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## Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy - NCT ID: NCT06377072 - Study ID: SHPL-W036-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-03 - Lead Sponsor: Shanghai Hutchison Pharmaceuticals Limited ### Study Description The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration. ### Conditions - Cervical Spondylotic Myelopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Shenqi Sherong Pill - Placebo ### Outcomes Primary Outcomes - Change in Modified Japanese Orthopaedic Association (mJOA) score Secondary Outcomes - Change in mJOA score - Change in sensation of mJOA score - Changes in pain or stiffness score for neck and shoulder - Change in chest tightness score - Changes in hand and arm numbness scores - Change in numbness (or pain) scores from the chest to the toes - Change in Motor dysfunction of the upper extremities of mJOA score - Proportion of participants with at least 1 grade decline in Nurick grades - Change in Traditional Chinese medicine (TCM) syndrome integrality - Change in TCM syndrome score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Detection of Complications During Immunotherapy for Haematological Malignancy - NCT ID: NCT06377059 - Study ID: 2024-RH-phase1-WARD - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-07-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description Aims* To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications* Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment. ### Conditions - Hematologic Cancer - CRS - Cytokine Release Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - WARD ### Outcomes Primary Outcomes - CRS Secondary Outcomes - Immune response - severe physiological deviations - clinical complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial - NCT ID: NCT06377046 - Study ID: NL86643.068.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Maastricht University Medical Center ### Study Description The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.The main question it aims to answer is:- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.Secondary questions it aims to answer are:* To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.* To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:* NT pro BNP levels* device detected atrial fibrillation burden and daily activity* echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain ### Conditions - Atrial Fibrillation - Permanent Atrial Fibrillation - Persistent Atrial Fibrillation - Pacemaker DDD - Paroxysmal Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Accelerated pacing - Current standard of care ### Outcomes Primary Outcomes - The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP. Secondary Outcomes - The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP). - The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO). - The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure. - The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. - The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. - Palpitations experienced as a result of (accelerated) pacing. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using the EHR to Advance Genomic Medicine Across a Diverse Health System - NCT ID: NCT06377033 - Study ID: 10877980 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-06-30 - Lead Sponsor: University of Pennsylvania ### Study Description Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management. ### Conditions - Genetic Predisposition - Paraganglioma - Pheochromocytoma - ALS - Parkinson Disease - Polyneuropathies - Frontotemporal Dementia - Alzheimer Disease - Cardiomyopathy Non-ischemic - Thoracic Aortic Aneurysm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Behavioral nudge ### Outcomes Primary Outcomes - Rate of Genetic Testing Secondary Outcomes - Rate of Genetic Test Orders/Referrals - Rate of Patient Engagement - Rate of Pathogenic variants and VUS - Rate of Clinician actions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevention and Choice for Type 2 - NCT ID: NCT06377020 - Study ID: 23-2490 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-10-30 - Lead Sponsor: University of Colorado, Denver ### Study Description People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2 , PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited. ### Conditions - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PACT2 ### Outcomes Primary Outcomes - Body weight Secondary Outcomes - Blood pressure - Physical activity - Energy intake - HbA1c - 24 hr glucose levels - Dietary adherence ### Location - Facility: University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States @@
## Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) - NCT ID: NCT06377007 - Study ID: WU66290 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-30 - Lead Sponsor: Walailak University ### Study Description Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - IOLMaster 700 (Carl Zeiss Meditec AG) - Argos (Alcon Laboratories, Inc.) ### Outcomes Primary Outcomes - Mean absolute prediction error Secondary Outcomes - Proportion of eyes with an absolute prediction error equal to or less than 0.25 ### Location - Facility: Walailak University, Nakhon Si Thammarat, N/A, 80160, Thailand @@
## Multi-Center Clean Air Randomized Controlled Trial in COPD - NCT ID: NCT06376994 - Study ID: IRB00407311 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-09 - Lead Sponsor: JHSPH Center for Clinical Trials ### Study Description This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use. ### Conditions - Chronic Obstructive Pulmonary Disease (COPD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Air cleaner - Sham air cleaner ### Outcomes Primary Outcomes - St. George's Respiratory Questionnaire (SGRQ) Secondary Outcomes ### Location - Facility: Johns Hopkins, Baltimore, Maryland, 21224, United States @@
## Hyaluronic Acid in Shoulder Tendinopathy - NCT ID: NCT06376981 - Study ID: CHD23_0025 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-11 - Lead Sponsor: Centre Hospitalier Departemental Vendee ### Study Description Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months. ### Conditions - Shoulder Tendinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hyaluronic acid injection - Corticosteroid injection - Placebo injection ### Outcomes Primary Outcomes - Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Secondary Outcomes ### Location - Facility: CHD Vendée, La Roche-sur-Yon, N/A, N/A, France @@
## Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis - NCT ID: NCT06376968 - Study ID: BA-G-H-1604 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-08 - Lead Sponsor: B.Braun Avitum AG ### Study Description The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.A crossover design is used to compare treatments with or without the BioLogic Fusion function activated. ### Conditions - Renal Dialysis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BioLogic Fusion ### Outcomes Primary Outcomes - Post-dialysis body weight Secondary Outcomes ### Location - Facility: Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione, Bologna, Emilia Romagna, 40138, Italy @@
## High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity - NCT ID: NCT06376955 - Study ID: IRB00014233-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-08-30 - Lead Sponsor: Badr University ### Study Description Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications. ### Conditions - Insulin Resistance - Abdominal Obesity - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High intensity interval exercise - Focused ultrasound ### Outcomes Primary Outcomes - Body mass index - Waist circumference - Skin fold - Value of HbA1c and HOMA-IR hormone Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy - NCT ID: NCT06376942 - Study ID: Int/IEC/2024/SPL-5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2025-06-15 - Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh ### Study Description No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy. ### Conditions - Subjects Undergoing Flexible Bronchoscopy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Glycopyrronium - Ipratropium - Saline ### Outcomes Primary Outcomes - Cough count Secondary Outcomes - Operator-estimated airway secretion - Operator-rated secretions on a visual analogue scale (VAS) - Operator-rated cough intensity on a visual analogue scale (VAS) - Patient-rated comfort on a visual analogue scale (VAS) - Adverse reactions ### Location - Facility: Bronchoscopy suite, PGIMER, Chandigarh, N/A, 160012, India @@
## Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level - NCT ID: NCT06376929 - Study ID: oralcarbohydrateinpediatric - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: Cairo University ### Study Description The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting. ### Conditions - Postoperative Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - oral carbohydrate containing fluid ### Outcomes Primary Outcomes - Mean values of Intraoperative random blood sugar in mg/dl Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR - NCT ID: NCT06376916 - Study ID: IRB00110863 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Aurora Health Care ### Study Description The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR. ### Conditions - Tachycardia Atrial - Atrial Fibrillation - Atrial Flutter With Rapid Ventricular Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Magnesium Sulfate 2 G - Magnesium Sulfate 4 G - Saline ### Outcomes Primary Outcomes - Ventricular rate control Secondary Outcomes - Time to achieve goal HR (heart rate) - Rate of conversion - Incidence of hypotension - Change in heart rate - Clinical need for rescue medication administration - Adverse effects ### Location - Facility: Advocate Christ Medical Center Emergency Department (ACMC ED), Oak Lawn, Illinois, 60453, United States @@
## Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women - NCT ID: NCT06376903 - Study ID: P.T.REC/012/004860 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-09-20 - Lead Sponsor: Cairo University ### Study Description • This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women ### Conditions - Urinary Stress Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pilates exercise - pelvic floor exercise - home advices ### Outcomes Primary Outcomes - • Revised urinary incontinence scale Secondary Outcomes - • Quality of Life Questionnaire (QOL) for stress urinary incontinence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico - NCT ID: NCT06376890 - Study ID: Chile24 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-07 - Lead Sponsor: New Mexico State University ### Study Description Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression. ### Conditions - Prediabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Red chili peppers - Green Chili Pepper - Placebo ### Outcomes Primary Outcomes - Concentration of resting and fasted blood glucose measured in mg/dl - Concentration of resting and fasted insulin measured in pmol/L - Concentration of circulating C-reactive protein reported as mg/dl. - Concentration of circulating interleukin (IL)-1 beta reported as pg/ml. - Concentration of circulating interleukin-6 (IL-6) reported as pg/ml. - Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml. Secondary Outcomes - Concentration of circulating superoxide dismutase (SOD) reported as ng/ml. - Concentration of circulating glutathione peroxidase reported as pg/ml. - Body composition measured as total fat mass and total fat free mass reported in kg. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Connectomic Targeted TMS Target for Refractory Anxiety - NCT ID: NCT06376877 - Study ID: 2024P000900 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2029-02-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension. ### Conditions - Anxiety Disorders - Mental Disorder - Psychiatric Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial magnetic stimulation - Sham transcranial magnetic stimulation ### Outcomes Primary Outcomes - Beck Anxiety Inventory (BAI) Secondary Outcomes - Inventory of Depression and Anxiety Symptoms-II - Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors - State-Trait Anxiety Inventory - Penn State Worry Questionnaire (PSWQ) - Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA) - Anxiety Sensitivity Index (ASI) - Intolerance of Uncertainty Scale (IUS) - Beck Depression Inventory (BDI) - TCI-R140 (Temperament and character inventory, revised 140-question format) - Emotional Conflict Resolution Task - Laboratory Fear Extinction Paradigm ### Location - Facility: Emma Jones, Boston, Massachusetts, 02115, United States @@
## Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children - NCT ID: NCT06376864 - Study ID: RC- FNRA-IG /20-21/SOSC/01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-07-30 - Lead Sponsor: Hong Kong Baptist University ### Study Description The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. ### Conditions - Child Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Activity Breaks ### Outcomes Primary Outcomes - Executive function - Psychological capacities - Working memory - Attention Secondary Outcomes - Physical activity (min/week) - Sedentary behavior (hour) - Body weight (kg) - Height (cm) ### Location - Facility: Department of Sport, Physical Education, and Health, Hong Kong Bapist University, Kowloon Tong, N/A, N/A, Hong Kong @@
## AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management - NCT ID: NCT06376851 - Study ID: CP-910-001 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-27 - Completion Date: 2030-03-27 - Lead Sponsor: HeartFlow, Inc. ### Study Description The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA). ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI-enabled quantitative coronary plaque analysis (AI-QCPA) ### Outcomes Primary Outcomes - Primary Endpoint Secondary Outcomes - Change in LDL levels - Change in HbA1c levels - Changes in Non HDL levels - Changes in HDL levels - Changes in TG levels - Changes in weight - Reclassification rate of medical management (across the groups) - Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG) - Number of CV hospitalizations ### Location - Facility: Moses Cone Memorial Hospital, Greensboro, North Carolina, 27401, United States @@
## To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet - NCT ID: NCT06376838 - Study ID: DLV-001-02 - Status: COMPLETED - Start Date: 2020-07-07 - Completion Date: 2023-05-04 - Lead Sponsor: DEXLEVO ### Study Description This clinical study is a confirmatory clinical study to prove that the test device, DLMR01, is non-inferior to the control device, Rejuran®, in terms of temporary wrinkle improvement effect on crow's feet and safety. After applying DLMR01, a test device, and Rejuran®, a control device, respectively to wrinkles around the eyes, randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices, subject-evaluator blinding, pair matching, It was designed as a comparative clinical study. ### Conditions - Crow's Feet Lines ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DLMR01 - Rejuran ### Outcomes Primary Outcomes - Crow's Feet Grading Scale by independent evaluators after 12 weeks of using Secondary Outcomes - (1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale - (2) The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the medical device both during rest and when smiling was evaluated. ### Location - Facility: Chung-ang University Hospital, Seoul, Dongjak-gu, 06973, Korea, Republic of @@
## The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout - NCT ID: NCT06376825 - Study ID: CSV202401 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-06-15 - Lead Sponsor: Ahmet Nalbant ### Study Description The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are:* Does the program reduce the level of burnout in teachers?* Does the program contribute to an increased sense of meaning for teachers?* How much of the program do teachers finish? ### Conditions - Burnout, Professional ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MyLife: An internet-based self-help program to reduce burnout ### Outcomes Primary Outcomes - Burnout Assessment Tool - Valued Living Questionnaire Secondary Outcomes - Acceptance and Action Questionnaire-2 - System Usability Scale - Attendance rate ### Location - Facility: CanSagligi Foundation Center for Contextual Behavioral Science, Istanbul, N/A, N/A, Turkey @@
## No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women - NCT ID: NCT06376812 - Study ID: 23-0320 - Status: NOT_YET_RECRUITING - Start Date: 2026-05 - Completion Date: 2029-01 - Lead Sponsor: The University of Texas Medical Branch, Galveston ### Study Description This study will test the effects of a physical activity intervention among midlife Hispanic women. ### Conditions - Elevated Blood Pressure - Perimenopause ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Physical activity intervention ### Outcomes Primary Outcomes - Days the activity monitor was worn Secondary Outcomes - Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months - Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months - Physical activity as measured by minutes of moderate intensity physical activity at 6 months - Physical activity as measured by minutes of moderate intensity physical activity at 6 months - Physical activity as measured by minutes of vigorous intensity physical activity at 6 months - Physical activity as measured by minutes of vigorous intensity physical activity at 6 months - Physical activity as measured by minutes of light intensity physical activity at 6 months - Physical activity as measured by minutes of light intensity physical activity at 6 months - Physical activity as measured by minutes of total physical activity at 6 months - Physical activity as measured by minutes of total physical activity at 6 months - Systolic blood pressure - Systolic blood pressure - Diastolic blood pressure - Diastolic blood pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Which Health-care Professional(s) to Talk About Advance Care Planning ? - NCT ID: NCT06376799 - Study ID: 38RC23.0437 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-02 - Lead Sponsor: University Hospital, Grenoble ### Study Description The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning.To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format. ### Conditions - Advance Care Planning - Patient Preference ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Self-questionnaire ### Outcomes Primary Outcomes - Determining the healthcare professional preferred by cancer patients to talk about advance care planning Secondary Outcomes - Determining cancer patients' second choice of healthcare professional to talk about advance care planning - Evaluation of patient preferences regarding advance care planning, concerning the form, the moment it should be carried out, whether or not they wish to be accompanied by a relative, and the benefit of systematization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Italian iTTP Registry - NCT ID: NCT06376786 - Study ID: ItaliTTP - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2030-05-31 - Lead Sponsor: Fondazione Luigi Villa ### Study Description ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy.A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years. ### Conditions - TTP - Thrombotic Thrombocytopenic Purpura ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Age at onset - Sex - Birth Country/Region - Race - Blood group - BMI - Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression. - Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs - Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms - Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin - Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin - Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin - Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin - Cardiac troponin - ADAMTS13 activity - Anti-ADAMTS13 antibodies - Number of daily therapeutic plasma exchange procedures - Proportion of acute iTTP patients treated with rituximab - Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab - Proportion of iTTP patients treated with caplacizumab - Incidence, type and severity of TTP-related drugs adverse events - Proportion of iTTP patients achieving clinical remission - Proportion of iTTP patients refractory to acute iTTP treatment - Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications - Proportion of iTTP patients experiencing clinical exacerbation - Proportion of iTTP patients achieving ADAMTS13 remission - Time to clinical response - Time to clinical remission - Time to ADAMTS13 remission - Proportion of iTTP patients with a clinical relapse - Proportion of iTTP patients with an ADAMTS13 relapse - Time to clinical relapse - Time to ADAMTS13 relapse - Incidence, type and severity of pregnancy complications in iTTP pregnant women Secondary Outcomes - iTTP incidence in Italy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping. - NCT ID: NCT06376773 - Study ID: 2022KY123 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-11-30 - Lead Sponsor: Fujian Medical University ### Study Description Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications. ### Conditions - Advanced Gastric Cancer - Neoadjuvant Therapy - Multi-omics Analysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - combination chemotherapy with Apatinib or Camrelizumab ### Outcomes Primary Outcomes - overall survival Secondary Outcomes - objective response rate ### Location - Facility: Fujian Medical University Union Hospital, Fuzhou, Fujian, 350000, China @@
## Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy - NCT ID: NCT06376760 - Study ID: KY2024-091-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-03-31 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern. ### Conditions - Insomnia - Digestive Endoscopy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No interventions, it is a observational study ### Outcomes Primary Outcomes - The total consumption of intravenous anesthetic drug Secondary Outcomes - The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope - The occurrence of the respiratory and cardiovascular adverse events - The occurrence of the other adverse events - The incidence of intraoperative recall or awareness - The recovery time - Duration of patients' PACU stay - The ease of operation at this level of sedation evaluated by the gastroenterologists - The satisfaction degree of anesthesia effect evaluated by the gastroenterologists - Patients' satisfaction - Patients' willingness ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100070, China @@
