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## Massage for Newborns Receiving Nasal CPAP - NCT ID: NCT06360159 - Study ID: Massage on Newborns - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-05-15 - Lead Sponsor: Sultan Besiktas ### Study Description One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP. ### Conditions - Massage - Stress - Newborn - Comfort ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intervention ### Outcomes Primary Outcomes - Stress Level - Salivary Cortisol Level - Comfort Score - Bilirubin Level - Nutrient ıntake amount - Abdominal Circumference Measurement - Defecation Frequency Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Mobilisation of Post Cardiac Surgery in Geriatrics. - NCT ID: NCT06360146 - Study ID: 120685123 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Ahi Evran University Education and Research Hospital ### Study Description Heart and blood vessel problems together referred to as cardiovascular diseases (CVD) include congenital heart disease, cerebrovascular illness, and coronary heart disease.Following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications.After cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations.A total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. There were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (Group A) and the control group (Group B).Older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises. ### Conditions - Cardiac Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early mobilisation ### Outcomes Primary Outcomes - International Physical Activity Questionnaire Secondary Outcomes - Two Minute Walking Test ### Location - Facility: İsmail Ceylan, Kırşehir, Merkez, 40100, Turkey @@
## Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease - NCT ID: NCT06360133 - Study ID: VVN001-CCS-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-03 - Lead Sponsor: VivaVision Biotech, Inc ### Study Description This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease. ### Conditions - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VVN001 Ophthalmic Solution, 5% - VVN001 Ophthalmic Solution, Vehicle ### Outcomes Primary Outcomes - Corneal Fluorescein Staining Secondary Outcomes - Eye Dryness ### Location - Facility: Eye & Ent Hospital of Fudan University, Shanghai, Shanghai, N/A, China @@
## Combining Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Large-vessel Ischemic Stroke - NCT ID: NCT06360120 - Study ID: 00023098816 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-05-10 - Lead Sponsor: Kafrelsheikh University ### Study Description Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects. ### Conditions - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atorvastatin 40 Mg Oral Tablet - Rosuvastatin 20mg ### Outcomes Primary Outcomes - the rate of new stroke at 90 days Secondary Outcomes - Value of National Institute of Health Stroke Scale (NIHSS) after one week - value of Modified Rankin Scale (mRS) at one week - value of Modified Rankin Scale(mRS) at three months - rate of composite recurrent stroke, myocardial infarction, and death due to vascular events - rate of drug adverse effects - Drug adverse effects: all side effects related to the drugs of our study will be reported ### Location - Facility: Kafr Elsheikh University Hospital, Kafr Ash Shaykh, N/A, 33511, Egypt @@
## RCT of a Brief Video Intervention Targeting Peer Inclusion to Reduce Depression-related Stigma in Adolescents - NCT ID: NCT06360107 - Study ID: 76729 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: New York State Psychiatric Institute ### Study Description The goal of this study is to test the efficacy of a brief video intervention emphasizing peer inclusion on depression-related stigma and stigma outcomes (e.g., help seeking attitudes, secrecy) among adolescents 14-18.Timely identification and treatment of depression in adolescents is a public health priority. However, most youth with depression do not seek treatment, and stigma has been identified as the primary barrier to help-seeking. Experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing depression-related stigma and increasing help-seeking among adolescents. However, given the extreme time constraints of these videos, optimizing the messaging is paramount. Prior research has indicated that concerns about peer social inclusion are fundamental in shaping stigma among adolescents.In this 3-arm RCT, we will recruit adolescents aged 14-18 using an online crowdsourcing platform, to test the efficacy of a) standard BVI that addresses mental health treatment but does not address concerns about peer inclusion/exclusion, b) novel BVI focused on mental health treatment and peer inclusion, and c) control condition that provides information without social contact. ### Conditions - Depression - Adolescent - Emotional Problem - Stigma, Social - Help-Seeking Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - brief video ### Outcomes Primary Outcomes - Depression Stigma Scale (modified) - Ultra-brief Self-stigma of Help-Seeking Secondary Outcomes - Adolescent Stigma Scale (modified) ### Location - Facility: New York State Psychiatric Institute, New York, New York, 10032, United States @@
## A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis - NCT ID: NCT06360094 - Study ID: 1490-0004 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-27 - Completion Date: 2025-08-06 - Lead Sponsor: Boehringer Ingelheim ### Study Description Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF.Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF.During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. ### Conditions - Idiopathic Pulmonary Fibrosis - Progressive Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 1839100 - Placebo ### Outcomes Primary Outcomes - IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (Cough count (CC)/h) - IPF cohort - Phase IIb: Change from baseline in 24-h cough frequency (CC/h) Secondary Outcomes - IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Numerical rating scale (NRS) score - IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity Visual analogue scale (VAS) score (mm) - IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% reduction in 24-h cough frequency (CC/h) - IPF cohort - Phase IIb: Absolute change from baseline in Forced vital capacity (FVC) (mL) - IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score - IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity VAS score (mm) - IPF cohort - Phase IIb: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) symptom cough domain score - IPF cohort - Phase IIb: Absolute change from baseline in Leicester Cough Questionnaire (LCQ) physical domain score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers - NCT ID: NCT06360081 - Study ID: 1479-0019 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2024-06-24 - Lead Sponsor: Boehringer Ingelheim ### Study Description The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Zongertinib ### Outcomes Primary Outcomes - Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72h (AUC0-72h) - Maximum measured concentration of the analyte in plasma (Cmax) Secondary Outcomes - Time from dosing to maximum measured concentration of the analyte in plasma (tmax) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Prospective, Single Arm, Open Label, Proof of Concept Clinical Study of Sulfasalazine in the Treatment of Active Systemic Lupus Erythematosus - NCT ID: NCT06360068 - Study ID: SLE-SASP POC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2025-05-01 - Lead Sponsor: Qiong Fu ### Study Description The goal of this clinical trial is to learn if sulfasalazine is safe and feasible in the treatment of active lupus erythematosus (SLE). The main questions it aims to answer are:Does drug sulfasalazine with stable background treatment help lower the disease activity (SLEDAI) at week 16? How many patients can reach SRI-4 at week 16? Can this regimen help lower the prednisone dosage the patients need at week 16? What about the change of the type I interferon related genes expression at week 16?Participants will:Take sulfasalazine 750mg/dose, twice a day for 16 weeks. The dosage will be increased to 1000mg/dose within one month, twice a day if the patient could tolerate.Visit the clinic once every 4 weeks for checkups and tests. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sulfasalazine Tablets ### Outcomes Primary Outcomes - the change of disease activity (SLEDAI score) Secondary Outcomes - the number of patients who can reach SRI-4 - the change of prednisone dosage ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults - NCT ID: NCT06360055 - Study ID: M2024130 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate, a P-glycoprotein probe substrate drug, in healthy adults ### Conditions - Health ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Dabigatran Etexilate - D-mannose ### Outcomes Primary Outcomes - Plasma concentration of dabigatran - Serum concentrations of glycoomics such as D-mannose Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC - NCT ID: NCT06360042 - Study ID: MA-HCC-II-021 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-03-31 - Lead Sponsor: Peking University Cancer Hospital & Institute ### Study Description This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC. ### Conditions - Unresectable Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adebrelimab plus Apatinib - Adebrelimab plus Bevacizumab - Camrelizumab plus Apatinib ### Outcomes Primary Outcomes - 12-month overall survival rate Secondary Outcomes - ORR - DCR - DoR - TTR - TTP - PFS - OS - safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0. ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, N/A, China @@
## The LvL UP Pilot Trial - NCT ID: NCT06360029 - Study ID: LvL UP - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-06 - Lead Sponsor: Singapore ETH Centre ### Study Description Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations (Castro et al., 2023). Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.The goal of this pilot study is to assess the feasibility of a Sequential, Multiple Assignment, Randomized Trial (SMART) aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability. The main questions it aims to answer are:1. What are the intervention's preliminary, short-term effects? What is the intervention's level of engagement? What is the number of dropouts? What is the percentage of missing data? What is the intervention's responder / non-responder rate after week 4? How easy was to recruit the target sample size and which channels worked best?2. Considering the above pilot study results: What is the overall feasibility of the SMART research protocol in its current form? Are there any changes required for the main trial? This includes: recruitment approach, intervention content and delivery (app, provision of human support), and/or trial assessments (online and in-person). ### Conditions - Health Behavior - Noncommunicable Diseases - Mental Health Issue - Lifestyle Risk Reduction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - LvL UP - LvL UP + MI - Comparison ### Outcomes Primary Outcomes - Mental well-being Secondary Outcomes - Subjective well-being - Mental health (depression) - Mental health (stress) - Health-related quality of life - Health behaviours (physical activity) - Health behaviours (steps) - Health behaviours (diet 1) - Health behaviours (diet 2) - Health behaviours (sleep) - Health behaviours (smoking and alcohol consumption) - Anthropometry (body weight) - Anthropometry (body height) - Anthropometry (waist circumference) - Anthropometry (hip circumference) - Anthropometry (self-reported height and weight) - Resting blood pressure - Blood metabolic profile ### Location - Facility: Saw Swee Hock School of Public Health, Singapore, N/A, 117549, Singapore @@
## Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs - NCT ID: NCT06360016 - Study ID: Protocol-RAP - Status: COMPLETED - Start Date: 2023-02-13 - Completion Date: 2024-02-01 - Lead Sponsor: Selcuk University ### Study Description Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants. ### Conditions - Self Regulation - Impulsive - Attention Difficulties - Emotion Regulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Recreation Activity Program ### Outcomes Primary Outcomes - Self-Regulation Assessment Secondary Outcomes ### Location - Facility: Selcuk University, Konya, N/A, 42400, Turkey @@
