disability Secondary Outcomes - Cervical range of motion (CROM) - Cervical lordosis Cobb angle - Hospital anxiety and depression scale ### Location - Facility: Consorci Sanitari de Terrassa., Terrassa, Barcelona, 08227, Spain @@
## Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression - NCT ID: NCT06389175 - Study ID: BON001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: University of Bonn ### Study Description The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD. ### Conditions - Depressive Disorder, Major ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Transcutaneous non-invasive vagus nerve stimulation (tVNS) - Sham stimulation ### Outcomes Primary Outcomes - Stimulation-induced acute changes in stomach-brain coupling - Stimulation-induced acute changes in gastric motility - Stimulation-induced mid-term changes in gastric motility - Stimulation-induced mid-term changes in self-reported interoception - Stimulation-induced mid-term changes in somatic symptoms - Stimulation-induced mid-term changes in depressive symptoms - Stimulation-induced acute neural changes in food cue reactivity - Stimulation-induced acute behavioral changes in invigoration - Stimulation-induced acute neural changes during foraging - Stimulation-induced acute behavioral changes in foraging decisions Secondary Outcomes - Stimulation-induced mid-term changes in positive and negative affect - Stimulation-induced mid-term changes in self-reported interoception - Stimulation-induced mid-term changes in motivation - Stimulation-induced mid-term changes in physical activity - Stimulation-induced mid-term changes in heart rate - Stimulation-induced acute changes in blood parameters - Stimulation-induced mid-term changes in blood parameters - Stimulation-induced mid-term changes in composition of microbiome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue - NCT ID: NCT06389162 - Study ID: UNLV-2024-115 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-04 - Completion Date: 2024-09-30 - Lead Sponsor: University of Nevada, Las Vegas ### Study Description The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are:1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?2. Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction.Researchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue.Participants will:Performing two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction. ### Conditions - Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - transcranial direct current stimulation ### Outcomes Primary Outcomes - Time to Task Failure - Fatigue Index Secondary Outcomes - Average EMG activity - Force error - Standard deviation of force - 9 Hole Pegboard Test ### Location - Facility: University of Nevada Las Vegas, Las Vegas, Nevada, 89154, United States @@
## Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease - NCT ID: NCT06389149 - Study ID: 0165-24-FB - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: University of Nebraska ### Study Description 1) The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. 2) To be eligible for this study, those with PAD must be between the ages of 50-85 years, women must be postmenopausal, must have a history of exercise-limiting claudication, have an ankle brachial index (ABI) 0.9. 3) Subjects will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, subjects will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, subjects will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, subjects will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively. 4) There will be no follow-up. ### Conditions - Peripheral Arterial Disease - Peripheral Vascular Disease - Peripheral Artery Occlusive Disease - Peripheral Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - LEAP therapy - no LEAP therapy ### Outcomes Primary Outcomes - Macrovascular Endothelial Function - Microvascular Vasodilatory Capacity - Femoral and Popliteal Artery Blood Flow - Walking capacity - Autonomic Function - Autonomic Activity - Arterial Stiffness - Muscle Oxygenation - Peripheral blood mononuclear cell mitochondrial function Secondary Outcomes ### Location - Facility: University of Nebraska - Omaha, Omaha, Nebraska, 68182, United States @@
## A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab - NCT ID: NCT06389136 - Study ID: M24-601 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-24 - Completion Date: 2026-03-09 - Lead Sponsor: AbbVie ### Study Description Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide.The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Upadacitinib Dose A - Dupilumab Dose A - Upadacitinib Dose B ### Outcomes Primary Outcomes - Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) Secondary Outcomes - Percentage of participants who achieve EASI 90 - Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 - Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas - NCT ID: NCT06389123 - Study ID: 1788760 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03-31 - Lead Sponsor: University of California, Davis ### Study Description This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. ### Conditions - Metastatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. ### Outcomes Primary Outcomes - [68Ga]Ga DOTA-5G PET/CT imaging Secondary Outcomes - [177Lu]Lu DOTA-ABM-5G treatment - [177Lu]Lu DOTA-ABM-5G treatment efficacy ### Location - Facility: The University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States @@
## Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children. - NCT ID: NCT06389110 - Study ID: SOPH201-1023/III - Status: NOT_YET_RECRUITING - Start Date: 2024-12-30 - Completion Date: 2027-06-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children. ### Conditions - Myopia - Myopia, Progressive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alleance® - Placebo ### Outcomes Primary Outcomes - Changes in the spherical equivalent - Changes in axial eye length Secondary Outcomes - Incidence of unexpected adverse events related to the interventions - Incidence of photophobia between interventions - Changes in pupillary diameter between the interventions - Changes in Best Corrected Visual Acuity (BCVA) - Changes in near best-corrected visual acuity - Changes in the amplitude of accommodation (AA) between interventions - Changes in intraocular pressure (IOP) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization - NCT ID: NCT06389097 - Study ID: J23152 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ### Study Description The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy. ### Conditions - Prostate Cancer - Advanced Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radium-223 - 177Lu-DOTATATE - 177Lu-PSMA-617 ### Outcomes Primary Outcomes - Mean absorbed dose to normal organs compared using different quantitative methods Secondary Outcomes - Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images - Mean absorbed dose to normal organs correlated with toxicity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Parents Together: Supporting Parents to Promote Healthy Behaviours in Children - NCT ID: NCT06389084 - Study ID: 179939 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: The Hospital for Sick Children ### Study Description The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health. ### Conditions - Child Eating Behaviours - Child Nutrition - Early Child Development - Parenting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Parents Together parenting course ### Outcomes Primary Outcomes - Child eating behaviours Secondary Outcomes - Dietary intake and food environment - Nutritional risk - Physical Activity, Sedentary Time, Sleep Duration - Physical activity - Social and emotional development - Child development - Family psychosocial health - Parenting - Parenting sense of competence - sociodemographic, maternal and child characteristics - zBMI - Waist circumference - Blood pressure ### Location - Facility: The Hospital for Sick Children, Toronto, Ontario, N/A, Canada @@
## Laser Treatment for Lichen Sclerosus - NCT ID: NCT06389071 - Study ID: PLS001 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-30 - Lead Sponsor: Sciton ### Study Description Fractional ablative laser treatment for Lichen Sclerosus lesion ### Conditions - Lichen Sclerosus Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fractional 2940 nm Laser ### Outcomes Primary Outcomes - Histological clearance Secondary Outcomes ### Location - Facility: Clinique Medicale Uro-Gyneco de l'Abitibi, Val-d'Or, Quebec, J9P1W1, Canada @@
## Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System - NCT ID: NCT06389058 - Study ID: G00014538 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-01 - Completion Date: 2026-11 - Lead Sponsor: San Diego State University ### Study Description The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a. ### Conditions - Severe Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Recommendation for the diagnoses and treatment of Severe Athma ### Outcomes Primary Outcomes - Identification of Patients with Severe Asthma Secondary Outcomes ### Location - Facility: San Diego State University, San Diego, California, 92182-1309, United States @@
## Profopol and Remifentanil Sedation in Endoscopic Ultrasonography - NCT ID: NCT06389045 - Study ID: EUS - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-07-01 - Lead Sponsor: Samsun University ### Study Description Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety. ### Conditions - Sedation Complication - Endoscopic Ultrasonography - Procedural Sedation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Procedural Sedation ### Outcomes Primary Outcomes - Anesthesia related major complications Secondary Outcomes - The prevalence of symptoms of inadequate sedation ### Location - Facility: Samsun University Faculty of Medicine, Samsun, N/A, N/A, Turkey @@
## PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education - NCT ID: NCT06389032 - Study ID: 21041503 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-06-30 - Lead Sponsor: Rush University Medical Center ### Study Description Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so.We aim to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. We will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. We