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## BeFit Toolbox Collaboration: Building Empowerment Through Fitness - NCT ID: NCT06293846 - Study ID: IRB-300012108 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population. ### Conditions - Low-Income Population - Women's Health ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - What I Learned at Home ### Outcomes Primary Outcomes - Barriers to Physical Activity Self-Report Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States @@
## Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan - NCT ID: NCT06293833 - Study ID: 003315 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-09-01 - Completion Date: 2026-01-01 - Lead Sponsor: University Hospital, Antwerp ### Study Description The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. ### Conditions - Lung Cancer, Nonsmall Cell - Lung Cancer - Smoking Cessation - Lung Cancer, Small Cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Low-dose CT scan - Smoking Cessation ### Outcomes Primary Outcomes - Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA Secondary Outcomes - Responders - Number of true and false positive nodules - Impact of smoking cessation intervention - Success of smoking cessation intervention - Evaluation of shared decision making tool ### Location - Facility: UZA, Edegem, Antwerp, 2650, Belgium @@
## A Study Of TL-925 For The Treatment of AC - NCT ID: NCT06293820 - Study ID: TL-925-304 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Telios Pharma, Inc. ### Study Description In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis. ### Conditions - Allergic Conjunctivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TL-925 - Placebo ### Outcomes Primary Outcomes - Ocular Itching - Conjunctival Redness Secondary Outcomes ### Location - Facility: Andover Eye Associates, Andover, Massachusetts, 01810, United States @@
## Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine - NCT ID: NCT06293807 - Study ID: 20220162HU - Status: COMPLETED - Start Date: 2022-06-06 - Completion Date: 2023-04-16 - Lead Sponsor: The University of Texas Health Science Center at San Antonio ### Study Description Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal. ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Xylocaine 2 % with 1:100,000 epinephrine - Bupivicaine 0.5% with 1:200,000 epinephrine - Placebo ### Outcomes Primary Outcomes - Change in pain using Visual Analog Scale (VAS) - Number of Ibuprofen administered - Number of Tylenol administered Secondary Outcomes - Arch Response - Number of teeth - Type of procedure - Gender of patient - Age of patient ### Location - Facility: The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States @@
## Decision Support for Heart Failure Prescribing - NCT ID: NCT06293794 - Study ID: 22-0991 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: University of Colorado, Denver ### Study Description Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS. ### Conditions - Decision Support Systems, Clinical - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Personalized Clinical Decision Support (CDS) - Traditional Clinical Decision Support (CDS) ### Outcomes Primary Outcomes - Number of CDS alerts resulting in the prescription of a recommended medication Secondary Outcomes - Number of patients the CDS alerted for - Number of alerts that were not outright dismissed - Number of prescription orders for guideline directed management and therapies (GDMT) for heart failure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Application of the Web-based Acceptance and Commitment Therapy for Depression - NCT ID: NCT06293781 - Study ID: GachonU - Status: RECRUITING - Start Date: 2022-12-19 - Completion Date: 2025-02-28 - Lead Sponsor: Gachon University ### Study Description PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Web-based ACT - Treatment as usual ### Outcomes Primary Outcomes - Acceptance and Action Questionnaire-II Secondary Outcomes - Cognitive Fusion Questionnaire ### Location - Facility: Kyoung-Sae Na, Incheon, Please Incheon, 21565, Korea, Republic of @@
## Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) - NCT ID: NCT06293768 - Study ID: FADOI.05.2018 - Status: COMPLETED - Start Date: 2019-09-23 - Completion Date: 2024-02-20 - Lead Sponsor: Fadoi Foundation, Italy ### Study Description Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. ### Conditions - Hospitalization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) ### Outcomes Primary Outcomes - difference in the incidence of major complications at 30 days Secondary Outcomes - number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward - Difference in the incidence of major complications at the end of the telemonitoring phase ### Location - Facility: Ospedale di Albano - Polo H2, Roma, N/A, N/A, Italy @@
## Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores - NCT ID: NCT06293755 - Study ID: COA022/66 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-06-25 - Lead Sponsor: Dhurakij Pundit University ### Study Description The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores. ### Conditions - Enlarged Pores ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Microneedle patch - Intradermal injection ### Outcomes Primary Outcomes - Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score Secondary Outcomes ### Location - Facility: Dhurakij Pundit University, Lak Si, Bangkok, N/A, Thailand @@
## ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants - NCT ID: NCT06293742 - Study ID: EC0007 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2024-04-19 - Lead Sponsor: Eccogene ### Study Description This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants. ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - ECC5004 - Midazolam - Rosuvastatin - Digoxin - Atorvastatin ### Outcomes Primary Outcomes - Atorvastatin PK parameters: AUC(0-tlast) - Atorvastatin PK parameters: AUC(0-inf) - Atorvastatin PK parameters: Cmax - Rosuvastatin PK parameters: AUC(0-tlast) - Rosuvastatin PK parameters: AUC(0-inf) - Rosuvastatin PK parameters: Cmax - Digoxin PK parameters: AUC(0-tlast) - Digoxin PK parameters: AUC(0-inf) - Digoxin PK parameters: Cmax - Midazolam PK parameters: AUC(0-tlast) - Midazolam PK parameters: AUC(0-inf) - Midazolam PK parameters: Cmax Secondary Outcomes - ECC5004 Safety parameters: Number of participants with adverse events (AEs) - ECC5004 Safety parameters: Number of participants with vital sign abnormalities - ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities - ECC5004 Safety parameters: Number of participants with physical examination abnormalities - ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities - Atorvastatin safety parameters: Number of participants with adverse events (AEs) - Atorvastatin safety parameters: Number of participants with vital sign abnormalities - Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) - Atorvastatin safety parameters: Number of participants with physical examination abnormalities - Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities - Rosuvastatin safety parameters: Number of participants with adverse events (AEs) - Rosuvastatin safety parameters: Number of participants with vital sign abnormalities - Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities - Rosuvastatin safety parameters: Number of participants with physical examination abnormalities - Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities - Digoxin safety parameters: Number of participants with adverse events (AEs) - Digoxin safety parameters: Number of participants with vital sign abnormalities - Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities - Digoxin safety parameters: Number of participants with physical examination abnormalities - Digoxin safety parameters: Number of participants with clinical laboratory abnormalities - Midazolam safety parameters: Number of participants with adverse events (AEs) - Midazolam safety parameters: Number of participants with vital sign abnormalities - Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities - Midazolam safety parameters: Number of participants with physical examination abnormalities - Midazolam safety parameters: Number of participants with clinical laboratory abnormalities - ECC5004 PK parameters: AUC (0-τ) - ECC5004 PK parameters: AUC(0-24) - ECC5004 PK parameters: tmax - ECC5004 PK parameters: t1/2 - ECC5004 PK parameters: CL/F - ECC5004 PK parameters: Ctau ### Location - Facility: Eccogene Investigational Site, Anaheim, California, 92801, United States @@
## Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients - NCT ID: NCT06293729 - Study ID: NGGT006-P-2302 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-03-01 - Lead Sponsor: Suzhou Municipal Hospital ### Study Description This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C). ### Conditions - Refractory Hypercholesterolemia - Familial Hypercholesterolemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NGGT006 ### Outcomes Primary Outcomes - Incidence of treatment-related adverse events (AE) and serious adverse events (SAE) - Absolute change and percent change in LDL-C Secondary Outcomes - Absolute change and percent change in non-high density lipoprotein cholesterol - Absolute change and percent change in apolipoprotein B - Absolute change and percent change in total cholesterol - Absolute change and percent change in HDL-C - Absolute change and percent change in triglycerides - Absolute change and percent change in very low-density lipoprotein cholesterol - Absolute change and percent change in lipoprotein(a) - Absolute change and percent change in apolipoprotein A-I ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CVL237 Tablets for APDS/PASLI - NCT ID: NCT06293716 - Study ID: CVL237-A2001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-03-30 - Lead Sponsor: Convalife (Shanghai) Co., Ltd. ### Study Description This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency). ### Conditions - PI3K and P110delta Hyperactivation Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CVL237 tablets - CVL237 placebo tablets ### Outcomes Primary Outcomes - part 1 : Incidence of Treatment-Emergent Adverse Events - part 2:After 84 days of treatment, changes in the sum of diameter product (SPD) of log10 conversion in target lesions and changes in the percentage of naive B cells to total B cells from baseline were observed Secondary Outcomes - Cmax - t1/2 - AUC - Tmax ### Location - Facility: Shanghai Public Health Clinical Center, Shanghai, Shanghai, 201508, China @@
## Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study) - NCT ID: NCT06293703 - Study ID: 23-1228 - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2030-12-11 - Lead Sponsor: Salvador Navarrete ### Study Description The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics. ### Conditions - Morbid Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Surgery ### Outcomes Primary Outcomes - To determine change in TWL after aRYGB compared to sRYGB in morbidly obese patients Secondary Outcomes - To compare rates of DM resolution between aRYGB Vs sRYGB by DM subgroup analysis - To investigate postoperative efficacy rates of aRYGB compared to sRYGB on alleviating metabolic syndrome in morbid obesity - To investigate the presence of postoperative vitamin and nutritional deficiencies between the groups. ### Location - Facility: Cleveland clinic, Cleveland, Ohio, 44195, United States @@
## Toripalimab Combined With SBRT for NSCLC - NCT ID: NCT06293690 - Study ID: L23-407 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-06-30 - Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China ### Study Description This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC ### Conditions - Non-small Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Toripalimab - Toripalimab ### Outcomes Primary Outcomes - Major pathological remission rate Secondary Outcomes - Complete pathological remission rate - disease-free survival（DFS） - overall survival ### Location - Facility: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200000, China @@
## Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance - NCT ID: NCT06293677 - Study ID: 2023-01013 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03 - Lead Sponsor: Centre Hospitalier Universitaire Vaudois ### Study Description This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem.The main questions this study aims to answer are, in these children:* Would higher doses of antibiotics result in better blood levels of antibiotics?* Would they have more sides effects with higher antibiotics dosages?* Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed. ### Conditions - Febrile Neutropenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dosage Adjustment Rules for Augmented Renal Clearance (DAR-ARC) for piperacillin-tazobactam and meropenem - Standard dosages of piperacillin-tazobactam or meropenem ### Outcomes Primary Outcomes - Achievement of antibiotic concentration targets in the intervention group (1i) vs control groupe (1c) Secondary Outcomes - Achievement of antibiotic concentration targets in control group 2 - Fever duration - Side effects of antibiotic therapy - Number of dosage adjustments required to achieve the target concentration - Difference between eGFR measured by creatinine-based Schwartz formula and other eGFR calculation formulas ### Location - Facility: Centre Hospitelier Universitaire Vaudois (CHUV), Lausanne, Vaud, 1011, Switzerland @@
## Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes - NCT ID: NCT06293664 - Study ID: RAHM-2023-006 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-04-04 - Lead Sponsor: Dasman Diabetes Institute ### Study Description Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM). ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - α-MSH infusion - Placebo solutions ### Outcomes Primary Outcomes - Difference in the total or incremental area under the curve of glucose and insulin concentration at an OGTT during saline vs. α-MSH infusion Secondary Outcomes - Difference in the total or incremental area under the curve of the concentration of metabolites (C-peptide, Glucagon, Gut hormones, α-MSH) during OGTT with saline or α-MSH infusion. ### Location - Facility: Dasman Diabetes Institute, Kuwait City, N/A, N/A, Kuwait @@
## Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors - NCT ID: NCT06293651 - Study ID: DA4505_AMST_I/IIa - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2030-04 - Lead Sponsor: Dong-A ST Co., Ltd. ### Study Description This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors. ### Conditions - Locally Advanced or Metastatic Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - DA-4505 - DA-4505 + Pembrolizumab ### Outcomes Primary Outcomes - Proportion of adverse events (AEs) meeting protocol-defined dose-limiting toxicity(DLT) criteria - PK parameters for DA-4505 (Peak Plasma Concentration (Cmax)) - PK parameters for DA-4505 (Area Under the Curve (AUC)) - PK parameters for DA-4505 (half-life (t1/2)) - Response per revised "Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor - NCT ID: NCT06293638 - Study ID: 23-1125 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2026-12-31 - Lead Sponsor: The Cleveland Clinic ### Study Description The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation. ### Conditions - Essential Tremor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Alcohol - Alprazolam - Cold Therapy - Peripheral Nerve Stimulation ### Outcomes Primary Outcomes - CTCM Coherence - Power of oscillatory activity across the CTCM network in response to tremor interventions Secondary Outcomes - Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS) - Essential tremor severity: Grip force - Essential tremor severity: Limb acceleration ### Location - Facility: Cleveland Clinic, Cleveland, Ohio, 44195, United States @@
## Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More - NCT ID: NCT06293625 - Study ID: LEPAGE PHRCK 2022-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2032-03 - Lead Sponsor: Centre Hospitalier Universitaire Dijon ### Study Description Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp).Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC.FOxTROT 2, a trial to test the role of NAC in older patients. ### Conditions - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Folfox - Surgery ### Outcomes Primary Outcomes - DFS (disease Free Survival) Secondary Outcomes ### Location - Facility: CHU Dijon Bourgogne, Dijon, N/A, 21000, France @@
## Constructing a Multimodal Imaging System to Predict the Risk of Heterochronous Metastasis of Rectal Cancer - NCT ID: NCT06293612 - Study ID: 22/449-3651 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2022-11-30 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description The goal of this observational study is to construct a multimodal intelligent model to predict the risk of heterochronous metastasis of rectal cancer, which is helpful for individualized diagnosis and treatment and follow-up planning. The main questions it aims to answer are:* what are the independent risk factors of distant metastasis (DM) in locally advanced rectal cancer (LARC)* What is the influence weight of the above factors on the heterochronous metastasis of LARC, and how to build a risk-prediction modelThis study will not affect or interfere with the routine medical diagnosis and treatment of participants, and will not increase the cost and risk of participants. Participant's information is protected and identified by a unique code. ### Conditions - Locally Advanced Rectal Cancer - Distant Metastasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention was administrated to the two cohorts. ### Outcomes Primary Outcomes - Heterochronous distant metastasis Secondary Outcomes - Distant metastasis-free survival ### Location - Facility: National Cancer Center, National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, N/A, 100021, China @@
## Effect of Scapular Stabilization Exercises Versus Virtual Reality Exercises in Basketball Players With Scapular Dyskinesia - NCT ID: NCT06293599 - Study ID: P.T.REC/012/003131 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-07-30 - Lead Sponsor: Cairo University ### Study Description this study will be conducted to compare virtual reality and scapular stabilizing exercise among basketball player with scapular dyskinesia on scapular muscle performance, rounded shoulder, pain intensity , disability and hand grip strength ### Conditions - Scapular Dyskinesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - scapular stabilization exercises - virtual reality exercises - regular routine exercises ### Outcomes Primary Outcomes - agonist antagonist ratio Secondary Outcomes - Hand grip strength - rounded shoulder posture - pain intensity level - The disabilities of the arm, shoulder and hand - peak force - total work - work fatigue - average power ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery - NCT ID: NCT06293586 - Study ID: MD-11-2022 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-03-30 - Lead Sponsor: Cairo University ### Study Description The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique. ### Conditions - Anesthesia, Local - Ophthalmopathy - Strabismus - Pediatric ALL ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - peribulbar block - sub-tenon block - Paracetamol ### Outcomes Primary Outcomes - The incidence of intraoperative oculocardiac reflex (OCR) Secondary Outcomes - blood pressure - heart rate ### Location - Facility: Cairo University faculty of medicine, Cairo, N/A, 11559, Egypt @@
## Whole- Body Vibration Among Egyptian Elderly With Sarcopenia - NCT ID: NCT06293573 - Study ID: 012/005031 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-01 - Lead Sponsor: Cairo University ### Study Description To investigate and compare between the effectiveness of whole body vibration and aerobic training exercises in management of sarcopenia, muscle mass, physical performance and muscle strength in elderly. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Whole-body vibration - aerobic exercises - resistance exercises ### Outcomes Primary Outcomes - Muscle Mass - muscle strength - timed Up and Go Test (TUG) - Gait Speed test - 400 m Walking Test - Six minute walk test (6MWT) Secondary Outcomes ### Location - Facility: Faculty of Physical Therapy, Dokki, Giza, 12612, Egypt @@
## Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children - NCT ID: NCT06293560 - Study ID: H-49046 - Status: RECRUITING - Start Date: 2022-09-25 - Completion Date: 2027-09 - Lead Sponsor: Baylor College of Medicine ### Study Description The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC ### Conditions - Microphthalmia - Coloboma - Anophthalmia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Stage 1 - Stage 2 - Stage 3 Secondary Outcomes ### Location - Facility: Baylor College of Medicine, Houston, Texas, 77030, United States @@
## Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial - NCT ID: NCT06293547 - Study ID: DIS-2022-295 - Status: COMPLETED - Start Date: 2022-08-10 - Completion Date: 2023-12-30 - Lead Sponsor: Cumhuriyet University ### Study Description Silver diamine fluoride (SDF) is a topical fluoride agent that has emerged in recent years and has a strong potential to arrest dentinal caries in early childhood caries. SDF has been developed as an effective non-invasive treatment method, especially in the non-cooperative preschool group, with its advantages such as easy application, low cost, and limited technical difficulties. The aims of this study were as follow: (a) to evaluate the efficacy of 38% GDF in arresting active dental caries lesions and reducing or preventing associated dental pain and infections in at-risk young children; and (b) how SDF treatment is perceived and acceptable by parents. The null hypothesis of the study was that 38% SDF treatment will be effective in arresting active dental caries lesions and reducing the incidence of pain and infection in young children, and is well-accepted by parents. The study group of this clinical research will consist of pediatric patients and their parents who were selected by easily accessible case sampling method and applied to Sivas Cumhuriyet University Faculty of Dentistry Pediatric Dentistry clinic. The working group will consist of a total of 48 children and their parents who meet the inclusion criteria. Parents will also be briefed on the GDF, follow-up instructions, oral hygiene instructions, and dietary education. After a baseline examination including radiographs taken during a standard dental examination, 38% GDF will be applied to carious lesions detected in primary teeth. Carious lesions will be treated with 38% SDF application once or twice. Children will be reassessed at 3-week, 3-month and 6-month follow-up sessions to assess color and structural changes in carious lesions (soft/hard). Parents will be asked to answer a questionnaire including questions about pain or infection symptoms and their views on SDF treatment. ### Conditions - Silver Diamine Fluoride ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Silver Diamine Fluoride ### Outcomes Primary Outcomes - Clinical Assessment of Arrested Caries Lesions Secondary Outcomes - Parental acceptance of SDF treatment ### Location - Facility: Sivas Cumhuriyet University, Sivas, Merkez, N/A, Turkey @@
## Thyroid Dysfunction in Patients With Major Psychiatric Disorders - NCT ID: NCT06293534 - Study ID: PsychThyroid - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Assiut University ### Study Description Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital ### Conditions - Thyroid Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TSH,T3,T4 ### Outcomes Primary Outcomes - the level of thyroid hormones among psychiatric patients Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries - NCT ID: NCT06293521 - Study ID: 06091995 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-16 - Completion Date: 2025-01-01 - Lead Sponsor: Cairo University ### Study Description This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits ### Conditions - Deep Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pulpotomy - Partial Pulpectomy ### Outcomes Primary Outcomes - Radiographic assessment Secondary Outcomes - Clinical effectiveness - Child cooperation - Time elapsed till final restoration performed ### Location - Facility: Cairo University, Cairo, N/A, N/A, Egypt @@
## mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public - NCT ID: NCT06293508 - Study ID: NMRR ID-22-02616-I2I - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Clinical Research Centre, Malaysia ### Study Description Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group. ### Conditions - Breast Neoplasm Female ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Standard Health Communication Intervention - Behavioural Change Health Communication Intervention ### Outcomes Primary Outcomes - Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram). Secondary Outcomes - Health literacy level - Perception based on domains in Health Belief Model - Perceived acceptance and usefulness of health communication program - Reasons behind participants not participating in breast cancer screening. ### Location - Facility: Institute for Clinical Research, National Institutes of Health, Malaysia, Shah Alam, Selangor, 40170, Malaysia @@
## Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures - NCT ID: NCT06293495 - Study ID: CUT-OUT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-04-01 - Lead Sponsor: Puerta de Hierro University Hospital ### Study Description The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate. ### Conditions - Proximal Femoral Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gamma 3 Nail (Stryker) - Chimaera Nail (Orthofix) ### Outcomes Primary Outcomes - Incidence of cut-out. Secondary Outcomes - Functional Ambulatory Categories (FAC) - Tip-apex distance - Parker index - Baumgaertner reduction quality criteria - Number of Surgical complications (Intraoperative) - Number of Surgical complications (post-operative) ### Location - Facility: Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, 28222, Spain @@
## Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population - NCT ID: NCT06293482 - Study ID: CAM5850 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-06 - Lead Sponsor: Cochlear ### Study Description This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits. ### Conditions - Hearing Loss, Sensorineural - Hearing Loss, Bilateral ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cochlear™ Nucleus® System ### Outcomes Primary Outcomes - Number of device and procedure-related adverse events and serious adverse events - Mean change on aided word recognition in the unilateral CI alone listening condition at 6 months post-activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted - Mean change on AzBio sentences in noise at 6 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition Secondary Outcomes - Number of device and procedure related adverse events and serious adverse events - Proportion of participants who demonstrate a change score of +1 or greater on the Speech, Spatial and Qualities of Hearing Scale (SSQ12) at 6-months post-activation compared to preoperative baseline - Mean change on the Tinnitus Handicap Inventory (THI) score at 6-months post-activation compared to preoperative baseline will exceed a 7-point improvement - Mean change on aided word recognition in the unilateral CI alone listening condition at 3 months post activation compared to pre-operative baseline in the unilateral aided listening condition for the ear to be implanted - Mean change on AzBio sentences in noise at 3 months post-activation in the everyday listening condition compared to pre-operative performance in the everyday listening condition - Percentage correct on aided word recognition in the unilateral condition in the implanted ear in the post-operative everyday listening condition - Percentage correct on AzBio sentences in noise in the post-operative everyday listening condition ### Location - Facility: Barrow Neurological Institute, Phoenix, Arizona, 85013, United States @@
## Accelerated Flap Coverage in Severe Lower Extremity Trauma - NCT ID: NCT06293469 - Study ID: IRB00434587 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-11 - Lead Sponsor: Johns Hopkins University ### Study Description The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility). ### Conditions - Open Tibia Fracture - Open Dislocation of Ankle - Extremity Fracture Lower - Extremity Injuries Lower ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Accelerated Flap Coverage Surgery - Standard of Care Flap Timing ### Outcomes Primary Outcomes - Clinical status Secondary Outcomes - Mortality - Amputation - Unplanned re-operation - Number of days in hospital - Quality of life as assessed by the Limb-Q ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients at End of Life - NCT ID: NCT06293456 - Study ID: 23-360 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-29 - Completion Date: 2026-01 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender (SGM) patients in hospice care. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones. ### Conditions - End of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dignity Therapy ### Outcomes Primary Outcomes - the number of patients who complete the intervention Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States @@
## Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System - NCT ID: NCT06293443 - Study ID: IMU-OP-TT-01 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-04-01 - Lead Sponsor: Medipol University ### Study Description The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests. ### Conditions - Amputation - Amputation; Traumatic, Leg, Lower ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Lower extremity unilateral amputee ### Outcomes Primary Outcomes - Amputee Mobility Scale Secondary Outcomes - One Leg Standing Test - Houghton Scale - 8-Shape Walking Test - joint range of motion - proprioception - l test - 10 Meter Walking Test ### Location - Facility: Istanbul Medıpol University, Istanbul, N/A, N/A, Turkey @@
## Registry on Luma Vision's VERAFEYE System (ENLIgHT) - NCT ID: NCT06293430 - Study ID: P002 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-15 - Completion Date: 2025-03-15 - Lead Sponsor: LUMA Vision Ltd. ### Study Description The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.Results from this study will be used to guide development of the VERAFEYE System. ### Conditions - Atrial Fibrillation - Left Atrial Appendage Closure - Atrial Arrhythmia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - VERAFEYE System ### Outcomes Primary Outcomes - Clinical Success of procedure - Procedural Complications Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM - NCT ID: NCT06293417 - Study ID: HT-EF-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-02-01 - Lead Sponsor: Korea University Anam Hospital ### Study Description The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:* major adverse cardiovascular events within 48 months of the trial duration* microvascular events within 48 months of the trial duration ### Conditions - T2DM (Type 2 Diabetes Mellitus) - Dyslipidemias ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Statin and Ezefeno - Statin doubling ### Outcomes Primary Outcomes - major adverse cardiovascular events and diabetic microvascular events for 48 months Secondary Outcomes - proportion of patients achieving Non-HDL-C less than 100mg/dL - proportion of patients achieving LDL less than 70mg/dL - change in Non-HDL-C at 48month from baseline - change in LDL at 48month from baseline - change in HDL-C at 48month from baseline - change in TG at 48month from baseline - change in LDL-C/HDL-C ratio at 48month from baseline - change in TC/HDL-C ratio at 48month from baseline ### Location - Facility: Korea University Anam Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia - NCT ID: NCT06293404 - Study ID: column flexion - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-04 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description The effect of two different positions on spinal anesthesia in hip fracture surgery ### Conditions - Hip Fractures - Spinal Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Bupivacain ### Outcomes Primary Outcomes - Hemodynamic change - Hemodynamic change - Hemodynamic change - Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. - Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. - Hemodynamic change blockade to the dependent lower limb in flexed and extended spine position. Secondary Outcomes - To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of bupivacaine 7.5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery - NCT ID: NCT06293391 - Study ID: 2022-11/2097 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-02-05 - Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital ### Study Description Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM. ### Conditions - Abdominal Cancer - Blood Pressure - Cardiac Indices ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - cardiac indices in supine and trendelenburg position ### Outcomes Primary Outcomes - Cardiac Output - Stroke Volume - Flow time corrected - Peak Velocity - Stroke Distance - Mean arterial pressure - Pulse Secondary Outcomes ### Location - Facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital, Ankara, N/A, 06200, Turkey @@
## Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis. - NCT ID: NCT06293378 - Study ID: Pengmingli - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2028-11-10 - Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University ### Study Description This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed. ### Conditions - Cirrhosis, Liver - Fibrosis, Liver ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sulfasalazine enteric-coated tablets ### Outcomes Primary Outcomes - Serum alkaline phosphatase (ALP) - Serum γ-glutamyl transpeptidase (GGT) - Serum bilirubin - Serum bile acids - Serum aspartate aminotransferase(AST) - Serum alanine aminotransferase (ALT) Secondary Outcomes - Hepatic fibrosis and the improvement of microbial metabolites ### Location - Facility: Chongqing Medical University, Chongqing, Chongqing, 400000, China @@
## Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease - NCT ID: NCT06293365 - Study ID: CVAY736A2202 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-26 - Completion Date: 2029-02-08 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE).A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS. ### Conditions - Sjögrens Disease - Systemic Lupus Erythematosus - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - VAY736 1ml PFS - VAY736 2 ml PFS - VAY736 2ml AI ### Outcomes Primary Outcomes - Cohort 1: Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab - Cohort 1: Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab - Cohort 2 (optional): Area under the curve (AUC) calculated to the end of a dosing interval (tau) at steady-state (AUCtau) for ianalumab - Cohort 2 (optional): Maximum (peak) observed serum drug concentration after dose administration (Cmax) for ianalumab Secondary Outcomes - Cohort 1: Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab - Cohort 2 (optional): Time to reach maximum (peak) serum drug concentration following dose administration (Tmax) for ianalumab - Cohort 1: Concentration at the end of a dosing interval (Ctrough) for ianalumab - Cohort 2 (optional): Concentration at the end of a dosing interval (Ctrough) for ianalumab - Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) - Anti-ianalumab antibodies (ADA) - Incidence of ADA positive participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection - NCT ID: NCT06293352 - Study ID: STU00220012 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Northwestern University ### Study Description In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in.There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction. ### Conditions - Prosthetic-joint Infection - Knee Infection - Arthroplasty Complications - Joint Infection - Arthroplasty, Replacement, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - All-cement articulating spacer - Durable, real-component articulating spacer - Rigid Spacer ### Outcomes Primary Outcomes - 24 month Knee Injury and Osteoarthritis Outcome Score (KOOS) Secondary Outcomes - 6 week Knee Injury and Osteoarthritis Outcome Score (KOOS) - 6 week 10-item PROMIS Global Health survey (PROMIS-10) - 6 month Knee Injury and Osteoarthritis Outcome Score (KOOS) - 6 month 10-item PROMIS Global Health survey (PROMIS-10) - 12 month Knee Injury and Osteoarthritis Outcome Score (KOOS) - 12 month 10-item PROMIS Global Health survey (PROMIS-10) - 24 month 10-item PROMIS Global Health survey (PROMIS-10) ### Location - Facility: Northwestern Medicine, Chicago, Illinois, 60611, United States @@
## Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge) - NCT ID: NCT06293339 - Study ID: CoGA-Re - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: Leiden University Medical Center ### Study Description This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606) ### Conditions - Malaria,Falciparum ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CHMI with 3D7 malaria ### Outcomes Primary Outcomes - Protective efficacy - Time to parasitaemia Secondary Outcomes - Humoral immune responses after homologous CHMI rechallenge - Cellular immune responses after homologous CHMI rechallenge ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants - NCT ID: NCT06293326 - Study ID: 22553 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-06-06 - Lead Sponsor: Bayer ### Study Description Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus).Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release).In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body.The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time.For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time.The participants will be randomly (by chance) assigned to one of two treatment groups:Participants in the first group will take the treatments at night.Participants in the second group will take the treatments during the day.All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first.Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes:1. visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study2. visits for treatment with a gap of 6-8 days between each treatment, and1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health.During the study, the doctors and their study team will:check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG)take images of the stomach at different times after taking the treatmentmeasure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomachask the participants questions about how easy it is to take the study treatmentask the participants what adverse events they are having.An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not.As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned. ### Conditions - Heartburn - Indigestion - Stomach Acid Related Symptoms - Nocturnal Stomach Acid Related Symptoms - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - bi-layer calcium carbonate tablet (BAY1180654) - Immediate release calcium carbonate tablet (BAY1180654) ### Outcomes Primary Outcomes - Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. Secondary Outcomes - Gastric pH levels as measured and recorded with tip of pH probe in gastric fundus. - Percentage of total time gastric pH is above pH 3.5 from time of dosing until 8h post-dose during night-time comparing the bi-layer tablet and standard comparator - Percentage of total time gastric pH is above pH 3.5 from time of dosing until 6h post-dose during daytime comparing the bi-layer tablet and standard comparator. - Change in mean gastric pH - Gastrointestinal tract location using scintigraphic images. - Initial radiolabel release time, using scintigraphic images - Disintegration rate (t50%) of each formulation will be determined quantitatively via analysis of scintigraphic images. - Complete radiolabel release time, using scintigraphic images - Gastric emptying kinetics of the dispersed radiolabeled material (t50% and t90%) of each formulation will be determined quantitatively via analysis of the scintigraphic images. - Participant questionnaire ### Location - Facility: BDD Pharma Bio-imaging Unit, Glasgow, N/A, G4 0SF, United Kingdom @@