## "Right Ventricular Outflow Tract Posterior Septum Pacing" in Predicting Ventricular Outflow Tract Ventricular Tachycardia Origin - NCT ID: NCT06360003 - Study ID: SAHoWMU-CR2024-01-109 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2025-08-01 - Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University ### Study Description The goal of this clinical trial is to make clear that a new method, right ventricular outflow tract (RVOT) posterior septum pacing, has a greater accuracy in predicting the origin of ventricular outflow tract (VOT) ventricular arrhythmias (VAs) compared to the previous electrocardiographic standards for the identification of the origin of ventricular outflow tract. The secondary aim is to investigate, by using the new method, if it can optimize the procedure of radiofrequency catheter ablation.Researches will break the method of this investigation into two steps:First step have enrolled 100 patients. This step would be used to compare the results predicted by right ventricular outflow tract posterior septum pacing, with the previously used electrocardiographic criteria and actual target site.The second step will enroll another 100 patients. In this step, patients will be divided into two groups, one being the new protocol group and the other being the convention group. Patients will also be followed up, for 1 month and 3 months at outpatient clinic post procedure. Procedure time, success rate, fluoroscopy exposure time and complications, are compared between RVOT posterior septum pacing group and convention group. ### Conditions - Ventricular Outflow Tract Ventricular Arrhythmias - Radio Frequency Catheter Ablation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Right Ventricular Outflow Tract Posterior Septum Pacing - systemic mapping and ablation ### Outcomes Primary Outcomes - Rate of Immediate Ablation Success - Rate of Ablation Complication - Accuracy of RVOT posterior septal pacing protocol Secondary Outcomes - Incidence of Complications Post-operative - Incidence of Complication - Rate of Recurrence during Follow up - Incidence of Complication - Rate of Recurrence during Follow up ### Location - Facility: Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China @@
## BrotherlyACT: A Culturally Congruent and Technology-Enhanced Youth Violence and Substance Use Intervention for Black Boys and Men - NCT ID: NCT06359990 - Study ID: RushUMCEmezue - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-02-15 - Lead Sponsor: Rush University Medical Center ### Study Description This study will adapt and test a culturally tailored, multi-component, and trauma-focused digital intervention to reduce the risk and effects of youth violence and substance use and bridge service access gaps for young Black males (YBM) in pediatric emergency and community-based low-resource settings. ### Conditions - Violence in Adolescence - Substance Use - Avoidance of Healthcare ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - BrotherlyACT - BrotherlyACT Waitlist Control Group (WCG) ### Outcomes Primary Outcomes - The Reactive-Proactive Aggression Questionnaire (RPQ) - Multidimensional Peer Victimization Scale (MPVS) - The Alcohol Use Disorders Identification Test (AUDIT) - Drug Use Disorders Identification Test (DUDIT) - Change in Attitude toward Substance Use Secondary Outcomes - Emotional Avoidance Strategy Inventory for Adolescents (EASI-A) - The Kessler Psychological Distress Scale (K-10) - The University of Rhode Island Change Assessment Scale (URICA) - Intensity-of-Care Measurements - Violent Intentions-Teen Conflict Survey ### Location - Facility: Rush University Medical Center, Chicago, Illinois, 60612, United States @@
## The Effect of Quantitative EEG Combined With Ultrasound and Sputum Volume on Predicting Weaning Failure - NCT ID: NCT06359977 - Study ID: YB-202442 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-05-15 - Lead Sponsor: Qingdao University ### Study Description Neurocritical patients often face the need for removal of endotracheal tubes. However, despite following the extubation criteria for general critical ill patients, neurocritical patients still exhibit a higher rate of weaning failure, significantly higher than that of general critical ill patients. The extubation criteria for general critical patients emphasize the assessment of lung conditions. However, neurological critical patients often have less severe lung damage, but factors such as consciousness level and coughing ability may significantly influence extubation. Quantitative EEG serves as an objective tool to reflect consciousness level status, while bedside ultrasound can assess respiratory muscle function. Additionally, sputum volume may reflect the condition of lung condition. Therefore, we believe that combination of these three indicators can better predict the success of extubation for neurocritical patients. ### Conditions - Weaning Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quantitative EEG monitoring and beside ultrasound evaluation ### Outcomes Primary Outcomes - Quantitative EEG indicators - Respiratory muscles thickness in centimeter - Respiratory muscles thickening fraction (%) - Sputum volume in milliliter Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Infective Complications in TP Biopsy Without Antibiotic Prophylaxis - NCT ID: NCT06359964 - Study ID: CRE2023.195 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transperineal Biopsy without antibiotics prophylaxis - Transperineal Biopsy with antibiotics prophylaxis ### Outcomes Primary Outcomes - The difference in UTI hospitalization rate between the two groups after biopsy - The difference in urosepsis rates between the two groups after biopsy Secondary Outcomes - Post-biopsy UTI rates between the two groups - Assessment of bacteriology and antibiotic resistant profile between the two groups ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Implementation of Project YES in Ambulatory Adolescent & Young Adult Medicine - NCT ID: NCT06359951 - Study ID: 24-0103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2026-01-31 - Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago ### Study Description This study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms. ### Conditions - Depression - Eating Disorders - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Project YES ### Outcomes Primary Outcomes - Short Mood and Feelings Questionnaire (SMFQ; Messer et al., 1995) - Patient Health Questionnaire-9 (PHQ-9) - Generalized Anxiety Disorder -7 (GAD-7) Secondary Outcomes - Dietary Restriction Screener - 2 (DRS 2) - Adult State Hope Scale - Self-Hate Scale - Beck Hopelessness -4 - Program Feedback Scale ### Location - Facility: Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States @@
## Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF - NCT ID: NCT06359938 - Study ID: Cer22/01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-04-01 - Lead Sponsor: Ceryx Medical Ltd ### Study Description The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out.The main questions the trial aims to answer are:* Is the new type of pacemaker safe?* Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)?Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients. ### Conditions - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atrial pacing with respiratory sinus arrhythmia (RSA) variability - Monotonic right atrial overdrive pacing ### Outcomes Primary Outcomes - Number of arrhythmia episodes per patient during pacing Secondary Outcomes ### Location - Facility: Cardiff & Vale University Health Board, Cardiff, N/A, CF14 4XW, United Kingdom @@
## Suprazygomatic Nerve Block in Tonsillectomy Patients - NCT ID: NCT06359925 - Study ID: Suprazygomatic nerve block - Status: NOT_YET_RECRUITING - Start Date: 2024-10-22 - Completion Date: 2026-02-20 - Lead Sponsor: Assiut University ### Study Description The use of suprazygomatic maxillary nerve block to reduce postoperative pain and hospital stay is greater than the use of NSAID and opioids. ### Conditions - Tonsillectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Suprazygomatic maxillary nerve block using dexmedetomidne and Bupivacaine - Suprazygomatic maxillary nerve block using Bupivacaine ### Outcomes Primary Outcomes - time and amount of first postoperative rescue analgesia after two different blocks using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score Secondary Outcomes - time and amount of first postoperative rescue analgesia after two different blocks using Paediatric Anaesthesia Emergence Delirium (PAED) scale - Parents satisfaction score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Preliminary Efficacy of Allogeneic Endothelial Progenitor Cells (EPCs) in Patients With Critical Limb Ischemia - NCT ID: NCT06359912 - Study ID: CNYX-EPCs-002-1 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Allife Medical Science and Technology Co., Ltd. ### Study Description The purpose of this study is to determine if allogeneic Endothelial Progenitor Cells (EPCs) intravenous infusion to a subject with leg ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound. ### Conditions - Critical Limb Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EPCs - Clinical standard treatment (CST) ### Outcomes Primary Outcomes - adverse events Secondary Outcomes - Painless walking and intermittent claudication distance - Blood flow of the affected limb - Rutherford grade - The area of skin ulcer - Vascular Quality of Life Questionnaire-6 score ### Location - Facility: Hui Shi, Beijing, Beijing, N/A, China @@
## A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD - NCT ID: NCT06359899 - Study ID: AK0901-2001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-10 - Lead Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. ### Study Description This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK0901 capsule - Placebo ### Outcomes Primary Outcomes - To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD. Secondary Outcomes - Change from baseline in ADHD-RS-5 total score at Week 4. - Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period - Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period. - Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period - CGI-I scores from V3 at each visit in the Double-Blind Treatment Period - Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment - Proportion of subjects with adverse events (AEs) occurring during the study - Proportion of subjects with serious adverse events (SAEs) occurring during the study - Changes in respiratory rate during the study - Changes in heart rate during the study - Changes in body temperature during the study - Changes in systolic blood pressure during the study - Changes in diastolic blood pressure during the study - Change from baseline in QT intervals from resting EKGs - Change from baseline in QTcF intervals from resting EKGs - Change from baseline in heart rate resting EKGs - Change from baseline in QRS intervals from resting EKGs - Change from baseline in PR intervals from resting EKGs - Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period ### Location - Facility: Beijing anding hospital capital medical university, Beijing, Beijing, N/A, China @@
## B-lynch Transverse Compression Suture - NCT ID: NCT06359886 - Study ID: FMASU MD 292/2022 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-09 - Lead Sponsor: Alexandria University ### Study Description Is B-Lynch transverse compression suture safe and effective in controlling excessive blood loss during conservative management of women with placenta previa? ### Conditions - Blood Loss, Surgical ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - B-Lynch Transverse Compression Suture ### Outcomes Primary Outcomes - Intraoperative blood loss - Postoperative blood loss - Number of received blood components - Peripartum haemoglobin level drop Secondary Outcomes ### Location - Facility: Ain Shams University, Cairo, N/A, 21526, Egypt @@
## Left Atrial Enlargement: A Crucial Indicator for Identifying Atrial Fibrillation in Patients With Hypertension - NCT ID: NCT06359873 - Study ID: LAD-AF - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2023-05-01 - Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University ### Study Description Based on the data of inpatients with hypertension and a cross-sectional study with a large sample size, this study aims to find the early warning value of the left anteroposterior atrial diameter for the possible occurrence of atrial fibrillation in patients with hypertension, and compare the advantages and disadvantages of the above two methods for the early warning of the risk of atrial fibrillation in patients with hypertension, so as to achieve the purpose of early identification of high-risk groups that may develop atrial fibrillation. ### Conditions - Atrial Fibrillation - Hypertension,Essential - Left Atrial Dilatation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CHA2DS2-VASc score, C2HEST score, and left atrial diameter (LAD) ### Outcomes Primary Outcomes - left atrial diameter (LAD) - CHA2DS2-VASc score - C2HEST score - Atrial fibrillation (AF) Secondary Outcomes - Area under the curve (AUC) of LAD and occurrence of AF - AUC of CHA2DS2-VASc score and occurrence of AF - AUC of C2HEST score and occurrence of AF ### Location - Facility: 2ndChongqingMU, Chongqing, Chongqing, 400010, China @@
## A Study of ST-1898 for Unresectable or Metastatic Melanoma - NCT ID: NCT06359860 - Study ID: ST-1898-203 - Status: RECRUITING - Start Date: 2023-11-07 - Completion Date: 2025-09 - Lead Sponsor: Beijing Scitech-Mq Pharmaceuticals Limited ### Study Description ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets. ### Conditions - Unresectable or Metastatic Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ST-1898 tablets ### Outcomes Primary Outcomes - Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) - Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D) - Phase II Expansion: Objective Response Rate (ORR) Secondary Outcomes - Phase Ib Dose Escalation: Trough concentration of ST-1898 - Phase Ib Dose Escalation: Peak concentration of ST-1898 - Phase Ib Dose Escalation: ORR - Phase Ib Dose Escalation: PFS - Phase Ib Dose Escalation: DoR - Phase Ib Dose Escalation: DCR - Phase Ib Dose Escalation: TTP - Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs) - Phase II Dose Expansion: Trough concentration of ST-1898 - Phase II Dose Expansion: Peak concentration of ST-1898 - Phase II Dose Expansion: PFS - Phase II Dose Expansion: DoR - Phase II Dose Expansion: DCR - Phase II Dose Expansion: TTP ### Location - Facility: Peking University Cancer Hospital & Institute, Beijing, N/A, 100142, China @@
## Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer - NCT ID: NCT06359847 - Study ID: ST-1898-202 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2025-12 - Lead Sponsor: Beijing Scitech-Mq Pharmaceuticals Limited ### Study Description ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity. ### Conditions - Differentiated Thyroid Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ST-1898 tablets ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs) - PFS - PFS6m - DCR - DOR - OS - Thyroglobulin (Tg) - Thyroglobulin Antibody (TgAb) - Pharmacokinetic (PK) Parameter: Tmax - Pharmacokinetic (PK) Parameter: T1/2 - Pharmacokinetic (PK) Parameter: Cmax - Pharmacokinetic (PK) Parameter: AUC ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography - NCT ID: NCT06359834 - Study ID: 4-2023-1693 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-04-30 - Lead Sponsor: Yonsei University ### Study Description Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography. ### Conditions - Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Remimazolam besylate - Propofol ### Outcomes Primary Outcomes - Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation Secondary Outcomes ### Location - Facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, N/A, 120-752, Korea, Republic of @@
## Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer - NCT ID: NCT06359821 - Study ID: Z-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2026-04-15 - Lead Sponsor: Sichuan University ### Study Description A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer ### Conditions - Metastatic Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ZA-001 ### Outcomes Primary Outcomes - The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ - Adverse Event Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis - NCT ID: NCT06359808 - Study ID: KY20232370 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Xijing Hospital ### Study Description Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients. ### Conditions - Colitis, Ulcerative - Sleep Quality - Gastrointestinal Microbiome - Autonomic Nervous System Imbalance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pittsburgh Sleep Quality Index (PSQI) - Disease activity - Heart Rate Variability (HRV) - Functional Magnetic Resonance Imaging - Neurotransmitter Agents - Gastrointestinal Microbiome Secondary Outcomes - Patient Health Questionnaire (PHQ-9) - Generalized Anxiety Disorder (GAD-7) - Inflammatory Bowel Diseases Questionnaire (IBDQ) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease - NCT ID: NCT06359795 - Study ID: FAPI-TED - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2027-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED. ### Conditions - Thyroid Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT ### Outcomes Primary Outcomes - Diagnostic accuracy Secondary Outcomes - The value to predict therapy response - Diagnostic accuracy comparison - FAPI expression and SUV metrics ### Location - Facility: Dept. of Nuclear Medicine, Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) - NCT ID: NCT06359782 - Study ID: NL76082.058.20 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-02 - Lead Sponsor: Haaglanden Medical Centre ### Study Description Aneurysmal subarachnoid hemorrhage (SAH) can lead to devastating outcomes for patients, like cognitive decline. This is caused by early brain injury (EBI) followed by delayed cerebral ischemia (DCI). Neuroinflammation, triggered by the complement system, has been investigated to be a key mediator in the pathophysiology of EBI and DCI. Inhibition of the complement system is therefore considered to be a potentially important new treatment for SAH.This trial aims to study the safety and efficacy of C1-inhibitor Cinryze, an approved inhibitor of the complement system, compared to placebo in patients with SAH. By temporarily blocking the complement system we hypothesize limitation of delayed cerebral ischemia and a more favourable clinical outcome for SAH patients due to a decrease in the inflammatory response. ### Conditions - Subarachnoid Hemorrhage, Aneurysmal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - C1 Esterase Inhibitor Injection [Cinryze] - Placebo ### Outcomes Primary Outcomes - Number of participants with delayed cerebral ischemia (DCI) - Number of participants with complications during hospitalization. Secondary Outcomes - Number of participants with cerebral infarction on brain CT - Number of participants dying - Neurological condition measured by Glasgow Coma Scale - Complement activity markers measured in serum and CSF - Inflammatory markers measured in serum and CSF - Number of days in the hospital - Number of ICU days - Number of ventilator days - Clinical outcome - Clinical outcome - Clinical outcome - Clinical outcome - Clinical outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Group Cognitive Evolutionary Therapy for Depression - NCT ID: NCT06359769 - Study ID: GROUPCET - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: University of Bucharest ### Study Description The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention. ### Conditions - Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group Cognitive Evolutionary Therapy ### Outcomes Primary Outcomes - Depressive symptomatology - Anxiety symptomatology Secondary Outcomes - Sleep quality - Perceived stress - Social provisions - Satisfaction with life - Self-perceived mate value ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ischemic Postconditioning in Carotid Surgery - NCT ID: NCT06359756 - Study ID: BRAIN-SAVE1 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-09-01 - Lead Sponsor: Institute for Cardiovascular Diseases "Dedinje" ### Study Description Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT). ### Conditions - Ischemic Postconditioning - Carotid Surgery - Stroke - Carotid Artery Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ischemic postconditioning in carotid surgery - Eversion Carotid Endarterectomy ### Outcomes Primary Outcomes - Number of Participants with perioperative stroke - Number of Participants with perioperative death Secondary Outcomes ### Location - Facility: Institute for Cardiovascular Diseases Dedinje, Belgrade, N/A, 11000, Serbia @@
## Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy - NCT ID: NCT06359743 - Study ID: 271/7 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Zagazig University ### Study Description Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery. ### Conditions - Post Hysterectomy Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Quadratus Lamborum versus superior hypogatric ### Outcomes Primary Outcomes - Opioid consumption decrease Secondary Outcomes ### Location - Facility: Faculty of medicine, Zagazig university, Zagazig, Sharkia, N/A, Egypt @@
## Incidence and Risk Factors of Low Anterior Resection Syndrome - NCT ID: NCT06359730 - Study ID: 253/26-March-2024 - Status: COMPLETED - Start Date: 2017-12-01 - Completion Date: 2022-12-01 - Lead Sponsor: Zagazig University ### Study Description Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt. ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LARS score questionnaire ### Outcomes Primary Outcomes - age - sex - medical disease - site of tumor - neoadjuvant therapy - site of anastmosis - type of meso-rectal excision - adjuvant therapy - type of surgery - type of anastmosis - LARS score Secondary Outcomes ### Location - Facility: Zagazig University Hospitals, Zagazig, N/A, 44519, Egypt @@
## Prospective Validation of PSMA-RADS - NCT ID: NCT06359717 - Study ID: ZU-10490 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-04-20 - Lead Sponsor: Zagazig University ### Study Description This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.Key points:* 186 patients with newly diagnosed or recurrent prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.* Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.* Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.* Inter-rater agreement was evaluated using Fleiss\' kappa statistic.* The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0. ### Conditions - Cancer Prostate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0 Secondary Outcomes - Inter-rater Agreement of PSMA-RADS v1.0 and v2.0 ### Location - Facility: Mohammad Abd Alkhalik Basha, Zagazig, Select, 44631, Egypt @@
## Intervention for Emotions in Caregivers of Dementia - NCT ID: NCT06359704 - Study ID: kevinszc - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-02-01 - Lead Sponsor: The University of Hong Kong ### Study Description This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes). ### Conditions - BPSD - Expressed Emotion - Depressive Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Caregivers Of dementia Processing Emotions (COPE) program ### Outcomes Primary Outcomes - Expressed emotions Secondary Outcomes - depressive symptoms - social dynamics - BPSD ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County - NCT ID: NCT06359691 - Study ID: 4UH3HL154302 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-06 - Lead Sponsor: University of California, Los Angeles ### Study Description The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics.To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS.LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team.Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Patient-focused strategies - Provider-focused strategies - Patient- and provider-focused strategies ### Outcomes Primary Outcomes - Overall provider adoption of evidence based practices Secondary Outcomes - Provider/Care Team EBP Acceptability, Appropriateness, Feasibility - Blood Pressure (BP) Control ### Location - Facility: Olive View-UCLA Medical Center, Sylmar, California, 91342, United States @@
## The Northstar Trial - NCT ID: NCT06359678 - Study ID: NL85844.015.23 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-01-01 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy. ### Conditions - Flutter, Atrial ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - NorthStar ### Outcomes Primary Outcomes - Accuracy of Catheter Localization Secondary Outcomes - Influences of breathing pattern - Influences of procedure duration - Influences of complications during ablation - Influences of patient characteristics ### Location - Facility: Amsterdam UMC, Amsterdam, N/A, N/A, Netherlands @@
## Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis - NCT ID: NCT06359665 - Study ID: HSR230544 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Brent DeGeorge ### Study Description The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are:* Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.* Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?* Is Turmeric safe for participants with thumb-joint arthritis?Participants will:* take 4 weeks of daily Turmeric capsules,* take 4 weeks of daily placebo capsules* answer daily surveys about how they are feeling and functioning. ### Conditions - Arthritis of Carpometacarpal Joint of Left Thumb - Arthritis of Carpometacarpal Joint of Right Thumb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Curcumin - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition Secondary Outcomes - Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition - Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition - Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition - Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score - Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score - Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index - Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index - Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH). - Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition - Change from Baseline in perseverance on the Brief Resilience Index (BRI) - Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition - Number of Participants With Treatment-Related Adverse Events - Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure - Change from Baseline in heart rate - Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure - Change from Baseline in heart rate - Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR) - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin - Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR) - Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets - Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin - Change from baseline in serum complete blood count (CBC) parameters: Hematocrit - Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) - Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Get Fit for Function - NCT ID: NCT06359652 - Study ID: IRB24-0421 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-04 - Lead Sponsor: University of Chicago ### Study Description The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program. ### Conditions - Thoracic - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Prehabilitation Program (Apple Watch Series 6 with exercise flipbook) ### Outcomes Primary Outcomes - The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation. Secondary Outcomes - Number of Participants with Postoperative Complications - Number of Participants length of hospital stay post-operative. - Number of Participants discharge to not-home post-operative. ### Location - Facility: The University of Chicago, Chicago, Illinois, 60637, United States @@