will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions. ### Conditions - Lewy Body Dementia - Parkinson Disease Dementia - Dementia With Lewy Bodies - Lewy Body Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Peer Mentor Support and Caregiver Education - Caregiver Education ### Outcomes Primary Outcomes - Multidimensional Caregiver Strain Index (MCSI) - Quality of Life in Alzheimer's Disease ( QoL-AD) - Dementia Attitudes Scale (DAS) - LBD Knowledge Test ( LBDK) - Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire Secondary Outcomes - Fortinsky Caregiver Self-Efficacy Score - Multidimensional Scale of Perceived Social Support (MSPSS) - Pearlin Mastery Scale ### Location - Facility: Rush University Medical Center, Chicago, Illinois, 60612, United States @@
## Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer - NCT ID: NCT06389019 - Study ID: BLCA_CMUFH - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-10-01 - Lead Sponsor: Mingzhao Xiao ### Study Description Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA. ### Conditions - Bladder Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Deep learning system for prognostication prediction in bladder cancer ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Recurrence free survival ### Location - Facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China @@
## To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer - NCT ID: NCT06389006 - Study ID: RC48-C025 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-12-31 - Lead Sponsor: RemeGen Co., Ltd. ### Study Description The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer ### Conditions - HR-positive, HER2-low Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Disitamab Vedotin for Injection - Toripalimab - Epirubicin - Cyclophosphamide ### Outcomes Primary Outcomes - Total pathological complete response (tpCR) rate Secondary Outcomes - Breast pathological complete response（bpCR） - Event free survival (EFS) - Disease-free survival (DFS) - Objective Response Rate (ORR) - Adverse events (AEs) - Change in cluster of differentiation 8 (CD8) - Health-related quality of life - EORTC-QLQ-C30 - Residual cancer burden score - Change in tumor-infiltrating lymphocytes (TILs) - Change in programmed cell death protein L1 (PD-L1) ### Location - Facility: Jiong Wu, Shanghai, Fudan University Shanghai Cancer Center, 200032, China @@
## Marrow Cellution™ vs. Traditional BMA Harvest Project - NCT ID: NCT06388993 - Study ID: 2023H0351 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-03-31 - Lead Sponsor: Ohio State University ### Study Description Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research, ### Conditions - Hip Arthropathy - Avascular Necrosis of Bone - Subchondral Cysts ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bone Marrow Collection ### Outcomes Primary Outcomes - Assess overall number of stem cells collected from each aspiration method Secondary Outcomes - Assess overall number of cytokines collected from each aspiration method - Assess overall number of growth factors collected from each aspiration method ### Location - Facility: Jameson Crane Sports Medicine Institute, Columbus, Ohio, 43202, United States @@
## Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds - NCT ID: NCT06388980 - Study ID: UFCIN1_2022 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-06-01 - Lead Sponsor: Corporacion Parc Tauli ### Study Description Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv ### Conditions - Nurse's Role - Knowledge, Attitudes, Practice - Wound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Validated questionnaires and ad hoc questions ### Outcomes Primary Outcomes - "What not to do in chronic wounds?" - ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test) Secondary Outcomes - Ad hoc open questions ### Location - Facility: Corporació Sanitària Parc Taulí, Sabadell, Barcelona, 08208, Spain @@
## Pancreatic Cancer Detection Consortium - NCT ID: NCT06388967 - Study ID: 19288/PCDC - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-11-21 - Lead Sponsor: City of Hope Medical Center ### Study Description This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma. ### Conditions - Pancreatic Cancer - Pancreatic Carcinoma - Pancreatic Adenocarcinoma - Pancreatic Ductal Adenocarcinoma - Pancreatic Neoplasms - Pancreatic Cancer Stage I - Pancreatic Cancer Stage - Pancreatic Cancer Resectable - Pancreatic Cancer Stage 0 - Pancreatic Cancer Stage II - Pancreatic Cancer Stage III - Pancreatic Cancer, Adult - Pancreatic Cancer Non-resectable ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PANcreatic cancer Exosome Early detectiON (PANXEON) ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Accuracy ### Location - Facility: Translational Genomics Research Institute, Phoenix, Arizona, 85004, United States @@
## Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke - NCT ID: NCT06388954 - Study ID: P.T.REC/012/005107 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2024-05-09 - Lead Sponsor: Cairo University ### Study Description Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment. ### Conditions - Stroke - Motor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS) - Sham Trancutaneous auricular Vagus Nerve Stimulation ### Outcomes Primary Outcomes - Muscle tone of the upper limb - Gross hand dexterity - Level of Plasma brain-derived Derived factor (BDNF) - Level of Serum Interleukin IL-6 Secondary Outcomes ### Location - Facility: Faculty of Physical Therapy, Cairo University, Giza, Ad Doqi, Giza District, Giza Governorate, 11432, Egypt @@
