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## Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study - NCT ID: NCT06282133 - Study ID: 2024-1862 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-01-01 - Lead Sponsor: Universite du Quebec en Outaouais ### Study Description Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.In the 1990s, a group of Canadian researchers developed a CBT protocol for GAD that included four components. Data from six clinical trials in adults suggest that one of the four components is particularly important for treatment success: exposing oneself to uncertainty rather than avoiding it in daily life. In other words, learning to tolerate and manage uncertainty seems to be the key to reducing worry and anxiety.Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments. ### Conditions - Generalized Anxiety Disorder - Adolescent - Emotional Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Behavioural Experiments for Intolerance of Uncertainty ### Outcomes Primary Outcomes - Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) Secondary Outcomes - Worry and Anxiety Questionnaire (WAQ) - Penn State Worry Questionnaire (PSWQ) - Beck Anxiety Inventory (BAI) - Beck Depression Inventory-II (BDI-II) ### Location - Facility: Universite du Quebec en Outaouais, Gatineau, Quebec, J8X 3X7, Canada @@
## Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer - NCT ID: NCT06282120 - Study ID: CSPC-DNY-BTC - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:* To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer. ### Conditions - Metastatic Biliary Tract Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy ### Outcomes Primary Outcomes - Progression Free Survival Secondary Outcomes - Overall Survival - Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1 - EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0) ### Location - Facility: Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, 300000, China @@
## Effectiveness and Safety of BiSAAE for Resistant Hypertension. - NCT ID: NCT06282107 - Study ID: BiSAAE-RHT - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: First Affiliated Hospital of Chengdu Medical College ### Study Description Hypertension is a common problem, affecting \>1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (SAAE) is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH. ### Conditions - Resistant Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BiSAAE - traditional triple antihypertensive treatment ### Outcomes Primary Outcomes - Change of 24-h average systolic blood pressure - Change of 24-h average systolic blood pressure - Change of 24-h average systolic blood pressure Secondary Outcomes - Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure - Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure - Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure - Change of home systolic and diastolic pressure - Change of home systolic and diastolic pressure - Change of home systolic and diastolic pressure - Difference in the change of office systolic and diastolic pressure between the intervention and control group - Difference in the change of office systolic and diastolic pressure between the intervention and control group - Difference in the change of office systolic and diastolic pressure between the intervention and control group - Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group - Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group - Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group - Change of plasma aldosterone - Change of plasma aldosterone - Change of plasma aldosterone - Change of plasma cortisol - Change of plasma cortisol - Change of plasma cortisol - Change of plasma renin measured - Change of plasma renin measured - Change of plasma renin measured - Change of liver enzymes - Change of liver enzymes - Change of liver enzymes - Change of kidney function - Change of kidney function - Change of kidney function - Change of fasting blood glucose - Change of fasting blood glucose - Change of fasting blood glucose - Change of lipids profiles - Change of lipids profiles - Change of lipids profiles - Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) - Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) - Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD) - Change of 24-h urine microalbumin - Change of 24-h urine microalbumin - Change of 24-h urine microalbumin - Change of 24-h urine creatinine - Change of 24-h urine creatinine - Change of 24-h urine creatinine - Change of echocardiography parameters (LVEF) - Change of echocardiography parameters (LVEF) - Change of echocardiography parameters (LVEF) - Change of carotid intima-media thickness - Change of carotid intima-media thickness - Change of carotid intima-media thickness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ViSiGi LUX Bariatric Sizing and Calibration System - NCT ID: NCT06282094 - Study ID: LUX - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-03 - Lead Sponsor: Boehringer Labs LLC ### Study Description This study investigates the new ViSiGi LUX. ### Conditions - Bariatric Surgery Candidate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Physician Feedback Secondary Outcomes ### Location - Facility: WellSpan, York, Pennsylvania, 17405, United States @@
## Serum Neurofilament Light in Multiple Sclerosis - NCT ID: NCT06282081 - Study ID: ML 45098 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Dent Neuroscience Research Center ### Study Description This prospective cohort study is designed to characterize the utility of sNfL as a biomarker in clinical practice. This study also aims to understand how access to sNfL measures affects patient and clinician knowledge of their disease status and capture how this may have the potential to influence clinical decision-making. Level of disability, cognitive changes, fatigue, depression, and quality of life to detect clinical and subclinical worsening will be measured. While there is strong evidence in support of sNfL as a potential biomarker, literature regarding the application of sNfL in a real-world clinical practice setting is lacking. Understanding the utility of this test to clinicians and patients as a biomarker of MS disease activity is essential. Additionally, the optimum sampling frequency in clinical practice should be investigated to further elucidate its practicality. Given recent advances in the treatment of MS, there is increasing need for convenient and accessible measures of treatment efficacy. ### Conditions - Multiple Sclerosis - Relapsing Remitting Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Serum Neurofilament Light ### Outcomes Primary Outcomes - Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' understanding of patient's clinical status before sNfL results are received vs. after sNfL results are received - Evaluate the utility of sNfL levels to aid with clinical decision-making by examining clinicians' opinion as to how sNfL results could guide clinical practice - Describe the optimal sNfL sampling frequency by capturing frequency of unscheduled clinician-ordered sNfL measurements. - Describe the optimal sNfL sampling frequency by capturing reason for unscheduled clinician-ordered sNfL measurements. - Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. - Describe the optimal sNfL sampling frequency by capturing usefulness of scheduled and unscheduled sNfL measurements based on a visual analog scale. Secondary Outcomes - Describe patient demographics - Describe patient comorbidities - Describe patient concomitant medications - Describe patient MS medications - Describe patient reasons for MS medication changes - Describe patient MS relapses including date of relapse - Describe patient MS relapses including clinical findings - Describe patient MS relapses including radiologic findings - Describe patient MS relapses including severity - Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patients' perceptions of undergoing sNfL measurements vs. receiving an MRI based on a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patients' understanding of their disease before sNfL results are received vs. after sNfL results are received via a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. - Explore patient attitudes towards sNfL measurements by capturing patient attitudes towards sNfL sampling via a structured questionnaire. - Compare sNfL levels after initiation of a new MS disease-modifying therapy (DMT; when patient is treated with a DMT) vs. prior to MS DMT initiation (when patient is not treated with any DMT) where available. - Compare sNfL levels at scheduled sampling time points between patients initiating any new MS DMT vs. patients who do not change MS DMT where available. - Compare sNfL levels in patients who have a clinical or radiologic relapse during the study vs. patients who do not. - Describe changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. - Describe changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. - Describe changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. - Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. - Describe changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. - Describe changes in sNfL levels with magnetic resonance imaging disease activity where available. - Describe changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. - Compare changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. - Compare changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. - Compare changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. - Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. - Compare changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. - Compare changes in sNfL levels with magnetic resonance imaging disease activity where available. - Compare changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. - Correlate changes in sNfL levels with Expanded Disability Status Scale (EDSS) where available. - Correlate changes in sNfL levels with Symbol Digit Modalities Test (SDMT) where available. - Correlate changes in sNfL levels with Patient Health Questionnaire-9 (PHQ-9) where available. - Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) physical health summary score where available. - Correlate changes in sNfL levels with Multiple Sclerosis Quality of Life - 54 (MSQOL-54) mental health summary score where available. - Correlate changes in sNfL levels with magnetic resonance imaging disease activity where available. - Correlate changes in sNfL levels with changes to multiple sclerosis disease-modifying therapy where available. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## AI Determine Malignancy of GGO on Chest CT - NCT ID: NCT06282068 - Study ID: CS2-23178 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-01 - Completion Date: 2026-02-28 - Lead Sponsor: Chung Shan Medical University ### Study Description Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment.Study Design Collect CT images of untreated lung nodules 4-30mm in size that are scheduled for surgery. No limits on age, gender, disease type, with image resolution \<2.5mm. AI and clinicians will judge nodule characteristics separately. Surgical resection followed by comparison with pathology reports will evaluate diagnostic accuracy.Study Procedures A double-blinded method will be used. AI and physicians will record nodules as likely benign or malignant separately. After surgical resection, the lesions will undergo pathological staging and the diagnostic accuracy of both groups will be compared.Expected Results Compare the diagnostic accuracy of AI and clinicians to improve AI training quality, achieve early diagnosis and treatment goals, and provide patients with better medical care quality.Monitoring Method AI and clinicians will read separately, adhering to shared decision making without affecting patient access to diagnosis and treatment.Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software ### Conditions - Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI computer-aided detection software ### Outcomes Primary Outcomes - The accuricy of the diagnostic power. Secondary Outcomes ### Location - Facility: Chung Shan Medical University Hospital, Taichung, South, 402, Taiwan @@
## Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes - NCT ID: NCT06282055 - Study ID: TIMES - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: DCB Research AG ### Study Description Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Identify different trajectories of insulin sensitivity throughout the menstrual cycle Secondary Outcomes - Total daily Insulin dose throughout the menstrual cycle - Coefficient of glucose variability throughout the menstrual cycle - Estimated insulin sensitivity throughout the menstrual cycle - Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle - Correlations between insulin sensitivity trajectories and confounders ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Transcatheter Mitral Valve Repair After Myocardial Infarction - NCT ID: NCT06282042 - Study ID: EMCAMI - Status: NOT_YET_RECRUITING - Start Date: 2024-06-17 - Completion Date: 2028-06-16 - Lead Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias ### Study Description To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up. ### Conditions - Acute Mitral Regurgitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early transcatheter edge-to-edge mitral valve repair (TEER). - MitraClip - Optimal medical treatment ### Outcomes Primary Outcomes - All-cause death or Cumulative Heart Failure hospitalizations Secondary Outcomes ### Location - Facility: Shaare Zedek Medical Center, Jerusalem, Jerusalen, 9103102, Israel @@