## The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level - NCT ID: NCT06293313 - Study ID: Inonu-SBF-SO-03 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-08-28 - Lead Sponsor: Inonu University ### Study Description The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test. ### Conditions - Dysmenorrhea - Anxiety - Anxiety Disorders and Symptoms - Pain, Menstrual ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindfulness training - Will not be given any application ### Outcomes Primary Outcomes - VAS Pain Scale Secondary Outcomes - State and Trait Anxiety Scale ### Location - Facility: Bartin University, Bartın, N/A, 74001, Turkey @@
## Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A) - NCT ID: NCT06293300 - Study ID: 20231056 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-08-30 - Lead Sponsor: University of Miami ### Study Description The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BoNT A ### Outcomes Primary Outcomes - Change in photophobia measured by Numerical Rating Scale - Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) Secondary Outcomes - Change in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8) - Change in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye). - Change in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25) - Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS) - Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6 - Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5) - Change in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI) - Change in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST) - Change in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST) ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy - NCT ID: NCT06293287 - Study ID: DJ-2023-02 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-01-30 - Lead Sponsor: Zhongshan Hospital (Xiamen), Fudan University ### Study Description The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure ### Conditions - Radial Artery Occlusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Subcutaneous enoxaparin sodium - Placebo ### Outcomes Primary Outcomes - RAO rate after 24 hours and 21days Secondary Outcomes ### Location - Facility: Zhongshan Hospital, Fudan University (Xiamen Branch), Xiamen, Fujian, 361015, China @@
## The Importance of Discharge Education for Mommy Blues - NCT ID: NCT06293274 - Study ID: sdilek5 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05-30 - Lead Sponsor: Kocaeli University ### Study Description The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province.The sample size of the study was calculated using the G\Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up. ### Conditions - Postpartum Sadness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Discharge training ### Outcomes Primary Outcomes - Motherhood Sadness Scale - Edinburgh Postnatal Depression Scale - EPDS Secondary Outcomes ### Location - Facility: Kocaeli University, Kocaeli, N/A, 41380, Turkey @@
## Multicenter, Prospective, Non-interventional, Observational Study to Confirm the Long-term Efficacy and Safety of Rosuampin Tab. in Patients With Hypertension and Hypercholesterolemia - NCT ID: NCT06293261 - Study ID: YMC043 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-06-27 - Completion Date: 2024-03-31 - Lead Sponsor: Yuhan Corporation ### Study Description This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia ### Conditions - Hypertension - Hypercholesterolemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg ### Outcomes Primary Outcomes - Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) Secondary Outcomes - Change from baseline to 6/12 months in SBP and DBP - Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C) - Change from baseline to 6/12 months in hs-CRP - Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose) - Change from baseline to 6/12 months in Diabetes indicator ( HbA1c) ### Location - Facility: Hallym University Sacred Heart Hospital, Anyang-si, N/A, N/A, Korea, Republic of @@
## Music Application in Patients Undergoing Percutaneous Coronary Intervention - NCT ID: NCT06293248 - Study ID: 77979112 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-10 - Completion Date: 2024-05-31 - Lead Sponsor: Kocaeli University ### Study Description This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used. ### Conditions - Healthy - Nurse's Role - Patient Satisfaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - musical application ### Outcomes Primary Outcomes - Means of subjective pain scores - Means of body temperature (0C) - Means of systolic blood pressure (mmHg) - Means of diastolic blood pressure (mmHg) - Means of heart rate (/minutes) - Means of respiratory rate (/minutes) - Means of oxygen saturation (%) - Means of subjective anxiety scores - Means of Perianesthesia Comfort Scale Scores - Means of Patient Satisfaction Survey on Nursing Care Quality Scores Secondary Outcomes ### Location - Facility: Kocaeli University Hospital, Kocaeli, Umuttepe Campus, İzmit, 41380, Turkey @@
## Towards Optimal Fertility, Fathering and Fatherhood studY - NCT ID: NCT06293235 - Study ID: 2024/2120 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-03 - Lead Sponsor: KK Women's and Children's Hospital ### Study Description This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics. ### Conditions - Reproductive Issues - Fertility Issues ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lifestyle and metabolic indicators ### Outcomes Primary Outcomes - Pregnancy rate Secondary Outcomes - Fertility index - Oxidative stress - Semen volume - Sperm concentration - Sperm total motility - Sperm progressive motility - Total progressive motile sperm count - Single strand sperm DNA fragmentation - Double strand sperm DNA fragmentation - mRNA level - sncRNA level - DNA methylation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families - NCT ID: NCT06293222 - Study ID: SCD Support - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-21 - Completion Date: 2024-04-30 - Lead Sponsor: King's College London ### Study Description Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families.Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research ### Conditions - Sickle Cell Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Workshops with participants to develop resources that enable children and young people with sickle cell disorder and their families to engage in research Secondary Outcomes ### Location - Facility: King's College London, London, N/A, SE5 9RS, United Kingdom @@
## Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani - NCT ID: NCT06293209 - Study ID: Sunpasitthiprasong Hospital - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-05-28 - Lead Sponsor: Thai Traditional Medical Knowledge Fund ### Study Description The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear.The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture ### Conditions - Ankle Fractures - Swelling - Cryotherapy Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3M cold pack - Perskindol cold spray - Placebo ### Outcomes Primary Outcomes - swelling Secondary Outcomes - pain score ### Location - Facility: Department of Orthopedics, Sunpasitthiprasong hospital, Ubonratchathani, Thailand., Multiple Locations, Ubonrachathani, 34000, Thailand @@
## Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes - NCT ID: NCT06293196 - Study ID: 20231107 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-06-30 - Lead Sponsor: Zhongnan Hospital ### Study Description This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye. ### Conditions - Investigating the Effects of Periocular Acupressure on Ocular Biological Indicators ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - acupressure ### Outcomes Primary Outcomes - Changes in blood flow to the eye Secondary Outcomes ### Location - Facility: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430000, China @@
## The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management - NCT ID: NCT06293183 - Study ID: EGE-HEM-STO-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-12-30 - Lead Sponsor: Ege University ### Study Description The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients\' quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized.This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management. ### Conditions - Cronich Kidney Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mobile app ### Outcomes Primary Outcomes - Fluid intake compliance Secondary Outcomes - Change of individual management ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Automated Screening for Clinically Ascertained Loss of Cerebral Functions - NCT ID: NCT06293170 - Study ID: 2024-DETECTIVENEUROLOGYUKD0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-01 - Lead Sponsor: Technische Universität Dresden ### Study Description Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF.Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support.Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trialStudy population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge.Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination.Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization.Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT. ### Conditions - Irreversible Loss of Brain Function (ILBF) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SCREENING ### Interventions - DETECT - Conventional care ### Outcomes Primary Outcomes - Number of patients with diagnosis of ILBF Secondary Outcomes - Number of patients who undergo deceased organ donation - Number of patients in whom diagnosis of ILBF was missed ### Location - Facility: Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, N/A, 01307, Germany @@
## Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease - NCT ID: NCT06293157 - Study ID: 2023/ABM/01/00013 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2033-12-31 - Lead Sponsor: Copernicus Memorial Hospital ### Study Description Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible. ### Conditions - Metastatic Spinal Cord Compression - Metastasis Spine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transpedicular spinal stabilization - carbon fibers-based implants - Transpedicular spinal stabilization - titanium implants - Stereotactic body radiotherapy ### Outcomes Primary Outcomes - The assessment of time to local recurrence after treatment with SBRT. - The assessment of frequency of local recurrence after treatment with SBRT. Secondary Outcomes - DICE convergence factor evaluation between groups of patients. - The subjective difficulty of planning radiotherapy treatment. - The frequency of radiation complications assessed according to the National Cancer Institute Common Toxicity Criteria (NCI CTC). - Failure rate of stabilizing systems. - Pain assessment on the VAS scale between groups. - Frequency of postoperative infections. - Differences in dosimetric parameter Dmin PTV/CTV. - Differences in dosimetric parameter D95. - Differences in dosimetric parameter D98. - Differences in dosimetric parameter D100. - Differences in dosimetric parameter conformity index (CI) / homogeneity index (HI)). ### Location - Facility: Copernicus Memorial Hospital in Lodz, Łódź, Łódzkie, 93-513, Poland @@
## the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People - NCT ID: NCT06293144 - Study ID: yuewei20231129 - Status: RECRUITING - Start Date: 2023-11-29 - Completion Date: 2024-05 - Lead Sponsor: Second Hospital of Shanxi Medical University ### Study Description Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM) ### Conditions - Sedation - ED95 - Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Ciprofol ### Outcomes Primary Outcomes - Modified Alertness Sedation Score (MOAA/S) - Bispectral index (BIS) Secondary Outcomes - systolic blood pressure （SBP） - diastolic blood pressure（DBP） - heart rate (HR) - pulse oxygen saturation（SpO2） ### Location - Facility: Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030001, China @@
## Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty - NCT ID: NCT06293131 - Study ID: yuewei20230705 - Status: COMPLETED - Start Date: 2023-05-29 - Completion Date: 2023-09-28 - Lead Sponsor: Second Hospital of Shanxi Medical University ### Study Description Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia ### Conditions - Sedation - ED50 - Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Ciprofol ### Outcomes Primary Outcomes - Modified Alertness Sedation Score (MOAA/S) - Bispectral index (BIS) Secondary Outcomes - systolic blood pressure （SBP） - diastolic blood pressure（DBP） - heart rate (HR) - pulse oxygen saturation（SpO2） ### Location - Facility: Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, 030001, China @@