## Iptacopan in Patients With ANCA Associated Vasculitis - NCT ID: NCT06388941 - Study ID: CLNP023R12201 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-28 - Completion Date: 2027-09-22 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL. ### Conditions - Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Iptacopan - Placebo - Rituximab ### Outcomes Primary Outcomes - Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. Secondary Outcomes - B cell counts - Total IgG levels - Complete remission at week 24 - Time to reach BVAS=0 - Time to major relapse - Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks - Cumulative dose of glucocorticoid (GC) - Glucocorticoid toxicity index over 48 weeks - 36-Item short form survey (SF-36) - Patient's Global Assessment (PtGA) - Physician's global assessment (PhGA) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists - NCT ID: NCT06388928 - Study ID: P.T.REC/012/004596 - Status: COMPLETED - Start Date: 2023-07-09 - Completion Date: 2023-12-26 - Lead Sponsor: Cairo University ### Study Description The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.This study was conducted to answer the following question:- Is there any effect of the menstrual cycle on the manual dexterity of female dentists? ### Conditions - Menstrual Cycle - Manual Dexterity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Manual dexterity assessment Secondary Outcomes ### Location - Facility: Horus University, Damietta, N/A, N/A, Egypt @@
## A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion - NCT ID: NCT06388915 - Study ID: K2202403004 - Status: COMPLETED - Start Date: 2024-03-12 - Completion Date: 2024-03-23 - Lead Sponsor: Weikang Chen ### Study Description Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. ### Conditions - Pelvic Fracture - Morel-Lavallee Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Site of MLL - Site of injury and Classification of pelvic fracture Secondary Outcomes - Time to treatment - Drainage volume ### Location - Facility: Fujian Provincial Hospital, Fuzhou, Fujian, 350000, China @@
## A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies - NCT ID: NCT06388902 - Study ID: BR115-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: BioRay Pharmaceutical Co., Ltd. ### Study Description This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study. ### Conditions - Advanced Solid Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BR115 for injection ### Outcomes Primary Outcomes - Treatment-emergent Adverse Events Following Treatment With BR115 Secondary Outcomes - Objective Response Rate - Progression-free survival (PFS) - Overall survival (OS) - Disease control rate (DCR) - Duration of response (DOR). - Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) - Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) - The anti-drug antibody (ADA) ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Phase III Long-Term Extension Study With Dexpramipexole - NCT ID: NCT06388889 - Study ID: AR-DEX-22-04 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-08 - Completion Date: 2027-06-01 - Lead Sponsor: Areteia Therapeutics ### Study Description The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. ### Conditions - Eosinophilic Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dexpramipexole Dihydrochloride ### Outcomes Primary Outcomes - Number and Percentage of Participants with a Treatment Emergent Adverse Event - Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations - Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight - Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters Secondary Outcomes - Severe Asthma Exacerbations - Change in Asthma Control Questionnaire-6 (ACQ-6) - Change in absolute eosinophil counts (AEC) ### Location - Facility: Research Site 20001-004, Tampa, Florida, 33607, United States @@
## The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes - NCT ID: NCT06388876 - Study ID: AnkaraYBUbk - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-07-30 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye. ### Conditions - Earthquake - Stress Disorders, Post-Traumatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - lifestyle advice ### Outcomes Primary Outcomes - Post-traumatic Stress Disorder Short Scale - Pittsburgh Sleep Quality Index Secondary Outcomes ### Location - Facility: Ankara Yildirim Beyazıt University, Ankara, N/A, N/A, Turkey @@
## Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease - NCT ID: NCT06388863 - Study ID: B2024-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-05-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Healthy donor-derived FMT capsule - Placebo capsule ### Outcomes Primary Outcomes - Response rate of constipation in Parkinson's Disease (PD) Secondary Outcomes - Change from baseline PD symptoms at week 5, week 13 and week 24 - Change from baseline anxiety at week 5, week 13 and week 24 - Change from baseline depression at week 5, week 13 and week 24 - Change from baseline quality of life at week 5, week 13 and week 24 - Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24 - Change from baseline fecal microbiota at week 5, week 13 and week 24 - Change from baseline fecal metabolites at week 5, week 13 and week 24 ### Location - Facility: 180 Fenglin Road, Shanghai, Shanghai, 200032, China @@
