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## A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM) - NCT ID: NCT06347159 - Study ID: EDG-7500-102 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Edgewise Therapeutics, Inc. ### Study Description This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy. ### Conditions - Hypertrophic Cardiomyopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - EDG-7500 - EDG-7500 ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events Secondary Outcomes - Change from baseline in left ventricular outflow tract (LVOT) gradient - Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax) ### Location - Facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine), Philadelphia, Pennsylvania, 19104, United States @@
## Bridges2Scale: Testing Implementation Strategies - NCT ID: NCT06347146 - Study ID: R01HD112323 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-07-31 - Lead Sponsor: Washington University School of Medicine ### Study Description The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect. ### Conditions - HIV/AIDS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Financial Literacy Training (FLT) workshops - Mentorship - Income Generation Activity (IGA) - Youth Development Accounts (YDA) ### Outcomes Primary Outcomes - Intervention Fidelity - HIV prevalence Secondary Outcomes - Sexual risk-taking behavior - Economic stability - School attainment - Depressive Symptoms - Proportion of adolescents living with HIV who are virally suppressed - Proportion of HIV negative adolescents who use PrEP - Hopelessness - Self-Esteem - Self-concept ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia - NCT ID: NCT06347133 - Study ID: AROAPOC3-3009 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-10 - Lead Sponsor: Arrowhead Pharmaceuticals ### Study Description This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety. ### Conditions - Hypertriglyceridemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Plozasiran Injection - Placebo ### Outcomes Primary Outcomes - Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Secondary Outcomes - Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo - Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo - Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment - Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment - Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo - Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo - Change from Baseline in C-peptide During the Treatment Period Compared to Placebo - Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo - Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo - Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo - Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo - Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 - Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction - NCT ID: NCT06347120 - Study ID: PI2024_843_0011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :* OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;* NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO. ### Conditions - Small Bowel Obstruction Adhesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - nasogastric tube - NOM without NGT insertion ### Outcomes Primary Outcomes - Decrease of complication rate in patient without NGT group compared to control group Secondary Outcomes - aspiration pneumonia rate in both patient groups ### Location - Facility: Amiens Universitary Hospital, Amiens, N/A, N/A, France @@
## Robotic Subretinal tPA Injection Study - NCT ID: NCT06347107 - Study ID: S67215 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:* The robotic stabilizer (prototype - FAMHP approval received)* 41G subretinal needle (CE marked - used within label)* Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review. ### Conditions - Subretinal Hemorrhage - Age-Related Macular Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Robotic subretinal tPA injection ### Outcomes Primary Outcomes - Percentage of patients with succesful subretinal insertion of the robot-held 41G needle - Percentage of patients with stable subretinal position of the needle for at least 3 minutes. Secondary Outcomes - Device-related adverse events - Functional outcome ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols - NCT ID: NCT06347094 - Study ID: 610/2023/SPER/UNIPR - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2025-12-31 - Lead Sponsor: University of Parma ### Study Description This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping. ### Conditions - Individual Variability in (Poly)Phenol Metabolism - Cardiometabolic Health - Personalized Dietary Intervention - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Personalized Dietary Plan - Oral (Poly)phenol Challenge Test (OPCT) - General Dietary Advice ### Outcomes Primary Outcomes - Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation - Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons Secondary Outcomes - Anthropometric measurements: weight, height and body mass index - Anthropometric measurements: waist and hip circumferences detection - Body composition: bioelectrical impedance analysis - Blood pressure - Heart rate - Biomarkers of cardiometabolic health: hematochemical and urine analysis - Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase - Biomarkers of cardiometabolic health: homocysteine - Biomarkers of cardiometabolic health: insulin - Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin - Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index - Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function - Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance - Inflammatory status - Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years - Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years - Risk prediction scores: Hard Coronary Heart Disease - 10-years risk - Risk prediction scores: First Coronary Heart Disease - 2-years risk - Risk prediction scores: Framingham Heart Study for Diabetes - Risk prediction scores: Framingham Heart Study for Hypertension - Risk prediction scores: Framingham Heart Study for Stroke - Risk prediction scores: Framingham Heart Study for Fatty Liver Disease - Risk prediction scores: Atherosclerotic Cardiovascular Disease - Risk prediction scores: QRESEARCH risk estimator version 3 - Risk prediction scores: QDiabetes Score - Risk prediction scores: Finnish Diabetes Risk Score - Risk prediction scores: Cuore Project - Calculating the individual risk score - Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index - Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index - Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index - Evaluation of adherence to healthy and sustainable dietary models: DASH Index - Evaluation of adherence to Mediterranean diet - Nutritional and energy assessment: LARN - Nutritional and energy assessment: EPIC - Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome - Lifestyle factors assessment: general information - Lifestyle factors assessment: sleep quality (PSQI) - Lifestyle factors assessment: sleep quality (ESS) - Lifestyle factors assessment: sleep quality (ISI) - Lifestyle factors assessment: physical activity (IPAQ) - Lifestyle factors assessment: state of health (BDI) - Lifestyle factors assessment: state of health (SF-36) - (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes - Other plant bioactive metabolites - Food/gut/host-derived metabolites - Biomarkers of food intake and of healthy dietary patterns - Untargeted metabolomics - Genetic differences - Gut microbiota composition - Oral microbiota composition - Biomarkers of adipose tissue function - Biomarkers of food intake regulation ### Location - Facility: University of Parma - Plesso Biotecnologico Integrato, Parma, PR, 43125, Italy @@
## Effect of Nd-YAG Laser on Hypertrophic Scar - NCT ID: NCT06347081 - Study ID: P.T.REC/012/00449 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2024-02-28 - Lead Sponsor: Cairo University ### Study Description A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures. ### Conditions - Hypertrophic Scar ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nd- YAG laser at 532nm wavelength ### Outcomes Primary Outcomes - hypertrophic scar maturation - hypertrophic scar volume Secondary Outcomes ### Location - Facility: Faculty of Physical Therapy, Cairo, N/A, 12613, Egypt @@
## Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells - NCT ID: NCT06347068 - Study ID: LCCC2128-ATL - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC). ### Conditions - Breast Cancer - Relapse - Resistant Cancer - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - iC9-CAR.B7-H3 T Cell Therapy - cyclophosphamide - fludarabine ### Outcomes Primary Outcomes - Toxicity: NCI-CTCAE - Toxicity: Cytokine Release Syndrome (CRS) - Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) Secondary Outcomes - The recommended phase 2 dose (RP2D) NCI-CTCAE v5. - The recommended phase 2 dose (RP2D) CRS Grading - The recommended phase 2 dose (RP2D) - Objective response rate - Progression Free Survival (PFS) - Overall Survival (OS) - Duration of Response (DOR) ### Location - Facility: University of North Carolina, Chapel Hill, North Carolina, 27599, United States @@
## NeuroControl of Nicotine Dependence - NCT ID: NCT06347055 - Study ID: 403690 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2030-04-30 - Lead Sponsor: University of Missouri-Columbia ### Study Description The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours. ### Conditions - Nicotine Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Repetitive Transcranial Magnetic Stimulation (rTMS) ### Outcomes Primary Outcomes - Acute effects of cTBS on cognitive control Secondary Outcomes - Exploratory: Acute effects of cTBS on fMRI brain response ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Qigong on Sleep Quality in Fibromyalgia - NCT ID: NCT06347042 - Study ID: 012/004897 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: Cairo University ### Study Description This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - qigong exercise + routine medical treatment +Anti-inflammatory diet - routine medical treatment +Anti-inflammatory diet only ### Outcomes Primary Outcomes - Sleep quality - Heart Rate variability Secondary Outcomes - Quality of Life o measure the quality of life of patients with problems found fibromyalgia. - pain self-administered questionnaire - Fatigue :prevalence and severity of fatigue - Depression and Anxiety assess Depression and Anxiety ### Location - Facility: Faculty of Physical therapy Cairo University, Cairo, Giza, N/A, Egypt @@
## Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies - NCT ID: NCT06347029 - Study ID: Endothelial dysfunction - Status: RECRUITING - Start Date: 2023-10-17 - Completion Date: 2024-12-31 - Lead Sponsor: Brugmann University Hospital ### Study Description The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation.For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula , because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery.Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction.Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023 , on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%.Interestingly, a third of the cohort presented an antibody profile that did not allow them to be classified according to the classification criteria in force. This group corresponds to patients with a single positive dosage, either not recontrolled or recontrolled negative. This group was called Fluctuating. This fluctuating group was associated with arteriovenous fistula complications in a 2019 study.Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD.The objective of this study is to evaluate the weight of antiphospholipid biology on endothelial dysfunction in hemodialysis patients, using the FMD test.1. Compare endothelial dysfunction by FMD according to the stage of chronic kidney disease and in comparison to a control group without chronic kidney disease.2. Characterize the FMD pre or post dialysis and according to the duration of the long (for example between Thursday and Sunday) vs. short (between Tuesday and Thursday) inter-dialytic period.3. Evaluate the relationship between endothelial dysfunction according to FMD, aPL positivity and arteriovenous fistula complications in hemodialysis patients.4. Evaluate the risk factors associated with endothelial dysfunction according to FMD, and in particular evaluate the impact of antiphospholipid antibodies.5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2). ### Conditions - Chronic Renal Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Urine sampling - Blood sampling - Flow mediated dilatation test ### Outcomes Primary Outcomes - Nitric oxide (NO) plasma level - Endothelin 1 (ET-1) plasma level - E-Selectine plasma level - P-Selectine plasma level - Intercellular Adhesion Molecule 1 (ICAM-1) plasma level - Interleukin 6 (IL-6) plasma level - Nitric oxide (NO) urine concentration - Endothelin 1 (ET-1) urine concentration - Tumour Necrosis Factor alpha (TNF alpha) urine concentration - Interleukin 6 (IL-6) urine concentration - Flow mediated dilatation test result (%) Secondary Outcomes ### Location - Facility: Brugmann University Hospital, Brussels, N/A, 1020, Belgium @@