## The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease - NCT ID: NCT06293118 - Study ID: 71055423.3.0000.0071 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-01-15 - Lead Sponsor: Hospital Israelita Albert Einstein ### Study Description Ischemic conditioning (IC) is a promising therapy that can mimic the physiological effects of physical exercise. IC consists of using a cuff to measure blood pressure and calibrate 200 mmHg on the upper or lower limb. Thus, at alternating intervals of 5 minutes, ischemia or reperfusion occurs, depending on whether the cuff is inflated or deflated. IC induces changes in spinal cord excitability for the last reflex reactions of recruited motoneurons with improved balance control in healthy young people and improved learning in the elderly. The objective of the present study is to evaluate the chronic effect of IC on the motor function and cognitive performance of patients with Parkinson's disease. Furthermore, the investigators will evaluate secondary outcomes such as mobility, quality of life, and immunological responses. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ischemic conditioning group - Sham group ### Outcomes Primary Outcomes - Motor function - Cognitive performance Secondary Outcomes - PDQ-39 - Timed up and go (TUG) - Assessment of cellular and soluble immune response - Quantifications of systemic soluble mediators - PBMC acquisition and flow cytometry ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Social Responses to Stigma - NCT ID: NCT06293105 - Study ID: MR/T040688/1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-31 - Lead Sponsor: King's College London ### Study Description The Social Responses to Stigma study will explore experiences of stigma and discrimination amongst people who are homeless in south London, and then seek to understand how this stigma is created, mediated or mitigated within health, social, housing and legal care and support systems and social contexts.The methodology is an ethnographic case study of the south London care and support system and its social context. The study will use a range of methods for data collection: interviews with people who are homeless, delivery stakeholders, and policy makers; a survey of peoples' experiences; observation within selected care sites; and gathering of documentary sources.The study will be implemented through two parallel studies. The first, with KCL-REMAS approval, will operate in non-NHS sites. The second, with NHS-IRAS approval, will operate in NHS sites. The protocols are aligned with adaptations for each type of site.A linked method to develop theory is cross-case comparison between South London and Vancouver, Canada, through secondary data analysis to linked studies ongoing there. The study will be ongoing from 2022 until January 2025. The project is funded in two phases, with potential to extend the study by a further three years, to January 2028.The results of the study will inform the design of a novel intervention strategy to address the social dimensions of stigma. Subject to additional funding applications, the intervention strategy will be piloted and evaluated from 2025 onwards. The study results will be disseminated through scientific publications, public reports and a range of public and policy engagement activities. ### Conditions - Stigma, Social - Drug Use ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Qualitative interview, participant observation ### Outcomes Primary Outcomes - Experiences of stigma and discrimination Secondary Outcomes ### Location - Facility: to Be Determined, London, N/A, N/A, United Kingdom @@
## Effect of Intradialytic Exercises in Chronic Kidney Disease Patients - NCT ID: NCT06293092 - Study ID: P.T.REC/012/004008 - Status: COMPLETED - Start Date: 2022-04-30 - Completion Date: 2024-01-30 - Lead Sponsor: Cairo University ### Study Description the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease. ### Conditions - Chronic Kidney Disease stage3 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - leg pedaling cycling device - sand bags - hemodialysis sessions ### Outcomes Primary Outcomes - Concentration of immunoglobulin g - Total leukocyte count - lymphocyte count - neutrophil count - Concentration of HbA1c Secondary Outcomes - hemoglobin concentration - thrombocytes count - diastolic blood pressure - Systolic blood pressure - six minute walk test - (KDQOL-SFTM) questionnaire ### Location - Facility: Fayoum hospital, Fayoum, N/A, N/A, Egypt @@
## The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis - NCT ID: NCT06293079 - Study ID: BiruniUnive - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2024-08-30 - Lead Sponsor: Biruni University ### Study Description The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise Program ### Outcomes Primary Outcomes - Gait Speed - Functional Capacity Secondary Outcomes - EMG muscle activation - EMG muscle activation - Modified Fatigue Impact Scale ### Location - Facility: Biruni University, İstanbul, N/A, N/A, Turkey @@
## Performance of Ultrasound in Women With Postmenopausal or Abnormal Uterine Bleeding Between White and Black Ethnic Groups- a Retrospective Cohort Study. - NCT ID: NCT06293066 - Study ID: KCH23-257 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-03-01 - Lead Sponsor: King's College Hospital NHS Trust ### Study Description Primary Objective:To assess whether there is a higher incidence of uninformative ultrasound in black vs white women ### Conditions - Postmenopausal Bleeding - Endometrial Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - To assess whether there is a higher incidence of uninformative ultrasound in black vs white women Secondary Outcomes ### Location - Facility: Suite 8, King's College Hospital, London, N/A, SE5 9RS, United Kingdom @@
## A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis - NCT ID: NCT06293053 - Study ID: PKM17836 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2027-11-03 - Lead Sponsor: Sanofi ### Study Description This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.The study consists of 3 periods:* Screening period: 2 to 4 weeks.* Treatment period: 24 weeks.* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).The total number of planned study visits for each participant will be 6. ### Conditions - Prurigo Nodularis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dupilumab ### Outcomes Primary Outcomes - Concentration of dupilumab in serum Secondary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) - Incidence of anti-drug antibodies (ADA) to dupilumab over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment - NCT ID: NCT06293040 - Study ID: IRB00434441 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-12 - Lead Sponsor: Johns Hopkins University ### Study Description This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states). ### Conditions - Cannabis Intoxication - Alcohol Intoxication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Cannabis - Alcohol - Placebo Cannabis - Placebo Alcohol ### Outcomes Primary Outcomes - DRUID application global impairment score - Correct Trials on Paced Auditory Serial Addition Task (PASAT) - Correct Trials on the Digit Symbol Substitution Task (DSST) - Cumulative score on Field Sobriety Tests - Drug Effect Questionnaire (DEQ) - Feel Drug Effect - Drug Effect Questionnaire (DEQ) - Feel High - Drug Effect Questionnaire (DEQ) - Confidence to Drive - Drug Effect Questionnaire (DEQ) - Willingness to Drive - Biphasic alcohol effects scale (BAES) - Sedative Score - Biphasic alcohol effects scale (BAES) - Stimulant Score - Subjective high assessment scale (SHAS) - Driving performance as assessed by standard deviation of lateral position (SDLP) - Driving performance as assessed by composite drive score Secondary Outcomes - Driving performance as assessed by standard deviation of speed (SDSP) - Driving performance (mean speed) - Driving performance (number of speed exceedances) - Driving performance (number of accidents) - Driving performance (total rule violations) - Driving performance (distance to lead vehicles) - Attempted Trials on the Digit Symbol Substitution Task (DSST) - Percentage Correct on attempted trials on the Digit Symbol Substitution Task (DSST) - Reaction time on Paced Auditory Serial Addition Task - Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test - Field Sobriety Test - Score on Walk and Turn test - Field Sobriety Test - Score on One Leg Stand - Field Sobriety Test - Score on Modified Romberg Balance - Drug Effect Questionnaire - Like Drug Effect - Drug Effect Questionnaire - Want more - Drug Effect Questionnaire - Dislike Drug Effect - Pharmacokinetics - CMax for THC and THC metabolites - Pharmacokinetics - AUC for THC and THC metabolites - Pharmacokinetics - Breath Alcohol Concentration (BAC) ### Location - Facility: Johns Hopkins Behavioral Pharmacology Research Unit, Baltimore, Maryland, 21224, United States @@
## Optical Imaging as a Tool for Monitoring Brain Function in Fragile X Syndrome - NCT ID: NCT06293027 - Study ID: IMAGINER FXS - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-15 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description The objective of this project is to explore the potential of functional near- infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Fragile X Syndrome (FXS) that is still without cure. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With clinical trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. The investigators seek to address this gap by assessing the prognostic reliability of both resting and task- evoked fNIRS. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with FXS; 2. to collect pilot data on individuals with FXS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. ### Conditions - Fragile X Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Resting-state functional connectivity - Amplitude of sensory-evoked hemodynamic responses Secondary Outcomes - Correlation between neurophysiology endpoints and the response on neuropsychological scale. ### Location - Facility: IRCCS Fondazione Stella Maris, Marina di Pisa-Tirrenia-Calambrone, Toscana, 56128, Italy @@
## TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer - NCT ID: NCT06293014 - Study ID: QLMA-CRC-IIT-001 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2026-11-28 - Lead Sponsor: Henan Cancer Hospital ### Study Description This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TAS-102+bevacizumab - Standard chemotherapy+bevacizumab ### Outcomes Primary Outcomes - Time to treatment failure (TTF) Secondary Outcomes - Objective response rate (ORR) - Disease control rate (DCR) - Duration of Response (DoR) - Progression-free survival (PFS) - Overall survival（OS） - Adverse Events - European Quality of Life Five Dimensions Five Level Scale Questionnaire (EQ-5D-5L) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) ### Location - Facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university, ZhengZhou, Henan, 450008, China @@
## Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the ADAP Shoulder Scale - NCT ID: NCT06293001 - Study ID: SBA 23/349 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2024-04-26 - Lead Sponsor: Hacettepe University ### Study Description Shoulder pain is a common musculoskeletal problem that increases disability and decreases quality of life in addition to socio-economic impact. Chronic pain is defined as pain lasting longer than three months. Chronic pain is a multidimensional and complex experience. According to this model, chronic pain is a multidimensional and complex experience. This experience may be accompanied by different pain beliefs, pain avoidance behaviours, pain-related fear of movement, anxiety and depression. Many conditions involving the shoulder complex including traumatic and non-traumatic pain, subacromial impingement, postoperative pain, rotator sheath tears, rotator sheath tendinopathy, shoulder arthritis, adhesive capsulitis, shoulder instabilities may lead to pain-related fear of movement.Until now, pain-related fear and avoidance behaviours in patients with shoulder pain have been evaluated with the Tampa Kinesiophobia Scale, Pain Avoidance Beliefs Scale and Fear of Pain Scale. However, only patients with low back pain were included in the development of these scales. There was no scale developed specifically for shoulder pain. To fill this gap in the literature, Ansanello et al. developed the "Avoidance Daily Activities Photo Scale for Patients With Shoulder Pain (ADAP)" scale to evaluate pain avoidance behaviours in individuals with shoulder pain. Cross-cultural adaptation, validity and reliability of the Turkish version of the ADAP scale has not been studied.The aim of our study was to perform cross-cultural adaptation, validity and reliability of the Turkish version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale). ### Conditions - Questionnaire - Shoulder Pain - Validity - Reliability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Investigating Cross-Cultural Adaptation, Validity and Reliability of the Turkish Version of the Avoidance of Daily Activities Photo Scale for Patients with Shoulder Pain (ADAP Shoulder Scale) Secondary Outcomes ### Location - Facility: Elif Turgut, Ankara, N/A, 06300, Turkey @@