## Evaluation of HRP Among Pre-K Through 5th Grade - NCT ID: NCT06388850 - Study ID: 5U01CE003393-03 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-03-23 - Completion Date: 2025-09-30 - Lead Sponsor: Northeastern University ### Study Description This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data. ### Conditions - Child Sexual Abuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Healthy Relationships Project ### Outcomes Primary Outcomes - Reports of child sexual abuse Secondary Outcomes - The Parental Knowledge Scale (PKS) - The Parental Discussions about Sex Abuse Scale (PDSAS) - The adapted Parenting Self Agency (PSAM) - The Parent Knowledge Questionnaire (PKQ) - HRP evaluation - The CSA Myths Scale - The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA) ### Location - Facility: Safe Shores, Washington, District of Columbia, 20001, United States @@
## Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone - NCT ID: NCT06388837 - Study ID: RECO6U/20- 2021 - Status: COMPLETED - Start Date: 2021-02-20 - Completion Date: 2023-03-01 - Lead Sponsor: October 6 University ### Study Description The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft ### Conditions - Symphysis Onlay Bone Graft - Platelet Rich Fibrin - Xenograft - Horizontal Alveolar Ridge Augmentation - Esthetic Zone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Injectable Platelet Rich Fibrin - Xenograft ### Outcomes Primary Outcomes - Alveolar ridge width Secondary Outcomes - Bone density ### Location - Facility: October 6 University, Giza, N/A, 12511, Egypt @@
## The Effect of Esketamine on Sleep Disturbance - NCT ID: NCT06388824 - Study ID: GWang028 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2024-10-10 - Lead Sponsor: Tianjin Medical University General Hospital ### Study Description To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance ### Conditions - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - normal saline - Esketamine ### Outcomes Primary Outcomes - The incidence of sleep disturbance on the first night after surgery Secondary Outcomes - The incidence of sleep disturbance on the second and third postoperative nights - The incidence of sleep disturbance on the seventh postoperative nights - Postoperative anxiety - Postoperative depression - Pain intensity - Adverse event - preoperative hemoglobin concentration - Human Chorionic Gonadotropin level - The incidence of sleep disturbance on the day before surgery - The incidence of sleep disturbance before surgery ### Location - Facility: Tianjin Medical University General Hospital, Tianjin, N/A, 300052, China @@
## Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire - NCT ID: NCT06388811 - Study ID: 2023/1162 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-12-15 - Lead Sponsor: Istanbul University ### Study Description The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation). ### Conditions - Early Knee Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Early Osteoarthritis Questionnaire ### Outcomes Primary Outcomes - Numeric Rating Scale - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic - NCT ID: NCT06388798 - Study ID: Ankara Etlik city hospital - Status: COMPLETED - Start Date: 2023-05-30 - Completion Date: 2023-07-30 - Lead Sponsor: Ankara Etlik City Hospital ### Study Description Summary:Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation.Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic.Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey.Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA). ### Conditions - Nursing Education - Psychoeducation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Education ### Outcomes Primary Outcomes - Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group. - Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation Secondary Outcomes ### Location - Facility: Ankara Etlik City Hospital, Ankara, N/A, N/A, Turkey @@
## A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia - NCT ID: NCT06388785 - Study ID: TAK-003-5001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-09-01 - Lead Sponsor: Takeda ### Study Description The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate. ### Conditions - Dengue Fever ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary Outcomes - Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) ### Location - Facility: Universiti Putra Malaysia, Serdang, Selangor, 43400, Malaysia @@