## Study of Plozasiran in Adults With Severe Hypertriglyceridemia - NCT ID: NCT06347016 - Study ID: AROAPOC3-3004 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-10 - Lead Sponsor: Arrowhead Pharmaceuticals ### Study Description This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. ### Conditions - Severe Hypertriglyceridemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Plozasiran Injection - Placebo ### Outcomes Primary Outcomes - Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Secondary Outcomes - Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo - Proportion of Subjects Who Achieve Fasting TG Levels of < 500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 - Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 - Proportion of Subjects Who Achieve Fasting TG Levels of <150mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo - Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo - Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment - Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment - Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment - Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo - Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo - Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo - Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo - Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo - Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo - Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo - Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 - Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 3 Study of Plozasiran in Adults With Severe Hypertriglyceridemia - NCT ID: NCT06347003 - Study ID: AROAPOC3-3003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-10 - Lead Sponsor: Arrowhead Pharmaceuticals ### Study Description This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol. ### Conditions - Severe Hypertriglyceridemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Plozasiran Injection - Placebo ### Outcomes Primary Outcomes - Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Secondary Outcomes - Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo - Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 Compared to Placebo - Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12 - Proportion of Participants Who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo - Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment - Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment - Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment - Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo - Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo - Change from Baseline in C-peptide During the Treatment Period Compared to Placebo - Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo - Incidence Rates of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo - Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo - Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo - Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 - Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG - NCT ID: NCT06346990 - Study ID: Faculty 2023-2024-2-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-05-15 - Lead Sponsor: Applied Science Private University ### Study Description This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome. ### Conditions - Coronary Artery Disease - Coronary Artery Bypass Graft Surgery - Delirium, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Holy Quran Recital ### Outcomes Primary Outcomes - Delirium Secondary Outcomes - Length of stay-ICU - Length of stay-hospital ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC - NCT ID: NCT06346977 - Study ID: DTO-20231214 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases.Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques.To address these pressing diagnostic and monitoring needs in NSCLC-LM management, the investigator proposes a forward-looking, non-interventional clinical study harnessing the power of cutting-edge proteomic technologies. These platforms, characterized by their high throughput, exquisite sensitivity, and minimal sample volume requirements, offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy. The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy, ultimately contributing to enhanced patient care and personalized therapeutic strategies. ### Conditions - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pemetrexed ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) ### Location - Facility: Union hospital, Wuhan, Hubei, 430000, China @@
## Self-Care Management in Older Adults - NCT ID: NCT06346964 - Study ID: 2024-341 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-06-30 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with a chronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate the compliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The research was planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronic diseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will be developed for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention. ### Conditions - Disease Self Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - mobile application ### Outcomes Primary Outcomes - Participation in social life (Social Inclusion Scale) - Participation in social life (Social Inclusion Scale) - Participation in social life (Social Inclusion Scale) Secondary Outcomes ### Location - Facility: Ankara Yıldırım Beyazıt University, Ankara, Çubuk/Turkey, 06760, Turkey @@
## Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS) - NCT ID: NCT06346951 - Study ID: LPan - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-09-30 - Lead Sponsor: Sichuan Provincial People's Hospital ### Study Description The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures. ### Conditions - Invasive Fungal Infections ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The survey on the hospital's diagnostic and treatment standards and infrastructure for invasive fungal infections - The survey on the awareness of an invasive fungal infection among intensive care physicians Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis - NCT ID: NCT06346938 - Study ID: 2024WHXH001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2027-03-26 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases. ### Conditions - Bronchiectasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Frequency of acute exacerbations of bronchiectasis Secondary Outcomes - Deterioration of lung function - Severity of dyspnoea - Degree of emphysema - Mucus plug score - Bhalla scores on CT of participants' lungs - Frequency of hospitalisation - Death ### Location - Facility: Wuhan Union Hospital, Wuhan, Hubei, 430022, China @@
## Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects. - NCT ID: NCT06346925 - Study ID: SHR8735-116 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description This study was designed as a single-center, randomized, open, two-cycle, cross-over trial. It is planned to enroll 18 healthy subjects ### Conditions - Adult Patients With Chronic Primary ITP - Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Herombopag Olamine Tablets ### Outcomes Primary Outcomes - Cmax - AUC0-t - AUC0-∞ Secondary Outcomes - Tmax - t1/2 - CL/F - V/F - Incidence and severity of adverse events (AEs) ### Location - Facility: The Second Hospital of Anhui Medical Uniersity, Hefei, Anhui, 230601, China @@
## CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL - NCT ID: NCT06346912 - Study ID: TXB2023022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04-15 - Lead Sponsor: Zhejiang University ### Study Description Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma. ### Conditions - Acute Lymphoblastic Leukemia,B-Cell - Non-hodgkin Lymphoma,B Cell ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CD19-BAFF Targeted CAR T-cells ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - Incidence of treatment-emergent adverse events (TEAEs) Secondary Outcomes - Overall response rate ,ORR - Duration of remission ,DOR - Event-free survival, EFS - Overall survival, OS ### Location - Facility: The first affiliated hospital of medical college of zhejiang university, Hangzhou, Zhejiang, 310000, China @@
## A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China - NCT ID: NCT06346899 - Study ID: TAK-743-4012 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-14 - Completion Date: 2025-08-13 - Lead Sponsor: Takeda ### Study Description The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study. ### Conditions - Hereditary Angioedema (HAE) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period - Median Time to Complete Attack Resolution for Icatibant Treated Participants Secondary Outcomes - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period - Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period - Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period - Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period - Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HTN App for HTN Control and Cardiovascular Health Among African-Americans - NCT ID: NCT06346886 - Study ID: 23-011703 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FAITH! HTN app ### Outcomes Primary Outcomes - Absolute Change in Systolic Blood Pressure (BP) - HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects) Secondary Outcomes - Proportion of subjects reaching BP control - Change in BP as assessed by home BP cuff measurements - CV Health Knowledge as measured by module assessment scores - Hypertension (HTN) Knowledge as assessed by 11-item questionnaire ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Demonstrating Efficacy of JOGO for the Treatment of Tremor - NCT ID: NCT06346873 - Study ID: 23-008090 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-09 - Lead Sponsor: Mayo Clinic ### Study Description This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice. ### Conditions - Functional Neurological Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - JOGO ### Outcomes Primary Outcomes - Change in TETRAS scores 1 month Secondary Outcomes - Change in TETRAS scores 2 months - Change in QUEST scores - Tremor prevalence - Tremor resolution 1 month - Tremor resolution 2 months - Change in BDI-II scores - Change in BAI scores - Change in Intolerance of Uncertainty Scale ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States @@
## Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery - NCT ID: NCT06346860 - Study ID: 09.2024.241 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Marmara University ### Study Description Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach. ### Conditions - Opioid Use - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Regional Block Comparison ### Outcomes Primary Outcomes - Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device Secondary Outcomes - Postoperative pain assessment with Numeric Rating Scale (NRS) - Comparison of the frequency of treatment related complications - Participant satisfaction ### Location - Facility: Marmara University School of Medicine, Istanbul, N/A, N/A, Turkey @@