## Predictive Factors for Medullary Thyroid Cancer Aggressiveness - NCT ID: NCT06292988 - Study ID: MYELO - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-04-15 - Lead Sponsor: Aristotle University Of Thessaloniki ### Study Description This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival. ### Conditions - Medullary Thyroid Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total Thyroidectomy ### Outcomes Primary Outcomes - Central lymph node metastasis - Lateral lymph node metastasis - Distant metastasis Secondary Outcomes - Nuclear atypia as histological predictor of aggressiveness - Amyloid as histological predictor of aggressiveness - Immunohistochemistry as histological predictor of aggressiveness - Desmoplasia as histological predictor of aggressiveness - CEA as Biochemical predictor of aggressiveness - Calcitonin as Biochemical predictor of aggressiveness - White blood cell as Biochemical predictor of aggressiveness - Platelet count as Biochemical predictor of aggressiveness - CEA drop as Biochemical cure marker - Calcitonin drop as Biochemical cure marker ### Location - Facility: Oregon Health & Science University, Oregon, Oregon City, Oregon, 97239, United States @@
## Exercise for Improving Radiotherapy Efficacy in Rectal Cancer - NCT ID: NCT06292975 - Study ID: RS210 - 326709 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-02 - Lead Sponsor: University of Hull ### Study Description This is a single arm feasibility study of exercise for improving short- course neoadjuvant radiotherapy efficacy in people diagnosed with locally advanced rectal cancer. The study aims to recruit up to 30 patients from the Queen's Centre for Oncology and Haematology of Castle Hill Hospital, Cottingham, diagnosed with locally advanced rectal cancer. Consenting patient's will be provided with a 7 weeks course of structured aerobic exercises and resistance training in the periods before, during and after their radiotherapy treatment. The patients will be followed up for 6 months post short course neoadjuvant radiotherapy, with a total of 3 assessment periods. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Supervised Vigorous intensity aerobic interval exercise ### Outcomes Primary Outcomes - Recruitment rate - Attendance rate - withdrawal rate Secondary Outcomes - Serum Carcinoembryonic antigen levels - Quality of life assessment - Quality of life assessment - Physical activity levels ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating the Impact of Vagus Nerve Stimulation on Diabetic Peripheral Neuropathic Pain - NCT ID: NCT06292962 - Study ID: SH-34988389 - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-03-03 - Lead Sponsor: Saima Abass Tahammal ### Study Description The purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes. ### Conditions - Diabetes Mellitus - Diabetic Neuropathies - Type2diabetes - Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - non-invasive transcutaneous vagal nerve stimulation (tVNS) - Sham device ### Outcomes Primary Outcomes - Neuropathic pain scores Secondary Outcomes - Quality of life score ### Location - Facility: Shifa Hospital, Lahore, N/A, N/A, Pakistan @@
## Clinical Study of Resistant Starch in Improving Constipation - NCT ID: NCT06292949 - Study ID: TJ-IRB20230956 - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2024-09-25 - Lead Sponsor: Huaping Xie ### Study Description Constipation is one of the most common gastrointestinal (GI) disorders in clinical practice, with approximately 11-20% of adults worldwide suffering from constipation. Clinically, the frequency of defecation is reduced, or the defecation is laborious, obstructed, difficult, and the stool is dry and difficult to solve, which is called constipation. Clinically, constipation is difficult to treat and over-reliance on laxatives often leads to water and electrolyte imbalance, gastrointestinal dysfunction, melanosis of the colon, relaxation of anal sphincter and other problems, and even leads to colorectal cancer, diabetes, anorexia nervosa and other complications in some cases. Therefore, it is very important to find a safe and effective laxative drug or diet to improve and relieve constipation symptoms. The health promotion effect of resistant starch is mainly due to the short-chain fat and gas produced by microbial fermentation in the colon, and its role in preventing colorectal cancer and some diet-related chronic diseases is stronger than dietary fiber, and it can effectively overcome the adverse odor, rough texture, poor quality and other drawbacks of food fortified with dietary fiber. Ruminococcus bromii is a specific microorganism that degrades resistant starch. The starch decomposing enzyme of R. bromii has a unique tissue structure and forms a multi-enzyme complex. Through the adhesion protein and dockerin module, it is attached to the cell surface through the scaffold protein in the cellulose body. Big data analysis showed that the relative abundance of R. bromii in healthy people was significantly higher than that in patients with constipation. Therefore, the purpose of this clinical trial is to supplement resistant starch to patients with constipation: (1) Observe whether the symptoms of patients with constipation have improved; (2) Analyze the changes of intestinal microorganisms in patients with constipation; and (3) Verify whether the relative abundance of R. bromii is increased and analyze the correlation between the relative abundance of R. bromii in intestine and the improvement of constipation symptoms in patients with constipation. ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Resistant starch ### Outcomes Primary Outcomes - Changes in constipation symptoms - Changes in the diversity of intestinal flora - Changes in the relative abundance of species of intestinal flora - Changes in the number of intestinal flora - Changes in the metabolic function of intestinal flora Secondary Outcomes ### Location - Facility: Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology, Wuhan, Hubei, 430030, China @@
## RemI for Post-Bariatric Surgery Weight Regain - NCT ID: NCT06292936 - Study ID: 30692 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2028-04-01 - Lead Sponsor: Temple University ### Study Description The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).The main research aims are:1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior. ### Conditions - Obesity - Bariatric Surgery Candidate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acceptance-Based Behavioral Intervention ### Outcomes Primary Outcomes - Weight Secondary Outcomes - Caloric Intake - Eating Behavior - Cognitive Constraint - Eating Behavior - Disinhibition - Eating Behavior - Hunger - Physical Activity - Weight-Related Medical Comorbidities - Number of participants with hypertension - Weight-Related Medical Comorbidities - Number of participants with diabetes - Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia - Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia ### Location - Facility: Rush University, Chicago, Illinois, 60612, United States @@
## A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients - NCT ID: NCT06292923 - Study ID: TILS-021 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2024-11 - Lead Sponsor: Tiziana Life Sciences LTD ### Study Description Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases.The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS).The primary objectives that this study aims to answer are:1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo2. To investigate the effect of foralumab relative to placebo on the change from baseline \[18F\]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment. ### Conditions - Secondary Progressive Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Foralumab - Placebo ### Outcomes Primary Outcomes - The number of patients with adverse event (AE) reports. - Changes in the Total Nasal Symptom Score (TNSS). - Change from baseline for [18F]PBR06-positron emission tomography (PET) scans for microglial activation after 12 weeks (3 months) of study treatment. Secondary Outcomes - Changes in the Expanded Disability Status Scale (EDSS). - Changes in the Multiple Sclerosis Functional Composite-4 (MSFC-4). - Changes in the Modified Fatigue Impact Scale (MFIS). ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery - NCT ID: NCT06292910 - Study ID: REC 64-299-1-1 - Status: COMPLETED - Start Date: 2021-08-08 - Completion Date: 2023-12-26 - Lead Sponsor: Prince of Songkla University ### Study Description The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial.The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research ### Conditions - Congenital Heart Disease - Perioperative/Postoperative Complications - Lactate Blood Increase ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - arterial and central venous blood gas analysis, lactate ### Outcomes Primary Outcomes - number of participant who developed low cardiac output syndrome related poor outcomes within 24 hour post operation Secondary Outcomes - ventilator days - inotrope days - length of stay in ICU ### Location - Facility: Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand @@
## Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression - NCT ID: NCT06292897 - Study ID: 3312 - Status: RECRUITING - Start Date: 2023-03-20 - Completion Date: 2027-01-15 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways. ### Conditions - Prostate Cancer - Prostate Adenocarcinoma - Prostate Neoplasm - Prostatic Neoplasm - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational study ### Outcomes Primary Outcomes - Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma Secondary Outcomes ### Location - Facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano, Milan, N/A, N/A, Italy @@
## Optical Imaging as a Tool for Monitoring Brain Function in Creatine Deficiency Syndromes - NCT ID: NCT06292884 - Study ID: IMAGINER CREATINE - Status: RECRUITING - Start Date: 2023-10-06 - Completion Date: 2025-12-15 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description The objective of this project is to explore the potential of functional near-infrared spectroscopy (fNIRS) as innovative functional biomarker for clinical trial readiness in Creatine Deficiency Syndromes (CDS), a group of rare neurodevelopmental disorders. Among these disorders, effective treatments are lacking for two. The limited availability of objective and quantitative biomarkers to monitor brain function poses challenges to advancing therapeutic research. With gene therapy trials on the horizon, the need for precise measurement to evaluate treatment efficacy is pressing. This project seeks to address this gap by assessing the prognostic reliability of both resting and task-evoked fNIRS. Arousal of participants will be also assessed through the measure of spontaneous heart rate (HR) fluctuations. The primary objectives of this pilot study are: 1. to determine the feasibility of fNIRS in individuals with CDS; 2. to collect pilot data on individuals with CDS to determine the patterns of cerebral oxygen consumption as measured by fNIRS; 3. to compare cerebral oxygen consumption changes at rest and from visual/auditory tasks in affected individuals versus age-appropriate healthy volunteers. The secondary objectives of this study are: 1. to correlate cerebral oxygen consumption changes from visual/auditory task in affected individuals to other measures of disease state (e.g., neuropsychological assessment, disease- specific severity rating scales); 2. to examine test-retest reliability of our fNIRS measures in both affected individuals and healthy controls. ### Conditions - Creatine Deficiency, X-linked - Creatine Deficiency Syndrome Due to Gamt Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Resting-state functional connectivity - Amplitude of sensory-evoked hemodynamic responses Secondary Outcomes - Correlation between neurophysiology endpoints and the response on neuropsychological scale. ### Location - Facility: IRCCS Fondazione Stella Maris, Pisa, N/A, 56128, Italy @@
## The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus - NCT ID: NCT06292871 - Study ID: 2023/2712 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: KK Women's and Children's Hospital ### Study Description To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically,i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform.ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire.iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM.iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM. ### Conditions - Gestational Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Additional GDM management through social media - Usual care ### Outcomes Primary Outcomes - Acceptance levels - Satisfaction levels Secondary Outcomes - Engagement levels - Appropriateness levels - Feasibility levels - Emotional wellbeing - Blood glucose levels - Proportion of participants with optimal blood glucose control ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors - NCT ID: NCT06292858 - Study ID: IMB071703-101 - Status: RECRUITING - Start Date: 2023-02-24 - Completion Date: 2025-08 - Lead Sponsor: Beijng Immunoah Pharma Tech Co., Ltd. ### Study Description A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors ### Conditions - Recurrent or Metastatic, Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - IMB071703 injection ### Outcomes Primary Outcomes - Incidence of adverse events/serious adverse event related with IMB071703 injection - Dose-limiting toxicity (DLT) - Maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of IMB071703 injection Secondary Outcomes - Maximum measured plasma concentration (Cmax) of IMB071703 injection. - Time to maximum plasma concentration (Tmax) of IMB071703 injection. - Half-life (T1/2) of IMB071703 injection. - Immunogenicity profile of IMB071703 injection. - Objective Response Rate (ORR) - Duration of Response (DOR) - Disease control rate (DCR) - Progression free survival (PFS) ### Location - Facility: Department of Oncology, Shanghai East Hospital, Tongji University, Shanghai, Shanghai, 200120, China @@
## Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents - NCT ID: NCT06292845 - Study ID: 11272 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-01 - Lead Sponsor: Erasmus Medical Center ### Study Description This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care. ### Conditions - Solid Tumor, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Topical application of a fluorescent imaging agent ### Outcomes Primary Outcomes - Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices. Secondary Outcomes - Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology - Difference in tumor-to-background ratio (TBR) between different imaging time windows - The concordance between the presence of tumor cells and fluorescence signal - Depth of the fluorescence signal on 4-μm tissue slides ### Location - Facility: Erasmus University Medical Center, Rotterdam, Zuid-Holland, 3015 GD, Netherlands @@
## Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control - NCT ID: NCT06292832 - Study ID: MSR/AZAST/AIP029/22/222/8/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-09-10 - Lead Sponsor: Al-Azhar University ### Study Description The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. ### Conditions - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ultrasound-guided pain block - Ultrasound Machine ### Outcomes Primary Outcomes - postoperative time to rescue analgesia requirement Secondary Outcomes ### Location - Facility: Al-Azhar University, Assiut, N/A, N/A, Egypt @@
## Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices - NCT ID: NCT06292819 - Study ID: CMUH112-REC2-214 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: China Medical University Hospital ### Study Description The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events. ### Conditions - Photobiomodulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bright light - Near-infrared light - Bright light+ near-infrared light ### Outcomes Primary Outcomes - Actigraphy-derived sleep indicators - Dim-light melatonin onset - Sleep quality - Emotional state Secondary Outcomes - Daytime sleepiness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Inhibin B/AFC Ratio for Ovarian Response - NCT ID: NCT06292806 - Study ID: 001-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Insemine Humen Reproduction Centre ### Study Description Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness.A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality. ### Conditions - IVF - Infertility, Female - Ovulation Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FSH-R ### Outcomes Primary Outcomes - serum Inhibin B levels - serum Anti Mullerian Hormone levels Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cyclical Sighing for Pain - NCT ID: NCT06292793 - Study ID: STUDY00004696 - Status: COMPLETED - Start Date: 2023-12-13 - Completion Date: 2024-02-26 - Lead Sponsor: Florida State University ### Study Description This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pain Coping Information - Cyclical Sighing ### Outcomes Primary Outcomes - Change in Pain Unpleasantness Numeric Rating Scale Secondary Outcomes - Change in Pain Intensity Numeric Rating Scale - Change in Anxiety Numeric Rating Scale - Change in Depression Numeric Rating Scale ### Location - Facility: Tallahassee Orthopedic Clinic (TOC), Tallahassee, Florida, 32308, United States @@
## A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) - NCT ID: NCT06292780 - Study ID: R5458-ONC-2274 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2035-02-26 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description This study is researching an experimental drug called linvoseltamab ("study drug").This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.The study consists of 2 phases (Phase 1 and Phase 2):* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.The study is looking at several other research questions, including:* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long* What the right dosing regimen is for linvoseltamab* What side effects may happen from taking linvoseltamab* How much linvoseltamab is in your blood at different times* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects) ### Conditions - Relapsed/Refractory Systemic Light Chain Amyloidosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Linvoseltamab ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity (DLTs) - Achievement of hematologic complete response (CR) as determined by the Independent Review Committee (IRC) Secondary Outcomes - Achievement of hematologic CR, as determined by the IRC - Achievement of hematologic very good partial response (VGPR) or better response (CR + VGPR), as determined by the IRC - Achievement of overall hematologic response (PR or better), as determined by the IRC - Time to initial hematologic response - Time to best hematologic response - Duration of hematologic response (ie, best response, VGPR or better, overall response), as determined by the IRC - Hematologic progression-free survival (PFS) - Incidence of death - Incidence of treatment-emergent adverse events (TEAEs) - Severity of TEAEs - Incidence of serious adverse events (SAEs) - Severity of SAEs - Incidence of adverse events of special interest (AESIs) - Severity of AESIs - Achievement of overall hematologic response (PR or better), as determined by the IRC in dose regimen 1 vs 2 - Incidence of TEAEs in dose regimen 1 vs 2 - Severity of TEAEs in dose regimen 1 vs 2 - Incidence of SAEs in dose regimen 1 vs 2 - Severity of SAEs in dose regimen 1 vs 2 - Incidence of AESIs in dose regimen 1 vs 2 - Severity of AESIs in dose regimen 1 vs 2 - Time from treatment initiation to hematologic disease progression as determined by the IRC - Time from treatment initiation to cardiac deterioration, as determined by the IRC - Time from treatment initiation to kidney deterioration as determined by the IRC - Time from treatment initiation to death as determined by the IRC - Time from initiation of treatment to date of death from any cause - Achievement of renal response in participants with renal involvement at baseline, as determined by IRC - Achievement of cardiac response in participants with cardiac involvement at baseline, as determined by IRC - Time to first renal response in participants with renal involvement at baseline - Time to first cardiac response in participants with cardiac involvement at baseline - Linvoseltamab concentration in serum over time - Incidence of anti-drug antibodies (ADAs) to linvoseltamab over time - Titers of ADAs to linvoseltamab over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiopulmonary Bypass on Mechanical Power and Postoperative Pulmonary Complications - NCT ID: NCT06292767 - Study ID: 2023/462 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-04-25 - Lead Sponsor: TC Erciyes University ### Study Description During cardiopulmonary bypass (CPB), oxygenation of the patient on the pump can be left completely under pump control, or the lungs can be ventilated with low tidal volume to reduce atelectasis. In recent years, the concept of mechanical power has been used to determine the extent of ventilator-related lung damage. This concept of mechanical power, by which the energy transferred by the ventilator to the lungs can be calculated, will be measured at certain intervals in CPB surgery patients on the pump and compared between the two groups. The investigators aimed to investigate the effect of two different ventilation methods on mechanical power and its relationship with postoperative pulmonary complications. ### Conditions - Postoperative Pulmonary Atelectasis - Pneumothorax - Pneumonia - Ards - Respiratory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mechanical power calculation ### Outcomes Primary Outcomes - mechanical power Secondary Outcomes - mechanical power ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rotator Cuff Repair With Magnesium Pin - NCT ID: NCT06292754 - Study ID: 2023.211 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes. ### Conditions - Arthroscopic Rotator Cuff Repair ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - magnesium pin in additional to the suture anchor - routine suture anchor ### Outcomes Primary Outcomes - Imaging Examinations - Cofield classification - Sugaya Score - Goutallier Classification Secondary Outcomes - Height measurement - Weight measurement - BMI measurement - Shoulder flexibility (range of motion) - Shoulder muscle strength - Western Ontario Rotator Cuff (WORC) Index Western Ontario Rotator Cuff (WORC) Index Index - Constant-Murley Score - Visual Analogue Scale (VAS) - Adverse events - C-reactive protein measurement - Calcium (Ca) measurement - Magnesium (Mg) measurement - Phosphorous (P) measurement - Creatinine (Cr) measurement - Urea measurement - Alanine transaminase (ALT) measurement - Aspartate aminotransferase (AST) measurement - Total protein (TP) measurement - Albumin (ALB) measurement - Globulin (GLB) measurement ### Location - Facility: The Chinese University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Autonomic Involvement in Patient With Cognitive Decline - NCT ID: NCT06292741 - Study ID: 4956 - Status: RECRUITING - Start Date: 2023-01-11 - Completion Date: 2026-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline ### Conditions - Dementia, Mild - Dementia of Alzheimer Type ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Sudoscan ### Outcomes Primary Outcomes - evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia Secondary Outcomes - correlation between the extent of autonomic involvement and the severity of cognitive decline - evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction. ### Location - Facility: Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS, Roma, Lazio, 00168, Italy @@
## ENDOPLY System in Humans: a Pilot Study - NCT ID: NCT06292728 - Study ID: ENDOPLY1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: ENDOPLY ### Study Description Prospective, non-randomized study aimed at defining the initial pattern of gastric plication with the ENDOPLY System, and assess feasibility, ergonomics and safety of the device Prospective, single-centre, open label, consecutive enrolment ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - ENDOPLY System ### Outcomes Primary Outcomes - Time of duration of the ENDOPLY System study procedure - Number of ligatures placed by ENDOPLY System study procedure - Gastric perforation events - Gastrointestinal bleeding events - Initial weight-loss Secondary Outcomes ### Location - Facility: Institut klinické a experimentální medicíny (IKEM), Klinika hepatogastroenterologie, Prague, N/A, 14021, Czechia @@
## Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism - NCT ID: NCT06292715 - Study ID: Microwave Ablation01 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2026-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism. ### Conditions - Secondary Hypersplenism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - microwave ablation of the spleen - Splenic artery balloon implantation ### Outcomes Primary Outcomes - Portal venous pressure - Hepatic artery blood flow velocity - Routine blood test - Adverse Events Secondary Outcomes ### Location - Facility: Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, 300060, China @@