## Cognitive Restructuring in Managing Breakup Distress and Promoting Posttraumatic Growth Among Malaysian Young Adults - NCT ID: NCT06359639 - Study ID: USM/JEPeM/KK/23080645 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: Michelle Choong Poh Kin ### Study Description The goal of this clinical trial is to assess the effectiveness of cognitive restructuring in reducing breakup distress and promoting personal growth among Malaysian young adults. Cognitive restructuring is a therapy skill that focuses on changing unhelpful thoughts. The main question it aims to answer is: Are there differences in their breakup distress and personal growth after receiving cognitive restructuring compared to counselling? Participants will receive five online sessions of either cognitive restructuring or counselling. Data on participants' breakup distress and personal growth will be collected before and after completion of sessions. The hypothesis is that cognitive restructuring will reduce breakup distress and increase personal growth more than counselling. ### Conditions - Breakup Distress - Posttraumatic Growth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive restructuring - Supportive counselling ### Outcomes Primary Outcomes - Breakup distress - Posttraumatic growth Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers - NCT ID: NCT06359626 - Study ID: YHP2205 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-09 - Completion Date: 2024-07-24 - Lead Sponsor: Yuhan Corporation ### Study Description A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - YHP2205 - YHR2401 ### Outcomes Primary Outcomes - Area under the plasma drug concentration-time curve [AUCt] - Maximum plasma concentration [Cmax] Secondary Outcomes - Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] - Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] - Time of peak concentration [Tmax] - Terminal phase of half-life [t1/2] ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy Assessment of Gluten Free Cupcakes - NCT ID: NCT06359613 - Study ID: 029/IRC/BMR - Status: COMPLETED - Start Date: 2019-10-03 - Completion Date: 2020-01-03 - Lead Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan ### Study Description Randomized controlled trial will be conducted after getting informed consent form from each study participant meeting inclusion criteria (n=70, 35 control group +35 intervention group, 3-8years of age). After consumer acceptance against various attributes of aglutenic cupcake, the product will be provided in polyethylene bags containing 28 cupcakes (35gm by weight/cupcake, 2 cupcakes for each day) providing approximately 20% daily value (DV) of energy. Cupcakes of equal weight and size made with rice flour (mostly used recipe) will be provided to the control group. Further product will be provided on follow-up visits. The compliance to a gluten free diet GFD and supplemented product will be confirmed by a Food Frequency Questionnaire (FFQ). ### Conditions - Celiac Disease in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - nutrient rich food product - food product ### Outcomes Primary Outcomes - Body Weight - Height of the patients - Mid upper Arm Circumference (MUAC) - Body Mass Index (BMI) - Complete Blood Count (CBC) - Total Protein - Lipid Profile - Liver Enzymes - Serum Electrolytes Secondary Outcomes - Gastrointestinal Symptoms ### Location - Facility: UVAS, Lahore, Punjab, 54000, Pakistan @@
## A Study of HS-10501 Tablets in Healthy Subjects - NCT ID: NCT06359600 - Study ID: HS-10501-101 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2025-06-30 - Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects. This is the first clinical study of HS-10501 tables. This study has 2 parts. Parts A involve a single dose of HS-10501 tables or placebo and will last about 8 days. Also, this part will also further explore the food effect. Parts B involve multiple doses of HS-10501 tables or placebo and will last about 4 weeks. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - HS-10501 tablet - Placebo ### Outcomes Primary Outcomes - Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. - Number of participants with clinically significant abnormalities in lab tests - Number of participants with clinically significant change from baseline in vital signs - Change from baseline in Electrocardiogram (ECG) Secondary Outcomes - Pharmacokinetic (PK) profile of HS-10501 - AUC0-t - Pharmacokinetic (PK) profile of HS-10501 - AUC0-∞ - Pharmacokinetic (PK) profile of HS-10501 - Cmax - Pharmacokinetic (PK) profile of HS-10501 - Tmax - Pharmacokinetic (PK) profile of HS-10501 - t1/2 - Pharmacokinetic (PK) profile of HS-10501 - CL/F - Pharmacokinetic (PK) profile of HS-10501- Vz/F - Pharmacokinetic (PK) profile of HS-10501-λz - Pharmacokinetic (PK) profile of HS-10501- AUC0-τ - Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood glucose-time curve after oral glucose tolerance test (OGTT) - Pharmacodynamic (PD) profile of doses of HS-10501 - AUC0-t of blood insulin-time curve after oral glucose tolerance test (OGTT) - body weight changes ### Location - Facility: The second hospital of Anhui University, Hefei, Anhui, 230601, China @@
## Re-Purposing the Ordering of Routine Laboratory Tests in Hospitals in British Columbia - NCT ID: NCT06359587 - Study ID: H22-03005 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2026-10-01 - Lead Sponsor: University of British Columbia ### Study Description The goal of this stepped-wedge cluster randomized trial is to assess the impact of a laboratory test overuse intervention bundle on laboratory test utilization in 6 health authorities (16 hospitals) in British Columbia. The main question it aims to answer is if the intervention bundle, inclusive of healthcare provider and patient engagement tools, can be effectively implemented for hospitalized medical inpatients in 16 hospitals across BC and reduce laboratory test over-use. Researchers will compare hospital clusters that receive the intervention at different (sequential) time points to see if there are significant changes in the measured outcomes after the intervention. ### Conditions - Hospital Acquired Condition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Laboratory test overuse (LTO) Bundle ### Outcomes Primary Outcomes - Change in number of target laboratory tests ordered per patient-day with LTO bundle compared to control period without LTO bundle Secondary Outcomes - Change in number of total laboratory tests ordered per patient-day with the LTO bundle - Rate of hospital re-admissions and mortality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Core Competency Model for Corrections - NCT ID: NCT06359574 - Study ID: IRB-24-0209 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-05 - Completion Date: 2025-01-30 - Lead Sponsor: University of North Carolina, Charlotte ### Study Description The overall goal of this project is to design, implement, and revise the Core Competency Model for Corrections (CCM-C), an evidence-based Self-Directed Violence (SDV) prevention training program for correctional mental health providers in the North Carolina Department of Adult Corrections (DAC). The proposed specific aims are:Aim 1: To create the CCM-C training program. Aim 2: To assess preliminary training effectiveness. Aim 3: To gather training program quality improvement feedback from corrections stakeholders. ### Conditions - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Core Competency Model for Corrections (CCM-C) Self-Directed Violence Prevention Training ### Outcomes Primary Outcomes - Feasibility - Acceptability - Appropriateness - Usability Secondary Outcomes - Perceived self-directed violence prevention skills - Willingness to intervene with a suicidal person - Beliefs about incarcerated persons engaging in self-directed violence - Self-directed violence prevention knowledge - Perceived importance of training ### Location - Facility: North Carolina Department of Adult Corrections, Raleigh, North Carolina, 27699, United States @@
## Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Patients With Cervical Lead Placement - NCT ID: NCT06359561 - Study ID: 2023-2201 - Cervical lead - Status: ENROLLING_BY_INVITATION - Start Date: 2023-10-05 - Completion Date: 2025-12-31 - Lead Sponsor: Rijnstate Hospital ### Study Description This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement. ### Conditions - Chronic Pain Syndrome - Multi Focal Pain - Failed Neck Surgery Syndrome - Polyneuropathies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - cervical lead placement ### Outcomes Primary Outcomes - Pain intensity in pain region(s) of pain using the 11-box pain numeric rating scale (NRS) Secondary Outcomes - Pain distribution using Patient Reported Dermatomal Coverage Map - Assessment of holistic outcomes: quality of life in seven domains (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance) assessed by the PROMIS-29 questionnaire - Pain-related medication intake. - Programming parameters. - Programming parameters. - Evaluate stimulation sensation (awareness and quality) - Evaluate stimulation coverage in pain region(s) - Posture Change Measurements ### Location - Facility: Rijnstate Hospital, Arnhem, Gelderland, 6815AD, Netherlands @@
## PEELED INTERNAL LIMITING MEMBRANE REPOSITION - NCT ID: NCT06359548 - Study ID: XH-24-002 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-11 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling. ### Conditions - Macular Holes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Peeled ILM Reposition - ILM Peeling ### Outcomes Primary Outcomes - The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively Secondary Outcomes - The MH closure rate - The range of inner retinal dimpling - Postoperative retinal thickness - The fixation stability and sensitivity threshold - mfERG P1 wave density amplitudes - M-score values - NEI-VFQ-25 questionnaire scores ### Location - Facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University Medicine School, Shanghai, N/A, N/A, China @@
## An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting - NCT ID: NCT06359535 - Study ID: HSK21542-IIT-02 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-11-06 - Lead Sponsor: Mengchang Yang ### Study Description This study analyzed the efficacy and safety results of HSK21542 injection for the prevention of postoperative nausea and vomiting in a multicentre, randomized, double-blind, placebo-controlled dose-exploration study, as well as the real-world clinical routine use of troisisone and other (not limited to other setron drugs) for the prevention of postoperative nausea and vomiting and related adverse reaction treatment data. It was transformed into an effect indicator, and the possible costs involved in the study were analyzed, reasonable price parameters of HSK21542 injection were set, and the economic value of HSK21542 was explored. ### Conditions - Nausea and Vomiting, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - HSK21542 - Placebo ### Outcomes Primary Outcomes - Total direct medical costs, direct non-medical costs, indirect costs Secondary Outcomes ### Location - Facility: Sichuan Provincial People's Hospital, Chengdu, Sichuan, N/A, China @@
## PDA Occlusion Using NIRS - NCT ID: NCT06359522 - Study ID: 22.0334 - Status: RECRUITING - Start Date: 2023-04-18 - Completion Date: 2025-09-30 - Lead Sponsor: University of Louisville ### Study Description Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy. ### Conditions - Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NIRS monitor ### Outcomes Primary Outcomes - Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. - Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol. Secondary Outcomes - Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment. ### Location - Facility: Norton Children's Hospital, Louisville, Kentucky, 40202, United States @@
## Study of SYS6020 in BCMA-positive Multiple Myeloma - NCT ID: NCT06359509 - Study ID: SYS6020-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2032-05 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BCMA Targeted CAR T-cells ### Outcomes Primary Outcomes - Incidence of adverse events (AEs) - Dose limiting toxicities (DLTs) Secondary Outcomes - Overall response rate (ORR) - Percentage of subjects who achieved complete response or strict complete response (CR/sCR) - Percentage of subjects who achieved very good partial response (VGPR) and higher response rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Split or Whole Liver Transplantation? A Multicenter Retrospective Cohort Study of Patients With Benign and Malignant Liver Disease - NCT ID: NCT06359496 - Study ID: CT2024-ZJU-OBS8 - Status: COMPLETED - Start Date: 2024-02-23 - Completion Date: 2024-04-02 - Lead Sponsor: Zhejiang University ### Study Description The primary objective of this study was to assess the safety and feasibility of split liver transplantation(SLT) for adult hepatocellular carcinoma (HCC) patients, while comparing the prognostic disparities between adult SLT and WLT also .Liver transplantation (LT) is an effective treatment for end-stage liver disease. As a traditional marginal donor liver, the application of SLT in pediatric patients is successful.However, its application in adult liver transplantation, especially in HCC patients, remains controversial.This retrospective study analyze outcomes among adults who underwent SLT and whole liver transplantation (WLT) at two centers from January 2018 to August 2022. A 1:1 propensity score matching (PSM) analysis was performed based on important donor and recipient variables. Baseline characteristics and postoperative outcomes of the above recipients were analyzed and compared. Statistical significance was determined using a two-sided p-value threshold of less than 0.05. ### Conditions - Zhejiang University ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention factor ### Outcomes Primary Outcomes - Postoperative complications were evaluated by postoperative imaging reports and serological indicators - The survival rate of each group was evaluated by follow-up survey and K-M curve Secondary Outcomes ### Location - Facility: Xiao Xu, Hangzhou, N/A, N/A, China @@
## The Impact of Meal Frequency on Bone Remodeling in Healthy Adults - NCT ID: NCT06359483 - Study ID: 108/2021 - Status: COMPLETED - Start Date: 2021-06-19 - Completion Date: 2021-07-04 - Lead Sponsor: University of Jordan ### Study Description The study aimed to investigate the effect of meal frequency on bone remodeling using the marker Procollagen Type 1 N-terminal propeptide (P1NP). Thirty healthy adult males from Jordan participated in a randomized controlled intervention trial. They were randomly assigned to three or eight daily meals for three consecutive days over two phases. Blood samples were obtained at the beginning and end of each phase, and P1NP levels were analyzed. The results showed a substantial drop in P1NP levels compared to the baseline, indicating that meal frequency influences bone development. There were no significant changes between the groups eating three and eight meals per day. The study emphasizes the importance of dietary patterns in bone health and advises additional research to understand the relationship between meal frequency and bone metabolism. ### Conditions - Healthy Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Meal Frequency Manipulation ### Outcomes Primary Outcomes - The title of the primary outcome is "Procollagen Type 1 N-terminal propeptide (P1NP) Levels." Secondary Outcomes ### Location - Facility: University of Jordan, Amman, N/A, N/A, Jordan @@
## the Modified Reversed Contralateral Axial Rotation Position - NCT ID: NCT06359470 - Study ID: CaiUni - Status: COMPLETED - Start Date: 