## Study to Assess Effects of Pasteurized Akkermansia Muciniphila vs Placebo in Participants With Diarrhea-predominant IBS - NCT ID: NCT06346847 - Study ID: TAC/231001/AKM/IBS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: A-Mansia Biotech S.A. ### Study Description The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of pasteurized Akkermansia muciniphila on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of pAkk on anxiety, low mood and stress of the participants, as well as its safety and tolerability.The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase). ### Conditions - Diarrhea-Predominant Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pasteurized Akkermansia muciniphila (pAKK) - Placebo ### Outcomes Primary Outcomes - To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. Secondary Outcomes - To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8 - To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score - To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12. - To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score - To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12. - To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS) - To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS) - To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study - To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores - To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value - To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product - To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance - To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument. ### Location - Facility: HCG Hospital, Ahmedabad, Gujarat, 380006, India @@
## Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers - NCT ID: NCT06346834 - Study ID: PRO-sIPV-4002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-12-30 - Lead Sponsor: Sinovac Biotech Co., Ltd ### Study Description To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV. ### Conditions - Poliomyelitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - sIPV ### Outcomes Primary Outcomes - Geometric Mean Increase (GMI) - Geometric Mean Titer (GMT) - Seropositivity rate - Seroconversion rate - Adverse reaction incidence - Serious adverse events incidence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data - NCT ID: NCT06346821 - Study ID: WestChinaGBMTTFieldsV1.0 - Status: RECRUITING - Start Date: 2023-07-04 - Completion Date: 2024-05-01 - Lead Sponsor: Sichuan University ### Study Description The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.Participants will:* Receive or not receive TTFields.* Concomitantly or adjuvantly receive TTFields. ### Conditions - Glioblastoma Multiforme ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Optune® (Tumor Treating Fields) ### Outcomes Primary Outcomes - Overall Survival (OS) Secondary Outcomes ### Location - Facility: West China Hospital, Chengdu, Sichuan, 610041, China @@
## Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC - NCT ID: NCT06346808 - Study ID: PDAC-OV - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Sichuan University ### Study Description The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Oncolytic virus Plus Anti-PD1 and Chemotherapy ### Outcomes Primary Outcomes - Incidence of Treatment-Related Adverse Events [Safety and Tolerability] Secondary Outcomes - R0 resection rate - ORR ### Location - Facility: West China Hospital, Sichuan University, Chengdu, Sichuan, 610000, China @@
## Class II Restorations With High-Filled Flowable Composites - NCT ID: NCT06346795 - Study ID: SelcukC - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Selcuk University ### Study Description In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05). ### Conditions - Dental Caries - Class II Dental Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-filling flowable dental composite ### Outcomes Primary Outcomes - Retention - Color match - Marginal discoloration - Marginal adaptation - Secondary caries - Surface texture - Anatomical form - Postoperative sensitivity Secondary Outcomes ### Location - Facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department, Konya, N/A, N/A, Turkey @@
## Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer - NCT ID: NCT06346782 - Study ID: IRB00370545 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2028-08-01 - Lead Sponsor: Johns Hopkins All Children's Hospital ### Study Description This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, if so, the participants will be randomly assigned to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey. ### Conditions - Pediatric Cancer - Oncology - Disruptive Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Internet-Based Parent-Child Interaction Therapy ### Outcomes Primary Outcomes - I-PCIT Feasibility as assessed by intervention completion - I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form Secondary Outcomes ### Location - Facility: Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, 33701, United States @@
## Composite Restorations Performed by Placing Polyethylene Fiber - NCT ID: NCT06346769 - Study ID: SelcukB - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-04-15 - Lead Sponsor: Selcuk University ### Study Description This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p\<0.05). ### Conditions - Endodontically Treated Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Polyethylene Fiber ### Outcomes Primary Outcomes - Retention - Color match - Marginal Discoloration - Marginal adaptation - Secondary caries - Surface texture - Anatomical form Secondary Outcomes ### Location - Facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department, Konya, N/A, N/A, Turkey @@
## Clinical Evaluation of Class II Restorations - NCT ID: NCT06346756 - Study ID: SelcukA - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-07-15 - Lead Sponsor: Selcuk University ### Study Description This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.The study included 62 patients and 147 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. GCI only in premolar teeth; GCA, TP, and FU have been used to restore premolar and molar teeth. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05). ### Conditions - Dental Caries - Dental Caries Class II ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Treatment of dental caries. ### Outcomes Primary Outcomes - Retention Secondary Outcomes - color match - marginal adaptation - marginal discoloration - surface texture - anatomical form - secondary caries - postoperative sensitivity ### Location - Facility: Selcuk University, Faculty of Dentistry, Konya, N/A, N/A, Turkey @@
## Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice. - NCT ID: NCT06346743 - Study ID: IRB/2023/1119/SIMS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: Muhammad Zark ### Study Description Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay. ### Conditions - Physiological Neonatal Jaundice - Physiological Hyperbilirubinaemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fenofibrate - Phototherapy ### Outcomes Primary Outcomes - number of days needed for serum bilirubin to decrease below phototherapy range Secondary Outcomes - Hospital length of Stay ### Location - Facility: Services Institute of Medical Sciences, Lahore, Punjab, 54000, Pakistan @@
## The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI) - NCT ID: NCT06346730 - Study ID: 142-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-09-30 - Lead Sponsor: Suleyman Demirel University ### Study Description This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group. ### Conditions - Virtual Reality - Anxiety - Patient Satisfaction - Intrauterine Insemination (IUI) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual reality glasses to intervention group ### Outcomes Primary Outcomes - State Trait Anxiety Inventory (STAI) - Patient's Perception of Nursing Care Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mobile Application Based Care for Total Knee Prosthesis Patients - NCT ID: NCT06346717 - Study ID: SINOPU-elif 2 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-03-30 - Lead Sponsor: Sinop University ### Study Description Total knee prosthesis (TKP); It is a surgical treatment used in the management of functional limitations and severe pain occurring on the degenerated joint surface as a result of rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and other nonspecific arthritis. Nursing care is of great importance in the success of TKP surgery. Reducing pain, preventing complications, increasing self-care ability, and improving the quality of life by improving postoperative knee functions are the main goals of postoperative nursing care. In order to achieve these goals, patients and their relatives need to receive training on home care in the post-operative period before discharge. With the increasing use of mobile technologies in daily life and the increasing adoption of e-health, the opportunity for people to improve their self-management skills through e-health is increasing. Mobile Health (m-Health) provides convenience in many areas such as educating the public, warning about potential diseases and disease risks, and communicating with messages, notifications and video when necessary. It also affects the way nursing services are delivered and provides great benefits in the delivery of nursing services. For all these reasons, it was aimed to examine the effect of mobile application-supported care given to patients with total knee prosthesis on functional status and self-care ability. ### Conditions - Knee Prosthesis - Mobile Application ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - "Knee Prosthesis-M" mobile application service ### Outcomes Primary Outcomes - Knee Injury and Osteoarthritis Outcome Score = KOOS Secondary Outcomes - Exercise of Self-Care Agency=ESCA ### Location - Facility: Elif ALTINKAYNAK SARAL, Merkez, Osmaniye Köyü, 5700, Turkey @@
## Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis - NCT ID: NCT06346704 - Study ID: PR5030-66 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2026-11-30 - Lead Sponsor: SYSNAV ### Study Description The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Digital HealthTechnology ### Outcomes Primary Outcomes - Longitudinal change of 95th centile of stride velocity Secondary Outcomes - Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease - NCT ID: NCT06346691 - Study ID: MTU-EC-IM-0-235/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-12-31 - Lead Sponsor: Thammasat University ### Study Description The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.The main questions it aims to answer are:* Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?* What medical problems do participants experience when taking doxofylline and procaterol?" ### Conditions - COPD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Doxofylline - Procaterol ### Outcomes Primary Outcomes - Forced expiratory volume in 1 second (FEV1) - Forced vital capacity (FVC) - Forced expiratory flow at 25-75% of FVC (FEF25-75) Secondary Outcomes - modified Medical Research Council (mMRC) score - COPD Assessment Test (CAT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease - NCT ID: NCT06346678 - Study ID: MTU-EC-IM-0-016/67 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-10-31 - Lead Sponsor: Thammasat University ### Study Description The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients? ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Accuhaler tester ### Outcomes Primary Outcomes - Accuracy of Accuhaler tester - Accuracy of Ellipta tester - Accuracy of Turbutester Secondary Outcomes - Prevalence of suboptimal peak inspiratory flow rate - Prevalence of insufficient peak inspiratory flow rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Transplant Cohort of the German Center for Infection Research - NCT ID: NCT06346665 - Study ID: DZIF Tx-Cohort - Status: RECRUITING - Start Date: 2016-01 - Completion Date: 2030-12 - Lead Sponsor: Technical University of Munich ### Study Description Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function. ### Conditions - Infections - Transplant Complication - Transplant Failure - Immunosuppression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection Secondary Outcomes ### Location - Facility: Technische Universität München, München, N/A, N/A, Germany @@
## Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients - NCT ID: NCT06346652 - Study ID: REC-UOL-216-03-2024 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-04-30 - Lead Sponsor: University of Lahore ### Study Description Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients. ### Conditions - Chronic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine Physical Therapy - Routine Physical Therapy+ PNF and Core Stregthening ### Outcomes Primary Outcomes - Static Standing Balance Secondary Outcomes - Plantar Pressure ### Location - Facility: The University of Lahore Teaching Hospital, Lahore, N/A, 54000, Pakistan @@
## Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators - NCT ID: NCT06346639 - Study ID: LithuananianSportsU-17 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2029-04-04 - Lead Sponsor: Lithuanian Sports University ### Study Description There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - 16-day hot and cold acclimation ### Outcomes Primary Outcomes - Change in body mass and body composition (kg) - Change in skinfold thickness (mm) - Change in body mass index (kg/m^2) - Change in body surface area (m^2) - Change in substrate oxidation - Change in substrate oxidation (g/day) - Change in ventilation (l/min) - Change in breathing frequency (t/min) - Change in resting energy expenditure (kcal/day) - Change in metabolic heat production (W) - Change in heart rate (bpm) - Change in blood pressure (mmHg) - Change in mean arterial pressure (mmHg) - Change in heart rate variability (ms) - Change in heart rate variability (time domain) (ms) - Change in heart rate variability (time domain) (Ln) - Change in heart rate variability (frequency domain) (ms^2) - Change in heart rate variability (frequency domain) (Ln) - Change in stroke volume (ml) - Change in stroke volume index (ml/m^2) - Change in cardiac output index (l/min//m^2) - Change in cardiac output index (l/min) - Change in contractility index - Change in ventricular ejection time (ms) - Change in ventricular ejection fraction (percent) - Change in end diastolic volume (ml) - Change in systemic vascular resistance (dyn.s/cm5.m^2) - Change in cardiac work index (kg.m/m^2) - Change in early diastolic filling ratio (percent) - Change in testosterone concentration (µg/dl) - Change in female sex hormones concentration (pg/mL) - Change in salivary cortisol concentration (µg/dl) - Change in cytokines concentrations (pg/ml) - Change in complete blood count (10^9/L) - Change in complete blood count (percent) - Change in lipid profile (mmol/l) - Change in catecholamines concentration (ng/ml) - Change in insulin concentration (μIU/ml) - Change in glucose tolerance (mmol/l) - Change in anxiety and depression (points) - Change in plasma metabolites of the kynurenine pathway (μm) - Change in body temperature (°C) - Change in physiological strain index - Change in cold strain index - Change in root mean square (RMS) amplitude (mV) - Change in pain sensations - Change in thermal sensations (points) - Change in shivering/sweating (points) - Change in thermal comfort (points) Secondary Outcomes - Height (m) - Change in physical activity (in h) - Change in sleep (in h) - Change in oxygen saturation (percent) ### Location - Facility: Lithuanian Sports University, Kaunas, N/A, LT-44221, Lithuania @@
## To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children - NCT ID: NCT06346626 - Study ID: 2WIN-S2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: He Eye Hospital ### Study Description Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded.Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features.This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S. ### Conditions - Optometry ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The optometric result (2WIN-S) Secondary Outcomes - The optometric result(ARK-1) - The optometric result(subjective refraction) - The optometric result ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU - NCT ID: NCT06346613 - Study ID: B2024-076R - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future. ### Conditions - Sleep Deprivation - Circadian Rhythm Disorders - Critical Illness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rhythmicity of melatonin levels. Secondary Outcomes - Overnight sleep duration - Wake after sleep onset(WASO) - Overnight Rapid Eye Movement (REM) proportion - Overnight non-rapid eye movement stage 1 (NREM1) proportion - Overnight non-rapid eye movement stage 2 (NREM2) proportion - Overnight non-rapid eye movement stage 3 (NREM3) proportion - Sleep period time ratio (sleep continuity) - Subject sleep quality - Activity counts ### Location - Facility: 180 Fenglin Road, Shanghai, N/A, 20032, China @@
## A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD - NCT ID: NCT06346600 - Study ID: SKG0106-LF - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2031-03 - Lead Sponsor: Skyline Therapeutics ### Study Description This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection. ### Conditions - Neovascular (Wet) Age-related Macular Degeneration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SKG0106 ### Outcomes Primary Outcomes - Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) Secondary Outcomes - Mean change in best corrected visual acuity (BCVA) at each visit from baseline - Mean change in macular central subfield thickness (CST) at each visit from baseline - Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline ### Location - Facility: Ophthalmic Consultants of Boston, Boston, Massachusetts, 02114, United States @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06346587 - Study ID: VRU751-C001 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial) - NCT ID: NCT06346574 - Study ID: STUDY-0004282 - Status: RECRUITING - Start Date: 2023-12-14 - Completion Date: 2024-12 - Lead Sponsor: Tufts University ### Study Description With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area.The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data.A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization. ### Conditions - Dietary Habits - Physical Inactivity - Sleep Hygiene ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Experimental ### Outcomes Primary Outcomes - Use of health and wellness App - Engagement with Guide - Nutrition behaviors - Physical activity behaviors - Sleep habits Secondary Outcomes - BMI - Cholesterol - Triglycerides - Blood pressure - Blood glucose ### Location - Facility: Tufts University, Boston, Massachusetts, 02111, United States @@
## The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study - NCT ID: NCT06346561 - Study ID: Soh-Med-24-02-10MS - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-08-30 - Lead Sponsor: Sohag University ### Study Description The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery. ### Conditions - Nasolacrimal Duct Obstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Labetalol ### Outcomes Primary Outcomes - Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension. Secondary Outcomes - Effectiveness of dexamedetomidine for prolongation of postoperative analgesia. ### Location - Facility: Sohag University hospitals, Sohag, N/A, N/A, Egypt @@
## Study on the Chromatic Perception of Digital Systems in Aesthetic Field - NCT ID: NCT06346548 - Study ID: VF-ES-DIG - Status: NOT_YET_RECRUITING - Start Date: 2024-09-27 - Completion Date: 2025-06-15 - Lead Sponsor: Paolone Gaetano ### Study Description The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice. ### Conditions - Color Detection of Upper Central Incisors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - oral photography ### Outcomes Primary Outcomes - Comparison of chromatic values of the upper central incisors Secondary Outcomes ### Location - Facility: IRCCS San Raffaele, Milano, N/A, 20132, Italy @@
## PrimeCog: Primary Care Cognitive Testing - NCT ID: NCT06346535 - Study ID: 2022-05703-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-04-01 - Lead Sponsor: Region Östergötland ### Study Description The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated. ### Conditions - Mental Health Issue - Cognitive Symptom - Primary Health Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cognitive Testing ### Outcomes Primary Outcomes - Cognitive Test Results regarding attention and processing speed - Cognitive Test Results regarding attention and processing speed - Cognitive Test Results regarding attention and processing speed - Cognitive Test Results regarding attention and processing speed - Cognitive Test Results regarding memory - Cognitive Test Results regarding memory - Cognitive Test Results regarding executive function - Cognitive Test Results regarding executive function - Cognitive Test Results regarding executive function - Cognitive Test Results regarding language - Cognitive Test Results regarding language - Cognitive Test Results regarding visuospatial capacity Secondary Outcomes - MRI features, measured by morphological and quantitative MR sequences of the brain - Biochemical Profile in blood regarding inflammation, stress and neurodegeneration - Biochemical Profile in saliva regarding inflammation and stress - Biochemical Profile in hair regarding exposure to stress ### Location - Facility: Region Ostergotland, primary care centrum, Linköping, Ostergotland, N/A, Sweden @@
## Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU - NCT ID: NCT06346522 - Study ID: FMASU R37/2024 - Status: RECRUITING - Start Date: 2024-02-24 - Completion Date: 2024-08 - Lead Sponsor: Ain Shams University ### Study Description Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder. ### Conditions - Catheter-related Bladder Discomfort (CRBD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Gabapentin (Gaptin ®) 400mg oral capsule once - Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule ### Outcomes Primary Outcomes - The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake Secondary Outcomes - Total fentanyl requirements in micrograms (µg) - Numerical Pain Rating Scale (NPRS) (0-10) - Side effects of the study drugs - Ramsay sedation score ### Location - Facility: Ain Shams University-Faculty of Medicine, Cairo, N/A, N/A, Egypt @@
## Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants - NCT ID: NCT06346509 - Study ID: PORT-77-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12-23 - Lead Sponsor: Portal Therapeutics, Inc. ### Study Description A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants. ### Conditions - Healthy Adult Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PORT-77 - Placebo ### Outcomes Primary Outcomes - Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) - Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II) Secondary Outcomes - Plasma concentration of a single-dose of PORT-77 (Part I) - Plasma concentration of the steady-state of PORT-77 (Part II) - Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) - Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) - Evaluate effects of single doses of PORT-77 on ECG parameters (Part II) ### Location - Facility: Celerion, Tempe, Arizona, 85283, United States @@
## Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study - NCT ID: NCT06346496 - Study ID: H23133 - Status: COMPLETED - Start Date: 2023-11-20 - Completion Date: 2024-01-15 - Lead Sponsor: Institute of Psychology, Chinese Academy of Sciences ### Study Description This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively. ### Conditions - LLM-based AI Dialogue Bot - Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Douyin Xinqing AI dialog bot - Douyin Xinqing AI dialog bot for delayed intervention ### Outcomes Primary Outcomes - Depression - Anxiety - Positive and negative moods Secondary Outcomes ### Location - Facility: Institute of Psychology, Chinese Academy of Sciences, Beijing, Beijing, N/A, China @@
## Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off - NCT ID: NCT06346483 - Study ID: STU00218929 - Status: RECRUITING - Start Date: 2023-06-09 - Completion Date: 2025-06-09 - Lead Sponsor: Northwestern University ### Study Description The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine. ### Conditions - Kidney Stone - Ureteral Stone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dusting ### Outcomes Primary Outcomes - Operative time - Stone Free Rate Secondary Outcomes - Lasing time - Total laser energy (kJ) - Detection of postoperative strictures ### Location - Facility: Northwestern Medicine, Chicago, Illinois, 60611, United States @@
## The Effect of Web-Based Breast Self-Examination Education - NCT ID: NCT06346470 - Study ID: 3430-12 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-05-31 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects. ### Conditions - Education - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Web-based breast self examination education ### Outcomes Primary Outcomes - Skill and Knowledge of BSE - Attitude of Web-Based Education - Self-Directed Learning Skills Secondary Outcomes ### Location - Facility: Florence Nightingale Faculty of Nursing, Istanbul, Şişli, 34381, Turkey @@
## Breast Cancer & Antiestrogenic Therapy & Brain - NCT ID: NCT06346457 - Study ID: IRTG_P08 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: International Research Training Group 2804 ### Study Description The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health. ### Conditions - Breast Cancer Female - Healthy Female - Menopause - Anti-estrogenic Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tamoxifen - Letrozole - Letrozole + GnRH ### Outcomes Primary Outcomes - Correlations between antiestrogen hormone therapy and brain function & structure - Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects - Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls - Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls - Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls Secondary Outcomes - Correlation between antiestrogen hormone therapy and psychosexual health - Correlation between antiestrogen hormone therapy and quality of life - Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls - Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls - Correlation between antiestrogen hormone therapy and cognitive changes - Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls ### Location - Facility: University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen, Tuebingen, BW, 72076, Germany @@
## Biomarkers in Rett Syndrome - NCT ID: NCT06346444 - Study ID: 2.780.113 - Status: RECRUITING - Start Date: 2020-08-03 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description Rett syndrome (RTT) is an X-linked genetic disorder that causes severe neurological development disorder. In its classic form, it seems to affect almost exclusively females with an incidence of up to one in 10,000 females. Patients affected by Rett Syndrome can present a wide range of symptoms, in different combinations and of varying intensity, such as slowed growth of head circumference, abnormalities in walking and balance, loss of functional use of the hands often replaced by repetitive and stereotyped hand movements like "hand washing", loss of communicative-relational skills including expressive language, epilepsy, breathing abnormalities, and osteo-muscular alterations. In light of the growing potential of clinical therapies, identification and early diagnosis are considered essential. Many disease modification strategies have been achieved through translational research studies and clinical trials that have allowed the recognition of the most effective therapeutic and clinical interventions to date.This study arises from the need to advance in the understanding of the pathogenesis of RTT through a multicentric collaboration in order to (a) identify early biomarkers of RTT (b) delve into the alterations of interconnectivity, crucial for understanding the loss of motor functions and language through systematic collection of anamnestic, genetic, and clinical-instrumental data. The aim is to provide a valuable contribution to the study of the clinical phenotype of Rett and the identification of early interventions. ### Conditions - Rett Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic test and behavioral ### Outcomes Primary Outcomes - Age at diagnosis - Mutation in MECP2 - Neuroscope alterations - Electroencephalogram (EEG) alterations - Brain magnetic resonance imaging (MRI) alteration - Bone densitometry alterations - Thoracic radiographic alterations - Lumbosacral spine radiographic alterations - Clinical Global Impression (CGI) scale - The Rett Syndrome Behavioural Questionnaire (RSBQ) Secondary Outcomes - Alterations of neurovisual functions - Possibility of applying alternative forms of communication to verbal communication ### Location - Facility: Trinity College Institute of Neuroscience, Lloyd Building, D2, Dublin, N/A, N/A, Ireland @@
## Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms - NCT ID: NCT06346431 - Study ID: 20240301 - Status: NOT_YET_RECRUITING - Start Date: 2026-03 - Completion Date: 2026-12 - Lead Sponsor: 7 Generation Games ### Study Description The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use. ### Conditions - Anxiety - Depressive Symptoms - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DSPT - Digital Support for Problem-solving Therapy ### Outcomes Primary Outcomes - Generalized Anxiety Disorder Scale-7 - Center for Epidemiological Studies Depression Scale - Drug Abuse Screening Test - Michigan Alcohol Screening Test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks - NCT ID: NCT06346418 - Study ID: PNRR-MR1-2022-12376622 - Status: RECRUITING - Start Date: 2023-05-19 - Completion Date: 2025-05 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Pathogenic variants in subcortical maternal complex (SCMC) have been identified not only in mothers of Beckwith-Wiedemann syndrome (BWS) babies but also in women with reproductive disturbances such as failed pregnancy attempts and recurrent pregnancy loss. Based on the higher incidence of BWS in children born from Assisted Reproductive Technology (ART), this project aims to investigate incidence and molecular mechanism of pathogenic variants of SCMC in women with reproductive disorders. Study objectives will be (i) assess the incidence of these variants as a cause of differences in reproductive outcomes in the infertile female population and mothers of children with BWS; (ii) identify methylation changes in women with reproductive problems including those with offspring affected by BWS; (iii) determine the molecular causes underlying female infertility and imprinting disorder associated with damaging SCMC gene variants by employing a mouse model. ### Conditions - Beckwith-Wiedemann Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - WES analysis - whole-genome methylation analysis ### Outcomes Primary Outcomes - MEG Incidence Secondary Outcomes - Compare DNA methylation ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, 20122, Italy @@
## Central Serous Chorioretinopathy and Micropulse Laser Treatment - NCT ID: NCT06346405 - Study ID: 10 - Status: RECRUITING - Start Date: 2023-05-31 - Completion Date: 2025-05-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone ### Conditions - Central Serous Chorioretinopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Subthreshold Micropulse Laser Treatment ### Outcomes Primary Outcomes - Vessel density changes Secondary Outcomes - Choroidal thickness - Choroidal thickness and vessel density - Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern - Metamorphopsia - Metamorphopsia and BCVA - Ellipsoid Zone Integrity - Improvement in retinal function - Quality of life (QoL) - Ellipsoid zone and BCVA ### Location - Facility: Fondazione Policlinico Agostino Gemelli, IRCCS, Roma, R, 00168, Italy @@
## AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 - NCT ID: NCT06346392 - Study ID: D9802C00001 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-10-09 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2. ### Conditions - Gastric Cancer - Gastroesophageal Junction Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AZD0901 - AZD0901 - Ramucirumab+ paclitaxel - Paclitaxel - Docetaxel - Irinotecan - TAS-102 - Apatinib ### Outcomes Primary Outcomes - Progression Free Survival (PFS) in all randomized participants - Overall Survival (OS) for 3L+ participants Secondary Outcomes - OS in all randomized participants - PFS for 3L+ participants - Objective Response Rate (ORR) in all randomized participants - ORR for 3L+ participants - Duration of Response (DoR) in all randomized participants - Serum concentrations of AZD0901, total antibody and MMAE - Status of ADA to AZD0901 - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs - PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE - PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE - Prevalence and incidence of ADA to AZD0901 - Titer of ADA to AZD0901 ### Location - Facility: Research Site, Duarte, California, 91010, United States @@
## The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients - NCT ID: NCT06346379 - Study ID: 2023-K086-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-01 - Lead Sponsor: Affiliated Hospital of Nantong University ### Study Description The aim of this study is to examine the effect of 12-month Baduanjin exercise on physical fitness and bone density in maintenance hemodialysis (MHD) patients. 50 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities. ### Conditions - Rehabilitation - Physical Fitness - Bone Density - Hemodialysis Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baduanjin exercise ### Outcomes Primary Outcomes - Muscle strength measurement - Five-times Sit-to-Stand Test (FTSST) - Timed "up and go" test (TUGT) - The sitting forward flexion test - The Standing on one-leg with eyes closed test (SOLECT) - Bone mineral density test Secondary Outcomes - Changes in the Short Form-36(SF-36) - Changes in the Hospital Anxiety and Depression Scale （HADS） - European Quality of Life Five Dimension（EQ-5D-5L) ### Location - Facility: Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226000, China @@
## Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy - NCT ID: NCT06346366 - Study ID: NL.82557.018.22 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-25 - Completion Date: 2024-04-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, \[IQR 71.05%-82.61%\] vs. 57.38% \[IQR 52.38%-81.35%\], p=0.03).Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over. ### Conditions - Pancreatic Neoplasms - Type 3c Diabetes - Total Pancreatectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Bihormonal artificial pancreas (BIHAP) / closed loop ### Outcomes Primary Outcomes - Time in range Secondary Outcomes - Efficacy of open and closed loop system - Efficacy of open and closed loop system - Efficacy of open and closed loop system - Efficacy of open and closed loop system - Efficacy of open and closed loop system - Adverse events and device issues associated with closed loop system with BIHAP - Patient reported outcomes on quality of life - WHO-5 - Patient reported outcomes on quality of life - EQ-5D-5L - Patient reported outcomes on quality of life - DTSQc andDTSQs - Patient reported outcomes on quality of life - PAID-20 - Patient reported outcomes on quality of life - HFS-II - Patient reported outcomes on quality of life - PSQI - Patient reported outcomes on quality of life - INSPIRE - Patient reported outcomes on quality of life - Hypoglycaemia unawareness - Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment ### Location - Facility: Amsterdam UMC, Amsterdam, N/A, 1081 HV, Netherlands @@