## Reducing Early Urinary Disorders After Stress Incontinence Surgery: The Role of Vaginal Wall Tension. - NCT ID: NCT06292702 - Study ID: Modified Burch Colposuspension - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2024-02-01 - Lead Sponsor: Damascus University ### Study Description The progress in surgical procedures for treating female stress urinary incontinence has led to the development of tension-free techniques such as the trans-obturator tape (TOT). Nonetheless, concerns regarding complications associated with the use of artificial mesh have sparked renewed interest in traditional retropubic suspension techniques (Burch). This study introduces a modified technique that creates lateral tension for the anterior vaginal wall before the conventional suspending to the Cooper ligament, limiting the tension on the urethra and reducing the risk of postoperative urinary voiding dysfunction with the same success rates. This technique offers the advantages of a tension-free procedure while still providing the benefits of retropubic suspension. Moreover, this modified technique eliminates the need for artificial mesh, reducing the risk of associated complications. This promising alternative offers effective support for the urethra and reduces postoperative emptying disorders. However, further research and studies are necessary to validate the long-term efficacy and safety of this modified technique. ### Conditions - Stress Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional Burch colposuspension - Modified Burch colposuspension ### Outcomes Primary Outcomes - Subjective voiding dysfunction after surgery, first evaluation - Urinary peak flow rate after surgery, first evaluation - Residual urine after surgery, first evaluation - Urinary retention after surgery, first evaluation - Subjective voiding dysfunction after surgery, second evaluation - Urinary peak flow rate after surgery, second evaluation - Residual urine after surgery, second evaluation - Urinary retention after surgery, second evaluation - Subjective voiding dysfunction after surgery, third evaluation - Urinary peak flow rate after surgery, third evaluation - Residual urine after surgery, third evaluation - Urinary retention after surgery, third evaluation Secondary Outcomes - Subjective recovery from urinary incontinence, first evaluation - Objective recovery from urinary incontinence, first evaluation - Subjective recovery from urinary incontinence, second evaluation - Objective recovery from urinary incontinence, second evaluation - Subjective recovery from urinary incontinence, third evaluation - Objective recovery from urinary incontinence, third evaluation ### Location - Facility: Damascus university, Damascus, N/A, N/A, Syrian Arab Republic @@
## A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer - NCT ID: NCT06292689 - Study ID: IRB-2024-5(IIT) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2027-03-22 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment. ### Conditions - Vulvar and Vaginal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cardunolizumab ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Progression-free survival (PFS) - Overall survival (OS) - Disease control rate (DCR) - Duration of response (DOR) - Adverse events (AEs) ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310005, China @@
## Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning - NCT ID: NCT06292676 - Study ID: ObGynEASC004 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-06-30 - Lead Sponsor: G. d'Annunzio University ### Study Description Mannequin training for emergency home delivery on medical doctors and nurses ### Conditions - Home Birth Delivery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - skills retained for home birth delivery in emergency ### Outcomes Primary Outcomes - Kirkpatrick levels improvement Secondary Outcomes ### Location - Facility: Claudio Celentano, Pescara, Italia, 65100, Italy @@
## Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? - NCT ID: NCT06292663 - Study ID: EMN-2023-08767 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-11 - Lead Sponsor: Zealand University Hospital ### Study Description The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:* Can preoperative information through a VR headset lower the patients preoperative anxiety?* Can VR information make the patients more ready for surgery. Painscore will also be collected.Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain ### Conditions - Anxiety - Surgery - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Virtual Reality ### Outcomes Primary Outcomes - Preoperative anxiety Secondary Outcomes - Cumulative sedative consumption - Opioid consumption - Patient preoperatively expectations - Patient preoperatively readiness - Adverse events ### Location - Facility: Zealand University Hospital, Køge, Zealand, 4600, Denmark @@
## Safety and Efficacy Study of Novel Gene Therapy ZM-02 for Retinitis Pigmentosa Patients - NCT ID: NCT06292650 - Study ID: ZM-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2028-12-25 - Lead Sponsor: Zhongmou Therapeutics ### Study Description This trial is meant to evaluate the safety and efficacy of ZM-02 in Retinitis pigmentosa (RP) patients. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZM-02-L - ZM-02-H - ZM-02-S ### Outcomes Primary Outcomes - Incidence of adverse events and serious adverse events - Changes in intraocular pressure (IOP) in Subjects Secondary Outcomes - Change of FST outcome - Change of MLMT level - Change of Quality of Life ### Location - Facility: Beijing Tongren Hospital of Capital Medical University, Beijing, Beijing, N/A, China @@
## Cognitive Behavioral and Faith Fellowship to Improve Thy Health - NCT ID: NCT06292637 - Study ID: 2020-1484 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-09 - Lead Sponsor: University of Wisconsin, Madison ### Study Description Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) ### Outcomes Primary Outcomes - Patient Health Questionnaire - Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR) Secondary Outcomes - Multidimensional Measure of Religious Involvement (MMRI) score - Client Satisfaction Inventory (CSI) score ### Location - Facility: Second Baptist Church, Madison, Wisconsin, 53711-3800, United States @@
## Effectiveness of Intermittent Vacuum Therapy Combined With Aerobic Exercise in Individuals With Diabetes Mellitus - NCT ID: NCT06292624 - Study ID: HSEARS20230417002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-04-30 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Consequences of the compromised vascular system in diabetes mellitus (DM) are among the most devastating complications. Reduction in blood flow and oxygen uptake of skeletal muscle leads to muscle fatigue and impaired skeletal muscle post-exercise adaptation. Recent studies showed that intermittent vacuum therapy (IVT) augments the blood flow of the foot in people with DM. This pilot study investigates the effects of combined IVT and aerobic exercise in improving lower limb muscle oxygenation and distal circulation in individuals with DM. Positive results of the study shed light on strategy that enhances the effectiveness of aerobic exercise in people with DM. ### Conditions - Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Intermittent vacuum therapy (Weyergans High Care® Medial, Germany) - Cycling exercise ### Outcomes Primary Outcomes - Muscle oxygenation - Muscle oxygenation Secondary Outcomes - Surface Electromyography - Surface Electromyography - Foot Sensation - Foot Sensation - Functional muscle strength - Functional muscle strength - Functional mobility - Functional mobility ### Location - Facility: The Hong Kong Polytechnic University, Hong Kong, N/A, N/A, Hong Kong @@
## Two Week Cumulative Extrinsic Stain Removal of a Battery-powered Toothbrush and a Manual Toothbrush - NCT ID: NCT06292611 - Study ID: ST-23-U35 - Status: COMPLETED - Start Date: 2023-11-27 - Completion Date: 2024-01-25 - Lead Sponsor: Church & Dwight Company, Inc. ### Study Description To evaluate and compare the extrinsic stain removal efficacy of a battery-powered toothbrush and a manual toothbrush following two weeks of brushing. ### Conditions - Dental Devices, Home Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Battery operated toothbrush - Manual toothbrush ### Outcomes Primary Outcomes - Extrinsic Stain Secondary Outcomes ### Location - Facility: Salus Research, Inc., Fort Wayne, Indiana, 46825, United States @@
## Bacterial Translocation and Gut Microbiota in Type 1 Narcolepsy Patients Versus a Control Population - NCT ID: NCT06292598 - Study ID: AOI2022/2023/CDR-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Centre Hospitalier Universitaire de Nīmes ### Study Description Narcolepsy type 1 (NT1) is a rare disease characterized by severe drowsiness, cataplexy, hypnagogic hallucinations, sleep paralysis, poor night sleep, and often obesity. NT1 is caused by irreversible loss of orexin (ORX)/hypocretin neurons in the lateral hypothalamus with decreased ORX levels in the cerebrospinal fluid (CSF). Although the underlying process leading to this destruction remains unclear; an autoimmune origin is suspected.The study authors recently compared the bacterial communities of the fecal microbiota of NT1 patients and control subjects. Initial results demonstrated a difference in overall bacterial community structure in NT1 compared to controls, as assessed by beta diversity, even after adjusting for body mass index (BMI). The Shannon biodiversity index was also correlated with the duration of NT1 disease. However, no association was found between the structure of the microbial community and the clinical characteristics of NT1 patients.In 2022, a second study from the SOMNOBANK cohort on a larger population confirmed these results, showing dysbiosis between NT1 patients and the control population. The altered intestinal microbial diversity supports the important role of the environment in the development and pathogenesis of NT1. Other studies have established a link between dysbiosis, intestinal permeability and inflammation in other neuroimmune pathologies. Currently, no study has focused on these phenomena of bacterial translocation, intestinal permeability and immune activation linked to the microbiota in type 1 narcolepsy patients.The study hypothesis is that NT1 patients with dysbiosis in their intestinal microbiota also present a bacterial translocation with an intestinal origin, leading to a systemic inflammatory syndrome favoring an autoimmune damage destroying hypocretin neurons in the hypothalamus. The study authors suspect that microbial elements (DNA) involved in the autoimmune process could be detected in the CSF. This bacterial translocation could vary over time depending on: i) the progression of the disease and its management; ii) changing dysbiosis and: iii) the increase in intestinal permeability and inflammation. ### Conditions - Narcolepsy Type 1 - Bacterial Translocation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample - Stool sample - CSF sample ### Outcomes Primary Outcomes - Plasma bacterial translocation profiles between groups Secondary Outcomes - Plasma bacterial translocation profiles in NT1 patients - Taxonomic characteristics of DNA in the CSF of NT1 patients according to narcolepsy severity - Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation - Taxonomic characteristics of plasma bacterial DNA in patients with high bacterial translocation - Beta diversity of the intestinal microbiota between groups - Beta diversity of the intestinal microbiota in NT1 patients - Alpha diversity of the intestinal microbiota between groups - Alpha diversity of the intestinal microbiota in NT1 patients - Composition of the intestinal microbiota between groups - Composition of the intestinal microbiota between groups - Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile between groups - Plasma Intestinal Fatty Acid Binding Protein (i-FABP) profile in NT1 patients - Plasma LPS-binding Protein (LBP) profile between groups - Plasma LPS-binding Protein (LBP) profile in NT1 patients - Plasma Soluble CD14 profile between groups - Plasma Soluble CD14 profile in NT1 patients - Age of onset of symptoms in NT1 patients - Duration of disease progression in NT1 patients - Severity of sleep-related symptoms in NT1 patients - Severity of narcolepsy symptoms in NT1 patients - Description of comorbidities in NT1 patients - Sleep onset latency in NT1 patients - Number of rapid eye movement sleep episodes in NT1 patients - Orexin levels in CSF in NT1 patients ### Location - Facility: Nîmes University Hospital, Nîmes, Gard, 30029, France @@
## Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT) - NCT ID: NCT06292585 - Study ID: AEDH-MT - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Changhai Hospital ### Study Description A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study. ### Conditions - EpiDural Hematoma - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MMA embolization plus medical therapy - Medical therapy alone ### Outcomes Primary Outcomes - The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma. Secondary Outcomes ### Location - Facility: Changhai hospital, Shanghai, Shanghai, 200433, China @@
## Clinical Characteristics and Surgical Outcomes of the Fellow Eye in Bilateral Retinal Detachments - NCT ID: NCT06292572 - Study ID: 2024PI029 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-11-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description To assess the clinical features and the surgical outcomes of RD repair surgery of the fellow eye in bilateral retinal detachments ### Conditions - Retinal Detachment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Retinal Detachment Surgery ### Outcomes Primary Outcomes - Rate of surgical success Secondary Outcomes - Visual Acuity ### Location - Facility: CHRU de Nancy, Vandoeuvre les nancy, Meurthe-et-Moselle, 54511, France @@
## A Comparison Between STN-DBS and GPi-DBS in Meige Syndrome Evaluated by Flexible Electrodes - NCT ID: NCT06292559 - Study ID: STN or GPi in Meige Syndrom - Status: RECRUITING - Start Date: 2023-11-30 - Completion Date: 2025-11-30 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description Deep-brain stimulation (DBS) is an effective treatment for patients with Meige syndrome. The globus pallidus interna (GPi) and the subthalamic nucleus (STN) are both accepted targets for this treatment. Researchers designed this study to compare the 12-month outcomes for patients who undergo bilateral stimulation of the GPi or STN. ### Conditions - Meige Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bilateral STN deep brain stimulation - Bilateral GPi deep brain stimulation ### Outcomes Primary Outcomes - Change in motor function Secondary Outcomes - health-related quality of life - sleep quality status - Mental syndrome - Mental syndrome ### Location - Facility: Chao Zhang, Jinan, Sichuan, 250100, China @@

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