2022-11-05 - Completion Date: 2024-01-14 - Lead Sponsor: Noha Khaled Shoukry ### Study Description This study aimed to investigate the effect of specific three-dimensional (3D) positions of the trunk on patients with lumbar discogenic pain with radiculopathy aiming to find a position that directly decompresses the impinged root as well as the effect of this position on the CSA of the L3-L4, L4-L5 and L5-S1 intervertebral foramen (IVF) using 3D-CT scan imaging of the real spine ### Conditions - Disc Prolapse With Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Positioning technique ### Outcomes Primary Outcomes - Straight leg raising test Secondary Outcomes - Foraminal cross sectional area ### Location - Facility: Faculty of Physical Therapy, Giza, N/A, 12556, Egypt @@
## Correlation Between Serum Progesterone Level And Primary Dysmenorrhea - NCT ID: NCT06359457 - Study ID: P.T.REC/012/005016 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-07 - Lead Sponsor: Cairo University ### Study Description This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females ### Conditions - Primary Dysmenorrhea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Serum progesterone level - Pain intensity - Physical and psychological symptoms Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD - NCT ID: NCT06359444 - Study ID: ONZ-2023-0453 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-03-15 - Lead Sponsor: University Ghent ### Study Description Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent. ### Conditions - Exercise Therapy - Metabolic Dysfunction-associated Steatotic Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Combined aerobic + strength training - Combined strength + HIIT training ### Outcomes Primary Outcomes - Liver steatosis by CAP - Liver steatosis on ultrasound Secondary Outcomes - Insulin sensitivity - Liver transaminases - Maximal exercise test - Strength - Cardiovascular function - Weight - Heigth - BMI - waist - BIA - Interleukine - TNF-alfa - Hepatokines - Myokines - Adipokines - SF-36 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening - NCT ID: NCT06359431 - Study ID: 1604/CE/CNERSH/SP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-30 - Lead Sponsor: GICMED ### Study Description Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care.Study sites: The study will be carried out in six health facilities in the centre region of Cameroon.Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination.Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine.Patient population: All women between the ages of 21 years and 49 years who come in for consultation.Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site.Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine.Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study. ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - Novel Smart Speculum - Standard speculum ### Outcomes Primary Outcomes - Visualization - Reliability in cervical cancer screening using a questionnaire Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Acupuncture for Obesity With Prediabetes - NCT ID: NCT06359418 - Study ID: 2024-007-KY - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2027-03-30 - Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ### Study Description The clinical trial aims to evaluate the efficacy and safety of acupuncture on weight loss and changes of glucose and lipid metabolism in obese adults with pre-diabetes. ### Conditions - Obesity - Pre-diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture - Sham acupuncture ### Outcomes Primary Outcomes - The percentage change in body weight from baseline to week 12 Secondary Outcomes - The percentage change in body weight compared to the baseline - Achievement of a reduction in body weight of 5% or more compared to the baseline - Achievement of a reduction in body weight of 7% or more compared to the baseline - The change in 1hPG from baseline and percentage of patients who returned to normal - The change in 2hPG from baseline and percentage of patients who returned to normal - The change in FPG from baseline and percentage of patients who returned to normal - The change in HbA1c from baseline and percentage of patients who returned to normal - The change in waist circumference from baseline - The change in BMI from baseline - The change in WHR from baseline - The change in WHtR from baseline - The change in blood pressure from baseline - Changes in appetite VAS score from baseline - The change in FINS from baseline - The change in HOMA-IR from baseline - The change in HOMA-β from baseline - The change in Serum total cholesterol from baseline - The change in Triglyceride from baseline - The change in Low-Density Lipoprotein Cholesterol from baseline - The change in High-Density Lipoprotein Cholesterol from baseline - The change in Serum Uric Acid from baseline - Changes of the score of the European five-dimensional Health scale (EQ-5D-5L) compared with the baseline. - Changes of the PHQ-4 score from the baseline. ### Location - Facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, N/A, N/A, China @@
## Evaluation of Nursing Students' Crisis Management Skills in Medication Safety Simulation - NCT ID: NCT06359405 - Study ID: UBeykentUni - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-05-02 - Lead Sponsor: University of Beykent ### Study Description This study aims to objectively evaluate student nurses' crisis management skills in drug safety simulation and examine an effective intervention to improve these skills through a randomized controlled study. The research aims to provide important findings that will contribute to the determination of strategies to increase the competencies of student nurses in the fields of drug safety and crisis management.Research Hypotheses:H1: The application of drug safety simulation has an effect on the crisis management skill level of nursing students.The aim of the intervention is to develop a simulation program to enhance nursing students' crisis management skills in drug safety. This simulation program will provide students with the opportunity to recognize, assess, and effectively intervene in medication errors in real-world scenarios.The simulation program will include interactive case scenarios, virtual patients, and simulation sessions led by an instructor providing feedback to students. Additionally, learning materials covering topics such as prevention, recognition, and correction of medication errors will be provided ### Conditions - Nurse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - drug safety simulation ### Outcomes Primary Outcomes - The effect of drug safety simulation application on the crisis management skill level of nursing students. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Palliative Care Messaging for American Indians - NCT ID: NCT06359392 - Study ID: DNZNC466DGR7 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-05-15 - Lead Sponsor: South Dakota State University ### Study Description The investigators will be conducting a randomized trial in 3 reservation communities to test the efficacy of the narrative as culture-centric health promotion model for increasing American Indian tribal members' palliative care knowledge and intentions to discuss palliative care. ### Conditions - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - No message - Culture-centric message - General messge ### Outcomes Primary Outcomes - Palliative Care Knowledge Scale (PaCKS) - Knowledge of Care Options (KOCO) - Hospice and Palliative Care Questionnaire (HPCQ) - Identification and Transportation with Palliative Care Message - Attitudes and Intentions to Discuss Palliative Care Secondary Outcomes ### Location - Facility: South Dakota State University, Rapid City, South Dakota, 57701, United States @@
## Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter - NCT ID: NCT06359379 - Study ID: S22-11168 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-02 - Lead Sponsor: Shuttle Pharmaceuticals, Inc. ### Study Description This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy. ### Conditions - Glioblastoma, IDH-wildtype ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ropidoxuridine ### Outcomes Primary Outcomes - Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0. - adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria. - Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. - Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily - Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. - Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. - Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily. Secondary Outcomes - Overall survival at 12 months - Radiographic Response Rate - Disease Control Rate - Best Overall Response - Duration of Response - Overall Survival - Progression-Free Survival - Six-Month Progression-Free Survival - Fraction of patients with tumor progression outside of the treatment area. - Quantification of 9 relevant neurologic domains based on the NANO scale. ### Location - Facility: Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, 20007, United States @@
## Perineal Massage Combined With Hip Joint Training - NCT ID: NCT06359366 - Study ID: ShenzhenH-guo - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-08-31 - Lead Sponsor: Shenzhen Hospital of Southern Medical University ### Study Description The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.Participants will:receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires ### Conditions - Pelvic Floor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - perineal massage combined hip joint training ### Outcomes Primary Outcomes - pelvic floor function(constipation) - pelvic floor function (urinary incontinence score) Secondary Outcomes - hip motion ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Pitavastatin on Bone - NCT ID: NCT06359353 - Study ID: B-1902-520-004 - Status: COMPLETED - Start Date: 2019-04-08 - Completion Date: 2023-12-19 - Lead Sponsor: Seoul National University Bundang Hospital ### Study Description This clinical trial investigates the effects of pitavastatin on bone health in postmenopausal women with osteopenia or osteoporosis and hypercholesterolemia. Given the high prevalence of osteoporosis in aging populations and the associated risks, even with existing treatments, this study addresses a critical gap in medical research. Statins, specifically HMG-CoA reductase inhibitors, are suggested to benefit bone metabolism by promoting bone formation and reducing resorption. However, the specific impact of pitavastatin on bone metabolism lacks clinical evidence.The study's primary goal is to determine the effects of a 12-month pitavastatin regimen on bone metabolism markers in this population. This research could significantly contribute to developing more effective osteoporosis treatments for postmenopausal women, combining bone health and cholesterol management strategies. ### Conditions - Osteoporosis, Osteopenia - Hypercholesterolemia - Menopausal Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Pitavastatin ### Outcomes Primary Outcomes - Change in blood urinary N-Telopeptide of Type I Collagen levels compared to baseline after 6 months Secondary Outcomes - Change in blood C-Telopeptide of Type I Collagen levels - Change in blood Osteocalcin levels - Change in urinary N-Telopeptide of Type I Collagen levels - Change in blood Procollagen Type 1 N-Terminal Propeptide levels - Change in blood LDL-cholesterol levels - Change in blood HbA1c levels - Changes in bone mineral density ### Location - Facility: Seoul National University Bundang Hospital, Seongnam, Gyeonggi, 463-707, Korea, Republic of @@
## Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder - NCT ID: NCT06359340 - Study ID: OBOT-2018C2-13158 - Status: RECRUITING - Start Date: 2020-03-13 - Completion Date: 2025-04-30 - Lead Sponsor: Public Health Management Corporation ### Study Description Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined. ### Conditions - Opioid-use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Psychosocial treatment ### Outcomes Primary Outcomes - Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry Secondary Outcomes - Days Retained in Office-Based Buprenorphine Treatment - Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry - Changes in multidimensional problem severity from baseline through one year post-study entry - Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry - Changes in ED utilization from baseline to one year post-study entry - Changes in opioid overdose rates - Changes in treatment satisfaction from baseline to one year post-study entry ### Location - Facility: Philadelphia College of Osteopathic Medicine, Philadelphia, Pennsylvania, 19131, United States @@