## ACT-group for Stroke Survivors (Pilot Study) - NCT ID: NCT06282029 - Study ID: I-2720-0018-0003 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-05 - Lead Sponsor: Bielefeld University ### Study Description The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:* Is the group therapy feasible?* Is the group therapy accepted by stroke survivors and therapists?* Are there first indications on the efficacy of the group therapy to improve mental health?Participants will take part in 8 weekly group therapy sessions of 90 minutes each. ### Conditions - Stroke - Intracerebral Hemorrhage - Depressive Symptoms - Anxiety - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Group Therapy ### Outcomes Primary Outcomes - Drop-out rate - Session adherence - Homework completion - Completion of outcome measures - Treatment fidelity - Group therapy session questionnaire - patients (Zoubek, 2013; Plain German) - Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German) - Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German) - Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German) Secondary Outcomes - Valuing Questionnaire (Smout, 2014; Plain German) - Self-as-context scale (Zettle, 2018; Plain German) - Patient Health Questionnaire-9 (Kroenke, 2001; Plain German) - Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German) ### Location - Facility: University Neuropsychological Outpatient Clinic, Bielefeld, N/A, 33607, Germany @@
## Risk Factors for Neuroendocrine Neoplasms - NCT ID: NCT06282016 - Study ID: BKR-2024-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: Bavarian Cancer Registry ### Study Description Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors. ### Conditions - Neuroendocrine Neoplasm of Lung - Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Case-control study (no intervention) ### Outcomes Primary Outcomes - Depression/Persistent mood disorder - Obesity - Metabolic syndrome - Previous malignant neoplasm - Alcohol buse - Diabetes - Ulcerative colitis - Crohn disease - Allergic rhinitis - Asthma Secondary Outcomes - Area deprivation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications - NCT ID: NCT06282003 - Study ID: 380-59-10106-21-111/148 - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2024-09-30 - Lead Sponsor: Masa Kontic ### Study Description Anesthetic effects, surgery, and invasive mechanical intubation can impair respiratory function during general anesthesia. The risk factors for postoperative pulmonary complications (PPCs) include the type of surgery and duration, ventilation-perfusion discrepancy, and the presence of pain. Mitigating PPCs under anesthesia is a goal, but effective strategies are yet to be defined. Conventional ventilation (CV) procedure uses more inspired oxygen during pre-oxygenation and anesthesia maintenance. The protective lung ventilation (PV) procedure, on the other hand, includes high positive end-expiratory pressure, lung recruitment maneuver, oxygen saturation levels above 94%, lower inspired oxygen levels, and continuous positive airway pressure before the tube is removed. In this study, 56 consecutive patients undergoing abdominal surgery were randomly assigned, with 30 in the CV and 23 in the PV group, while 3 were lost during the follow-up. We concluded that the implementation of protective lung ventilation strategies has the potential to reduce the occurrence of PPCs, recommending these strategies be adopted as the standard practice in general anesthesia. ### Conditions - Well-Being, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - The procedure of protective lung ventilation ### Outcomes Primary Outcomes - Oxygentation Secondary Outcomes ### Location - Facility: General hospital Zabok, Zabok, N/A, 49210, Croatia @@
## Education and Information for Bariatric Surgery Patients - NCT ID: NCT06281990 - Study ID: BAUN-SBF-PO-01 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2024-01-05 - Lead Sponsor: Balikesir University ### Study Description The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs. ### Conditions - Bariatric Surgeries - Education of Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Education ### Outcomes Primary Outcomes - Data collection form - Visual Analog Scale (VAS) - State-Trait Anxiety Inventory (STAI) Secondary Outcomes ### Location - Facility: Pınar Ongün, Balıkesir, N/A, 38000, Turkey @@
## Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm - NCT ID: NCT06281977 - Study ID: ES613 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-07-01 - Lead Sponsor: Ottawa Heart Institute Research Corporation ### Study Description The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit. ### Conditions - Ventricular Tachycardia - Ventricular Arrhythmias - Ventricular Fibrillation - Recurrent Ventricular Tachycardia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Normal saline ### Outcomes Primary Outcomes - The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation. Secondary Outcomes - All-cause in-hospital death - Ventricular arrhythmia requiring treatment after study drug initiation - Resuscitated cardiac arrest after study drug initiation - Renal failure requiring new initiation of renal replacement therapy after study drug initiation - Intubation following study drug initiation - Length of stay in the intensive care unit - Length of stay in hospital - Need for mechanical circulatory support device after study drug initiation - Ventricular Arrhythmia requiring treatment only during active study drug treatment - Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. - NCT ID: NCT06281964 - Study ID: PLB1004-III-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-12-30 - Lead Sponsor: Avistone Biotechnology Co., Ltd. ### Study Description Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion. ### Conditions - Non-Small-Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PLB1004 - Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) by BICR Secondary Outcomes - Progression-Free Survival (PFS) by the investigator - Intracranial Overall Response Rate（ORR） - Duration of Response (DOR) - Disease Control Rate (DCR) - Overall Survival (OS) - Incidence of Treatment-Emergent Adverse Events (TEAEs) - Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nebulized Fentanyl in Healthy Volunteers - NCT ID: NCT06281951 - Study ID: 2022/0271/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-09-01 - Lead Sponsor: University Hospital, Rouen ### Study Description Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study ### Conditions - Analgesia - Emergencies ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Fentanyl - Inhalation by facial nebulization - Fentanyl - Nebulisation ### Outcomes Primary Outcomes - Measurement of [F] bioavailability via facial nebulization and intranasal inhalation. Secondary Outcomes - Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation. - Measurement of the difference between observed and predicted PUAL values by a PK/PD model. - Time required to achieve >30% decrease in PUAL compared to baseline. - Measurement of dose required to achieve >30% decrease in PUAL compared to baseline. - Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless). ### Location - Facility: University Hospital, Rouen, Rouen, N/A, 76031, France @@
## Machine Learning and 3D Image-based Modeling for Body Weight Estimation. - NCT ID: NCT06281938 - Study ID: 1617209 - Status: NOT_YET_RECRUITING - Start Date: 2026-06 - Completion Date: 2027-09 - Lead Sponsor: Florida Atlantic University ### Study Description The goal of this randomized controlled clinical trial is to \[learn about, test, compare etc.\] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question\[s\] it aims to answer are:* Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?* Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group. ### Conditions - No Specific Conditions - Weight, Body - Drug Dose - Weight-Estimation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Weight estimation using 3D camera - Standard care weight estimation ### Outcomes Primary Outcomes - Weight estimation accuracy - Time to obtain weight estimate - Drug dosing accuracy - Correct dosing scalar used Secondary Outcomes - Accuracy of in-bed scales ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cryotherapy & Oxaliplatin - NCT ID: NCT06281925 - Study ID: 22-01363 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12-31 - Lead Sponsor: NYU Langone Health ### Study Description The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy. ### Conditions - Colon Cancer - Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryotherapy Gloves ### Outcomes Primary Outcomes - Proportion of Participants with Peripheral Neuropathy at Visit 2 - Proportion of Participants with Peripheral Neuropathy at Visit 3 - Proportion of Participants with Peripheral Neuropathy at Visit 4 - Proportion of Participants with Peripheral Neuropathy at Visit 5 Secondary Outcomes ### Location - Facility: NYU Langone Health, Mineola, New York, 11501, United States @@
## Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients - NCT ID: NCT06281912 - Study ID: 4504/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-11 - Lead Sponsor: Azienda Ospedaliera di Perugia ### Study Description This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease ### Conditions - Early Melanoma - Advanced Melanoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - rate of objective response Secondary Outcomes - adverse event incidence ### Location - Facility: Aix-Marseille Universite, Marseille, N/A, N/A, France @@
## Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus - NCT ID: NCT06281899 - Study ID: 01/2022 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-03-31 - Lead Sponsor: Anemia Working Group Romania ### Study Description This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus ### Conditions - Chronic Kidney Diseases - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10 mg Tab - Low protein diet ### Outcomes Primary Outcomes - Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death Secondary Outcomes - Rate of decline in the estimated Glomerular Filtration Rate - Variation of albuminuria - Variation of HbA1C - Variation of serum cholesterol levels - Variation of serum bicarbonate levels - Variation of serum potassium levels - Variation of serum sodium levels - Variation of hemoglobin levels - Variation of hematocrit levels - All cause hospitalizations - Variation in body weight - Variation in BMI - Variation in handgrip strength - Variation in serum albumin levels - Variation in CRP levels - Changes in the quality of life ### Location - Facility: Carol Davila University of Medicine and Pharmacy Bucharest, Bucharest, N/A, N/A, Romania @@
## Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma - NCT ID: NCT06281886 - Study ID: GASTO-10107 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-12-01 - Lead Sponsor: Sun Yat-sen University ### Study Description This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma ### Conditions - Esophageal Squamous Cell Carcinoma - Efficacy - Toxicity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Induction Immunotherapy-Toripalimab - Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin - Radiotherapy - Apatinib - Capecitabine ### Outcomes Primary Outcomes - Progression free survival rate Secondary Outcomes - Overall survival - Objective response rate - Local-regional progression-free survival - Incidence of Treatment-related Adverse Events - Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer) - Distant metastasis-free survival ### Location - Facility: Sun yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy - NCT ID: NCT06281873 - Study ID: 0645 - Status: COMPLETED - Start Date: 2023-03-27 - Completion Date: 2024-02-07 - Lead Sponsor: Alexandria University ### Study Description the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis. ### Conditions - Oroantral Fistula ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - closure by PRF membrane ### Outcomes Primary Outcomes - Evaluation of the soft tissue wound's healing Secondary Outcomes - Secondary radiographic outcomes, assessment of bone formation ### Location - Facility: Faculty of Dentistry, Alexandria, N/A, 562589, Egypt @@
## Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration - NCT ID: NCT06281860 - Study ID: PITHAC - Status: RECRUITING - Start Date: 2023-11-24 - Completion Date: 2026-02-01 - Lead Sponsor: Dr Jean Yannis PERENTES ### Study Description Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD). ### Conditions - Mesothelioma, Malignant - Carcinoma, Non-Small-Cell Lung - Carcinoma Breast Stage IV - Ovarian Cancer - Esophageal Cancer - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Cisplatine Teva® ### Outcomes Primary Outcomes - Dose Escalation and Maximum Tolerated Dose determination (Part A): - Expansion phase (Part B): Secondary Outcomes - Dose Escalation and MTD determination (Part A): - Expansion phase (Part B): ### Location - Facility: Centre Hospitalier Universitaire Vaudois, Lausanne, N/A, N/A, Switzerland @@
## An Adaptive Open-label Multicentre Phase 1/2 Trial, to Determine the Recommended Phase 2 Dose of CCTx-001, and to Assess Safety, Tolerability, and Clinical Activity in Patients With Relapsed/Refractory Acute Myeloid Leukaemia - NCT ID: NCT06281847 - Study ID: CCTx-001-AML-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2041-08 - Lead Sponsor: Advesya SAS ### Study Description The purpose of this adaptive Phase 1/2 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antileukemic activity of CCTx-001 in adult patients with r/r Acute Myeloid Leukemia (AML). CCTx-001 targets IL-1RAP, which is specifically expressed in leukemic cells. In preclinical studies, IL-1RAP-targeted Chimeric antigen receptors (CARs) have demonstrated encouraging activity in both in vitro and in vivo experiments in AML models. Based on these promising preclinical results, it is expected that CCTx-001 could potentially alter the natural course of r/r AML and provide a potential novel treatment option. ### Conditions - Acute Myeloid Leukemia, in Relapse - Acute Myeloid Leukemia Refractory ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CCTx-001 ### Outcomes Primary Outcomes - Phase 1: To evaluate the safety, tolerability, and to define the recommended phase 2 dose (RP2D) of CCTx-001 - Phase 2: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 Secondary Outcomes - Phase 2: To evaluate the clinical activity, as assessed by the complete remission rate, in patients treated with CCTx-001 - Phase 1: To evaluate the clinical activity, as assessed by the composite complete response rate, in patients treated with CCTx-001 - Phase 2: To assess the safety of CCTx-001 - Phase 2: To assess HRQoL for patients treated with CCTx-001 - Phase 2: To assess HRQoL for patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To assess additional parameters of clinical activity in patients treated with CCTx-001 - Phase 1 & 2: To evaluate the overall safety and the tolerability of CCTx-001 ### Location - Facility: Besançon Regional and University Hospital, Besançon Cedex, N/A, N/A, France @@
## Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention - NCT ID: NCT06281834 - Study ID: 2024P000306 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-06 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population. ### Conditions - Pediatric HIV Infection - Latent Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rifapentine - Dolutegravir ### Outcomes Primary Outcomes - Dolutegravir AUC during weekly rifapentine/isoniazid Secondary Outcomes - Rifapentine AUC - Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study - NCT ID: NCT06281821 - Study ID: 4947 [Study 2] - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2024-12-01 - Lead Sponsor: Boston University Charles River Campus ### Study Description Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention. ### Conditions - Alcohol Drinking - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mhealth-pc ### Outcomes Primary Outcomes - Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale - Time Line Follow-Back-30 Day Weekly Drinking Secondary Outcomes - Time Line Follow-Back 30-Day Heavy Episodic Drinking - Perceptions of Treatment Questionnaire - Systems Usability Scale ### Location - Facility: Boston University, Boston, Massachusetts, 02215, United States @@