## The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients - NCT ID: NCT06376747 - Study ID: KDAR- PBM 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-31 - Lead Sponsor: Brno University Hospital ### Study Description The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system. ### Conditions - Iatrogenic Anaemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - In line sampling - Standard blood sampling technique ### Outcomes Primary Outcomes - Average amount of blood collected for laboratory diagnostic purposes Secondary Outcomes - Cumulative amount of blood drawn per day of ICU hospitalization - Absolute amount of blood drawn and blood used for laboratory testing - Trend of haemoglobin decline over time - Incidence of anaemia - Incidence of anaemia up to transfusion trigger - Frequency of blood product transfusions and their quantity - Type and frequency of laboratory tests - Incidence of coagulopathy - Incidence of catheter-related complications - Time to catheter replacement in case of catheter exchange ### Location - Facility: KDAR - department of pediatrics anesthesia and resuscitation, Brno, N/A, 62500, Czechia @@
## Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness - NCT ID: NCT06376734 - Study ID: 2024p000528 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2030-06-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits. ### Conditions - Major Depressive Disorder - Obsessive-Compulsive Disorder - Schizophrenia - Generalized Anxiety Disorder - Mood Disorders - Psychiatric Disorder - Mental Disorder - Depression, Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - TMS ### Outcomes Primary Outcomes - Clustering of multiple behavioral measures Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma - NCT ID: NCT06376721 - Study ID: TREC2024-KY016 - Status: RECRUITING - Start Date: 2024-04-14 - Completion Date: 2027-10-31 - Lead Sponsor: Beijing Tongren Hospital ### Study Description The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment. ### Conditions - Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type - T-lymphoblastic Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Linperlisib - Camrelizumab - Pegaspargase - Dexamethasone ### Outcomes Primary Outcomes - The best objective response rate（ORR） over 6 treatment cycles Secondary Outcomes - Objective Response Rate（ORR） - Complete Response （CR） - Progression Free Survival (PFS) - Overall Survival (OS) - Disease Control Rate（DCR） ### Location - Facility: Liang Wang, Beijing, Beijing, N/A, China @@
## Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation - NCT ID: NCT06376708 - Study ID: 3-3-13 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-07-01 - Lead Sponsor: Cairo University ### Study Description comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin ### Conditions - Maxillary Sinus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - platelet rich fibrin - Polyether ether ketone ### Outcomes Primary Outcomes - Bone quantity Secondary Outcomes - Bone quality ### Location - Facility: Faculty of Dentistry Cairo University, Cairo, N/A, N/A, Egypt @@
## Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes - NCT ID: NCT06376695 - Study ID: RADX-P-2407 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-10 - Lead Sponsor: Radicle Science ### Study Description A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes ### Conditions - Abdominal Pain - GI Disorders - Digestion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Radicle GI Health Placebo Control Form 1 - Radicle GI Health Active Study Product 1.1 Usage ### Outcomes Primary Outcomes - Change in GI (Gastrointestinal) Health (1) - Change in GI (Gastrointestinal) Health (2) - Change in GI (Gastrointestinal) Health (3) - Change in GI (Gastrointestinal) Health (4) - Change in GI (Gastrointestinal) Health (5) - Change in GI (Gastrointestinal) Health (6) Secondary Outcomes - Change in feelings of anxiety - Change in GI-related Quality of Life (QOL) - Change in mood (emotional distress-depression) - Minimal clinically important difference (MCID) in GI Health (1) - Minimal clinically important difference (MCID) in GI Health (2) - Minimal clinically important difference (MCID) in GI Health (3) - Minimal clinically important difference (MCID) in GI Health (4) - Minimal clinically important difference (MCID) in GI Health (5) - Minimal clinically important difference (MCID) in GI Health (6) - Minimal clinically important difference (MCID) in feelings of anxiety - Minimal clinically important difference (MCID) in GI-related QOL - Minimal clinically important difference (MCID) in mood (emotional distress-depression) ### Location - Facility: Radicle Science, Inc, Del Mar, California, 92014, United States @@
## EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy - NCT ID: NCT06376682 - Study ID: CA-BO-CIP-0060 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-02-28 - Lead Sponsor: Quantum Surgical ### Study Description Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. ### Conditions - Bone Metastases - Fractures, Bone - Bone Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CT-guided bone percutaneous procedure ### Outcomes Primary Outcomes - Successful instrument insertion with the EPIONE device. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma - NCT ID: NCT06376669 - Study ID: J2421 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2030-08 - Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ### Study Description This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival. ### Conditions - Renal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Proton Stereotactic Body Radiation therapy (SBRT) ### Outcomes Primary Outcomes - Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels - Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values Secondary Outcomes - Number of PROTON-BASED SBRT treatment Adverse Events - Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions - Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions - Time to locoregional progression - Overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Successful Aging and Age-related Decline - NCT ID: NCT06376656 - Study ID: LRGS/1/2019/SYUC/02/1 - Status: RECRUITING - Start Date: 2022-05-20 - Completion Date: 2030-05 - Lead Sponsor: Sunway University ### Study Description Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline. ### Conditions - Aging - Elderly - Cognitive Decline - Physical Decline - Intervention Study ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cognitive stimulation - Physical activity ### Outcomes Primary Outcomes - Changes in cognitive scores - Changes in electroencephalogram (EEG) - Changes in structural magnetic resonance imaging (MRI) - Cost-benefit analysis of intervention - Changes in levels of human salivary lactoferrin - Changes in levels of human salivary C-reactive proteins - Changes in salivary telomere length Secondary Outcomes - Changes in depression scores - Changes in anxiety scores ### Location - Facility: Sunway University, Petaling Jaya, Selangor, 47500, Malaysia @@
## Augmented Reality to Support Cardiopulmonary Resuscitation - NCT ID: NCT06376643 - Study ID: InterFACE-AR - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2025-10-31 - Lead Sponsor: Johan Siebert, MD ### Study Description A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine. ### Conditions - Cardiopulmonary Arrest - Resuscitation - Pediatric ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Augmented reality supportive tool - Conventional method (AHA pocket reference card) ### Outcomes Primary Outcomes - Time to first dose of epinephrine Secondary Outcomes - Time to initiation of cardiopulmonary resuscitation - Time to defibrillation - Time to delivery of epinephrine - Time to delivery of amiodarone - Time to secure definitive airway - Medication dosage errors - Types of Medication Errors - Frequency of Medication Errors - Frequency of pauses in cardiopulmonary resuscitation - Duration of pauses in cardiopulmonary resuscitation - Causes of pauses in cardiopulmonary resuscitation - Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation - Cardiopulmonary resuscitation quality: Chest compression fraction - Cardiopulmonary resuscitation quality: Peri-shock pause duration - Provider workload (NASA-TLX) - User Experience Questionnaire (UEQ) - System Usability Scale (SUS) - Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) - State-Trait Anxiety Inventory (STAI) form Y-1 ### Location - Facility: Alberta Children's Hospital, Calgary, Alberta, AB T3B 6A8,, Canada @@
## Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI - NCT ID: NCT06376630 - Study ID: 298-2024 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2030-01-29 - Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation ### Study Description Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction.First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement.Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection.Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \> 12 months post-infarction.Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement. ### Conditions - Myocardial Infarction - Coronary Stenosis - Coronary Microvascular Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esmolol Hcl 10Mg/Ml Inj ### Outcomes Primary Outcomes - Composite of adverse cardiac outcomes Secondary Outcomes - Degree of microvascular obstruction - Infarct size ### Location - Facility: NMRCCardiologyRu, Moscow, N/A, N/A, Russian Federation @@
## Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma - NCT ID: NCT06376617 - Study ID: MS.24.03.2743 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-05-20 - Lead Sponsor: Mansoura University ### Study Description This study is to assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma ### Conditions - Bronchial Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - fibroptic bronchoscopy ### Outcomes Primary Outcomes - assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies - NCT ID: NCT06376604 - Study ID: LNT55 - Status: RECRUITING - Start Date: 2021-09-08 - Completion Date: 2025-12-30 - Lead Sponsor: L-Nutra Inc ### Study Description This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies. ### Conditions - Cancer, Ovarian - Chemotherapy Effect - Calorie Deficiency - Fasting, Intermittent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Fasting Mimicking Diet - Chemotherapy ### Outcomes Primary Outcomes - Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire - Rate of Adherence Secondary Outcomes - Change in Body Weight - Change in Body Composition - Change in HbA1c - Change in Insulin Like Growth Factor 1 (IGF-1) Concentration - Change in Fasting Insulin Concentration - Change in Fasting Glucose Concentration - Change in High-sensitivity C reactive protein Concentration - Change in Leptin Concentration - Change in planned chemotherapy regimen - Number of Hospitalization Days - Rate of Chemotherapy Side Effects ### Location - Facility: The University of Tennessee Medical Center, Knoxville, Tennessee, 37920, United States @@
## Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency - NCT ID: NCT06376591 - Study ID: LUMHS/B12/Temp/12.04.2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-08-31 - Lead Sponsor: Liaquat University of Medical & Health Sciences ### Study Description Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being. ### Conditions - Vitamin B 12 Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral Vitamin B12 supplement - Control group ### Outcomes Primary Outcomes - Supplementation effect on circulatory vitamin B12 levels Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) ### Location - Facility: Liaquat University of Medical and Health Sciences, Jamshoro, N/A, 76090, Pakistan @@
## Exercise Interventions for Improving Health in Breast Cancer Survivors - NCT ID: NCT06376578 - Study ID: 245256 - Status: COMPLETED - Start Date: 2018-09-05 - Completion Date: 2020-01-30 - Lead Sponsor: University of Bath ### Study Description Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure. ### Conditions - Breast Cancer Female ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise intervention - Polar A380 wristwatch physical activity tracker ### Outcomes Primary Outcomes - Change in VO2max (maximum oxygen uptake) Secondary Outcomes - Change in Body composition ### Location - Facility: University of Bath, Bath, N/A, BA2 7AY, United Kingdom @@
## Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps - NCT ID: NCT06376565 - Study ID: 22-000647 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2028-03 - Lead Sponsor: Jonsson Comprehensive Cancer Center ### Study Description This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps. ### Conditions - Colorectal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Best Practice - Communication Intervention - Communication Intervention - Communication Intervention - Interview - Interview ### Outcomes Primary Outcomes - Stakeholder perspectives on the multilevel intervention (Aim 1) - Completion of surveillance colonoscopy (Aim 2) - Implementation quality (Aim 3a) - Cost effectiveness (Aim 3b) Secondary Outcomes - Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) ### Location - Facility: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States @@
## Artificial Intelligence for the Prioritization of Genetic Background in Brugada Syndrome - NCT ID: NCT06376552 - Study ID: AI4Cardio - Status: COMPLETED - Start Date: 2018-12-19 - Completion Date: 2022-06-06 - Lead Sponsor: IRCCS San Raffaele ### Study Description Brugada Syndrome (BS) is an inherited heart condition that can cause sudden cardiac arrest in young individuals. It's diagnosed through specific changes seen on an electrocardiogram (ECG). Currently, the only treatment option is a cardioverter defibrillator (ICD). Despite advances, much about BS remains unclear, including its genetic basis. This study aims to use advanced genetic sequencing and artificial intelligence to uncover new genetic factors contributing to BS. By understanding these factors better, we hope to improve risk assessment and treatment for affected individuals. ### Conditions - Brugada Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - New candidate genes, likely associated with Brugada Syndrome using an AI based approach. Secondary Outcomes - Identification of genetic risk factors associated with the worse phenotype. ### Location - Facility: IRCCS San Raffaele, Milan, N/A, 20132, Italy @@
## Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor. - NCT ID: NCT06376539 - Study ID: CEAVEC: 111/2024/Oss/IOR - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-04 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved. ### Conditions - Bone Neoplasm - Rehabilitation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Toronto Extremity Salvage Score (TESS) - Toronto Extremity Salvage Score (TESS) Secondary Outcomes - Range of motion (ROM) - Rang of motion - 2 (ROM) - Number of participants able to walk - Time Up and Go -2 (TUG) - Time Up and Go (TUG) - Muscle Strength - Muscle Strength-2 - Number of day from surgery to first walking ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## IMMUNOPLANT for Newly Diagnosed Multiple Myeloma - NCT ID: NCT06376526 - Study ID: 20230236 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2029-06-30 - Lead Sponsor: Dickran Kazandjian, MD ### Study Description The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Linvoseltamab ### Outcomes Primary Outcomes - Minimal Residual Disease (MRD) Negativity Rate Secondary Outcomes - Sustained MRD-Negativity Rate - Progression-Free Survival (PFS) - Overall Survival - Number of Participants Experiencing Treatment-Related Adverse Events ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Evaluation of Penile Prosthesis Pump Manipulation - NCT ID: NCT06376513 - Study ID: 69HCL24_0031 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration.Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners.These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses.Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction.In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation.The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with* Rigidity of erections with penile prosthesis* Patient's sexual satisfaction* Partner's sexual satisfaction* Satisfaction related to pump manipulation ### Conditions - Penile Prosthesis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Evaluation ### Outcomes Primary Outcomes - Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength - Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength - Describing the manipulation abilities of patients with penile prosthesis : proprioception - Describing the manipulation abilities of patients with penile prosthesis :discrimination - Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living Secondary Outcomes - Correlation of manipulation parameters (main outcome) with rigidity of erections - Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS - Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP - Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction - Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire) ### Location - Facility: Department of Urology, Lyon Sud Hospital,, Pierre-Bénite, N/A, 69310, France @@
## Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome - NCT ID: NCT06376500 - Study ID: HSEARS20240223001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-02 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI. ### Conditions - Transcranial Direct Current Stimulation - Post-Concussion Syndrome - Functional Magnetic Resonance Imaging - Magnetic Resonance Spectroscopy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tDCS with cognitive training programme ### Outcomes Primary Outcomes - Executive function Secondary Outcomes - Change in CANTAB® cognitive test - Reaction Time (RTI) - Change in CANTAB® cognitive test - Multitasking Test (MTT) - Change in CANTAB® cognitive test - Spatial Working Memory (SWM) ### Location - Facility: The Hong Kong Polytechnic University, Hung Hom, Kowloon, N/A, Hong Kong @@
## Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound - NCT ID: NCT06376487 - Study ID: 75202423.2.0000.0071 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-01-31 - Lead Sponsor: Hospital Israelita Albert Einstein ### Study Description The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question\[s\] it aims to answer are:* If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated* If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluatedThe belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance.Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages. ### Conditions - Bronchiolitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Flow rate evaluation ### Outcomes Primary Outcomes - diaphragm thickening fraction - abdominal muscle thickening fraction - EELZ (end-expiration lung impedance) Secondary Outcomes ### Location - Facility: Hospital Israelita Albert Eisntein, São Paulo, N/A, 05653000, Brazil @@
## To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage - NCT ID: NCT06376474 - Study ID: HM005PS1S06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd ### Study Description The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment. ### Conditions - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hemay005 ### Outcomes Primary Outcomes - Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） - Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） - Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) - Relevant pharmacokinetic parameters，half-life (T1/2) - Relevant pharmacokinetic parameters，clearance (CL/F) - Relevant pharmacokinetic parameters，volume of distribution (Vz/F) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients - NCT ID: NCT06376461 - Study ID: 333874 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: University Hospitals of North Midlands NHS Trust ### Study Description Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders. ### Conditions - Gastrointestinal Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection ### Outcomes Primary Outcomes - 28 day outcome - 90 day outcome Secondary Outcomes - ICU length of stay - ICU length of stay - Hospital length of stay - Hospital length of stay - Free of organ support ### Location - Facility: University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, N/A, N/A, United Kingdom @@
## An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough - NCT ID: NCT06376448 - Study ID: cc-obs-01 - Status: RECRUITING - Start Date: 2022-10-24 - Completion Date: 2025-02-10 - Lead Sponsor: Hull University Teaching Hospitals NHS Trust ### Study Description Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period. ### Conditions - Chronic Cough ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients Secondary Outcomes - measure of cough severity - describe any correlation between severity of cough and cough pattern - reproducibility of questionnnare ### Location - Facility: Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital, Cottingham, East Yorkshiure, HU16 5JQ, United Kingdom @@
## A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia - NCT ID: NCT06376435 - Study ID: HBHQ-CTIT-RWS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-07-01 - Lead Sponsor: Hebei Medical University Fourth Hospital ### Study Description The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy. ### Conditions - Cancer, Therapy-Related ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Herombopag Olamine Tablets ### Outcomes Primary Outcomes - The proportion of patients recovered to 100×109/L Secondary Outcomes - The proportion of patients recovered to 75×109/L - Time for platelet recovery to 100×109/L - Proportion of patients with treatment delay or dose reduction - TRAE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss - NCT ID: NCT06376422 - Study ID: EU-CT-2023-508271-36-00 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-04-30 - Lead Sponsor: Privatpraxis für Knie- und Schulterchirurgie ### Study Description The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are:* Can partial meniscal replacement improve knee function?* Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function.Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery. ### Conditions - Meniscus Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spongioflex® - non-operated ### Outcomes Primary Outcomes - To evaluate efficacy of the procedure - Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better) - Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better) - Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better) Secondary Outcomes - Safety of the patient (adverse events (AE) and serious adverse events (SAE)) - Efficacy of the procedure, progression to osteoarthrosis - Menuiscus size - extrusion of meniscus - Size of meniscal extrusion - Patient satisfaction ### Location - Facility: Privatpraxis für Knie und Schulterchirurgie, Dortmund, N/A, 44137, Germany @@
## Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females - NCT ID: NCT06376409 - Study ID: NW-HGN-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-06-01 - Lead Sponsor: Nutraceutical Wellness Inc. ### Study Description A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. ### Conditions - Hair Thinning ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nutrafol Women's Hair Growth Supplement - Nutrafol Women's Balance Hair Growth Supplement - Nutrafol Women's Vegan Hair Growth Supplement - Nutrafol Women's Postpartum Hair Growth Supplement ### Outcomes Primary Outcomes - The percent change in hair growth rate at Day 180 relative to baseline (Day 0) Secondary Outcomes - The percent change in hair growth rate at Day 90 relative to baseline (Day 0) - The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days - The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days - The change in terminal to vellus ratio - The change in terminal to vellus ratio - The change in anagen to telogen ratio - The change in anagen to telogen ratio - The change in average number of hairs per follicular unit - The change in average number of hairs per follicular unit - The change in total hair width per cm2 - The change in total hair width per cm2 - The change in mean inter-follicular distance - The change in mean inter-follicular distance - Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days - Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days ### Location - Facility: Integrative Skin Science and Research, Sacramento, California, 95815, United States @@
## Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis - NCT ID: NCT06376396 - Study ID: 101103306 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: R-Evolution Worldwide S.r.l. Impresa Sociale ### Study Description The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis. ### Conditions - Neurocysticercosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - albendazole and praziquantel - Albendazole ### Outcomes Primary Outcomes - Cyst resolution or reduction in both study arms Secondary Outcomes - Seizures frequency - Quality of Life questionnaire - Headache - Serological test results correlation with neuroimaging results ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea - NCT ID: NCT06376383 - Study ID: TETT-RHG - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-09 - Lead Sponsor: University of Aarhus ### Study Description The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity. ### Conditions - Obstructive Sleep Apnea - Tonsillar Hypertrophy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tonsillectomy - Tonsillotomy ### Outcomes Primary Outcomes - Postoperative hemorrhage - Postoperative pain - Recovery time - Sick leave - Morbidity Secondary Outcomes - AHI - DISE - VOTE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient - NCT ID: NCT06376370 - Study ID: 16.04.24/2 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-26 - Completion Date: 2024-07-28 - Lead Sponsor: Selcuk University ### Study Description The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life. ### Conditions - Epilepsy - Computer-assisted Cognitive Rehabilitation - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Application of computer-assisted cognitive rehabilitation program ### Outcomes Primary Outcomes - Mini Mental State Test - Epilepsy Quality of Life Scale - MOXO Test - Epilepsy Self-Management Scale Secondary Outcomes ### Location - Facility: ülkü Saygili Düzova, Selçuklu, Konya, N/A, Turkey @@
## The Effect of Foot Massage With Roles on Cancer Patients - NCT ID: NCT06376357 - Study ID: 16.04.24/1 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-27 - Completion Date: 2024-07-30 - Lead Sponsor: Selcuk University ### Study Description It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life. ### Conditions - Breast Neoplasms - Over Cancer - Foot Massage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Foot Massage with roller ### Outcomes Primary Outcomes - EORTC QLQ C-30 Quality of Life Scale - CIPN20 Neuropathy Scale - One Leg Standing Test - Brief Pain Inventory BPI - Pain Threshold Assessment Test - Two Point Discrimination Secondary Outcomes ### Location - Facility: ülkü Saygili Düzova, Selçuklu, Konya, N/A, Turkey @@
## The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy. - NCT ID: NCT06376344 - Study ID: 16.04.24 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-28 - Completion Date: 2024-07-10 - Lead Sponsor: Selcuk University ### Study Description This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy. ### Conditions - Cancer - Neuropathy - Therapy-Associated Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - myofascial release with tennis ball ### Outcomes Primary Outcomes - EORTC QLQ C-30- CIPN20 Scale - One Leg Standing Test - Lateral Reach Test - Pain Assessment - Pressure Pain Threshold Assessment - Two Point Discrimination Secondary Outcomes ### Location - Facility: ülkü Saygili Düzova, Selçuklu, Konya, N/A, Turkey @@
## Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder - NCT ID: NCT06376331 - Study ID: ADHD20240403 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-07-01 - Lead Sponsor: The Second Hospital of Nanjing Medical University ### Study Description Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism. ### Conditions - Attention-deficit/Hyperactivity Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - washed microbiota transplantation ### Outcomes Primary Outcomes - change of Swanson, Nolan and Pelham-IV (SNAP-IV). - change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ). Secondary Outcomes - change of the Sleep Disturbance Scale for Children (SDSC). - change of the Gastrointestinal Symptom Rating Scale (GSRS) . - the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome. - the difference of the serum neurotransmitters between children with ADHD and healthy children - intestinal barrier ### Location - Facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, N/A, China @@
## Shock and Acute Conditions OutcOmes Platform - NCT ID: NCT06376318 - Study ID: 19-138 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Saint-Louis Hospital, Paris, France ### Study Description In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention.To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials.This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature). ### Conditions - Circulatory Shock - Sepsis - Cardiogenic Shock - Major Trauma - Surgical Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Inotrope - Mechanical circulatory support - anti-bodies ### Outcomes Primary Outcomes - Mortality rate Secondary Outcomes - Mortality rate - Renal replacement therapy use rate - Mechanical circulatory support use rate - Vasopressors and inotropes-free days ### Location - Facility: St Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada @@
## EndoBarrier in Obstructive Sleep Apnoea Study - NCT ID: NCT06376305 - Study ID: 176786 - Status: COMPLETED - Start Date: 2016-03 - Completion Date: 2019-12 - Lead Sponsor: Dr Bob Ryder ### Study Description Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment. ### Conditions - Type 2 Diabetes - Obstructive Sleep Apnoea - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - EndoBarrier ### Outcomes Primary Outcomes - Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months Secondary Outcomes - Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months - Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months - Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months - Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months - Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months - Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months - Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI - Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months - Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months - Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months - Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months ### Location - Facility: City Hospital, Birmingham, N/A, B18 7QH, United Kingdom @@
## A Prospective Study of Whole-Brain RT Combined With Thiotepa Sheath Injection Combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors - NCT ID: NCT06376292 - Study ID: Y⒛24-0106 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-02-01 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa sheath injection combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid TumorsHow works well was the combined therapy？ How safe was combined therapy？ Participants will receive whole brain radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. Evaluate the efficacy and safety every 2 cycles.Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies. ### Conditions - Solid Tumor Leptomeningeal Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Secondary Outcomes - OS - 3-month PFS - 6-month PFS - 1-year PFS ### Location - Facility: The Second Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310000, China @@
## Genetic Diagnosis in Inborn Errors of Metabolism - NCT ID: NCT06376279 - Study ID: 2008/351-31 - Status: ENROLLING_BY_INVITATION - Start Date: 2008-04-29 - Completion Date: 2030-12-31 - Lead Sponsor: Region Stockholm ### Study Description Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism. ### Conditions - Metabolic Disease - Mitochondrial Diseases - Epilepsy in Children - Epilepsy - LHON - Motor Neuron Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - IEM-EP ### Outcomes Primary Outcomes - Genetic variant identification using NGS for diagnosis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals - NCT ID: NCT06376266 - Study ID: 202305083RSC - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-09-30 - Lead Sponsor: National Taiwan University Hospital ### Study Description Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - nutritional supplements ### Outcomes Primary Outcomes - the scale of sarcopenia - the scale of sarcopenia - the scale of sarcopenia Secondary Outcomes ### Location - Facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers - NCT ID: NCT06376253 - Study ID: CGIZ943A12101 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-06 - Completion Date: 2030-08-30 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC). ### Conditions - Ovarian Cancer - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - [68Ga]Ga-EVS459 - [177Lu]Lu-EVS459 ### Outcomes Primary Outcomes - Number of participants with dose limiting toxicities of [177Lu]Lu-EVS459 - Incidence and severity of adverse events and serious adverse events of [177Lu]Lu- EVS459 - Dose modifications for [177Lu]Lu- EVS459 - Dose intensity for [177Lu]Lu- EVS459 Secondary Outcomes - Overall response rate (ORR) - Duration of Response (DOR) - Disease control rate (DCR) - Progression free survival (PFS) - Area Under the Curve (AUC) of [177Lu]Lu-EVS459 - Total body clearance of [177Lu[Lu-EVS459 - Observed maximum plasma concentration (Cmax) of [177Lu]Lu-EVS459 - Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-EVS459 - Terminal elimination half-life (T1/2) of [177Lu]Lu-EVS459 - Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) - Renal clearance of [177Lu]Lu- EVS459 - Absorbed dose of [177Lu]Lu- EVS459 - Time-activity curves (TACs) related to [177Lu]Lu-EVS459 uptake in organs and tumor lesions - Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-EVS459 - Visual and quantitative assessment of [68Ga]Ga-EVS459 uptake in normal tissues and tumor lesions over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes - NCT ID: NCT06376240 - Study ID: NL85203.068.23 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2025-12-31 - Lead Sponsor: Maastricht University Medical Center ### Study Description Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation. ### Conditions - Type 2 Diabetes - Microvascular Function - Retinopathy, Diabetic - Nephropathy, Diabetic - Neuropathy, Diabetic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Pyridoxamine 300mg per day - Placebo 300mg placebo per day ### Outcomes Primary Outcomes - Central retinal artery equivalent of the eye Secondary Outcomes ### Location - Facility: Academic Hospital Maastricht, Maastricht, N/A, 6229 HX, Netherlands @@
## Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation - NCT ID: NCT06376227 - Study ID: jamesdukeryan - Status: COMPLETED - Start Date: 2020-04-01 - Completion Date: 2023-12-28 - Lead Sponsor: Northern Jiangsu People's Hospital ### Study Description Brief SummaryBackground The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function. ### Conditions - Rectal Cancer - Left Colic Artery Stenosis (Diagnosis) - Robotic Assisted Laparoscopic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - with or without Left Colic Artery Preservation ### Outcomes Primary Outcomes - The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation. Secondary Outcomes - The genitourinary function of the patients after the radical resection with or without left colic artery preservation. ### Location - Facility: Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou, Yangzhou, Jiangsu, 225001, China @@
## Daratumumab for Patients With Light Chain Amyloidosis - NCT ID: NCT06376214 - Study ID: 2024-02 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Nanjing University School of Medicine ### Study Description This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis. ### Conditions - Light Chain (AL) Amyloidosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dratumumab / Hyaluronidase Injection [Darzalex Faspro] - Pomalidomide 4 MG - autologous stem cell transplantation (ASCT) ### Outcomes Primary Outcomes - Hematological complete response rate - Organ response rate Secondary Outcomes - Time to Next Treatment - Progression-free survival - Overall survival ### Location - Facility: National Clinical Research Center for Kidney Diseases, Jinling Hospital, Nanjing, Jiangsu, 210016, China @@
## A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease - NCT ID: NCT06376201 - Study ID: NFEC-2024-018 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed. ### Conditions - Invasive Fungal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Amphotericin B cholesterol-sulfate complex for injection ### Outcomes Primary Outcomes - Treatment is effective Secondary Outcomes - Incidence of the single index in the five criteria of treatment success - Completion rate of ABCD treatment for at least 14 days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving Breaking Bad News in Pediatrics by Simulated Communication - NCT ID: NCT06376188 - Study ID: 1582/2021 SimCom - Status: COMPLETED - Start Date: 2021-09-01 - Completion Date: 2022-09-30 - Lead Sponsor: Medical University of Vienna ### Study Description Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication ### Conditions - Communication - End of Life - Pediatric ALL ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - communication training ### Outcomes Primary Outcomes - score by simulation parents Secondary Outcomes - score by participants - score of video analysis ### Location - Facility: Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program - NCT ID: NCT06376175 - Study ID: LL-016 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-08-31 - Lead Sponsor: Lumos Labs, Inc. ### Study Description Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games. ### Conditions - Healthy Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - BOLD response during gameplay - Responder rates - Structural MRI volumetrics: Volume - Structural MRI volumetrics: Cortical thickness - Structural MRI volumetrics: Brain-Predicted Age Difference - Behavior response: Game score - BAMS-7 (Brief Attention and Mood Scale of 7 Items) - VGPQ (Video Game Playing Questionnaire) Secondary Outcomes ### Location - Facility: UC Davis Imaging Research Center (IRC), Sacramento, California, 95817, United States @@
## Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia - NCT ID: NCT06376162 - Study ID: ITCC-101/APAL2020K - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-08 - Lead Sponsor: LLS PedAL Initiative, LLC ### Study Description The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK). ### Conditions - Relapsed/Refractory KMT2A-r Acute Leukemia - Relapsed/Refractory NUP98-r Acute Leukemia - Relapsed/Refractory NPM1-m Acute Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ziftomenib - Cytarabine - Fludarabine ### Outcomes Primary Outcomes - Number of Participants Who Experience a Dose-limiting Toxicity (DLT) - Area Under the Plasma Concentration-time Curve (AUC) of Ziftomenib Secondary Outcomes - Number of Participants Who Experience an Adverse Event (AE) - Number of AEs by Severity - Maximum Observed Plasma Concentration (Cmax) of Ziftomenib - Minimum Observed Plasma Concentration (Cmin) of Ziftomenib - Time to Cmax (Tmax) - Truncated AUC (AUC0-t) of Ziftomenib in Combination with FLA Chemotherapy - Extrapolated AUC (AUC0-∞) of Ziftomenib in Combination with FLA Chemotherapy - Oral Plasma Clearance (CL/F) of Ziftomenib in Combination with FLA Chemotherapy - Volume of Distribution (Vz/F) of Ziftomenib in Combination with FLA Chemotherapy - Terminal Elimination Half-life (t1/2) of Ziftomenib in Combination with FLA Chemotherapy - HSCT Rate - Morphological Overall Response Rate (ORR) - Flow-based ORR - Flow-based Measurable Residual Disease (MRD) Negativity Rate - Duration of Response (DOR) - Event-free Survival (EFS) - Overall Survival (OS) - Cumulative Incidence of Relapse (CIR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## M3-JIA: Making Mindfulness Matter for Children With JIA - NCT ID: NCT06376149 - Study ID: 124973 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-02 - Lead Sponsor: Lawson Health Research Institute ### Study Description The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level. ### Conditions - Juvenile Idiopathic Arthritis - Children - Mental Health - Mental Well-being ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - M3 Intervention group - M3 Waitlist Group ### Outcomes Primary Outcomes - conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s). Secondary Outcomes - Effects of M3 on health related quality of life of children with JIA - Effects of M3 on health quality of life for parents - Does M3 have a positive effect on children's severity of JIA - Does M3 have a positive effect on children's executive function ### Location - Facility: McMaster Children's Hospital,, Hamilton, Ontario, L8N 3Z5, Canada @@
## An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study - NCT ID: NCT06376136 - Study ID: BAT-8010+1006-001-CR - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-12-09 - Lead Sponsor: Bio-Thera Solutions ### Study Description This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BAT8010 for Injection - BAT1006 for Injection ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - vital signs - Physical examination - Adverse events - Clinical laboratory tests - Number of participants with abnormal clinical auxiliary tests - Duration of Response(DOR) - Disease Control Rate (DCR) Secondary Outcomes - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Antibody - Antibody ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation - NCT ID: NCT06376123 - Study ID: Nkangarli001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-09-15 - Lead Sponsor: Bezmialem Vakif University ### Study Description The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly. ### Conditions - One-lung Ventilation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Alveolo-arterial gradient - Alveolo-arterial gradient Secondary Outcomes - Alveolo-arterial gradient change - Alveolo-arterial gradient change ### Location - Facility: Bezmialem Vakif University Dragos Hospital, Istanbul, Maltepe, 34844, Turkey @@
## Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production - NCT ID: NCT06376110 - Study ID: AviClear-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: Austin Institute for Clinical Research ### Study Description This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI. ### Conditions - Acne ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Topical Antioxidant Serum - AviClear Laser ### Outcomes Primary Outcomes - Change in Product Tolerability - Change in Product Efficacy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service. - NCT ID: NCT06376097 - Study ID: D5162R00036 - Status: RECRUITING - Start Date: 2023-04-19 - Completion Date: 2025-01-30 - Lead Sponsor: AstraZeneca ### Study Description Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Absolute number and frequency of false-negative lung nodules . Secondary Outcomes - Assess adherence to smoking cessation treatment in active smokers who enter screening. - Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic. - Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program. ### Location - Facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB), Botucatu, São Paulo, 18618-686, Brazil @@
## Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC - NCT ID: NCT06376084 - Study ID: D5161R00055 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-24 - Completion Date: 2028-02-28 - Lead Sponsor: AstraZeneca ### Study Description To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS. ### Conditions - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Respiratory Tract Neoplasms - Thoracic Neoplasms - Neoplasms by Site - Neoplasms - Lung Diseases - Respiratory Tract Diseases - Carcinoma, Bronchogenic - Bronchial Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Real-World Progression Free Survival (rwPFS) Secondary Outcomes - Chemotherapy regimen - Duration of chemotherapy (induction and maintenance cycles) - Response rate - Duration of response - Overall survival (OS) ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, 200030, China @@
## Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis . - NCT ID: NCT06376071 - Study ID: fungal rhinosiusitis - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: Assiut University ### Study Description This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::1. anatomical variations and correlate radiological finding with intraoperative finding.2. other associated factors like demographic ,environmental, immunological and climatic risk factors . ### Conditions - Allergic Fungal Rhinosinusitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - functional endoscopic sinus surgery ### Outcomes Primary Outcomes - Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section - NCT ID: NCT06376058 - Study ID: 434/06-06-2022 - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2026-01-10 - Lead Sponsor: Aretaieion University Hospital ### Study Description This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections ### Conditions - Cesarean Section - Local Anesthetic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chloroprocaine 1% Injectable Solution - Ropivacaine 0.75% Injectable Solution ### Outcomes Primary Outcomes - Time from spinal anesthesia to T10 block (min) - Time from spinal anesthesia to T4 block (min) - Time of spinal anesthesia to Bromage =3 - level of sensory block every 3 min - level of sensory block every 15 min - highest level of sensory block - time from spinal anesthesia to highest level of sensory block - duration of sensory block - pain at surgical incision - pain at neonatal delivery - pain at peritoneal manipulation - pain at Post Anesthesia Care Unit (PACU) admission - pain at Post Anesthesia Care Unit (PACU) discharge - need for rescue analgesia intraoperatively - Bromage scale every 3 min after spinal anesthesia - Bromage scale every 15 min - duration of motor block - duration of staying in PACU Secondary Outcomes - Neonatal Apgar score at 1 minute - Neonatal Apgar score at 5 minutes - neonatal blood gases - incidence of neonatal acidosis - incidence of hypotension - incidence of bradycardia - need for vasoconstrictor - need for atropine - incidence of nausea/vomiting - incidence of dizziness - incidence of drowsiness - incidence of discomfort - incidence of shivering - need for rescue analgesia in PACU - time from spinal anesthesia to rescue analgesia in PACU - incidence of neurological symptoms during hospital stay - incidence of neurological symptoms 2 months after the operation - incidence of low back pain - time from spinal anesthesia to mobilization - mother's satisfaction from anesthesia - gynecologist's satisfaction ### Location - Facility: Aretaieion University Hospital, Athens, N/A, 11528, Greece @@
## A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma - NCT ID: NCT06376045 - Study ID: 20220093 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2026-10-02 - Lead Sponsor: Amgen ### Study Description The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations. ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rocatinlimab - Placebo ### Outcomes Primary Outcomes - Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period Secondary Outcomes - Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) - Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period - Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 - Change From Baseline in Pre-BD FEV1 - Change From Baseline in Asthma Symptom Diary (ASD) Score - Number of Participant Achieving ACQ-6 Response at Week 48 - Change From Baseline in ACQ-6 - Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score - Number of Participants Achieving AQLQ (S) Response at Week 48 - Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period - Time to First Asthma Exacerbation Event - Time to First CompEx Event - Number of Participants with a CompEx Event During the Double Blinded Treatment Period - Annualized Rate of CompEx Events - Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels - Serum Rocatinlimab Concentrations - Trough Concentration (Ctrough) of Rocatinlimab - Number of Participants with Treatment-emergent Adverse Events - Number of Participants with Serious Adverse Events - Number of Participants with Anti-rocatinlimab Antibody Formation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EndeavorOTC® Research Study in College Students - NCT ID: NCT06376032 - Study ID: Akili-068 - Status: RECRUITING - Start Date: 2024-01-10 - Completion Date: 2025-12-31 - Lead Sponsor: Akili Interactive Labs, Inc. ### Study Description The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students. ### Conditions - Attention - Cognition - University Students ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - EndeavorOTC® ### Outcomes Primary Outcomes - Computerized Adaptive Test, Mental Health (CAT-MH®) - PROMIS Cognitive Function v2.0 - Short Form - PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0) - General Academic Self-Efficacy scale (GASE) - Mental Health Quality of Life Scale (MHQoL) - Adult ADHD Self-Report Scale (ASRS) - Patient Health Questionnaire-4 (PHQ-4) Secondary Outcomes ### Location - Facility: Villa Maria College, Cheektowaga, New York, 14225, United States @@
## Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants - NCT ID: NCT06376019 - Study ID: FDASU-RecID11352 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-09-15 - Lead Sponsor: Ain Shams University ### Study Description complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture. ### Conditions - Edentulous Jaw ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - solitary Implant loading with ball attachment - splinted Implant loading with intra oral welding - complete denture ### Outcomes Primary Outcomes - Assessment of occlusion/disocclusion time Secondary Outcomes ### Location - Facility: Faculty of Dentistry Ain Shams University, Cairo, N/A, 11361, Egypt @@
## Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees - NCT ID: NCT06376006 - Study ID: 1798538 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-05-11 - Completion Date: 2024-12-01 - Lead Sponsor: AdventHealth ### Study Description Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs). ### Conditions - Competence - Assessment, Self ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EMR STAT - Survey ### Outcomes Primary Outcomes - Primary Endpoint Secondary Outcomes ### Location - Facility: AdventHealth Orlando, Orlando, Florida, 32804, United States @@
## A Phase 1 Study of ADI-001 in Lupus Nephritis - NCT ID: NCT06375993 - Study ID: ADI-202300103 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-12 - Lead Sponsor: Adicet Bio, Inc ### Study Description ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion safety/efficacy study in patients with lupus nephritis. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up ### Conditions - Lupus Nephritis - Autoimmune Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ADI-001 - Fludarabine - Cyclophosphamide ### Outcomes Primary Outcomes - The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort - Proportion of treatment emergent and treatment related adverse events Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications - NCT ID: NCT06375980 - Study ID: ANKARA_OR_MP - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2022-12-31 - Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital ### Study Description This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. We record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively ### Conditions - Lung Injury - Pulmonary Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intraoperative Mechanical Ventilation Strategies ### Outcomes Primary Outcomes - Relationship between mechanical power and postoperative pulmonary complications Secondary Outcomes ### Location - Facility: Ankara Oncology Training and Research Hospital, Ankara, N/A, 06200, Turkey @@
## EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) - NCT ID: NCT06375967 - Study ID: CARPEGIEM - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: Hospital Universitari de Bellvitge ### Study Description The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients. ### Conditions - Malignant Biliary Obstruction - Biliary Tract Neoplasms - Pancreatic Cancer Non-resectable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endoscopic biliary drainage - Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) - Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) ### Outcomes Primary Outcomes - SAFETY (ADVERSE EVENTS) - Recurrent biliary obstruction Secondary Outcomes - CLINICAL SUCCESS - TECHNICAL SUCCESS - BILIARY REINTERVENTIONS (BRI) - HOSPITAL STAY - MORTALITY - COST ANALYSIS ### Location - Facility: Hospital Universitari de Bellvitge, L'Hospitalet De Llobregat, Barcelona, Catalonia, 08907, Spain @@
## EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) - NCT ID: NCT06375954 - Study ID: CARPEDIEM-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Hospital Universitari de Bellvitge ### Study Description The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction. ### Conditions - Malignant Biliary Obstruction - Pancreatic Cancer - Biliary Tract Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endoscopic biliary drainage - Self-expandable metallic stent (SEMS) - Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) ### Outcomes Primary Outcomes - Delay in days between endoscopic biliary drainage and chemotherapy treatment start Secondary Outcomes - Technical success - Clinical success - AE - biliary drainage - AE - surgery - Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) ### Location - Facility: Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, 08907, Spain @@
## Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars - NCT ID: NCT06375941 - Study ID: ProStars - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2034-04-01 - Lead Sponsor: Italian Sarcoma Group ### Study Description This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS. ### Conditions - Angiosarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational ### Outcomes Primary Outcomes - Demographic characteristics - General characteristics - Cancer data - Origin of Tumor - Tumor characteristics - Tumor size - Tumor aspects - Pathological characteristics - Tumor phenotype - Molecular characteristics Secondary Outcomes ### Location - Facility: IRCCS Istituto Nazionale Tumori - Milano, Milano, N/A, 20133, Italy @@
## EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial) - NCT ID: NCT06375928 - Study ID: CARPEDIEM-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Hospital Universitari de Bellvitge ### Study Description The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction. ### Conditions - Malignant Biliary Obstruction - Pancreatic Cancer Resectable - Biliary Tract Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Endoscopic biliary drainage - Self-expandable metallic stent (SEMS) - Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) ### Outcomes Primary Outcomes - Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) Secondary Outcomes - Technical success - Clinical success - AE - biliary drainage - AE - surgery ### Location - Facility: Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907, Spain @@
## Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy - NCT ID: NCT06375915 - Study ID: PM-CARE - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Francesco De Cobelli ### Study Description Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - radioembolization with Y-90 - Durvalumab - Cisplatin - Gemcitabine ### Outcomes Primary Outcomes - Overall response rate (ORR) - Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Secondary Outcomes - Median progression free survival - Overall response rate - Overall response rate - Overall response rate - Overall response rate - Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor circulating markers - Tumor tissue based evaluation - Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Tumor tissue-based markers tumor circulating markers tumor tissue-based markers - Quantitative imaging based biomarkers - Quantitative biomarkers - Overall Survival (OS) ### Location - Facility: Department of Radiology, IRCCS Ospedale San Raffaele, Milano, N/A, 20132, Italy @@
## The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them - NCT ID: NCT06375902 - Study ID: 2022289RNA - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: IRCCS San Raffaele ### Study Description Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique ### Conditions - Schizophrenia; Psychosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PragmaCom ### Outcomes Primary Outcomes - Tracking down the difficulties in metaphor comprehension via a behavioural task - Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording Secondary Outcomes - Evaluation of psychopathology - Evaluation of cognition - Evaluation of Theory of Mind - Evaluation of functioning - Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage - NCT ID: NCT06375889 - Study ID: 69HCL24_0250 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-13 - Completion Date: 2025-06-13 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology. ### Conditions - Aneuvrysmal Subarachnoid Hemorrhage - Delayed Cerebral Ischemia - Endotheliopathy - Platelets Kinetic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - blood test ### Outcomes Primary Outcomes - The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation. Secondary Outcomes ### Location - Facility: Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital, Bron, Auvergne-Rhône-Alpes, 69005, France @@
## Single Session Intervention to Promote Hope - NCT ID: NCT06375876 - Study ID: 2000034173 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Yale University ### Study Description The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage. ### Conditions - Domestic Violence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Single-session intervention (SSI) ### Outcomes Primary Outcomes - Feasibility assessed by percent enrolled - Feasibility assessed by time to complete - Feasibility assessed by post-intervention survey/process supplement - Acceptability/likability assessed using the Program Feeback Scale - Safety assessed using end of study survey - Change in Hope assessed using Herth Hope Index - Change in Hope assessed using Trait Hope Scale - Change in Hope assessed using Beck Hopelessness Scale (single item) Secondary Outcomes - Change in Self-worth - Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R) - Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2) - Change in Emotional wellbeing measured by the State Joy Scale ### Location - Facility: The Consultation Center at Yale, New Haven, Connecticut, 06511, United States @@
## QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia - NCT ID: NCT06375863 - Study ID: 44-2023 - Status: COMPLETED - Start Date: 2023-03-29 - Completion Date: 2023-05-29 - Lead Sponsor: Haseki Training and Research Hospital ### Study Description QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death.Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation.Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population.To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients. ### Conditions - Anesthesia, Spinal - Sevoflurane - Long QT Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - QT and QTc interval ### Outcomes Primary Outcomes - QTc interval Secondary Outcomes - QT ### Location - Facility: Health Science University, Haseki Training and Research Hospital, Istanbul, N/A, N/A, Turkey @@
## Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial. - NCT ID: NCT06375850 - Study ID: Effects of topical sesame oil - Status: RECRUITING - Start Date: 2022-06-05 - Completion Date: 2025-05-11 - Lead Sponsor: Hospital Universitario Marqués de Valdecilla ### Study Description Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis. ### Conditions - Phlebitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sesame oil - Saline solution ### Outcomes Primary Outcomes - Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically Secondary Outcomes - Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters ### Location - Facility: Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, 39008, Spain @@
## Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites - NCT ID: NCT06375837 - Study ID: bioactive-NCCLs - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-06-15 - Lead Sponsor: Hacettepe University ### Study Description The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests. ### Conditions - Tooth Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - an alkasite-based restorative material - hybrid resin composite - a highly filled flowable resin composite ### Outcomes Primary Outcomes - Clinical performances of different restorative systems according to FDI criteria (Esthetic properties) Secondary Outcomes - Clinical performances of different restorative systems according to FDI criteria (Functional properties) ### Location - Facility: Hacettepe University, Ankara, N/A, N/A, Turkey @@
## Bufei Recipe Reduces the Incidence Rate of COPD - NCT ID: NCT06375824 - Study ID: TCM for Pre-COPD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-10-31 - Lead Sponsor: Henan University of Traditional Chinese Medicine ### Study Description Establish early TCM prevention and treatment program to reduce the incidence rate of COPD. ### Conditions - Preserved Ratio Impaired Spirometry ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bufei Recipe - Bufei Recipe placebo ### Outcomes Primary Outcomes - Incidence rate of COPD Secondary Outcomes - FVC - FEV1 - FEV1% pred - FEV1/FVC - IPAG-Q - LFQ - COPD-PS - CAT - SF-36 - Clinical symptoms - Biochemical indicators ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp - NCT ID: NCT06375811 - Study ID: 2000027121_temp - Status: RECRUITING - Start Date: 2024-03-16 - Completion Date: 2026-06-30 - Lead Sponsor: Yale University ### Study Description A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. ### Conditions - Infertility - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Elagolix 200 MG - Placebo or SOC IVF ### Outcomes Primary Outcomes - Live birth rate Secondary Outcomes - Fertilization rate - Number of embryos transferred - Implantation rate - Biochemical pregnancy rate - Clinical pregnancy rate - Miscarriage rate - Overall pregnancy complication rate - Gestation age at delivery - Infant birth weight ### Location - Facility: University of Colorado Department of Obstetrics & Gynecology, Aurora, Colorado, 80045, United States @@
## Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer - NCT ID: NCT06375798 - Study ID: 2020137 - Status: RECRUITING - Start Date: 2020-11-19 - Completion Date: 2026-11-19 - Lead Sponsor: Hebei Medical University Fourth Hospital ### Study Description A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery. ### Conditions - Breast Cancer - HER2-negative Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - radiotherapy ### Outcomes Primary Outcomes - LRFS Secondary Outcomes ### Location - Facility: The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, N/A, China @@
## Two Different Exercise Methods in Geriatrics - NCT ID: NCT06375785 - Study ID: LSVT-BIG vs Otago - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2024-03-01 - Lead Sponsor: Halic University ### Study Description The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people ### Conditions - Elderly People - Nursing Homes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Otago-based (slow rhythmic) exercise group - LSVT BIG-based (large amplitude) exercise group ### Outcomes Primary Outcomes - Timed Up &Go Test - Performanz Balance System - Functional Reaching Test - Six Minute Walking Test - Tinetti Balance and Gait Assessment Secondary Outcomes - Activity-Specific Balance and Confidence Scale - Five Times Sit to Stand - Montreal Cognitive Assessment Test - KATZ Activities of Daily Living Scale - Clinical Frailty Scale ### Location - Facility: Haliç University, Istanbul, Eyüpsultan, N/A, Turkey @@

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