## Effect of Consumption of Pep19 on Quality of Life - NCT ID: NCT06359327 - Study ID: Pro00075623 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2024-08-15 - Lead Sponsor: Proteimax Biotechnology Israel LTD ### Study Description Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods. Pep19 has no effect on the brain, heart, pancreas or skeletal muscle. It is highly purified, not allergenic or mutagenic, and free of microbes, metals and other contaminants. Preliminary, open-label, uncontrolled studies have shown that Pep19 is well tolerated in rodents, dogs, and humans. This placebo-controlled study will evaluate the effects of two doses of Pep19™ -- 2 mg and 5 mg - on quality of life and sleep quality in obese subjects. ### Conditions - Quality of Life - Obesity - Sleep Quality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Placebo - Pep19 2 mg - Pep19 5 mg ### Outcomes Primary Outcomes - Improvement on QoL - Improvement on Sleep quality Secondary Outcomes - Temperature - Blood pressure - Heart rate - circumference - blood tests - Body fat - Body weight ### Location - Facility: Precision Clinical Research, LLC, Sunrise, Florida, 33351, United States @@
## Anxiety Lowering and Deprescribing Through Emotion Regulation - NCT ID: NCT06359314 - Study ID: STU00219362 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: Northwestern University ### Study Description The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are:* Is ALDER relevant to and satisfactory for older adult BZRA users?* Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications?Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after. ### Conditions - Benzodiazepine Dependence - Anxiety Disorders - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ALDER ### Outcomes Primary Outcomes - Feasibility of intervention - Acceptability of intervention - Adoption of intervention Secondary Outcomes - Patient benzodiazepine receptor agonist (BZRA) use - Patient attitude towards deprescribing BZRAs - Patient-reported sleep disturbance - Patient-reported anxiety - Patient-reported stress - Patient-reported depression - Patient-reported positive affect - Patient-reported meaning and purpose - Patient-reported comorbidities ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## H-34 DELTA Revision Cup - NCT ID: NCT06359301 - Study ID: H-34 - Status: RECRUITING - Start Date: 2021-09-14 - Completion Date: 2029-03-31 - Lead Sponsor: Limacorporate S.p.a ### Study Description THis study is aimed to provide a clinical and radiographic evaluation of 49 suitable subjects who underwent a total hip arthroplasty with DELTA Revision acetabular cup. ### Conditions - Hip, Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DELTA Revision acetabular cup ### Outcomes Primary Outcomes - Harris Hip Score (HHS) Secondary Outcomes - ROM measurement - Oxforn Hip Score (OHS) - Survival rate - Radiographic implant evaluation and stability assessment of the DELTA Revision acetabular cup - Incidence, type and severity of all the Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), and Serious Adverse Device Effects (SADEs) occurred at each follow-up ### Location - Facility: Samodzielny Publiczny Szpital Kliniczny im. Prof. Adama Grucy CMKP, Otwock, N/A, 05-400, Poland @@
## Preterm Newborn Mothers' Anxiety and Self-Efficacy - NCT ID: NCT06359288 - Study ID: 2023/01.11/2023/6 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-23 - Lead Sponsor: Kocaeli University ### Study Description The aim of this study was to evaluate the effect of QR code supported infant care training given to mothers of preterm newborns on maternal self-efficacy and maternal anxiety level . ### Conditions - Nursing Care - Mother-Infant Interaction - Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Group receiving QR code supported training ### Outcomes Primary Outcomes - Perceived Maternal Self-Efficacy Scale (PMES)- Survey Secondary Outcomes - State-Trait Anxiety Inventory (STAI)- Survey Scale ### Location - Facility: Kocaeli University, Kocaeli, İzmit, 41380, Turkey @@
## PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients - NCT ID: NCT06359275 - Study ID: iPULSAR-PC - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-10-01 - Lead Sponsor: Fudan University ### Study Description This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PD-1 - Nab-paclitaxel - Gemcitabine - PULSAR ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Progression-free survival (ORR) - Overall survival (OS) - Surgical Conversion Rate ### Location - Facility: Fudan University Shanghai Cancer Center, Shanhai, N/A, N/A, China @@
## Evaluating the Hope@School Prevention Program - NCT ID: NCT06359262 - Study ID: KI-HAS-001 - Status: NOT_YET_RECRUITING - Start Date: 2027-01-01 - Completion Date: 2028-12-30 - Lead Sponsor: Karolinska Institutet ### Study Description This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).The primary objectives of the study are:To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health. ### Conditions - Mental Health Wellness 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Hope@School - Treatment as usual ### Outcomes Primary Outcomes - KIDSCREEN-27 Child version Secondary Outcomes - KIDSCREEN-27 Parent version - Mental Health-Promoting Knowledge (MHPK-10) - Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1 - Digital Addiction Scale for Children (DASC) - Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Do the Symptoms of Chronic Constipation Improve With a Primary Care Programme Based on Behavioural Re-education and Abdominal Massage? - NCT ID: NCT06359249 - Study ID: V.3-06/02/2024 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-28 - Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina ### Study Description Constipation is one of the most common digestive problems in today's society. In Spain, it is estimated that this condition affects between 12% and 20% of the population, being more frequent in women, contributing considerably to the quality of life, to the increase of medical visits and to high costs for the health system. The objectives of the study are to reduce the rate of constipation and laxative use in the short term with a structured rehabilitation programme consisting of abdominal massage therapy and behavioural re-education, to improve the quality of life of these patients, and to assess whether the proposed treatment is effective in the short and medium term. ### Conditions - Constipation Chronic Idiopathic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - change of habits - change of habits + auto abdominal massage ### Outcomes Primary Outcomes - Degree of constipation - Stool characteristics - Quality of life focused on patients with constipation - The number of laxatives taken by each participant Secondary Outcomes - Other patient characteristics such as sex, age, previous conditions, and level of physical activity with the VREM questionnaire. ### Location - Facility: Cristina Segura Bayona, Igualada, Barcelona, 08700, Spain @@
## Development and Effectiveness of Cognitive Behavioral Therapy Based Weight Control Mobile Application "BI'KILO" - NCT ID: NCT06359236 - Study ID: 122S049 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-01 - Completion Date: 2024-04-01 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description The primary purpose of this project is to observe the effects of Cognitive Behavioral Psychotherapy-based weight-loss mobile application (Bi' Kilo) in 4 essential areas (Anthropometric, Biochemical, Psychometric, Cognitive) in overweight and obese individuals and to test whether these effects will persist after ten weeks. In this context, the original value of the proposed study is that a mobile application will be produced that is suitable for the culture and whose effectiveness has been scientifically proven.In our current project proposal, the measurements of the participants will be evaluated holistically together with both tests and inventories, as well as physical measurements and biochemical data. In this study, the usability of the mobile application to be developed will also be evaluated and reported.The study group of the research will consist of overweight and obese individuals. The first stage will be a pilot study to identify the shortcomings of the Bi'Kilo mobile application. After eliminating the deficiencies of the Bi' Kilo mobile application, a working group will be formed in the second phase of the research. At this stage, the sample will be divided into two different groups within the scope of the study and a study group and a control group will be formed.The study consists of three phases as preparation, implementation, and follow-up. Measurements of the participants will be made at the beginning (Anthropometric, Biochemical, Psychometric, Cognitive), at the end of the six-week implementation phase (Anthropometric), and at the end of the four-week follow-up phase (Anthropometric, Biochemical, Psychometric, Cognitive). ### Conditions - Weight Loss - Obesity - Overweight and Obesity - Eating Behavior - Eating Habit ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI'KILO Intervention ### Outcomes Primary Outcomes - Body Mass Index (BMI) Secondary Outcomes - Weight - Height - Waist Circumference (WC) - Hip Circumference - Waist-Hip Ratio (WHR) - Body Fat Percentage (BFP) - Visceral Fat - Blood Glucose Level - Blood Insulin Level - Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) - Serum Leptin Level - Serum Ghrelin Level - Emotional Eating Scale (EES) Turkish Form - Mindful Eating Questionnaire (MEQ) Turkish Form - Modified Yale Food Addiction Scale Version 2.0 Turkish Form (mYFAS 2.0) - Motor Screening Task (MOT) - Spatial Working Memory (SWM) - Stop Signal Task (SST) - Rapid Visual Information Processing (RVP) - Cambridge Gambling Test (CGT) ### Location - Facility: Eskisehir Osmangazi University Faculty of Medicine, Eskişehir, N/A, N/A, Turkey @@
## Effect of Coffee Consumption on Pain and Intestinal Motility After Caesarean Section: - NCT ID: NCT06359223 - Study ID: 2400602 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-12-30 - Lead Sponsor: TC Erciyes University ### Study Description Purpose: It will be performed to minimize the problems that the mother and the newborn may experience in the postpartum period by eliminating the negative symptoms related to postpartum pain and delayed intestinal motility.Design: It will be conducted as a randomized controlled experimental study. Method: It will consist of women who had cesarean section surgery at Necmettin Erbakan University Faculty of Medicine Hospital between April and July 2024. The sample of the research; The sample will consist of women who meet the selection criteria and voluntarily agree to participate in the research. Considering the possible 10% data loss in randomized controlled studies, a total of 50 women, 25 in each group, were planned to be sampled. Data will be collected using a personal information form and visual pain scale (VAS). . Immediately before coffee application (6-12-18 hours after surgery), women\'s pain intensity and bowel motility will be evaluated. Women will then be asked to consume 100 ml of unsweetened caffeinated coffee at 6, 12 and 18 hours after surgery. 6,12,18. Half an hour after coffee consumption, women will be evaluated for pain using VAS. In the control group, no procedure will be applied and pain assessment will be made with VAS at the same hours.Conclusion: It is aimed to reduce the pain and increase intestinal motility of patients who consume coffee after cesarean section.Key Words: Caesarean Section, Coffee, Pain, Motility ### Conditions - Operation - Cesarean Section ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - coffee consumption - control group ### Outcomes Primary Outcomes - Postoperative Pain - intestinal motility Secondary Outcomes ### Location - Facility: KTO Karatay Unıversty, Konya, Karatay, 42000, Turkey @@
## Sustaining Physical Activity After Cancer Exercise Sessions - NCT ID: NCT06359210 - Study ID: 4973 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-12-31 - Lead Sponsor: Colorado State University ### Study Description The goal of this clinical trial is to develop and test an adaptive physical activity (PA) maintenance intervention for cancer survivors, after participating in a community-based exercise oncology program. The main questions it aims to answer are:* Aim 1: Examine the feasibility and acceptability of the intervention among cancer survivors and community partners. The researchers will utilize quantitative surveys, focus groups, and semi-structured interviews to collect information about feasibility, implementation, adaptation, and sustainability.* Aim 2: Examine the effects of the intervention among cancer survivors. The researchers will compare the proportion of participants achieving the exercise guidelines for cancer survivors six-months following completion of the initial exercise program.Participants will participate in a community-based exercise oncology program and then return to three months of free living. Based on the PA measured at the three-month follow-up, participants will be categorized as a "Responder" or "Incomplete Responder", and then randomized to the PA maintenance intervention. Researchers will compare those that are classified as Responders (meeting exercise guidelines for cancer survivors) and Incomplete Responders (not meeting guidelines for cancer survivors) to see what level of intervention is needed to influence sustainable behavior change in this population. ### Conditions - Exercise Oncology - Physical Activity Behavior - Behavior Change Interventions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Responder Monthly Behavior Change Discussion Sessions - Incomplete Responder Monthly Behavior Change Discussion Sessions - Incomplete Responder Monthly Behavior Change Discussion Sessions + Bi-Weekly Exercise Sessions ### Outcomes Primary Outcomes - Physical Activity program Secondary Outcomes - Quality of Life (QOL) - Physical Fitness - Aerobic - Physical Fitness - muscular strength and endurance ### Location - Facility: Anschutz Medical Center, Aurora, Colorado, 80045, United States @@
## Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease - NCT ID: NCT06359197 - Study ID: 2024-17022-GRA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-06-01 - Lead Sponsor: Hamilton Health Sciences Corporation ### Study Description Caffeine is one of the most widely consumed substances worldwide. This study looks to test and measure the changes in different biomarkers in the blood before and after having caffeine using capillary and venous blood sampling methods. A biomarker is a measurable indicator of biological processes. The primary goal of this clinical trial is to evaluate participant rate and adherence. It will also learn about how caffeine affects different biomarkers that may be related to cardiovascular disease. Finally, it will assess the accuracy of the capillary blood samples compared to the venous blood samples. The main questions it aims to answer are:* What is the feasibility of recruiting and retaining participants?* Are the study procedures appropriate to be translated to a larger future study?Researchers will compare caffeine to a placebo (a look-alike substance that contains no drug) to see ifParticipants will:* Be randomly assigned to the control group or the caffeine group. Individuals in the control group will be taking a placebo pill with no effect and those in the caffeine group will be taking 400mg of caffeine in pill form.* Be asked to undergo a fast of at least 8 hours overnight before taking two placebo pills or the 400 mg of caffeine via two caffeine pills. They will be required to stay fasted for 6 hours after taking the pill as well. The total time fasted will be at least 14 hours.* Have blood collected using three different methods before taking the two pills, 3 hours after taking the pills and 6 hours after taking the pills. The 3 methods include intravenous (IV) blood sampling, finger prick and collection on Whatman 903 Protein Saver Card and collection using the TASSO+ device. The TASSO+ blood collection device is a small capillary blood collection device that is designed to be easy to use and able to be used outside of a hospital/lab setting. Whatman 903 Protein Saver Cards are special filter paper with five circles for samples, that are designed for the collection and storage of blood. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Caffeine Pill - Placebo - TASSO+ Device - Finger prick and collection on Whatman Protein 903 Saver Cards - Intravenous Sampling ### Outcomes Primary Outcomes - Participant rate - Participant Adherence - Participant satisfaction Secondary Outcomes - Significant changes in biomarkers observed after the ingestion of caffeine - Determine the correlation between capillary sampling and intravenous sampling - Determine the stability of capillary samples ### Location - Facility: David Braley Research Institute, Hamilton, Ontario, L8L 2X2, Canada @@