## Photon Counting Detector CT Image Quality - NCT ID: NCT06281808 - Study ID: R490 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2026-12-31 - Lead Sponsor: Reto Sutter, MD ### Study Description This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard. ### Conditions - Diagnostic Imaging - Tomography, X Ray Computed ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Photon Counting Detector CT ### Outcomes Primary Outcomes - Image Quality PCD CT - Diagnostic Accuracy PCD CT Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neuromodulation of the Autonomic Nervous System in Athletes - NCT ID: NCT06281795 - Study ID: 1.24. - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-31 - Lead Sponsor: Bakulev Scientific Center of Cardiovascular Surgery ### Study Description There are few studies in the literature that have evaluated the effects of using percutaneous stimulation of the auricular branch of the vagus nerve for sports purposes (to accelerate recovery after physical exertion). It has been demonstrated that tVNS in athletes improved the rate of heart rate recovery, reduced lactic acid levels in blood plasma, reduced pain, reduced overtraining syndrome and fatigue levels. ### Conditions - Efficacy, Self - Fatigue; Muscle, Heart - Fatigue, Mental - Fatigue; Combat ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tVNS ### Outcomes Primary Outcomes - Dynamics of maximum oxygen consumption (VO2max). - The dynamics of the treadmill speed at the level of the anaerobic threshold of metabolism. Secondary Outcomes - Dynamics of the treadmill speed at the level of the aerobic metabolism threshold of metabolism. - The dynamics of the heart rate (HR) at the level of the anaerobic threshold of metabolism. - The dynamics of the heart rate (HR) at the level of the aerobic threshold of metabolism. - The dynamics of RMSSD. - HF dynamics - Dynamics of the LF/HF ratio. ### Location - Facility: Autonomous Non-Profit organization of additional education sports school BECOME A CHAMPION, Krasnodar, N/A, N/A, Russian Federation @@
## Platelet-rich Plasma With Topical Retinoids Versus Topical Retinoids Alone in Acne Vulgaris - NCT ID: NCT06281782 - Study ID: PRP with topical retinoids - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-05 - Lead Sponsor: Assiut University ### Study Description Acne vulgaris is the most common skin disease in adolescents and young adults. Adult or post-adolescent acne occurs in 12-14% of this population.It is a chronic, inflammatory disease of the pilosebaceous unit .The clinical features of acne include seborrhoea, non-inflammatory lesions (open and closed comedones), inflammatory lesions (papules and pustules), and various degrees of scarring.Platelet-rich plasma (PRP) is prepared by simple centrifugation of whole blood to concentrate platelets and simultaneously remove red blood cells. The resultant supernatant is the PRP that contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), and hepatocyte growth factor (HGF).These growth factors are involved in the healing of soft tissue and can regulate cellular processes such as chemotaxis, angiogenesis, mitogenesis, differentiation, and metabolism .Topical retinoids are used in the treatment of both noninflammatory and inflammatory acne.Food and Drug Administration (FDA) approved three topical retinoids: adapalene, tazarotene, and tretinoin. These agents help normalize follicular keratinization and decrease keratinocyte cohesiveness, thereby reducing follicular occlusion and comedon formation .Topical retinoids also compete with factors involved in the acne inflammation response, enhance penetration of other topical acne medications, and accelerate the resolution of acne-induced post-inflammatory hyperpigmentation.Updates from the Global Alliance on Improving Outcomes in Acne consider topical retinoids as first-line therapy, individually or in combination with benzoyl peroxide. However, the common side effects of skin irritation and discomfort may impede adherence to long-term therapy.For patients with acne, combination therapy with a topical retinoid and platelet-rich plasma (PRP) has not yet been tested.PRP with topical retinoids will be evaluated and campared with topical retinoids alone in acne tretment. ### Conditions - Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - topical retinoids and platalet rich plasma ### Outcomes Primary Outcomes - change of acne lasions Secondary Outcomes ### Location - Facility: Faculty of Medicine, Assiut, N/A, N/A, Egypt @@
## Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision - NCT ID: NCT06281769 - Study ID: NL82101.000.22 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2025-01-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway). ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision - MRI targeted biopsy pathway ### Outcomes Primary Outcomes - Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI. Secondary Outcomes - Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway. - Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway). - Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway. - Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI. ### Location - Facility: Amsterdam UMC - location VUmc, Amsterdam, N/A, N/A, Netherlands @@
## Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia - NCT ID: NCT06281756 - Study ID: STUDY00022285 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2028-02 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems. ### Conditions - Insomnia - Insomnia Chronic - Insomnia, Primary - Blood Pressure - Blood Pressure, High ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Treatment for Insomnia (CBT-I) - Trazodone - Placebo ### Outcomes Primary Outcomes - Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) - Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) - Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment Secondary Outcomes - Insomnia Severity Index (ISI) Score following CBT-I - Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) - Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) - Evening Cortisol levels following CBT-I - Insomnia Severity Index (ISI) Score following RCT - PSG Total Sleep Time (TST) following RCT - Actigraphy Total Sleep Time (TST) following RCT - Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) - Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) - Evening Cortisol levels following RCT - Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment ### Location - Facility: National Jewish Health, Denver, Colorado, 80206-2761, United States @@
## Attitudes to Decisions to Withdraw or Withhold Life-sustaining Treatments in Critically Ill Children - NCT ID: NCT06281743 - Study ID: LST-Ped Survey - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Göteborg University ### Study Description The aim of this study is to investigate attitudes on decisions to withdraw or withhold life-sustaining treatments in critically ill children in Swedish intensive care units. This is a survey among pediatric critical care physicians. ### Conditions - Pediatric Disorder - Critical Illness - Ethics, Narrative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Attitudes and experiences -questionnaire Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of New Generation Fetoscopes in Pregnancies Affected by Fetal Diseases Amenable to Fetoscopy Therapy - NCT ID: NCT06281730 - Study ID: 23-009197 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2044-02 - Lead Sponsor: Mayo Clinic ### Study Description The Researchers are trying to determine feasibility and safety of performing surgery in the womb with the Karl Storz fetoscopes (a tool used to access the baby in the body of the mother). This are new and improved fetoscopes that are not yet approved by the FDA. ### Conditions - In Utero Procedure Affecting Fetus or Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Karl Storz New Generation Fetoscope - curved 11508AAK - Karl Storz New Generation Fetoscope - straight 11506AAK ### Outcomes Primary Outcomes - Adverse events - Serious Adverse Events - Device malfunctions Secondary Outcomes - Mean gestational age at delivery - Successful Completion - Satisfaction scores - Live births - Neonatal deaths ### Location - Facility: Mayo Clinic Minnesota, Rochester, Minnesota, 55905, United States @@
## A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia - NCT ID: NCT06281717 - Study ID: IRB-P00045047 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-08-30 - Lead Sponsor: Alireza Shamshirsaz ### Study Description The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age. ### Conditions - Congenital Diaphragmatic Hernia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fetal Endotracheal Occlusion (FETO) ### Outcomes Primary Outcomes - Successful Ballon Placement - Successful Balloon Removal - Balloon placement operative time - Balloon removal operative time - Type of FETO release - Maternal Complications - Gestational age at delivery Secondary Outcomes - Fetal lung volume - O/E LHR - Infant survival - Oxygen dependency - Number of infants requiring ECMO - NICU stay - Ventilator support - Presence of periventricular leukomalacia - Presence of neonatal sepsis - Presence of intraventricular hemorrhage - Retinopathy of prematurity - Presence of gastro-esophageal reflux - CDH repair type - Pulmonary function - Infant Neurodevelopment - Route of delivery - Maternal hospitalization ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02115, United States @@
## A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis - NCT ID: NCT06281704 - Study ID: AK101-102 - Status: COMPLETED - Start Date: 2020-11-26 - Completion Date: 2022-12-31 - Lead Sponsor: Akeso ### Study Description This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis. ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK101 IV - AK101 SC - Placebo - AK101 IV/AK101 SC ### Outcomes Primary Outcomes - Adverse Events - Adverse Events - Elimination half-life (T1/2) of AK101 - Mean residence time (MRT) of AK101 - Area under curve (AUC) of AK101 - Apparent distribution volume (VD/F) of AK101 - Systemic clearance (CL/F) of AK101 - Maximum (peak) plasma concentration (Cmax) of AK101 - Time to maximum plasma concentration (Tmax) of AK101 Secondary Outcomes - Proportion of subjects with clinical response at Week8(per Adapted Mayo Score without physician's global assessment). - Proportion of subjects with clinical response at Week8(per the Mayo score). - Immunogenicity index ### Location - Facility: The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, 233099, China @@
## GreenBladder - Early Detection of Bladder Cancer in Residents in Greenland Using a Urinary Marker and a Mobile Cystoscopy Unit - NCT ID: NCT06281691 - Study ID: GreenBladder - Status: ENROLLING_BY_INVITATION - Start Date: 2023-04-28 - Completion Date: 2025-11-30 - Lead Sponsor: Jørgen Bjerggaard Jensen ### Study Description The goal of this observational study is to evaluate whether a urinary biomarker (Xpert® Bladder Cancer Detection Test) can be used as a selection tool to decide which patients that should undergo cystoscopy in haematuria work-up or in other indications where bladder tumor is suspected. Hereby, the investigators will investigate in which patients where cystoscopy can be omitted, particularly in areas with limited access to urological service. With these more selected investigations, patients with bladder tumors will potentially be selected to earlier diagnosis compared to the current non-selected investigations with the inherent logistic and economical challenges. With this strategy, the investigators aim at improving the current poor prognosis for bladder cancer patients in Greenland. ### Conditions - Urinary Bladder Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Xpert® Bladder Cancer Detection Test ### Outcomes Primary Outcomes - Accuracy of urinary marker (Xpert Bladder Cancer Detection Test) in patients undergoing cystoscopy for bladder cancer investigation Secondary Outcomes ### Location - Facility: Department of Urology, Aarhus University Hopsital, Aarhus, N/A, 8000, Denmark @@
## A Study of IBI363 in Subjects With Advanced Solid Malignancies - NCT ID: NCT06281678 - Study ID: CIBI363A202 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd. ### Study Description This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies. ### Conditions - Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IBI363 ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Adverse Event （AE） - Dose-limiting Toxicity （DLT） ### Location - Facility: University of Kansas Medcial Center Research Institute, Fairway, Kansas, 66205, United States @@
## Treatment With Aspirin After Preeclampsia: TAP Trial - NCT ID: NCT06281665 - Study ID: STUDY23080099 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-01 - Lead Sponsor: Alisse Hauspurg ### Study Description The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital. ### Conditions - Hypertensive Disorder of Pregnancy - Pre-Eclampsia - Hypertension - Eclampsia - Gestational Hypertension - Cardiovascular Diseases - Toxemia - Pregnancy Complications - Vascular Diseases - Hypertension, Pregnancy Induced - Hypertension;Pre-Eclamptic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Low-dose aspirin - Placebo ### Outcomes Primary Outcomes - Percent of participants eligible, enrolled and retained (feasibility) Secondary Outcomes - Study visit systolic BP - Study visit diastolic BP - Study visit systolic BP - Study visit diastolic BP - Study visit mean arterial pressure - Study visit mean arterial pressure - Anti-hypertensive medication use - Anti-hypertensive medication use - Therapeutic intensity score - Therapeutic intensity score - Mean home systolic blood pressure - Mean home diastolic blood pressure - Mean home mean arterial pressure - Mean daytime systolic blood pressure - Mean nocturnal systolic blood pressure - Mean daytime diastolic blood pressure - Mean nocturnal diastolic blood pressure - Mean nocturnal mean arterial pressure - Mean daytime mean arterial pressure - Mean overall mean arterial pressure - Mean overall systolic blood pressure - Mean overall diastolic blood pressure - Classification of hypertension - Classification of hypertension - Endothelial function EC50% - Endothelial function EC50% - Endothelial function Emax - Endothelial function Emax - Endothelial function change in Emax - Endothelial function change in EC50% - Change in systolic blood pressure - Change in diastolic blood pressure - Change in mean arterial pressure ### Location - Facility: University of Pittsburgh Magee-Womens Hospital, Pittsburgh, Pennsylvania, 15213, United States @@
## Cognitive Intervention With Go and Chess in Early and Subjective Cognitive Decline - NCT ID: NCT06281652 - Study ID: Cognichess - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-02-13 - Lead Sponsor: University of Milano Bicocca ### Study Description The goal of this clinical trial\]is to evaluate if learning to play traditional board games could improve cognition in subjects with mild cognitive impairment and subjective cognitive decline. The main questions it aims to answer are:* Do Go and Chess improve cognition?