## Substance Consumption, Personality, and Cognitive Functioning of Chess Players - NCT ID: NCT06346353 - Study ID: Chess Cognition SUD - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-05-31 - Lead Sponsor: Central Institute of Mental Health, Mannheim ### Study Description The aim of this project is to find out if there is a difference in addictive behavior, personality traits, and cognitive abilities between chess players and non-chess players. ### Conditions - Addiction - Alcohol - Nicotine - Drugs - Personality - Depression - Anxiety ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Substance Craving - Alcohol Use - Automatic Alcohol Craving - Severity of Nicotine Dependence - Automatic Cigarette Craving - Smoking Consequences - Drug Abuse - Personality - Depression - Anxiety - self-efficacy - coping with stress - Inhibition capacity - Working Memory capacity Secondary Outcomes ### Location - Facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit, Mannheim, N/A, N/A, Germany @@
## A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy - NCT ID: NCT06346340 - Study ID: 936 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-09 - Lead Sponsor: Bausch & Lomb Incorporated ### Study Description A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy ### Conditions - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Miebo ### Outcomes Primary Outcomes - Mean difference between absolute deviations from predicted refractive error in the study eye. Secondary Outcomes ### Location - Facility: Site 105, Laguna Hills, California, 92655, United States @@
## Clinical Significance Of Intermittently Absent End-Diastolic Flow Of The Fetal Umbilical Artery On Perinatal And Neonatal Outcomes Dr. Zeynep Kayaoğlu Yıldırım Dr. Alperen İnce Dr Gökhan Bayanmelek Dr Gökhan Bolluk - NCT ID: NCT06346327 - Study ID: Absent End-Diastolic Flow - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2023-10-30 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Objective: This study aimed to estimate the risk of adverse perinatal outcomes among pregnant patients with intermittently absent (iAEDF) and persistently absent end-diastolic umbilical artery flow (pAEDF). The fetal risks associated with persistently absent end-diastolic flow have been described. However, the risks associated with intermittent absent end-diastolic flow are not well-known.Study design: We performed a retrospective cohort study of patients diagnosed with the iAEDF or pAEDF at our institution from 2020 to 2023. Fetuses were classified under two categories: iAEDF group and pAEDF group.Neonatal outcomes, demographic information, pregnancy outcomes and pregnancy complications were compared between patients with iAEDF and those with pAEDF. ### Conditions - Absent End-Diastolic Flow Of The Fetal Umbilical Artery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - neonatal outcomes - latency from the time of absent endiastolic flow diagnosis to delivery - pregnancy complications (Number of Pregnancies complicated with IUMF, ablatio placenta, fetal distress, Intrauterine growth restriction and amniotic fluid abnormalities). Secondary Outcomes ### Location - Facility: İstanbul Başakşehir Çam ve Sakura City Hospital, Istanbul, Türkiye, 34480, Turkey @@
## Is There an Immediate Effect on Pectoralis Minor Length After Performing a Prone Scapular Retraction Exercise - NCT ID: NCT06346314 - Study ID: 12241976 - Status: COMPLETED - Start Date: 2021-07-15 - Completion Date: 2022-01-10 - Lead Sponsor: Andrews University ### Study Description The goal of this clinical trial is to test normal participants.The main question it aims to answer is:• Do the participant's pectoralis minor muscles change length immediately after performing an exercise that recruits the scapular retractor muscles? Participants will have their pectoralis minor muscle measured, then perform an exercise recruiting the scapular retractor muscles, and then have their pectoralis muscle measured again. ### Conditions - Pectoralis Minor Length ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Scapular retraction exercise ### Outcomes Primary Outcomes - Pectoralis Minor Length Secondary Outcomes ### Location - Facility: North Idaho Physical Therapy, Hayden, Idaho, 83835, United States @@
## Imagery Rescripting as a Stand-alone Treatment for OCD and BDD. - NCT ID: NCT06346301 - Study ID: NL83374.018.23 - Status: RECRUITING - Start Date: 2023-04-21 - Completion Date: 2027-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description The goal of this multiple baseline case series study is to test the effect of imagery rescripting (ImRs) in Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD).Primary objective :The course of schema or core beliefs and change in OCD and BDD. To investigate the effectiveness of imagery rescripting on factors presumed to underlie the disorder, according to schema theory, and on OCD and BDD symptoms.Secondary objective: The change in OCD and BDD symptoms (full questionnaire), schemata and modes, core emotions, mood, affect and obtrusiveness of intrusion.Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview.For this study, a multiple-baseline single-case experimental design (SCED) is used testing different outcome variables in 18 OCD patients and 18 BDD patients. After a variable baseline period of 3-8 weeks participants will start twice weekly with imagery rescripting for 12 sessions, followed by a 6 week follow up.Participants will rate schema- or core beliefs and OCD or BDD severity on a visual analogue scale. In addition participants will rate core emotions, affect and obtrusiveness of the intrusion. Secondary we will asses four times questionnaires about OCD of BDD symptoms, depression and schemas en modes. After treatment participants will be interviewed about their experiences. ### Conditions - Obsessive-Compulsive Disorder - Body Dysmorphic Disorders - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Imagery rescripting ### Outcomes Primary Outcomes - Schema of core beliefs - Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms Secondary Outcomes - Core Emotions, affect strength, obtrusiveness of intrusion. - Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD)) - Hamilton Depression Rating Scale (HDRS) - Young Schema Questionnaire (YSQ) and Schema Mode Inventory (SMI) ### Location - Facility: Department of Psychiatry, AMC, Amsterdam-Zuidoost, Noord-Holland, 1105 AZ, Netherlands @@
## A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease - NCT ID: NCT06346288 - Study ID: M24-144 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-05-27 - Lead Sponsor: AbbVie ### Study Description Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBDRisankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects. ### Conditions - Inflammatory Bowel Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Breast Milk Sampling - Risankizumab ### Outcomes Primary Outcomes - To determine the concentration of risankizumab in breastmilk Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex - NCT ID: NCT06346275 - Study ID: 3rdZhejiangCMU-11 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-04 - Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University ### Study Description Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients. ### Conditions - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture ### Outcomes Primary Outcomes - Three-dimensional gait analysis - Cerebral hemodynamics Secondary Outcomes - Mini-Mental State Examination - Montreal Cognitive Assessment - Barthel Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care - NCT ID: NCT06346262 - Study ID: STUDY20230921 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2026-01-01 - Lead Sponsor: Martha Sajatovic ### Study Description This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures. ### Conditions - Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - SMART RM - Valtoco Nasal Product ### Outcomes Primary Outcomes - Change in number of seizures as measured by patient report. Secondary Outcomes - Change in quality of life as measure by QOLIE-31 - Change in functional status as measure by Short-Form Health Survey (SF-36) - Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9) - Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES) - Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS) - Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS) - Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS) - Change in number of emergency room visit as measure by patient report - Change in number of hospitalizations as measure by patient report - Change in number of non study outpatient services utilization as measure by patient report ### Location - Facility: University Hospitals Medical Center, Cleveland, Ohio, 44106, United States @@
## Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain. - NCT ID: NCT06346249 - Study ID: 49/2024 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-05 - Lead Sponsor: Universidad de Extremadura ### Study Description The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain. ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electrical Stimulation Therapy - Manual Therapy - Exercise Therapeutic ### Outcomes Primary Outcomes - Changes in Pain - Changes Pressure Pain - Changes in Disability Secondary Outcomes - Changes in Range of Motion - General Health. ### Location - Facility: María de los Ángeles Cardero Durán, Badajoz, N/A, 06006, Spain @@
## Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity. - NCT ID: NCT06346236 - Study ID: 69HCL21_0843 - Status: COMPLETED - Start Date: 2020-03-01 - Completion Date: 2022-09-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis. ### Conditions - Transient Hypothyroxinemia of Prematurity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - L-thyroxine at a dose of 7.5 µg/kg/d for THOP - THOP without treatment - NoTHOP ### Outcomes Primary Outcomes - Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation. Secondary Outcomes ### Location - Facility: HFME, Bron, N/A, 69300, France @@
## Mindfulness-Based Intervention for Family Caregivers - NCT ID: NCT06346223 - Study ID: HSEARS20230928006 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-08 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points. ### Conditions - Caregiving Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindfulness and psychoeducation - Psychoeducation ### Outcomes Primary Outcomes - Perceived Caregiving Stress in the Family Caregiver Secondary Outcomes - Depressive Symptoms in the Family Caregiver - Positive Aspect of Caregiving in the Family Caregiver - Dyadic Relationship Between the Family Caregiver and the Care Recipient - Trait Mindfulness in the Family Caregiver - Neuropsychiatric Syndromes in the Care Recipient - Feasibility of Eligibility and Enrollment - Feasibility of Attendance Rate - Feasibility of Adherence to Self-Practice - Feasibility of Retention Rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients - NCT ID: NCT06346210 - Study ID: UNT: U1111-1288-2037 - Status: COMPLETED - Start Date: 2024-04-02 - Completion Date: 2024-04-02 - Lead Sponsor: Uppsala University ### Study Description Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tracheostomy ### Outcomes Primary Outcomes - Ventilator free days alive Secondary Outcomes - 60 day mortality ### Location - Facility: Uppsala University, Uppsala, N/A, N/A, Sweden @@
## Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas - NCT ID: NCT06346197 - Study ID: ET23-185 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2028-05-15 - Lead Sponsor: Centre Leon Berard ### Study Description CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm). ### Conditions - Gastric Cancer - MSI-H - Metastatic Cancer - Advanced Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Balstilimab - Botensilimab - Folfox Protocol - XELOX - Nivolumab ### Outcomes Primary Outcomes - Survival of patients Secondary Outcomes - Progression free survival - Objective response rate - Duration of response - Adverse Event description as assessed by CTCAE V5.0 - EORTC QLQ C30 ### Location - Facility: Centre Léon Bérard, Lyon, N/A, N/A, France @@