## Yoga, Mother's Stress and Baby - NCT ID: NCT06359184 - Study ID: GO21/1011 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-02-15 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems. ### Conditions - Mother-Child Relations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - yoga - control ### Outcomes Primary Outcomes - Perceived Stress Scale (PSS) - Infancy and Early Childhood Feeding Process Mother's Attitudes Scale - Pittsburg Sleep Quality (PSQI) - Period Adaptive Eating Behavior Scale - Brief Infant/Child Sleep Questionnaire (BISQ) Secondary Outcomes ### Location - Facility: Ayşe Nur Ozan, Istanbul, Sarıyer, 34460, Turkey @@
## Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT - NCT ID: NCT06359171 - Study ID: RBHP 2023 LANHERS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2026-01-31 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Application ARTH-e ### Outcomes Primary Outcomes - Exercise Adherence Rating Scale Secondary Outcomes - Pain Visual Analog Scale - EPAP questionnaire - TSK questionnaire - Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire - EQ-5D-3L questionnaire - Mobility - Average number of steps per day - Parameters for use of the ARTHE application - Functional tests - 30 sec chair lifts - Functional tests - Stair Climbing Test - Functional tests - 6MWT - Functional tests - quadriceps isometric strength test with dynamometer - Medico-economic analysis ### Location - Facility: CHU Clermont-Ferrand, Clermont-Ferrand, N/A, N/A, France @@
## Enhancing Respiratory Auscultation Skills Among Medical Students: Digital Stethoscopes in Medical Education - NCT ID: NCT06359158 - Study ID: eStethoscope for Med Student - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-31 - Lead Sponsor: Chung Shan Medical University ### Study Description Objectives: This study aims to assess the effectiveness of a novel digital stethoscope curriculum integrated into respiratory auscultation training for medical students. It seeks to compare the auscultation proficiency gained through this innovative approach with that from traditional teaching methods, to understand the potential of digital stethoscopes in reinvigorating clinical skills training.Methods: In a single-center, controlled, longitudinal, randomized experimental design, 84 medical students undergoing clinical clerkship rotations at Chung Shan Medical University Hospital were enrolled. Participants were randomly assigned to either the intervention group, receiving training with digital stethoscopes and the Eko auscultation software, or the control group, following a traditional curriculum. Pre- and post-intervention assessments measured auscultation skills, and student feedback on teaching quality was collected. The primary outcome was the improvement in auscultation proficiency, while secondary outcomes included student engagement and feedback on the educational approach.Expected Results: The investigators hypothesize that the integration of digital stethoscopes into the curriculum will significantly improve the auscultation skills of medical students compared to traditional methods. Enhanced engagement and positive feedback from students are anticipated, underscoring the pedagogical value of incorporating digital health technologies in medical education. ### Conditions - Auscultation - Breathing Sound - Asthma - Pneumonia - Pleural Effusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Digital stethoscope use ### Outcomes Primary Outcomes - Pre-test and Post-test using the Zuvio Interactive Response System (Zuvio, Taipei, Taiwan) - Student Feedback Secondary Outcomes ### Location - Facility: Chung Shan Medical University Hospital, Taichung, South, 402, Taiwan @@
## Prediction of COPD Severity Using Electrical Impedance Tomography - NCT ID: NCT06359145 - Study ID: EIT and COPD - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-08-01 - Lead Sponsor: Chinese PLA General Hospital ### Study Description The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD. ### Conditions - Electric Impedance - Respiratory Function Tests - Pulmonary Disease, Chronic Obstructive ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The predictive power of EIT and PFT for CT visual scoring of emphysema Secondary Outcomes ### Location - Facility: PLA, Beijing, Beijing, 100853, China @@
## mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients. - NCT ID: NCT06359132 - Study ID: TeleConvert-AF - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-01-01 - Lead Sponsor: Maastricht University Medical Center ### Study Description Despite a clear definition in the European Society of Cardiology (ESC) guidelines, the differentiation between paroxysmal (self-terminating) and persistent (nonself- terminating) atrial fibrillation (AF) remains challenging in clinical practice. Some patients with presumed persistent AF are planned for electrical cardioversion (ECV) but appear to have a paroxysmal pattern or present in sinus rhythm (SR) at the scheduled ECV appointment. This results in unnecessary visits or interventions for patients, and costs and burden for the hospitals and health insurances. Based on the feasibility of the TeleCheck-AF approach, which is an on-demand mobile health (mHealth) infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation, the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV. ### Conditions - Atrial Fibrillation - Arrhythmia - Mobile Health - Electrical Cardioversion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments Secondary Outcomes - Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions - Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire - Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments - Number of patients with paroxysmal AF - Time to recurrence of AF - Time period of monitoring heart rate and rhythm using the mHealth-based application - Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments ### Location - Facility: Maastricht University Medical Center, Maastricht, Limburg, N/A, Netherlands @@
## Implementation of Apnoea Test for Patients With Suspected Brain Death - NCT ID: NCT06359119 - Study ID: IMAPing SUBDEP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-31 - Lead Sponsor: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged ### Study Description This study consists of a survey created for intensive care physicians regarding their current practice of the implementation of apnoea test for patients with suspected brain death. ### Conditions - Brain Death ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of apnoea tests - Timeframe between apnoea tests - Preoxygenation - Baseline arterial carbon dioxide (CO2) level Secondary Outcomes - Detection of possible spontaneous breath movements - Satisfaction with current practice ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Different Inhaled Oxygen Concentrations on Lung Function in Older Patients After Laparoscopic Gastrointestinal Surgery Under General Anesthesia - NCT ID: NCT06359106 - Study ID: 2024.3.1 - Status: RECRUITING - Start Date: 2024-05-10 - Completion Date: 2025-12-31 - Lead Sponsor: China Medical University, China ### Study Description This was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low FiO2 (40%) and high FiO2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. ### Conditions - Oxygenation Index ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 80% Oxygen - 40% Oxygen ### Outcomes Primary Outcomes - Oxygenation Index Secondary Outcomes - pH value in blood gas analysis 48 hours after the operation - oxygen inhalation time - inspired oxygen concentration - oxygen uptake rate - 7 days pulmonary complications - 30-day Mortality - PaCO2 in blood gas analysis 48 hours after the operation - Lactic acid in blood gas analysis 48 hours after the operation ### Location - Facility: Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning, 110001, China @@
## Prevalence Of Non-Carious Cervical Lesions, Associated Risk Indicators and Salivary Assessment Among Middle Adulthood Patients. - NCT ID: NCT06359093 - Study ID: 14422023557605 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-09 - Lead Sponsor: Cairo University ### Study Description The aim of this study is to describe the prevalence of non-carious cervical lesions in middle adulthood patients attending the Cairo University Dental Educational Hospital and to analyze the distribution of lesions by gender and age, tooth functional group, jaw, arch side and tooth surface. Moreover, to explore the associated risk indicators of the lesions as well as the quantity of saliva, as one of the potential etiological factors, will be assessed. ### Conditions - Non-carious Cervical Lesions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of non-carious cervical lesions (NCCLs) in Middle adulthood patients (41-60 years old) attending Diagnostic central clinic at the Cairo University Dental Educational Hospital. Secondary Outcomes - Associated risk indicators for all participants. 3.Salivary assessment regarding flow rate and pH for subgroup diagnosed with non-carious cervical lesions. ### Location - Facility: Faculty of Dentistry, Cairo, N/A, N/A, Egypt @@
## Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL) - NCT ID: NCT06359080 - Study ID: 120200004OL - Status: COMPLETED - Start Date: 2022-05-08 - Completion Date: 2022-12-11 - Lead Sponsor: JelikaLite LLC ### Study Description The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cognilum TM: Light Treatment Condition ### Outcomes Primary Outcomes - Change in Autism Symptoms Secondary Outcomes ### Location - Facility: Dr. Steingold Psychology PC, Brooklyn, New York, 11229, United States @@
## A Real-World Study of Bispecific Antibodies in Multiple Myeloma - NCT ID: NCT06359067 - Study ID: APHP240295 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2023-12-31 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP). ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Treated by bispecific antibodies, teclistamab or elranatamab in usual care - Not treated by bispecific antibodies in usual care ### Outcomes Primary Outcomes - Infection rate Secondary Outcomes - Global survival - Progression-free survivals ### Location - Facility: Assistance Publique - Hôpitaux de Paris (AP-HP), Paris, IDF, 75004, France @@
## The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging - NCT ID: NCT06359054 - Study ID: CelalBayarNRG - Status: COMPLETED - Start Date: 2020-11-11 - Completion Date: 2023-09-15 - Lead Sponsor: Celal Bayar University ### Study Description Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 18F FDG PET/CT - 68Ga DOTATATE PET/CT ### Outcomes Primary Outcomes - Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT Secondary Outcomes ### Location - Facility: Manisa Celal Bayar University Faculty of Medicine, General Surgery Department, Manisa, N/A, 45030, Turkey @@
## RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis - NCT ID: NCT06359041 - Study ID: CAB-201-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2029-09 - Lead Sponsor: Cabaletta Bio ### Study Description RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis ### Conditions - Generalized Myasthenia Gravis (gMG) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CABA-201 ### Outcomes Primary Outcomes - To evaluate incidence and severity of adverse events (AEs) Secondary Outcomes - To evaluate the incidence and severity of adverse events (AEs) - To characterize the pharmacodynamics (PD) - To characterize the pharmacokinetics (PK) - To evaluate disease-related biomarkers - To evaluate efficacy by change in Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over time. - To evaluate efficacy by change in Quantitative Myasthenia Gravis (QMG) score over time. - To evaluate efficacy by change in Myasthenia Gravis Composite (MGC) score over time. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers - NCT ID: NCT06359028 - Study ID: 300103 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-06-20 - Lead Sponsor: HALEON ### Study Description The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste. ### Conditions - Dentin Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stannous fluoride toothpaste - Crest cavity protection toothpaste ### Outcomes Primary Outcomes - Change from Baseline in Schiff Sensitivity Score at Day 56 Secondary Outcomes - Change from Baseline in Tactile Threshold at Day 56 - Change from Baseline in Schiff sensitivity score at Day 28 - Change from Baseline in Tactile Threshold at Day 28 - Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56 - Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56 - Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56 - Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56 - Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56 - Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56 - Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56 - Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56 - Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56 ### Location - Facility: Salus Research, Fort Wayne, Indiana, 46825, United States @@
## Metformin and Esomeprazole in Preterm Pre-eclampsia - NCT ID: NCT06359015 - Study ID: 41138 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-02-11 - Completion Date: 2025-06 - Lead Sponsor: Christiana Care Health Services ### Study Description The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia. ### Conditions - Preeclampsia Severe - Pre-Eclampsia - Preeclampsia - Preeclampsia Second Trimester - Preeclampsia Complicating Childbirth - Preeclampsia Puerperium - Preterm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin - Esomeprazole ### Outcomes Primary Outcomes - Mean plasma difference in sFlt-1 Secondary Outcomes - Mean plasma difference in vascular endothelial growth factor (VEGF) - Mean plasma difference in placental growth factor (PIGF) - Mean plasma difference in soluble endoglin (sEng) - sFlt-1:PIGF ratio - Prolongation of gestation ### Location - Facility: Christianacare Health System, Newark, Delaware, 19718, United States @@
## Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. - NCT ID: NCT06359002 - Study ID: BYON4413.001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-03 - Lead Sponsor: Byondis B.V. ### Study Description This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS. ### Conditions - Relapsed / Refractory AML - Relapsed / Refractory MDS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BYON4413 ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (dose escalation) - Composite Complete Remission Rate (expansion) Secondary Outcomes - Incidence and severity of adverse events - Number of patients with dose modifications - Rate of early death - Maximum Plasma Concentration (Cmax) BYON4413 - Time to Cmax (Tmax) BYON4413 - Area under the curve (AUC) BYON4413 - Percentage of patients with confirmed anti-BYON4413 antibodies - Composite Complete Remission Rate (dose escalation) - Percentage of blasts in bone marrow change from baseline - Percentage of blasts in peripheral blood change from baseline - Objective response rate - Duration of response - Relapse-free survival - Event-free survival - Time to response - Overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults - NCT ID: NCT06358989 - Study ID: Insulin resistance - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Assiut University ### Study Description The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults ### Conditions - Insulin Resistance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HOMA IR ### Outcomes Primary Outcomes - Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Anti-Spastic Splint With Focal Muscle Vibration for Stroke Hand Spasticity - NCT ID: NCT06358976 - Study ID: Spasticity splint and FMV - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2024-12-30 - Lead Sponsor: Arab American University (Palestine) ### Study Description Title: The Effect of Vibrating Splint on Hand Function After StrokeSummary:This study aims to investigate the effectiveness of a vibrating splint in improving hand function and reducing spasticity among individuals who have experienced a stroke. Stroke is a major global health issue, often resulting in long-term disability and impairments in the upper limbs. Spasticity, a common complication of stroke, causes stiffness and involuntary muscle contractions, leading to difficulties in performing daily activities.Current treatment options for spasticity include medications and physical therapy techniques. However, these approaches may have limitations in terms of effectiveness and duration of benefits. Therefore, non-pharmacological interventions are being explored to enhance rehabilitation outcomes.The hypothesis of this study is that the use of a vibrating splint, which applies mechanical vibrations to the hand muscles, will decrease spasticity and improve hand functionality in individuals with chronic stroke. The vibrations from the splint stimulate the sensory receptors in the skin and muscles, leading to muscle relaxation and improved motor control.The study will be conducted as a pilot randomized controlled trial, involving participants who meet specific eligibility criteria. The participants will be divided into three arms, with each arm receiving a different intervention. Outcome measures, including assessments of spasticity, range of motion, pain levels, and functional abilities, will be collected before and after the intervention period.The findings from this study will contribute to the understanding of non-pharmacological approaches in managing spasticity and improving hand function after stroke. If the vibrating splint proves to be effective, it could offer a safe and accessible option for stroke survivors to enhance their recovery and regain independence in daily activities.This research is essential as it addresses the need for more effective interventions for spasticity management and hand rehabilitation after stroke. By providing valuable insights into the potential benefits of the vibrating splint, this study has the potential to improve the quality of life for individuals who have experienced a stroke and empower them to regain control over their hand movements. ### Conditions - Spasticity as Sequela of Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: OTHER ### Interventions - Vibration plus anti-spastic hand splint - Anti-spastic hand splint - Vibration ### Outcomes Primary Outcomes - Modified Ashworth Scale (MAS) - Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - Range of Motion Assessment - Numeric pain rating scale (NRS) Secondary Outcomes ### Location - Facility: Arab American University, Jenin, N/A, 240, Palestinian Territory, occupied @@
## CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva. - NCT ID: NCT06358963 - Study ID: 131 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-20 - Completion Date: 2024-05-10 - Lead Sponsor: Amirhossein Farahmand ### Study Description Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials) ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Receive 30 mg of Coq10 - Non-Medicare Drugs ### Outcomes Primary Outcomes - reduction of bleeding on probing Secondary Outcomes - total Antioxidant capacity of saliva ### Location - Facility: Amirhossein Farahmand, Tehran, N/A, 1947833113, Iran, Islamic Republic of @@
## A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 - NCT ID: NCT06358950 - Study ID: ALKS 2860-201 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-07 - Lead Sponsor: Alkermes, Inc. ### Study Description The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone. ### Conditions - Narcolepsy Type 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ALKS 2680 - Placebo ### Outcomes Primary Outcomes - Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6 Secondary Outcomes - Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6 - Mean weekly cataplexy rate (WCR) as derived by subject cataplexy - Incidence of adverse events ### Location - Facility: Alkermes Investigational Site, Huntersville, North Carolina, 28708, United States @@
## Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis - NCT ID: NCT06358937 - Study ID: #7/2023 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-05 - Lead Sponsor: Mahmoud Salem ### Study Description The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis. ### Conditions - Periodontal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser Assisted New Attachment Procedure using ND:YAG laser - Laser Assisted New Attachment Procedure using diode laser - Scaling and Root Planing using ultrasonic and curettes ### Outcomes Primary Outcomes - Microbiological assessment of Fusobacterium nucleatum - Microbiological assessment of Porphyromonas gingivalis - Microbiological assessment of Tannerella forsythia Secondary Outcomes - Gingival index - Plaque index - Clinical attachment loss - Probing depth ### Location - Facility: Faculty of Dentistry, Alexandria University, Alexandria, N/A, N/A, Egypt @@
## Effect of Different Desensitizing Agents on Post-bleaching Hypersensitivity and Shade Stability - NCT ID: NCT06358924 - Study ID: FDASU-RecID032004 - Status: COMPLETED - Start Date: 2021-11-13 - Completion Date: 2023-09-20 - Lead Sponsor: Ain Shams University ### Study Description This study compared the effect of four different desensitizing agents on shade stability and dental hypersensitivity following dental bleaching procedure. The follow-up periods ranged from 24 hours to 1 year. ### Conditions - Tooth Hypersensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Potassium nitrate with fluoride - Casein phosphopeptide-amorphous calcium phosphate with fluoride - Hydroxyapatite with fluoride - PAMAM-carboxylic acid dendrimer ### Outcomes Primary Outcomes - Post-bleaching hypersensitivity - Shade stability Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Ain Shams University, Cairo, El Weilli, 4393005, Egypt @@
## A Clinical Study for the Effect of 4th Generation Poly AmidoAmine Dendrimer on Post-Bleaching Hypersensitivity and Shade Stability - NCT ID: NCT06358911 - Study ID: FDASU-RecID022001 - Status: COMPLETED - Start Date: 2021-11-13 - Completion Date: 2023-09-10 - Lead Sponsor: Ain Shams University ### Study Description This study assessed the impact of four desensitizing agents on both color stability and dental sensitivity following a bleaching procedure, spanning from the 24-hour to the 1-year follow-up assessment periods. ### Conditions - Tooth Hypersensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Poly amido amine dendrimer (PAMAM) - Manufacturer's desensitizing agent, Ultra EZ - MI paste plus, desensitizing agent - Hydroxyapatite and F (ReminPro), desensitizing agent ### Outcomes Primary Outcomes - Post-bleaching dental hypersensitivity - Shade stability Secondary Outcomes ### Location - Facility: Faculty of Dentistry - Ain Shams University, Cairo, El Weili, 4393005, Egypt @@
## Digital Mood-enhanced CBT-I to Improve Depressive Symptoms in Adolescents - NCT ID: NCT06358898 - Study ID: 20221207 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2026-12-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Emerging encouraging evidence showed that sleep focused treatment can simultaneously improve sleep and depression in adult with comorbid conditions. Although these favorable changes in depressed adults is encouraging, little is known in the potential efficacy of CBT-I in altering depression trajectory in adolescent population. This current study aims to compare the effect of digitally delivered, mood enhanced cognitive behavioral therapy for insomnia (M-dCBT-I) and standard digital cognitive behavioral therapy for insomnia (dCBT-I) in improving depressive symptoms in adolescents, and to examine the potential sustained treatment effect in mood outcomes following M-dCBT-I or dCBT-I treatment. ### Conditions - Insomnia - Depression - Adolescent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Standard dCBT-I - Modified Mood enhanced CBT-I (M-dCBT-I) ### Outcomes Primary Outcomes - Depressive symptoms Secondary Outcomes - Assessor-rated depressive symptomatology - Overall severity of depression symptoms - Severity of insomnia symptoms - Sleep-wake pattern - Sleep-related beliefs and cognitions - Daytime sleepiness - Anxiety and depression symptoms - Quality of life by KIDSCREEN-27 ### Location - Facility: Department of Psychiatry, the Chinese University of Hong Kong, Sha Tin, New Territories, N/A, Hong Kong @@
## IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention - NCT ID: NCT06358885 - Study ID: 22-3123 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI. ### Conditions - HIV-1-infection - Unhealthy Alcohol Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Facilitation (FAC) - Experiential Brief Alcohol Intervention (EBAI) ### Outcomes Primary Outcomes - Fidelity Score - Viral Suppression Secondary Outcomes - BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale - BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers - BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers - Penetration- Proportion of PWH Screened with the AUDIT-C - Penetration - Proportion of PWH who screen positive who receive at least one counseling session - Costs - Sustainability Score: Provider Support of Sustainment Scale (PRESS) - AUDIT (total score) - Clinic staff - AUDIT (total score) - PWH - Fidelity (Extended Window) ### Location - Facility: Hanoi Medical University, Hanoi, N/A, N/A, Vietnam @@
## Azithromycin for Child Survival in Niger II - NCT ID: NCT06358872 - Study ID: 23-39839 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2028-04-29 - Lead Sponsor: University of California, San Francisco ### Study Description Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years. ### Conditions - Mortality - Antimicrobial Resistance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Azithromycin for Oral Suspension ### Outcomes Primary Outcomes - All-cause mortality - All-cause mortality - Prevalence of resistance to macrolides - nasopharyngeal swabs - Prevalence of resistance to macrolides - nasopharyngeal swabs - Load of genetic determinants of resistance to macrolides - rectal swabs - Load of genetic determinants of resistance to macrolides - rectal swabs Secondary Outcomes - Number of clinic visits - infectious - Number of clinic visits - infectious - Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs - Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs - Program Cost Per Dose Delivered ### Location - Facility: Program National de Santé Oculaire, Niamey, N/A, N/A, Niger @@

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