* Is a game better than the other? Is the effect of both games on cognition synergistic?* Do Go and Chess improve quality of life?* Do Go and Chess improve mood?* Do Go and Chess improve lifestyle?Participants will be randomized to one of four groups:* Group intervention with Go, once a week, for 12 weeks* Group intervention with Chess, once a week, for 12 weeks* Group intervention with Go and Chess, twice a week, for 12 weeks* Control group ### Conditions - Mild Cognitive Impairment - Subjective Cognitive Decline ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Go classes - Chess classes ### Outcomes Primary Outcomes - General cognition Secondary Outcomes - Digit Span Forward - Digit Span Backwards - Trail Making Test - part A - Trail Making Test - part B - Semantic fluency - Quality of life indicator - Depression - Lifestyle ### Location - Facility: Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, 20900, Italy @@
## RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging - NCT ID: NCT06281639 - Study ID: RAPID - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: University of Minnesota ### Study Description The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box. ### Conditions - Congenital Heart Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - RAPID ### Outcomes Primary Outcomes - RAPID imaging quality Secondary Outcomes ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25 - NCT ID: NCT06281626 - Study ID: 2024_RIPH_01_Preservatif - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Université de Reims Champagne-Ardenne ### Study Description For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022). ### Conditions - Comdom ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection ### Outcomes Primary Outcomes - use of free male condoms Secondary Outcomes ### Location - Facility: Ufr Medecine Urca, Reims, N/A, 51100, France @@
## Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients - NCT ID: NCT06281613 - Study ID: 2024-AMCOPTEO - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2024-04-05 - Lead Sponsor: University of Pavia ### Study Description The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1). ### Conditions - Skeletal Malocclusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AMCOP group - High-pull headgear ### Outcomes Primary Outcomes - Change in cephalometric angular measurements - Linear regressions - Change in cephalometric linear measurements Secondary Outcomes ### Location - Facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## An Intervention Study Using HMOs to Improve IBS Symptoms - NCT ID: NCT06281600 - Study ID: REC: 23/SW/0042 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-09-20 - Lead Sponsor: Glenn Gibson ### Study Description There is now strong evidence implicating the human gut microbiota in many gastrointestinal diseases, including irritable bowel syndrome (IBS). Importantly, this enteric population is susceptible to dietary intervention and represents an exciting target for the prevention and treatment of gut mediated disorders. This study will investigate microbial components and activities associated with the gut microbiome, using a global systems biology approach to explore the capacity of a human milk carbohydrate intervention in modulating this microbial community to target IBS, with the primary objective of improving IBS symptoms.IBS is a highly prevalent gastrointestinal (GI) disorder with significant negative impact on quality of life of patients and high healthcare costs. Although prognosis of IBS is benign, it is a disorder that poses a considerable burden on the individual sufferer and society. Patients typically present with chronic abdominal pain and an altered bowel habit, frequently accompanied by bloating and distension. Often, IBS will afflict sufferers for life, with flares of activity followed by periods of remission. Incidence commonly peaks in the third and fourth decades of life.IBS is suggested to be a disorder of gut-brain interaction, and alterations of the microbiota-host interactions at the mucosal border may cause symptoms such as those previously mentioned. Therefore, microbiota-targeted interventions may benefit some people with IBS by beneficially modulating the gut microbiome. Several studies have confirmed that prebiotics, such as galactooligosaccharides (GOS), are able to successfully stimulate gut bifidobacteria and alleviate symptoms in IBS. Prebiotics are defined as "a substrate that is selectively utilised by host microorganisms conferring a health benefit" \[8\]. These studies suggest that prebiotics may have potential as therapeutic agents in IBS.Breastmilk is known to play a crucial role in the development of infants, providing key nutrients and immunological compounds important for initial protection against pathogens \[9\]. Among these compounds, human milk oligosaccharides (HMOs) represent the third most important component of breastmilk after lipids and lactose. HMOs have also been investigated for potential health benefits in adults, including their potential role as prebiotics for improved gut microbiota modulation.Studies looking specifically at HMO interventions in humans with IBS are sparse. These include a phase II, parallel, RCT in 58 IBS volunteers by Iribarren et al. and an open-label trial with 245 IBS participants from 17 sites across USA by Palsson et al.. None have been sufficiently powered to a degree which could influence clinical practice, but crucially tolerability and safety profiles of HMOs investigated, to date, have been consistently high.Using the global systems biology approach not yet applied to this research question, a pre-competitive approach to selecting a candidate HMO, and a crossover feasibility trial design, the investigators hope to forge a new direction in establishing the merits of HMO use in IBS.This study will look specifically at patients with all IBS subtypes, an area where there is a real therapeutic gap and clinical need for safe, effective therapy to improve quality of life. Participants will be randomly allocated to be given either the HMO or a placebo, with neither the patient nor the researchers knowing which they are receiving (randomised and double blind design). They will take this HMO or placebo for 28 days (randomly distributed), and then stop taking it in a 'washout' period of 28 days, allowing the gut microbiota to return to baseline. Then, the participants will take the other intervention (placebo or prebiotic, whichever they did not take in the first half of the study) for 28 days, then have a further washout period of 14 days. The study will then be over.With this proposal, the aim is to explore how HMOs affect the gut microbiota and whether they can do so in a manner that positively influences patients with IBS. The investigators also hope to develop molecular profiling as part of a research toolkit for gut microbiome-based HMO supplement studies. ### Conditions - Irritable Bowel Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Human milk oligosaccharide - Maltodextrin placebo ### Outcomes Primary Outcomes - IBS-SSS Secondary Outcomes - Change in anxiety and depression scores (ADS) - Improvement of the Pittsburgh Sleep Quality Index (PSQI). - Changes in faecal microbiota e.g. Bifidobacterium ### Location - Facility: The University of Reading, Reading, Berkshire, RG6 6LA, United Kingdom @@
## Pathogenetic Risk Factors for Corneal Graft Rejection - NCT ID: NCT06281587 - Study ID: SNFyodorov - Status: COMPLETED - Start Date: 2011-01 - Completion Date: 2019-01 - Lead Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution ### Study Description There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection.Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity. ### Conditions - Graft Rejection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - penetrating keratoplasty ### Outcomes Primary Outcomes - Cohort group Kaplan-Meier survival analysis (clear graft engraftment) Secondary Outcomes ### Location - Facility: N/A, Krasnodar, N/A, 350012, Russian Federation @@
## What Are the Determinants for RTW After SA - NCT ID: NCT06281574 - Study ID: S67346 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-13 - Completion Date: 2025-02-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Shoulder arthroplasty is becoming increasingly common, due to ageing of the population. Historically, surgeons have been reluctant to use a shoulder replacement in younger patients. During the last decades however, there was an improvement of surgical techniques and implants which resulted in the fact that these procedures are nowadays more frequently used in younger patients. Combined with the increasing life expectancy and the increased age of retirement, both elderly and younger patients hope to continue their jobs after prosthetic replacement.Recent literature shows that the majority patients is able to resume their work following shoulder arthroplasty.This study aims to analyze the RTW percentage in a Belgian cohort of patients with a shoulder replacement. This study hopes to identify factors that might influence the RTW. ### Conditions - Shoulder Arthroplasty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires ### Outcomes Primary Outcomes - Return to work Secondary Outcomes - Type of shoulder arthroplasty - WORQ-UP (work-related questionnaire for upper extremity disorders) - SSV (Subjective Shoulder Value) - SST (Dutch translation of the Simple Shoulder Test) - OSS (Oxford Shoulder Score) - Self-made questionnaire - Belgisch Kenniscentrum over welzijn op het werk (BeSWIC) ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance - NCT ID: NCT06281561 - Study ID: FirstAHXiamenU-YB - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance.Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery.Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality. ### Conditions - Postoperative Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Normal Saline - Dexmedetomidine ### Outcomes Primary Outcomes - Change from baseline sleep quality at after intervention - Pittsburgh sleep quality index(PSQI) Secondary Outcomes - Early recovery evaluated by Aldrete rating scale - Later Recovery evaluated by QoR-40 questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs - NCT ID: NCT06281548 - Study ID: 23-2937 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-04-30 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement. ### Conditions - Stigma, Social - Substance Use ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - RESTART ### Outcomes Primary Outcomes - Change in Stigma Resistance Scale (SRS) Score - Change in Substance Abuse Self-Stigma Scale (SASSS) Score - Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment) - Percentage of Prospective Participants Recruited into Study (Feasibility - Enrollment) - Time to Sample Saturation (Feasibility - Recruitment) - Percentage of Participants Retained in Study (Feasibility - Retention) - Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User) - Percentage of Participants with High Text Message Frequency (Feasibility - User) - Percentage of Participants with High Text Messaging Comfort (Feasibility - User) - Percentage of Participants with Cell Phone Device Challenges (Feasibility - User) - Percentage of Participants with Cell Phone Plan Challenges (Feasibility - User) - Percentage of Participants who Read Messages Daily (Feasibility - User) Secondary Outcomes - Change in Adult Dispositional Hope Scale Score - Change in Rosenberg Self-Esteem Scale Score ### Location - Facility: SHRPS Syringe Service Program, Portsmouth, Ohio, 45662, United States @@
## Early Versus Conventional Loading for Fully Guided Immediate Implant Placement - NCT ID: NCT06281535 - Study ID: 21789 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-06-15 - Lead Sponsor: Ain Shams University ### Study Description Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate. ### Conditions - Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Implant loading ### Outcomes Primary Outcomes - Implant stability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Importance of Inflammatory Markers Calculated From Preoperative and Postoperative Peripheral Blood Results in the Diagnosis and Treatment of Patients Operated for Hydatid Cyst of the Lung (Lung Echinococcus Granulosus) - NCT ID: NCT06281522 - Study ID: University of Health Sciences - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2024-06-30 - Lead Sponsor: Abdullah Adiyaman ### Study Description This study aims to investigate the role of these laboratory findings in the differential diagnosis and management of pulmonary hydatid cyst (PHC) by examining the number of euzonophils, neutrophils, lymphocytes, platelets and neutrophil/lymphocyte ratio, platelet/lymphocyte ratio and systemic immune inflammatory index values in the peripheral blood of patients diagnosed with pulmonary hydatid cyst (PHC) in the preoperative period and post-operative 3rd month. Although we have extensive data on hydatid liver cysts, there is limited information in the literature on the laboratory values of patients with PHC. This study aims to provide more scientific basis for the diagnosis and management of PHC and is considered as an inexpensive, reproducible and easily calculable method to improve the accurate diagnosis and management of AKH in clinical practice. ### Conditions - Lung Hydatid Cyst ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Operated patients with hydatid cyst of the lung ### Outcomes Primary Outcomes - Calculation of laboratory markers Secondary Outcomes ### Location - Facility: University of Health Sciences, Van Training and Research Hospital, Van, N/A, N/A, Turkey @@
## Palmaris Longus Muscle and Dupuytren - NCT ID: NCT06281509 - Study ID: S68374 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-02-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Dupuytren disease is a medical condition characterized by the painless formation of nodules in the palm of the hand. Cords are formed on the palmar fascia, a connective tissue sheet in the palm of the hand. This fascia is seen as the vestigial remnant of the palmaris longus tendon. The PLM attaches to the fascia palmaris. A muscle that not everyone has and can therefore be clearly missed. This raises the question of whether the presence of the musculus palmaris longus has any association with the development, recurrence and/or progression of DD and contractures. To investigate a potential predisposition, this study intend to assess the prevalence of the PLM in a group of individuals affected by DD and compare it with a control group (age matched, no signs of DD) without the condition. ### Conditions - Dupuytren's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Non-invasive tests to determine the presence or absence of the palmaris longus tendon in both hands. - Ultrasound ### Outcomes Primary Outcomes - PLM in the DD versus control - PML in mild versus severe DD-group Secondary Outcomes - PLM presence in DD affected group - PLM presence in control group - Dominant versus non-dominant hand - Male versus female population ### Location - Facility: Universitaire Ziekenhuizen KU Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation - NCT ID: NCT06281496 - Study ID: Rigshospitalet, Hematology - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase. ### Conditions - Hematological Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - AlloCare ### Outcomes Primary Outcomes - EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) Secondary Outcomes - Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## PRP Versus PRF Versus Conventional Treatment in Chronic Non-healing Skin Ulcers - NCT ID: NCT06281483 - Study ID: APCs in chronic skin ulcers - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01 - Lead Sponsor: Kafrelsheikh University ### Study Description To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment. ### Conditions - Chronic Non-healing Skin Ulcers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - platelet-rich plasma - platelet-rich fibrin - Surgical debridement, normal saline washing and dressing coverage ### Outcomes Primary Outcomes - Objective assessment of ulcer size for effectiveness, using Image J software. - Pain assessment - Any adverse effects related to treatment modality Secondary Outcomes ### Location - Facility: Badr Hospital - Helwan University and Kafrelseikh University Hospital, Cairo, N/A, N/A, Egypt @@
## The Safety and Tolerability of WS016 in Healthy Chinese Volunteers - NCT ID: NCT06281470 - Study ID: WS016-Ⅰ-01 - Status: COMPLETED - Start Date: 2023-02-13 - Completion Date: 2023-06-15 - Lead Sponsor: Waterstone Pharmaceutical (Wuhan) Co., LTD. ### Study Description This clinic trial evaluates the safety and tolerability of single- and multiple- ascending doses of WS016 in healthy adult participants. There will be about 64 participants,48 active and 16 placebo. ### Conditions - Hyperkalemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - WS016 Single Dose(6g) - WS016 Single Dose(12g) - WS016 Single Dose(24g) - WS016 Single Dose(36g) - WS016 Single Dose(48g) - SAD matching placebo - WS016 Multiple Dose(12g) - WS016 Multiple Dose(24g) - WS016 Multiple Dose(48g) - MAD matching placebo ### Outcomes Primary Outcomes - Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single- and multiple- ascending dose Secondary Outcomes ### Location - Facility: Zhejiang Xiaoshan Hospital, Hangzhou, Zhejiang, 310000, China @@
## Probing the Role of Feature Dimension Maps in Visual Cognition: Impact of Task Demands (Expt 2.1) - NCT ID: NCT06281457 - Study ID: 5-24-0030: 2.1 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: University of California, Santa Barbara ### Study Description How does one know what to look at in a scene? Imagine a "Where's Waldo" game - it's challenging to find Waldo because there are many 'salient' locations in the picture, each vying for one's attention. One can only attend to a small location on the picture at a given moment, so to find Waldo, one needs to direct their attention to different locations. One prominent theory about how one accomplishes this claims that important locations are identified based on distinct feature types (for example, motion or color), with locations most unique compared to the background most likely to be attended. An important component of this theory is that individual feature dimensions (again, color or motion) are computed within their own 'feature maps', which are thought to be implemented in specific brain regions. However, whether and how specific brain regions contribute to these feature maps remains unknown.The goal of this study is to determine how brain regions that respond strongly to different feature types (color and motion) and which encode spatial locations of visual stimuli transform 'feature dimension maps' based on stimulus properties as a function of task instructions. The investigators hypothesize that feature-selective brain regions act as neural feature dimension maps, and thus encode representations of relevant location(s) based on their preferred feature dimension, such that the stimulus representation in the most relevant feature map is up-regulated to support adaptive behavior. The investigators will scan healthy human participants using functional MRI (fMRI) in a repeated-measures design while they view visual stimuli made relevant based on a cued feature dimension (e.g., color or motion). The investigators will employ state-of-the-art multivariate analysis techniques that allow them to reconstruct an 'image' of the stimulus representation encoded by each brain region to dissect how neural tissue identifies salient locations. Each participant will perform a challenging discrimination task based on the cued feature (report motion direction or color of stimulus dots) of a stimulus presented in the periphery, which are identical across trial types. Across trials the investigators will manipulate the attended feature value (color, motion, or fixation point). This manipulation will help the investigators fully understand these critical relevance computations in the healthy human visual system. ### Conditions - Basic Science: Visual Attention in Healthy Participants - Basic Science: Neural Representations of Location ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Stimulus properties: task-defining feature ### Outcomes Primary Outcomes - Blood Oxygenation Level Dependent (BOLD) fMRI signal - Gaze position - Behavioral response (button press) Secondary Outcomes ### Location - Facility: University of California, Santa Barbara, Santa Barbara, California, 93117, United States @@
## Effectiveness of Radial Extracorporeal Shock Wave Therapy in Patients With Knee Osteoarthritis - NCT ID: NCT06281444 - Study ID: i07-453-23 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-07-31 - Lead Sponsor: Ankara University ### Study Description Osteoarthritis (OA) is a degenerative joint disease characterized by unsuccessful repair of joint damage resulting from stresses in any of the synovial joint tissues. Symptoms include pain (initially only after movement), joint stiffness, limitation of joint movement, feeling of insecurity in the joint, and difficulty walking. The diagnosis of knee osteoarthritis can be easily made with a detailed history and a comprehensive physical examination. Radiographic examinations are used to support clinical findings and exclude other possible pathologies. The main purpose of treating knee osteoarthritis is to reduce pain and make daily life easier. Since there is no standard treatment method, the patient's treatment must be individualized by taking into account age, comorbidity, severity of the clinical picture, patient preferences and cost of treatment. Conservative treatment includes pharmacological and non-pharmacological treatment, and the optimal treatment should be applied as a combination of these two methods. Patient education, lifestyle modification, exercise, different physical therapy modalities (TENS, Interferential current, ESWT...), acupuncture are some non-pharmacological methods.Extracorporeal shock wave therapy (ESWT), which is considered within the scope of conservative treatment, started in the seventies with the practice of breaking ureteric stones and has become one of the physical therapy modalities used in the treatment of various musculoskeletal diseases. Considering the historical development of ESWT, it has started to be used as a therapeutic modality in the treatment of knee osteoarthritis in recent years. The process, which started with animal experiments, continued with human studies, and evidence is presented that ESWT reduces knee pain and contributes to functionality. It is noteworthy that there are few studies and their short follow-up periods. In the light of these studies, it was planned to investigate the effectiveness of ESWT treatment, which will be applied together with exercise, on pain, functionality and walking distance in individuals diagnosed with knee osteoarthritis, in comparison with the control group receiving sham ESWT. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ESWT - Sham-ESWT ### Outcomes Primary Outcomes - Change in pain [by using the Visual Analogue Scale(VAS)] Secondary Outcomes - Change from baseline in functionality and walking distance - Change from baseline in walking distance ### Location - Facility: Ankara University, Ankara, Altındağ, 06230, Turkey @@
## A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain - NCT ID: NCT06281431 - Study ID: CPSP - Status: RECRUITING - Start Date: 2023-06-12 - Completion Date: 2025-09-30 - Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University ### Study Description Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. \>20% of patients suffer from chronic postoperative pain. China has \>70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management. ### Conditions - Chronic Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Echogenic nerve block needle - Non-echogenic nerve block needle ### Outcomes Primary Outcomes - Chronic postoperative pain - Moderate to severe pain Secondary Outcomes - Acute postoperative pain - Acute postoperative pain - Acute postoperative pain - Puncture operation time - Number of needle passes ### Location - Facility: He Huang, Chongqing, Chongqing, 4000000, China @@
## Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy - NCT ID: NCT06281418 - Study ID: 5-24 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-10 - Lead Sponsor: Future University in Egypt ### Study Description Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC. ### Conditions - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Granisetron 1 Mg/mL Intravenous Solution - Normal saline ### Outcomes Primary Outcomes - VAS score Secondary Outcomes - Time to analgesic request - Quality of life (QoL) after laparoscopic cholecystectomy (LC) ### Location - Facility: National Hepatology and Tropical Research Institute, Cairo, N/A, 11617, Egypt @@
## CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer - NCT ID: NCT06281405 - Study ID: FDRT-2023-290-3409 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-12-31 - Lead Sponsor: Fudan University ### Study Description TORCH-iTNT is a prospective, multicentre, randomized phase II trial. 198 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with total neoadjuvant therapy (TNT) and assigned to Group A and Group B (1:1). Group A receives 6 cycles of Toripalimab combined with CAPOX (ToriCAPOX). Group B receives SCRT (25Gy/5Fx) followed by 6 cycles of ToriCAPOX. TME surgery is scheduled after TNT while a watch and wait (W\&W) option can be applied to patients achieving clinical complete response (cCR). The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc. ### Conditions - Locally Advanced Rectal Cancer - Neoadjuvant Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PD-1 antibody - Capecitabine - Short-course radiotherapy ### Outcomes Primary Outcomes - Complete response (CR) rate Secondary Outcomes - Grade 3-4 adverse effects rate - 3 year anal preservation rate - 3 year disease free survival rate - 3 year local recurrence free survival rate - 3 year overall survival rate - Rate of surgical complications ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, N/A, N/A, China @@
## Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study) - NCT ID: NCT06281392 - Study ID: CEIm: 106/23 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2026-11-15 - Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana ### Study Description Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD). ### Conditions - Inflammatory Bowel Diseases - Dysplasia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - CADe system - NBI ### Outcomes Primary Outcomes - "Per lesion" dysplasia detection rate (DDR) - "Per patient" dysplasia detection rate (DDR) Secondary Outcomes - Duration of endoscopic examination ### Location - Facility: Antonio López-Serrano, Valencia, N/A, 46017, Spain @@
## Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: - NCT ID: NCT06281379 - Study ID: Basaksehir City Hospital - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2024-01-01 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.Study design:Randomised-controlled studyPlace and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization. ### Conditions - Gastric Cancer - Gastric Neoplasm - Gastric Cancer Stage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Total mesogastrectomy ### Outcomes Primary Outcomes - Postoperative outcome Secondary Outcomes ### Location - Facility: Yigit Duzkoylu, Istanbul, N/A, 34480, Turkey @@
## Diamine Oxidase and Adverse Pregnancy Outcomes - NCT ID: NCT06281366 - Study ID: PR(AMI)470-2023 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-12-31 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity. ### Conditions - Pregnancy Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diamine oxidase activity first trimester - Diamine oxidase gene polymorphisms Secondary Outcomes - Blood Diamine oxidase activity at delivery - Placental Diamine oxidase activity at delivery - Blood histamine levels at delivery - Placental histamine levels at delivery - Urine histamine levels at delivery ### Location - Facility: Manel Mendoza, Barcelona, N/A, 08035, Spain @@
## The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue - NCT ID: NCT06281353 - Study ID: 22-07-0754 - Status: COMPLETED - Start Date: 2022-08-16 - Completion Date: 2023-09-06 - Lead Sponsor: Indonesia University ### Study Description The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include:* To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and* To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin.The main questions it aims to answer are:* Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)?* Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls?* Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW?Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW. ### Conditions - Anogenital Wart ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Curcumin Oral Capsule - Trichloroacetic acid - Blood sample collection - Cotton swab ### Outcomes Primary Outcomes - Clinical improvement in patients with AGW Secondary Outcomes - Level of IFN-γ in lesions of AGW patients - Level of FOXP3+Treg in lesions of AGW patients - Level of NFĸB in lesions of AGW patients ### Location - Facility: Cipto Mangunkusumo Hospital, Jakarta Pusat, DKI Jakarta, 10430, Indonesia @@
## Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy - NCT ID: NCT06281340 - Study ID: He-ankle US - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-04-21 - Lead Sponsor: Investigación en Hemofilia y Fisioterapia ### Study Description Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage. ### Conditions - Hemophilia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Manual therapy - Placebo therapy ### Outcomes Primary Outcomes - Change from baseline sonographic changes after 4 hours Secondary Outcomes - Change from baseline joint pain after 4 hours - Change from baseline joint damage after 4 hours - Change from baseline degree of joint inflammation after 4 hours ### Location - Facility: University of Oviedo, Oviedo, Asturias, 33006, Spain @@
## Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia - NCT ID: NCT06281327 - Study ID: TX-ITP-001 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy, excessive platelet fluctuation or intolerance, or patient preference, economic reasons, and other reasons. ### Conditions - Immune Thrombocytopenia - Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Avatrombopag ### Outcomes Primary Outcomes - Overall efficacy response after AVA treatment within 12 weeks Secondary Outcomes - Treatment response-1 - Treatment response-2 - Time to Response - Persistent response - Emergency treatment - Reduction of concomitant drug - Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale. - Number of participants with clinically significant bleeding as assessed using the bleeding scale for pediatric patients with ITP. - Health-related quality of life survey of subjects(HRQoL)-1 - Health-related quality of life survey of subjects(HRQoL)-2 - Health-related quality of life survey of subjects(HRQoL)-3 - Health-related quality of life survey of subjects(HRQoL)-4 ### Location - Facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, N/A, N/A, China @@
## The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment - NCT ID: NCT06281314 - Study ID: VESPA 2.0 - Status: COMPLETED - Start Date: 2021-03-01 - Completion Date: 2023-12-31 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders. ### Conditions - Neurodegenerative Diseases - Cognitive Decline - Parkinson Disease Dementia - Alzheimer Disease - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vespa software ### Outcomes Primary Outcomes - Montreal cognitive assessment (MoCA) Secondary Outcomes ### Location - Facility: IRCCS Centro Neurolesi Bonino Pulejo, Messina, Sicily, 98124, Italy @@
## Improving Patient Understanding of Macrosomia - NCT ID: NCT06281301 - Study ID: HSC-MS-23-1023 - Status: RECRUITING - Start Date: 2024-01-30 - Completion Date: 2024-09-01 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description The purpose of this study is to evaluate the effectiveness of a graphic based education tool on patient knowledge of macrosomia through the use of a survey and to evaluate knowledge at 1-2 weeks after initial review of the education tool. ### Conditions - Macrosomia, Fetal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - education tool - no additional information ### Outcomes Primary Outcomes - Number of participants that showed Macrosomia knowledge greater than 50 percent as assessed by the score on a survey Secondary Outcomes ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms - NCT ID: NCT06281288 - Study ID: P.T.REC/012/004754 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-25 - Completion Date: 2024-03 - Lead Sponsor: Doaa Tammam Atia ### Study Description PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptomsBACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: PREVENTION ### Interventions - Cognitive-Behavioral Therapy - Exercise Training ### Outcomes Primary Outcomes - Center for Epidemiological Studies Depression Scale for Children (CES-DC), Secondary Outcomes ### Location - Facility: doaa Tammam Atia, Suez, N/A, N/A, Egypt @@
## A Study of the Association Between Frailty and Acute Postoperative Pain in Elderly Thoracoscopic Surgery Patients - NCT ID: NCT06281275 - Study ID: TJ-IRB202402008 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2024-10-30 - Lead Sponsor: Huazhong University of Science and Technology ### Study Description To gain a clearer understanding of the association between frailty and postoperative acute pain in elderly thoracoscopic surgery patients and its underlying mechanisms, to provide new solution ideas to reduce the level of postoperative acute pain and improve the debilitating state of elderly thoracoscopic surgery patients, and consequently improve their quality of life and mental status. ### Conditions - Frailty - Acute Postoperative Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All patients' Numerical Rating Scale （NRS） scores for most significant pain at rest in the 48h postoperative period - Numerical Rating Scale （NRS） scores for the most pronounced pain in the patient's coughing state in the 48h postoperative period Secondary Outcomes - PCA pump consumption - Number of PCA pump presses ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Selected Immunological Indicators and Microbiota in Patients With Premature Birth and Preeclampsia - NCT ID: NCT06281262 - Study ID: GIP-23-L-04-223 - Status: RECRUITING - Start Date: 2023-06-30 - Completion Date: 2025-03-30 - Lead Sponsor: General University Hospital, Prague ### Study Description The goal is to demonstrate the relationship of the circulating pool of T-regulatory lymphocytes in the mother's peripheral blood with populations in the placentas and to compare with controls, what is the difference in the expression of individual regulatory molecules of T-regulatory lymphocytes according to new paradigms. The proportional and functional characteristics of T-regulatory lymphocytes will be correlated with the composition of the intestinal and vaginal microbiota. ### Conditions - Preterm Birth - Preeclampsia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Peripheral blood collection - Swab sample collection ### Outcomes Primary Outcomes - Changes in selected T cell subpopulations in the first trimester associated with subsequent spontaneous preterm birth - Changes in selected T cell subpopulations in the first trimester associated with subsequent pre-eclampsia Secondary Outcomes - Association of maternal microbiota and maternal T regulatory cell populations. ### Location - Facility: Department of Gynaecology, Obstetrics and Neonatology of the First Faculty of Medicine of the Charles University and General University Hospital in Prague, Prague, N/A, 128 08, Czechia @@
## Neuraxial Ultrasound Device Study - NCT ID: NCT06281249 - Study ID: 73172 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03 - Lead Sponsor: Stanford University ### Study Description The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method. ### Conditions - Labor Pain - Cesarean Delivery Regional Anesthesia Induction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ultrasound placement device ### Outcomes Primary Outcomes - Incidence of difficult block placement Secondary Outcomes - Incidence of failed block - Incidence of post-dural puncture headache ### Location - Facility: Stanford University, Stanford, California, 94305, United States @@
## A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) - NCT ID: NCT06281236 - Study ID: SPI-62-CL-1002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Sparrow Pharmaceuticals ### Study Description This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited. ### Conditions - Polymyalgia Rheumatica ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Prednisolone - SPI-62 ### Outcomes Primary Outcomes - Erythrocyte sedimentation rate - C-reactive protein - Plasma fibrinogen Secondary Outcomes ### Location - Facility: Emovis Gmbh, Berlin, N/A, N/A, Germany @@
## Study of Brain-spinal Cord Neural Connectivity in Spasticity - NCT ID: NCT06281223 - Study ID: JBR_2023_9 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-05 - Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild ### Study Description Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic. ### Conditions - Spasticity, Muscle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intraoperative neuroelectrophysiological monitoring ### Outcomes Primary Outcomes - variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery - NCT ID: NCT06281210 - Study ID: IEO 2034 - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2028-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT. ### Conditions - Breast Cancer - Triple Negative Breast Cancer - HER2-positive Breast Cancer - Neoadjuvant Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Omission of surgical treatment ### Outcomes Primary Outcomes - Event-free survival Secondary Outcomes - Positive predictive value of MRI - Contrast-Enhanced Mammography (CEM) positive predictive value ### Location - Facility: Istituto di Candiolo IRCCS, Candiolo, Turin, 10060, Italy @@
## Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume - NCT ID: NCT06281197 - Study ID: 2021/48 - Status: COMPLETED - Start Date: 2021-01-15 - Completion Date: 2022-05-15 - Lead Sponsor: TC Erciyes University ### Study Description After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation. ### Conditions - Maxillofacial Abnormalities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional - Subspinal ### Outcomes Primary Outcomes - Evaluation of Septum Deviation - Evaluation of Nasal Airway Secondary Outcomes - nasal obstruction scale evaluation ### Location - Facility: Selin Çelebi, Kayseri, Meligazi, 38320, Turkey @@