## A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers - NCT ID: NCT06346184 - Study ID: HM-EMMA-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-06-08 - Lead Sponsor: Hanmi Pharmaceutical Company Limited ### Study Description The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HCP2303 - RLD2302 - RLD2102 ### Outcomes Primary Outcomes - AUCt - Cmax Secondary Outcomes - AUCinf - Tmax - t1/2 - CL/F - Vd/F ### Location - Facility: Jeonbuk University Hospital, Jeonju, Jeollabuk-do, N/A, Korea, Republic of @@
## VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain - NCT ID: NCT06346171 - Study ID: 408/06.03.2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-28 - Completion Date: 2024-11-30 - Lead Sponsor: Grigore T. Popa University of Medicine and Pharmacy ### Study Description Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality. ### Conditions - Procedural Anxiety - Procedural Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality Integrative Psychotherapy - Virtual Reality Distraction ### Outcomes Primary Outcomes - Reduction in Procedure-Related Anxiety - Pain perception Secondary Outcomes - Feasibility and Acceptability of VRIP-Col Interventions - Qualitative Feedback on VRIP-Col Interventions ### Location - Facility: University of Medicine and Pharmacy Grigore T Popa, Iaşi, Iasi, 700115, Romania @@
## Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia - NCT ID: NCT06346158 - Study ID: 2024-3615 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Ciusss de L'Est de l'Île de Montréal ### Study Description The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by* Electroencephalographic (EEG) features available prior to induction of anesthesia* Cognitive performance* Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded. ### Conditions - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cognitive testing - electroencephalogram - High density electroencephalogram - General anesthesia ### Outcomes Primary Outcomes - Concentration at the effect-site propofol associated with deep anesthesia (CeDA) Secondary Outcomes - Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia - Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia - Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Bariatric Surgery on Heart Disease Compared to Standard Care - NCT ID: NCT06346145 - Study ID: MIMS study - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-01 - Lead Sponsor: Danderyd Hospital ### Study Description Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS. ### Conditions - Obesity, Morbid - Bariatric Surgery Candidate - Heart Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bariatric surgery - Standard care ### Outcomes Primary Outcomes - MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis. Secondary Outcomes - Total event rate - All-cause mortality - Cardiovascular death - Remission of type 2 diabetes (T2D) and hypertension - Myocardial infarction - Stroke - Myocardial revascularization (not related to MI) - hospital admission because of heart failure as a primary ICD diagnosis. - hospital admission because of atrial fibrillation as a primary ICD diagnosis. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation. - NCT ID: NCT06346132 - Study ID: 2024-00043 CE 4516 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Schlotterbeck Hervé ### Study Description The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia. ### Conditions - Virtual Reality - Medical Device - Local Anesthesia - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual reality application ### Outcomes Primary Outcomes - Global pain intensity experienced during the procedure. Secondary Outcomes - Need for supplementary sedation and/or analgesia during the procedure. - Global anxiety intensity experienced during the procedure. - Patient's comfort during the procedure assessed by the surgeon and cardiologist. - Incidence of motion sickness during the virtual reality experience. - Patient's perceived procedure duration. - Maximal systolic arterial blood pressure. - Incidence of hypotensive or hypoxic events during procedure. - Total dose of local anaesthetic used during the procedure. - Change in anesthetic strategy during procedure. - Interruption of virtual reality experience during the procedure. - Intra- and post-procedure complications. - Overall patient's comfort and satisfaction experienced during the procedure. ### Location - Facility: Istituto CardioCentro, Lugano, Ticino, 6900, Switzerland @@
## Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital - NCT ID: NCT06346119 - Study ID: PI-2023-01 - Status: RECRUITING - Start Date: 2023-02-27 - Completion Date: 2025-12-31 - Lead Sponsor: Centre Hospitalier de Niort ### Study Description This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation. ### Conditions - Reaction Anxiety - Difficult or Failed Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day ### Outcomes Primary Outcomes - chemical restraint Secondary Outcomes - self-extubations - patient discomfort - respiratory rate - Ratio chemical restraint use - cardiac frequency ### Location - Facility: Centre Hospitalier de Niort, Niort, N/A, 79000, France @@
## The Diagnostic Experience of Male Rett Syndrome - NCT ID: NCT06346106 - Study ID: 23-0075 - Status: RECRUITING - Start Date: 2023-05-24 - Completion Date: 2024-04-30 - Lead Sponsor: Children's Hospital Colorado ### Study Description The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided. ### Conditions - Rett Syndrome - RTT ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Male Rett ### Outcomes Primary Outcomes - Diagnostic experiences - Attainment of developmental milestones and any regressions - QI-disability - Parent priorities for care and counseling - Parenting experience - Information regarding child's death, if applicable Secondary Outcomes - Family demographics - Systems of supports - Healthcare preferences ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer - NCT ID: NCT06346093 - Study ID: CHEC2024-089 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-12-31 - Lead Sponsor: Xiangyu Kong ### Study Description This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD-L1 therapy in the advanced gastric cancer. ### Conditions - Advanced Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fecal Microbiota Transplantation Capsules - Placebo ### Outcomes Primary Outcomes - Objective response rate (ORR) - Rate of Disease Control Secondary Outcomes - Progression-free Survival (PFS) - Overall Survival (OS) - Incidence of Adverse Events Related to Treatment - Change in the intestinal microbiome community - Quality of life based on the questionnaire - Quality of life based on the questionnaire - Change in the immunity ### Location - Facility: Changhai Hospital, Shanghai, Shanghai, 200433, China @@
## Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment - NCT ID: NCT06346080 - Study ID: s68670 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-08-01 - Lead Sponsor: KU Leuven ### Study Description The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.The main question it aims to answer are:* Which diagnostic modality is preferred by patients and the general population?* Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?* Are geographical differences present in regard to the preference for a diagnostic modality?Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors. ### Conditions - Esophageal Cancer - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Survey ### Outcomes Primary Outcomes - The rate of contribution of diagnostic features to the preference of participants - The percentage differences in preference of participants between geographical regions Secondary Outcomes - Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio - Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2) - NCT ID: NCT06346067 - Study ID: ERAS-254-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-12 - Lead Sponsor: Erasca, Inc. ### Study Description Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy). ### Conditions - Advanced or Metastatic NRAS-mutant Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Naporafenib - Dacarbazine - Temozolomide - Trametinib ### Outcomes Primary Outcomes - Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 - Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 - Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 - Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 - Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2 - Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy) Secondary Outcomes - Adverse Events - Duration of Response (DOR) - Time to Response (TTR) - Disease Control Rate (DCR) - Overall Response Rate (ORR) - Plasma concentration (Cmax):Stage 1 only - Area under the curve (AUC):Stage 1 only - Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma. ### Location - Facility: SCRI Oncology Partners (formerly Tennessee Oncology), Nashville, Tennessee, 37203, United States @@
## Molecular Assessment for Gastro-Esophageal Cancer - NCT ID: NCT06346054 - Study ID: s68669 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2029-07-01 - Lead Sponsor: KU Leuven ### Study Description The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.The main questions this study aims to answer:Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.Participants will provide a breath and blood sample during their routine standard of care visits. ### Conditions - Esophageal Cancer - Gastric Cancer - Barrett Esophagus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Breath analysis - Blood analysis ### Outcomes Primary Outcomes - Identification of the concentrations of oncometabolites Secondary Outcomes - Assessment of incidence of early-stage cancer - Assessment of incidence of therapy response - Assessment of percentage change of therapy response - Assessment of incidence of recurrence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors - NCT ID: NCT06346041 - Study ID: HJG-IDOV-SAFE-LYSW - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors. ### Conditions - Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oncolytic Virus injection(IDOV-SAFETM) ### Outcomes Primary Outcomes - Dose Limiting Toxicities (DLT) - Incidence of adverse events and severe adverse events - MTD/MFD Secondary Outcomes - The Pharmacokinetics characteristics of IDOV-SAFETM((biological distribution and viral expulsion)) - Immunogenicity of IDOV-SAFETM - ORR - DCR - DOR - PFS - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of Transcranial Magnetic Stimulation for Smoking Cessation - NCT ID: NCT06346028 - Study ID: 2023/086 - Status: RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-06-30 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.Participants will be asked to come to CAMH to:* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.Objectives• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health. ### Conditions - Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Brainsway H4 deep rTMS coil and Brainsway stimulator system ### Outcomes Primary Outcomes - The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment. - Identify rates of adoption of rTMS in Nicotine Dependence Clinic - Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach. Secondary Outcomes - Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC. - Explore patient-HCP communication about shared treatment decision-making for rTMS. ### Location - Facility: Center for Addiction and Mental Health (CAMH), Toronto, Ontario, N/A, Canada @@
## Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH - NCT ID: NCT06346015 - Study ID: HX-A-2023050 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-31 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Patients with aneurysmal subarachnoid hemorrhage were selected and randomized into intervention group (audio adjuvant group) and control group (conventional treatment group). Patients in the intervention group will receive audio therapy after surgery, and patients in the control group will receive usual care. EEG, fMRI and mRS scores were evaluated after 3 months of follow-up. ### Conditions - Subarachnoid Hemorrhage, Aneurysmal - Cognitive Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gamma Entrainment Stimulation ### Outcomes Primary Outcomes - Montreal Cognitive Assessment (MoCA) scores < 22 - mini-mental state examiniation (MMSE) < 27 - modified Rankin Scales (mRS) > 2 Secondary Outcomes - electroencephalogram (EEG) indicators - functional Magnetic Resonance Imaging (fMRI) indicators ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children - NCT ID: NCT06346002 - Study ID: 2026_e_2017 - Status: COMPLETED - Start Date: 2017-03-01 - Completion Date: 2020-03-31 - Lead Sponsor: Bishop's University ### Study Description Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI. ### Conditions - Mindfulness-based Intervention - Elementary School Children - Mental Health Wellness 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Mindfulness-based intervention ### Outcomes Primary Outcomes - Symptoms of Mental Health Disorders - Basic Psychological Needs Satisfaction - Process Measure Secondary Outcomes ### Location - Facility: École primaire Préville, Saint-Lambert, Quebec, J4S 1M8, Canada @@
## Time and Cost-implications of Intraoral Scans vs Alginate Impressions: A Randomised Controlled Trial - NCT ID: NCT06345989 - Study ID: 187157 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: University of Sheffield ### Study Description This research project investigates the time and cost implications of two common techniques in orthodontics: alginate impressions and intraoral scans. Alginate impressions (putty moulds) are a traditional technique that has been used in orthodontic practice for many years. Intraoral scans are a more modern method and are becoming more commonly used in orthodontic practice. Both alginate impressions and intraoral scans are a means of recording a copy of a patient's teeth which aids in record keeping and treatment planning.Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning, it remains common practice to use alginate impressions for orthodontic records. Considerations such as time implications, device costs, associated software expenses, and the need for clinician training pose challenges to widespread adoption of intraoral scanning. When comparing chairside time taken for intraoral scans versus alginate impressions, there are varying findings, requiring a thorough investigation.The main question being addressed is:- Are intraoral scans more time efficient than alginate impressions?The secondary question being addressed is:- Are intraoral scans more cost effective than alginate impressions?This research protocol outlines a clinical trial, evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions. The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital.The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings, thereby informing clinical practices within the United Kingdom. This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care. ### Conditions - Chairside Time and Costs Associated With Intraoral Scanning Versus Alginate Impressions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Alginate impression - Intraoral scan ### Outcomes Primary Outcomes - Chairside time taken for alginate impressions vs intraoral scans. Secondary Outcomes - Cost implications of alginate impressions vs intraoral scans. ### Location - Facility: Queens Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom @@
## Functional Impairment in Albinism - NCT ID: NCT06345976 - Study ID: RLX_2023_10 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild ### Study Description Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including :* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare. ### Conditions - Albinism, Ocular ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaire ### Outcomes Primary Outcomes - To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1) - NCT ID: NCT06345963 - Study ID: HSC-MS-23-1044 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-01 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - active H-coil delivered rTMS ### Outcomes Primary Outcomes - brain microstructural integrity from magnetic resonance imaging (MRI) - Resting-state functional connectivity (rsFC) from functional MRI Secondary Outcomes - Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG) - Cognitive insight, depression, perception, and delusion measured from questionnaires - Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB) ### Location - Facility: The University of Texas Health Science Center, Houston, Houston, Texas, 77054, United States @@
## Pharmacokinetics and Safety of a New Micellar Glutathione Formulation - NCT ID: NCT06345950 - Study ID: 2022-04-003 - Status: COMPLETED - Start Date: 2022-06-21 - Completion Date: 2023-06-30 - Lead Sponsor: Factors Group of Nutritional Companies Inc. ### Study Description This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period. ### Conditions - Bioavailability - Safety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Liposomal Glutathione - Standard Glutathione - New Micellar Glutathione (Lipomicel) ### Outcomes Primary Outcomes - AUC: the area under the concentration-time curve - Cmax: maximum plasma concentration - Tmax: the time point of maximum plasma concentration Secondary Outcomes - Alanine aminotransferase (ALT) - Aspartate aminotransferase (AST) - Alkaline phosphatase (ALP) - Bilirubin - Serum creatinine - Blood urea nitrogen (BUN) - Glomerular filtration rate (GFR) - C-reactive protein (CRP) - White blood cell count (WBC) - Hemoglobin (Hb) - Hematocrit (Hct) - Platelet count - Fasting blood glucose - Total cholesterol - Low-density lipoprotein (LDL) cholesterol - High-density lipoprotein (HDL) cholesterol - Triglycerides ### Location - Facility: ISURA, Burnaby, British Columbia, V2N 4S9, Canada @@
## Multiple Risk Factor Intervention Trial (Ms. FIT) - NCT ID: NCT06345937 - Study ID: REB #44724 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-08-01 - Lead Sponsor: University of Toronto ### Study Description This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?* What is the effect modification of adding a diet quality intervention to exercise?* What is the effect modification by menopausal status?The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause. ### Conditions - Metabolic Disturbance - Sedentary Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Behavioural Experimental: guidelines-based physical activity - Behavioural Experimental: guidelines-based physical activity and healthy eating - Behavioural: Stretching exercise ### Outcomes Primary Outcomes - Insulin resistance Secondary Outcomes - Hepatic insulin resistance - Metabolic syndrome severity - Framingham 10-year risk (%) ### Location - Facility: University of Toronto, Toronto, Ontario, M5S 2C9, Canada @@
## Music Therapy for Cancer Patients(Meraki_PC) - NCT ID: NCT06345924 - Study ID: Meraki_Palliative Care - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-07 - Lead Sponsor: University of Valencia ### Study Description The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out. ### Conditions - Cancer - Palliative Care ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MERAKI_PC ### Outcomes Primary Outcomes - Change in Anxiety and Depression Symptomatology (T1, T2 and T4) - Change in Quality of Life (T1, T2 and T4) - Change in emotional distress (T1, T2, T3 and T4) Secondary Outcomes - Change in Social Suport (T1 and T4) - Change in Resilience (T1 and T4) - Change in Spirituality (T1 and T4) - Change Knowledge of the disease (T1 and T4) - Barthel Index - Pfeiffer Short Form Mental State Questionnaire, SPMSQ - Charlson Comorbidity Index (CCI) ### Location - Facility: Hospital Dr. Moliner, Serra, Valencia, N/A, Spain @@
## Do Vacutainers With Animal Characters Reduce Fear and Anxiety? - NCT ID: NCT06345911 - Study ID: NEU-49/899 - Status: COMPLETED - Start Date: 2021-12-01 - Completion Date: 2022-03-30 - Lead Sponsor: Burdur Mehmet Akif Ersoy University ### Study Description The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters. ### Conditions - Procedural Pain - Acute Pain - Fear - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental group ### Outcomes Primary Outcomes - Children's Fear Scale - Wong-Baker FACES Pain Rating Scale Secondary Outcomes ### Location - Facility: Karaman Education and Research Hospital, Karaman, N/A, N/A, Turkey @@
## Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS) - NCT ID: NCT06345898 - Study ID: 2023-1479 - Status: RECRUITING - Start Date: 2023-11-17 - Completion Date: 2029-12-30 - Lead Sponsor: West China Hospital ### Study Description This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002. ### Conditions - X Linked Retinoschisis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - JWK002 ### Outcomes Primary Outcomes - Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) Secondary Outcomes - Best corrected visual acuity (BCVA) - Full-field electroretinogram(ff-ERG) - Macular structure as assessed by swept source optical coherence tomography - Visual field ### Location - Facility: West China Hospital, Chengdu, Sichuan, 610023, China @@
## Immunogenicity and Safety of One Dose of HPV Vaccine - NCT ID: NCT06345885 - Study ID: PROPMHP002 - Status: COMPLETED - Start Date: 2023-02-23 - Completion Date: 2024-01-17 - Lead Sponsor: Xiamen Innovax Biotech Co., Ltd ### Study Description This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil ### Conditions - Human Papillomavirus Vaccines ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HPV vaccine ### Outcomes Primary Outcomes - Anti-HPV seropositivity Secondary Outcomes - Anti-HPV Seropositivity - HPV Antibody Titers - Local and Systemic Reactions/Event ### Location - Facility: Fujian Provincial Center for Disease Control and Prevention, Fuzhou, Fujian, 350012, China @@
## Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain - NCT ID: NCT06345872 - Study ID: STUDY005883 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-07 - Lead Sponsor: University of South Florida ### Study Description The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain. ### Conditions - Chronic Pain - Chronic Insomnia - Opioid Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CBT-I - Treatment as usual - Tapered Withdrawal ### Outcomes Primary Outcomes - Change in Insomnia Severity Index - Change in Pain Intensity - Daily Electronic Sleep Diaries - Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries - Change in Sleep Onset Latency- Daily Electronic Sleep Diaries - Change in Sleep Efficiency- Daily Electronic Sleep Diaries - Change in Fatigue - Daily Electronic Sleep Diaries - Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries - Change in Perceived Stress Scale - Change in Peripheral Arousal - Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging - Change in Thermal Pain Response - Change in Opioid Use (Quantitative) - Change in Opioid Use (Self-Report) Secondary Outcomes - Change in Objective Wake After Sleep Onset (Actigraph) - Change in Objective Sleep Onset Latency (Actigraph) - Change in Objective Sleep Efficiency (Actigraph) - Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging - Short Inventory of Problems - Change in Pain Catastrophizing Scale ### Location - Facility: University of South Florida, Tampa, Florida, 33612, United States @@

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