## A Post-trial Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate Treatment in Adults With Erosive Hand OA. - NCT ID: NCT06281184 - Study ID: DIA2024.1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-02-01 - Lead Sponsor: Diakonhjemmet Hospital ### Study Description In response to the high prevalence of synovitis in hand osteoarthritis (OA) and its association with pain, there\&#39;s a compelling rationale for investigating the efficacy of MTX in managing inflammatory erosive hand OA. Recent guidelines highlight the need for large, well-designed trials to assess the effectiveness of MTX. A recent trial (METHODS study) showed promising pain reduction with MTX, but due to pandemic-related protocol changes, the duration of the study was limited to six months. The ongoing MERINO trial randomizes participants to MTX or placebo for one year. After completing the MERINO trial, several participants asked for MTX open label. In the subsequent MERINO:2 study, participants completing the trial will be invited to a structured follow-up after one year, including electronic questionnaires and hand radiographs, providing valuable long-term data on the effects of MTX in hand OA. Together, these trials aim to fill gaps in understanding the long-term impact of MTX in hand OA, particularly on structural progression. ### Conditions - Hand Osteoarthritis - Erosive Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Methotrexate - No treatment ### Outcomes Primary Outcomes - Effect of MTX on radiographic progression of erosive hand OA. Secondary Outcomes - Effect of MTX on pain, function and life quality - Effect of MTX on radiographic progression of hand OA. ### Location - Facility: Diakonhjemmet Hospital, Oslo, N/A, 0319, Norway @@
## Evaluation of SkillTalk for Autistic Young Adults - NCT ID: NCT06281171 - Study ID: 90BISB0022 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-31 - Lead Sponsor: dfusion Inc ### Study Description The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships.The main questions it aims to answer are:* Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)?* Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills?* Does using SkillTalk increase interpersonal competence?* Does using SkillTalk increase ability to cope with rejection?* Does using SkillTalk improve mental health and wellbeing?Participants will be asked to:* Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up* Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up* Watch a minimum of 85% of the 60 minutes of video assigned ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - SkillTalk for Autistic Young Adults - Flyer Library ### Outcomes Primary Outcomes - Demonstrated Skill Score in communication skills. Secondary Outcomes - Participant Confidence & Satisfaction in their communication skills - Interpersonal Competence Score - Coping with Rejection, Jealousy and Relationship Anxiety - Mental Health and Wellbeing ### Location - Facility: Virtual Study, Santa Cruz, California, 95060, United States @@
## A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants - NCT ID: NCT06281158 - Study ID: DNLI-F-0009 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Denali Therapeutics Inc. ### Study Description This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - [14C]-DNL343 ### Outcomes Primary Outcomes - PK Parameter: AUC0-∞ - PK Parameter: AUC0-tlast - PK Parameter: Cmax - PK Parameter: Tmax - PK Parameter: t1/2 - Total radioactivity in plasma and whole blood - Total radioactivity in blood-to-plasma ratio - Extent and rate of recovery of total radioactivity in urine and feces Secondary Outcomes - PK Parameter: AUC0-∞ - PK Parameter: AUC0-tlast - PK Parameter: Cmax - PK Parameter: Tmax - PK Parameter: t1/2 - DNL343 and a DNL343 metabolite recoveries in urine - Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs) ### Location - Facility: Clinical Site, Madison, Wisconsin, 53704, United States @@
## Stress-Reducing Intervention in Patients With Colorectal and Breast Cancer - NCT ID: NCT06281145 - Study ID: RSV-SK001/UC-SK004/OUSA - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2029-03-15 - Lead Sponsor: Comenius University ### Study Description The goal of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in 2 cohorts of patients. Cohort A will evaluate the effect of the addition of HRV BI in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, SOC) followed by local therapy (surgery +/-radiotherapy). Cohort B will evaluate the effect of the addition of HRV BI in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, SOC). ### Conditions - Breast Cancer - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Heart-rate variability biofeedback intervention ### Outcomes Primary Outcomes - Primary endpoint - inflammation - Primary endpoint - QoL - Primary endpoint - executive functions - Primary endpoint- salivary cortisol slopes - Primary endpoint- sleep quality - Primary endpoint - heart rate variability (HRV) - Primary endpoint - Working memory Secondary Outcomes - Secondary endpoint - Pathologic Complete Response (pCR) and Residual Cancer Burden (RCB) rate in cohort A - Secondary endpoint - Relapse-free Survival (RFS) - Secondary endpoint - Overall survival (OS) - Secondary endpoint - Serious Adverse Events (SAE) ### Location - Facility: St. Elizabeth Cancer Institute, Bratislava, N/A, 81250, Slovakia @@
## Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic After Oral Administration of CKD-341 and D956 in Healthy Adults - NCT ID: NCT06281132 - Study ID: A126_03BE2316 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2024-05-14 - Lead Sponsor: Chong Kun Dang Pharmaceutical ### Study Description The objective was to evaluate and compare the pharmacokinetic profiles and safety after administration of test drug (CKD-341) and reference drugs (D956) in healthy adults. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - CKD-341, D956 ### Outcomes Primary Outcomes - area under curve(AUC) of CKD-341, D956 - Cmax of CKD-341, D956 Secondary Outcomes ### Location - Facility: Jeonbuk National University Hospital, Jeonju, N/A, N/A, Korea, Republic of @@
## Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years - NCT ID: NCT06281119 - Study ID: SII-qHPV/MC-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-05 - Lead Sponsor: Serum Institute of India Pvt. Ltd. ### Study Description Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years. ### Conditions - Human Papillomavirus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cervavac as three dose regimen - Cervavac as two dose regimen - Gardasil as three dose regimen ### Outcomes Primary Outcomes - Geometric mean titers of anti HPV 16 and 18 IgG antibodies Secondary Outcomes - Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies - Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion - Adverse Events ### Location - Facility: Centre For Clinical Research, Kemri, Nairobi, N/A, 54840-00200, Kenya @@
## TYK2 Inhibition in Paradoxical Psoriasis - NCT ID: NCT06281106 - Study ID: IM011-1118 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: Prof Curdin Conrad ### Study Description Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis. ### Conditions - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Deucravacitinib ### Outcomes Primary Outcomes - Paradoxical Psoriasis Investigator Global Assessment Secondary Outcomes - Paradoxical Psoriasis Body Surface Area - Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index - Paradoxical Psoriasis Scalp Investigator General Assessment - Psoriasis Area and Severity Index (PASI) - American College of Rheumatology (ACR) Score ### Location - Facility: Centre hospitalier universitaire vaudois (CHUV), Lausanne, VD, 1011, Switzerland @@
## Radiofrequency Fields in Neonatology: Exposure and Impact on the Nervous System - NCT ID: NCT06281093 - Study ID: PI2022_843_0089 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2026-10 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Previously, the investigators showed that preterm newborns are exposed chronically to very low radiofrequency levels in average while hospitalized in NICUs. Most of the infants were nevertheless frequently exposed to transient values above 1 V/m. The investigators also showed that an increase in RF exposure is likely to alter the activity of some neurophysiological functions and their regulatory systems in preterm newborns. The investigators hypothesize that above results are extremely specific to the location of the previous study and may be different in other NICU environments.This study will aim at quantifying RF levels to which preterm newborns are exposed during their stay in several NICUs spread across the French territory, and assessing its impact on the central and peripheral nervous systems. The first step of this study will be to quantify the precise, continuous and individual levels of daily RF exposure to which each recruited neonate is subjected during his stay in the different NICUs from birth to 1 week postnatal life. Infants' clinical data (medical history, nutrition, morphology...) will also be continually monitored. At 1 week postnatal life, the investigators will investigate cerebral activity (EEG) and autonomic nervous system activity (ECG, heart rate variability). The impact of RF will be evaluated by analyses of the relationship between exposure levels and the various parameters extracted from the neurophysiological investigation phase. ### Conditions - Preterm Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - questionary - Daily continuous recording of radiofrequency exposure levels - Follow-up of daily infants clinical parameters - recording of cerebral (EEG) - autonomic nervous (ECG) activity ### Outcomes Primary Outcomes - Variation of the spectral power in the α band (8-12 Hz) of the EEG Secondary Outcomes - variation of the spectral power in the delta (δ, 0.5-4 Hz) of the EEG ### Location - Facility: Amiens University Hospital, Amiens, Picardie, 80054, France @@
## First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours - NCT ID: NCT06281080 - Study ID: CRE2023.589-T - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-09-30 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - En-Bloc Resection of Bladder Tumours ### Outcomes Primary Outcomes - Successful en-bloc tumour resection by the robotic system Secondary Outcomes - Dissection time and speed - Total procedure time - Surgeon Console time - Presence of detrusor muscle in specimen - Resection Margin - Intra-operative bladder perforation event - Post-operative complications - Need of bladder irrigation - Residual tumour or upstaging of tumour after second look TURBT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine - NCT ID: NCT06281067 - Study ID: 271.673 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2026-01-01 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description The "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment. ### Conditions - Myocardial Bridge ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - "full-physiology approach" arm - "standard approach" arm ### Outcomes Primary Outcomes - The composite of significant angina and MACE Secondary Outcomes - Rate of patients with significant angina (SAQ Angina Summary Score ≤ 70) - Incidence of MACE - Rate of cardiac death - Rate of MI - Rate of cardiac hospitalization - Rate of TLR ### Location - Facility: Ospedale Generale Regionale F. Miulli, Acquaviva Delle Fonti, N/A, N/A, Italy @@
## Acute Myocardial Infarction in Cancer Patients - NCT ID: NCT06281054 - Study ID: SMC2023-12-027 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2002-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description Using national health insurance service database, current study aim to evaluate the risk and prognosis of acute myocardial infarction in cancer patients and to find the optimal treatment strategy for acute myocardial infarction that can improve long-term prognosis. ### Conditions - Acute Myocardial Infarction - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Revascularization ### Outcomes Primary Outcomes - All-cause death Secondary Outcomes - Myocardial infarction - Revascularization - Hospitalization for heart failure - Stroke - Clinically relevant bleeding ### Location - Facility: Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, N/A, N/A, Korea, Republic of @@
## Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention - NCT ID: NCT06281041 - Study ID: NHIS20240220 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2013-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR).Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR\>0.80). ### Conditions - Coronary Artery Disease - Coronary Artery Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Antiplatelet Agents ### Outcomes Primary Outcomes - Major adverse cardiac and cerebrovascular events - Gastrointestinal bleeding Secondary Outcomes - All-cause death - Myocardial infarction - Unplanned revascularization - Stroke - Major bleeding - Gastrointestinal bleeding necessitated hospitalization without documented transfusion - Intracranial hemorrhage ### Location - Facility: Chonnam National University Medical School, Gwangju, N/A, N/A, Korea, Republic of @@
## SOLACEA-H in Heparin-sparing Haemodialysis - NCT ID: NCT06281028 - Study ID: 2023-A02280-45 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche ### Study Description The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU) ### Conditions - Dialysis Membrane Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - SOLACEA-H/HYDROLINK-NVU - HYDROLINK-NVU/SOLACEA-H ### Outcomes Primary Outcomes - SOLACEA-H vs HYDROLINK-NVU efficacy Secondary Outcomes ### Location - Facility: Hôpital Privé La Louvière, Lille, N/A, 59800, France @@
## Artificial Intelligence and Bone Tomoscintigraphies Achieved With CZT Camera - NCT ID: NCT06281015 - Study ID: 2023PI095-407 - Status: COMPLETED - Start Date: 2023-08-30 - Completion Date: 2023-10-30 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description This study aimed to determine whether the whole-body bone Single Photon Emission Computed Tomography (SPECT) recording times of around 10 minutes, routinely provided by a high-sensitivity 360 degrees cadmium and zinc telluride (CZT) camera, can be further reduced by a deep learning noise reduction (DLNR) algorithm. ### Conditions - Bone Lesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Whole-body bone single photon emission tomography (SPECT) for detection or follow-up of bone metastasis ### Outcomes Primary Outcomes - Assess a dedicated deep learning noise reduction algorithm Secondary Outcomes ### Location - Facility: CHRU Nancy, Vandoeuvre les Nancy cedex, N/A, 54511, France @@
## Trueness of Full Arch Scans and Generated Digital Implant Models - NCT ID: NCT06281002 - Study ID: FDASU-RecIM112323 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible. ### Conditions - Denture - Complete Edentulism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - conventional impression stone casts digitization - digital scanning with coupled scanning aiding device - Digital Implant Model assessment of accuracy ### Outcomes Primary Outcomes - Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies. Secondary Outcomes - Trueness of the generated 3D-printed digital implant models. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain - NCT ID: NCT06280989 - Study ID: P.T.REC/012/004768 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08 - Lead Sponsor: Cairo University ### Study Description the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - kinesio taping - myofascial release technique ### Outcomes Primary Outcomes - pain intensity - pain pressure threshold Secondary Outcomes - severity of dysmenorrhea - Assess the function disability level ### Location - Facility: Hala mohamed ahmed morsy, Giza, N/A, 12511, Egypt @@
## Aggressive Risk-Prevention Therapies for Coronary Atherosclerotic Plaque (ART-CAP) - NCT ID: NCT06280976 - Study ID: 23.0001 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-01-31 - Lead Sponsor: University of Louisville ### Study Description The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat. ### Conditions - Coronary Artery Disease - Atherosclerosis - Heart Attack ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Statin - Aspirin tablet - Nexlizet - LEQVIO - Vascepa - Jardiance - Colchicine ### Outcomes Primary Outcomes - Plaque quantification - Characterization of plaque to evaluate for high-risk features - positive remodeling - Quantification of stenosis - Quantification of pericoronary fat attenuation. - Characterization of plaque to evaluate for high-risk features - low CT attenuation - Characterization of plaque to evaluate for high-risk features - napkin-ring sign - Quantification of epicardial fat attenuation. Secondary Outcomes - Major adverse cardiac and cardiovascular events (MACCE) - Polygenic risk score (PRS) - Next generation sequencing (NGS) - Change in Lipoprotein (a) - Change in myeloperoxidase (MPO) activity - Change in trimethylamine-N-oxide (TMAO) levels - Change in lipoprotein-associated phospholipase A2 (Lp-PLA2) levels - Change in interleukin-6 (IL-6) levels - Change in high sensitivity C-creative protein (HS-CRP) levels - Buffy coat for chromatin immunoprecipitation (ChIP) - Change in high sensitivity Troponin (HS-Tn) - Change in natriuretic peptide (BNP, NT-pro BNP - Change in levels of open reading frame 1 protein (ORF1p) ### Location - Facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases, Louisville, Kentucky, 40202, United States @@
## Posterior Innominate Mobilization Versus Muscle Energy Technique on Lumbopelvic Angles in Sacroiliac Joint Dysfunction - NCT ID: NCT06280963 - Study ID: 012/005532 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-08-03 - Lead Sponsor: Mahmoud Yousry Rashwan Hefny ### Study Description the goal of this clinical trial study is to compare between posterior innominate mobilization and muscle energy techniqueon lumbopelvic angles in sacroiliac joint dysfunction patients.the main questions they aim to answer are1. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on lumbopelvic angles in sacroiliac joint dysfunction patients ?2. are there statistical significant effects of posterior innominate mobilization versus muscle energy technique on pain intensity level in sacroiliac joint dysfunction patients ? * purpose of the study is to measure the effect of muscle energy technique versus posterior innominate mobilization on lumbopelvic angles in sacroiliac joint dysfunction ### Conditions - Sacroiliac Joint Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - muscle energy technique - posterior innominate mobilization - conventional treatment ### Outcomes Primary Outcomes - lumbopelvic angles Secondary Outcomes - pain intensity ### Location - Facility: Faculty of Physical Therapy, Dokki, Giza, 12612, Egypt @@
## Expanding Liver Transplant Immunosuppression Minimization Via Everolimus - NCT ID: NCT06280950 - Study ID: DAIT CTOT-43 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2029-06-01 - Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) ### Study Description This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months. ### Conditions - Liver Transplant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Everolimus - Tacrolimus (continued reduction) - Tacrolimus (maintain 50% reduction) - Everolimus ### Outcomes Primary Outcomes - Percent change in estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation. Between Cohorts INT-1 and INT-2 - Proportion of subjects with treated Biopsy Proven Acute Rejection (tBPAR) per local pathology. Between cohorts INT-1 and INT-2 Secondary Outcomes - Percent change in Estimated Glomerular Filtration Rate (eGFR) in Renal function - Percentage of subjects with treated Biopsy Proven Acute Rejection (tBPAR) in Liver Function - Changes in liver graft function: Total bilirubin - Changes in liver graft function: Direct bilirubin - Changes in liver graft function: Alanine Aminotransaminase (ALT) - Changes in liver graft function: Aspartate Aminotransferase (AST) - Changes in liver graft function: Alkaline Phosphatase - Time to graft failure in liver function defined as relisting for transplantation, re-transplantation itself or death with failed graft - Time to all-cause mortality - Proportion of subjects experiencing a Major Adverse Cardiac Event (MACE) - Proportion of subjects experiencing infection requiring hospitalization - Proportion of subjects experiencing any malignancy - Proportion of subjects developing severe Estimated Glomerular Filtration Rate (eGFR) deterioration >40 percent from baseline using the CKD-EPI 2021 equation - Proportion of subjects developing any major immunosuppressive therapy complications - Proportion of subjects developing new onset peripheral edema - Proportion of subjects developing new onset cytopenia deemed WBC <3.0x10^9 /L, Hb <8.0 g/dL, or platelets <50 x 10^9/L. - Proportion of subjects developing new onset oral/gastrointestinal ulcerations - Proportion of subjects developing new onset gastrointestinal symptoms (nausea, vomiting, abdominal pain, or diarrhea) related to everolimus therapy. - Proportion of subjects developing new onset pneumonitis - Proportion of subjects developing new onset hepatic artery thrombosis - Proportion of subjects developing other adverse events deemed - Proportion of subjects developing any adverse events related to everolimus therapy ### Location - Facility: Mayo Clinic Hospital Arizona (Site #: 71144), Phoenix, Arizona, 85054, United States @@
## Short Term Effect of Wearing a Tie - NCT ID: NCT06280937 - Study ID: BEUFTR-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-01 - Lead Sponsor: Bitlis Eren University ### Study Description The goal of this randomized controlled study is to assess the short term effect of wearing a ties on musculoskeletal system. In this scope viscoelastic properties and the mechanosensitivity of the muscles, and cervical range of motion will be measured. In addition to these measurements activity limitation due to wearing a tie and trunk mobility will be assessed. ### Conditions - Musculoskeletal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Wearing a tie ### Outcomes Primary Outcomes - The Change in the Viscoelastic Properties of the Muscles - The Change in the Pressure Pain Threshold of the Spine and Upper Trapezius - Cervical Range of Motion Secondary Outcomes - Activity Limitation - Global Rating of Change - Trunk Forward Bending Mobility - Trunk Lateral Bending Mobility - Neck Circumference ### Location - Facility: Bitlis Eren University, Bitlis, Merkez, 13000, Turkey @@
## Prehab Prior to Stem Cell Transplantation in Multiple Myeloma - NCT ID: NCT06280924 - Study ID: HREBA.CC-23-0220 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-06-30 - Lead Sponsor: University of Alberta ### Study Description The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy. ### Conditions - Multiple Myeloma - Exercise - Prehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Supported Exercise - Standard Care ### Outcomes Primary Outcomes - Study completion rate Secondary Outcomes - Recruitment rate - Attendance rate - Edmonton Symptom Assessment System - Functional Assessment of Cancer Therapy Multiple Myeloma - Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item) - Body weight - Body height - Grip Strength - Calf muscle size - Thigh muscle thickness - Short Physical Performance Battery - Six-minute walk test - One leg stance balance - Shoulder flexion range of motion - Sit and reach test ### Location - Facility: University of Alberta/ Cross Cancer Institute, Edmonton, Alberta, T6G 2G4, Canada @@
## The Effect of Consumption of Date Fruit and Nipple Stimulation in Late Pregnancy - NCT ID: NCT06280911 - Study ID: 098 - Status: COMPLETED - Start Date: 2013-10-10 - Completion Date: 2017-12-30 - Lead Sponsor: Selcuk University ### Study Description The study was conducted to determine the effect of consumption of date fruit and nipple stimulation on labor.The samples were applied to pregnant women satisfying the research criteria in a state hospital in Istanbul between October 2013 and June 2014. ### Conditions - Augmentation - Induction - Labor - Stimulation, Self ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Date Fruit group - Nipple group ### Outcomes Primary Outcomes - The spontaneous onset of labor - Induction and augmentation of labor Secondary Outcomes - Mode of delivery ### Location - Facility: Zeynep Kamil Women's and Children's Diseases Training and Research Hospital, Istanbul, N/A, N/A, Turkey @@
## Perioperative Factors and Early Postoperative Kidney Graft Function Recovery - NCT ID: NCT06280898 - Study ID: KC22RISI0395 - Status: COMPLETED - Start Date: 2020-05-01 - Completion Date: 2022-03-14 - Lead Sponsor: Seoul St. Mary's Hospital ### Study Description Divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. Acute kidney injury group, Acute Kidney Injury Network (AKIN), Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE), or Kidney Disease: Improving Global Outcomes (KDIGO) I would like to divide it according to the definition. After testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the Shapiro-Wilk test, continuous data was tested using the student t-test or Mann-Whitney U test. Sizes are compared using , and categorical data is compared with proportions using the χ2 test or Fisher's exact test. Analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis. ### Conditions - Heart Injuries - Kidney Transplant; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Remote ischemic conditioning ### Outcomes Primary Outcomes - Troponin I Secondary Outcomes - Troponin T - QTc interval ### Location - Facility: Seoul St. Mary's hospital, Seoul, N/A, 06591, Korea, Republic of @@
## A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy - NCT ID: NCT06280885 - Study ID: FIERCE - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-31 - Lead Sponsor: University of Dublin, Trinity College ### Study Description The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise - Health Behaviour Change (Pedometer) ### Outcomes Primary Outcomes - Feasibility: Recruitment rates - Feasibility: Adherence rates - Feasibility: Attendance rates - Feasibility: Retention Rates - Feasibility: Reason for drop0out Secondary Outcomes - Cardiorespiratory Fitness - Muscular Strength - Body Mass Index - Mid-arm circumference - Waist Circumference - Bioimpedance Analysis - Health Related Quality of Life - Fatigue ### Location - Facility: St James's Hospital, Dublin, N/A, 8, Ireland @@
## Physiologically Based Cord Clamping To Improve Neonatal Outcomes In Moderate And Late Preterm Newborns - NCT ID: NCT06280872 - Study ID: P2023/Neonat/PhyCordPrem - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2026-07 - Lead Sponsor: Queen Fabiola Children's University Hospital ### Study Description Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way.A baby born prematurely may have breathing problems because of extra fluid staying in the lungs related to the immaturity of the lung structure. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. The newborn is separated from the mother to provide emergency respiratory support. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after a premature birth while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in moderate or late preterm infants and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother. ### Conditions - Premature Birth - Respiratory Distress Syndrome in Premature Infant - Sepsis - Intraventricular Hemorrhage of Prematurity - Bronchodysplasia - Jaundice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiological Based Cord Clamping - Differed Cord Clamping ### Outcomes Primary Outcomes - Duration of non-invasive or invasive respiratory support. Secondary Outcomes - Rate of neonatal mortality - Rate of neonatal resuscitation - Rate of neonatal respiratory morbidity - Number of admission to the NICU or special care baby unit - Length of hospitalization - Gestational age corrected at discharge - Changes in physiological variables during neonatal transition - Early neonatal parameters - Hemoglobin level - Bilirubin level - Occurrence of Neonatal adverse events - Biological markers of oxidative stress - Maternal perioperative parameters - Maternal postoperative hemoglobin level - Number of maternal adverse events - Maternal-infant bonding - Maternal-infant bonding - Maternal-infant bonding - Rate of Maternal-infant bonding - Rate of Maternal-infant bonding - Rate of Maternal-infant bonding - Maternal-infant bonding - Parental satisfaction survey - Child development assessment - Success of PBCC ### Location - Facility: CHU Brugmann, Brussels, N/A, 1020, Belgium @@
## Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana - NCT ID: NCT06280859 - Study ID: 18784 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-06-10 - Lead Sponsor: Indiana University ### Study Description The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities. ### Conditions - Cardiovascular Diseases - Sedentary Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Hoosier Sport ### Outcomes Primary Outcomes - Feasibility of Intervention Measure (FIM) - Acceptability of Intervention Measure (IAM) - Intervention Appropriateness Measure (AIM) Secondary Outcomes - Daily Steps of Participants - Daily Moderate to Vigorous Physical Activity of Participants - Heart Rate of Participants - Blood Pressure of Participants - Basic Psychological Needs of Participants in Intervention Environment - Physical Literacy of Participants - Cardiovascular Fitness Levels of Participants - Muscular Endurance Levels of Participants - Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants - Nutrition Knowledge of Participants - Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior. ### Location - Facility: Indiana University, Bloomington, Indiana, 47405, United States @@
## High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain - NCT ID: NCT06280846 - Study ID: P.T.REC/012/004878 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-10-30 - Lead Sponsor: Cairo University ### Study Description The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP). ### Conditions - Chronic Nonspecific Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - high-intensity laser acupuncture and Exercise therapy program - low-intensity laser acupuncture and Exercise therapy program - Sham laser acupuncture ### Outcomes Primary Outcomes - peak torque - peak torque - Fatigue - Fatigue Secondary Outcomes - Pain Intensity - Pain Intensity - lumbar flexion ROM assessment - lumbar flexion ROM assessment - Disability - Disability ### Location - Facility: Doaa Ayoub Elimy, Giza, N/A, 11251, Egypt @@