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## The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section - NCT ID: NCT06304246 - Study ID: FU-S.OZCAN 001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-30 - Lead Sponsor: Firat University ### Study Description Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures.It is known that one of the most important factors affecting mothers\&#39; approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients\&#39; perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors.We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels.In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use. ### Conditions - Obstetric Pain - Cesarean Section - Postoperative Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measurement Pain Threshold - Measurement of Serum Asprosin ### Outcomes Primary Outcomes - Preoperative Asprosin Level - Postoperative Pain Secondary Outcomes - Postoperative analgesic consumption ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - NCT ID: NCT06304233 - Study ID: 606103 - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2038-06 - Lead Sponsor: Norwegian University of Science and Technology ### Study Description To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia. ### Conditions - Heart Diseases - Heart; Functional Disturbance - Schizophrenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography - Cardiac Magnetic Resonance Imaging - Electrocardiography - Blood sampling ### Outcomes Primary Outcomes - Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography - Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography - DISC1 mRNA quantification - Levels of high sensitive-CRP - Levels of CK-MB - Levels of Troponin T - Levels of Troponin I - Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter - Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter - Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter - Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter - Left ventricular mass measured by echocardiography - Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography - Fractional shortening measured by echocardiography - Global longitudinal strain (GLS), echocardiographic parameter - TAPSE echocardiographic parameter of right ventricular longitudinal systolic function - Echocardiographic parameter MPI, Myocardial performance index - Echocardiographic parameter Mitral E/A ratio - Echocardiography parameter of peak E velocity - Echocardiography parameter of E wave deceleration time - Echocardiography parameter of ratio of E/e' - Echocardiographic parameters septal e' and lateral e' velocities - Echocardiographic parameter LAVI, left atrial volume indexed - Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity - Echocardiographic parameter, S wave velocity - Echocardiographic parameter, Indexed LV and RV stroke volumes - Levels of NT-proBNP - Levels of IGF1 - Levels of ANP - Levels of BDNF, brain derived neurotrophic factor - Levels of Tumor Necrosis Factor alpha - Levels of Transforming Growth Factor Beta - Levels of cardiac Myosin-Binding Protein C - Interleukin levels Secondary Outcomes - native T1 time, cardiac MRI - Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI - Indexed LV mass, cardiac MRI - LV Ejection Fraction, cardiac MRI - ECG corrected QT interval - Number of participants with and abnormal ECG - Number of participants with abnormal liver function - Number of participants with abnormal kidney function - Number of participants with abnormal thyroid function - Number of participants with low Vitamin D levels - Incidence of cardiovascular disease or mortality as registered in a health registry on follow up - Triglyceride levels - High-density lipoprotein, HDL-cholesterol levels - Low-density lipoprotein, LDL-cholesterol levels - Fasting glucose levels - Glycated Hemoglobin (HbA1c) levels - Heart rate measured on ECG - Systolic Blood Pressure - Diastolic Blood Pressure - Lipoprotein a - Magnesium levels - Calcium levels - Sodium levels - Potassium levels ### Location - Facility: Norwegian University of Science and Technology, Trondheim, N/A, N/A, Norway @@
## Comparison of Two PPOS Models for Pituitary Suppression - NCT ID: NCT06304220 - Study ID: MedroGestrel - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: NextFertility ### Study Description The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients. ### Conditions - Infertility, Female - Fertility Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cerazet ### Outcomes Primary Outcomes - Total number of oocytes retrieved from follicular puncture - Number of mature oocytes (MII) retrieved from follicular puncture Secondary Outcomes - Oocyte quality variables - Ovarian sensitivity index (OSI - Follicles ### Location - Facility: NextFertility, Valencia, Comunidad Valenciana, 46009, Spain @@
## Telehealth and Onsite Maintenance Exercise in COPD - NCT ID: NCT06304207 - Study ID: 300423 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2026-03-01 - Lead Sponsor: MGH Institute of Health Professions ### Study Description The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD.The specific aims of the study are:* To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention.* To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation.Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention. ### Conditions - Copd - COPD Exacerbation - COPD Bronchitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Onsite Maintenance Exercise Training - Telehealth Maintenance Exercise ### Outcomes Primary Outcomes - Exercise Capacity - Exercise Capacity - Exercise Capacity - Dyspnea - Dyspnea - Dyspnea - Physical Function - Physical Function - Physical Function - Quality of life measure - Quality of life measure - Quality of life measure Secondary Outcomes - Inspiratory muscle strength - Inspiratory muscle strength - Inspiratory muscle strength - Physical activity - Physical activity - Physical activity - Participants adherence to the program - Healthcare utilization - Adverse events - PROMIS Global 10 score - PROMIS Global 10 score - PROMIS Global 10 score ### Location - Facility: MGH Institute of Health Professions, Charlestown, Massachusetts, 02129, United States @@
## Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology - NCT ID: NCT06304194 - Study ID: BIOMARC_ONCO - Status: RECRUITING - Start Date: 2023-07-05 - Completion Date: 2028-07-05 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection. ### Conditions - Oncologic Disease - Hematologic Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Analysis of biological samples ### Outcomes Primary Outcomes - Average sample delivery time and % of accepted sample - Appropriateness sample labelling - Percentage of sample suitable for RNA extraction - Quantity and quality of extracted material. - Research report production time Secondary Outcomes - Genetic variants - Completed patient cards ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, N/A, N/A, Italy @@
## Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy - NCT ID: NCT06304181 - Study ID: KY-2023-195 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-30 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group. ### Conditions - Postoperative Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Paracetamol and Mannitol Injection - Parecoxib ### Outcomes Primary Outcomes - NRS scores - RASS score Secondary Outcomes - Time of first use of remedial analgesics or analgesic pump - Total analgesic pump drug use - Postoperative liver enzyme level - Postoperative bilirubin level - Postoperative creatinine level - Postoperative cortisol level - Postoperative IL-6 level - Postoperative IL-8 level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study - NCT ID: NCT06304168 - Study ID: 19-000890 - Status: RECRUITING - Start Date: 2019-05-13 - Completion Date: 2028-05-15 - Lead Sponsor: Mayo Clinic ### Study Description This study explores the potential value of a new blood test approach for early detection of cancer. ### Conditions - Hematopoietic and Lymphatic System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Overall cancer (Y/N) - blood test - Overall cancer (Y/N) - urine test - Cancer specific site prediction - blood samples/MDM - Cancer specific site prediction - urine samples/MDM - Cancer specific site prediction - blood samples/RNA - Cancer specific site prediction - urine samples/RNA Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer - NCT ID: NCT06304155 - Study ID: 202437 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University ### Study Description According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT(computer tomography), MR(magnetic resonance), and laryngoscopy, but they cannot make accurate judgments on the systemic TNM(primary tumor, regional nodes, metastasis) staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI(18F-fibroblast activation protein inhibitors) is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic efficacy,SUV ### Outcomes Primary Outcomes - Diagnostic efficacy Secondary Outcomes - SUV ### Location - Facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, Chongqing, Chongqing, 400010, China @@
## Effect of Lidocaine Block on Gastroesophageal Reflux Disease - NCT ID: NCT06304142 - Study ID: SGB-reflux - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom. ### Conditions - Gastroesophageal Reflux Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Injection - Lidocaine hydrochloride ### Outcomes Primary Outcomes - Gastroesophageal Reflux Disease Questionnaire Secondary Outcomes - Pressure pain threshold - Modified Mayo Clinic Dysphagia-30 questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers - NCT ID: NCT06304129 - Study ID: 2023-A00709-36 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2026-09-02 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description .The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:* to define a threshold value for each of the plasma,* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital. ### Conditions - Alzheimer Blood Biomarkers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Blood ponction ### Outcomes Primary Outcomes - Aβ40 and Aβ42, P-Tau, Tau and NFL Secondary Outcomes - Sensitivity/specificity - Co-mobidity - Final diagnosis ### Location - Facility: CHRU De Nancy, Nancy, Grand Est, 54500, France @@
## Effect of Lidocaine Block in Traumatic Brain Injury - NCT ID: NCT06304116 - Study ID: SGB-TBI - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Stellate ganglion block - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Modified Barthel Index - Swallowing duration - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome - NCT ID: NCT06304103 - Study ID: AND017-MDS-206 - Status: NOT_YET_RECRUITING - Start Date: 2024-12 - Completion Date: 2027-05 - Lead Sponsor: Kind Pharmaceuticals LLC ### Study Description This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB). ### Conditions - Myelodysplastic Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AND017 ### Outcomes Primary Outcomes - Percentage of HI-E/RBC-TI responding subjects Secondary Outcomes - Mean level and change from baseline in untransfused Hb throughout the first 8 weeks of treatment - Mean level and change from baseline in untransfused Hb at each visit throughout the treatment period and - Percentage of visits in which untransfused Hb was maintained in this range after reaching two consecutive increases of ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period - Mean time required after two consecutive increases in untransfused Hb ≥1.5 g/dL and ≥1.0 g/dL from baseline, respectively, throughout the treatment period - For changes in mean transfusion units throughout the treatment period compared to baseline (mean transfusion units 16 weeks prior to first dose) - For LTB cohorts, the average time required to reach first transfusion independence throughout the treatment period - Levels of reticulocyte count at each visit and change from baseline - Levels of hematocrit at each visit and change from baseline - Levels of mean corpuscular volume at each visit and change from baseline - Levels of mean corpuscular hemoglobin at each visit and change from baseline ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia - NCT ID: NCT06304090 - Study ID: SGB-NT - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - routine rehabilitation treatment - Stellate ganglion block - Lidocaine Hydrochloride ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Restorative Environments for Gait Therapy With VR - NCT ID: NCT06304077 - Study ID: 2023-01894 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02 - Lead Sponsor: ETH Zurich ### Study Description The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants. ### Conditions - Gait Analysis - Virtual Reality - Attention - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Forest - Urban - Rural ### Outcomes Primary Outcomes - Gait Stability Secondary Outcomes - Variability (Gait Parameter) - Speed (Gait Parameter) - Asymmetry (Gait Parameter) - Stance (Gait Parameter) - Max. Heel Clearance (Gait Parameter) - 1-Minute-Sit-to-Stand Test (1-Min-STST) - Perceived Restorativeness Scale (PRS) (Attention Restoration) - Perceived Stress Scale (PSS) (Stress Reduction) - Skin Conductance Levels (SCL) (Stress Reduction) - Non-Specific Skin Conductance Responses (NS-SCRs) (Stress Reduction) - Event-related Skin Conductance Responses (ER-SCRs) (Stress Reduction) - Standard deviation of all NN (normal-to-normal) intervals (SDNN) (Heart Rate Variability (HRV), Stress Reduction) - Root Mean Square of Successive Differences (RMSSD) (Heart Rate Variability (HRV), Stress Reduction) - LF/HF-ratio (Heart Rate Variability (HRV), Stress Reduction) - Heart Rate change (ΔHR) (Meaning / Valence of Landscapes) - Questionnaire / structured interview on landscape preferences and meanings ascribed to landscapes (Meaning / Valence of Landscapes) - Gaze patterns ### Location - Facility: Geriatrische Klinik St. Gallen, St. Gallen, Saint Gallen, 9000, Switzerland @@
## Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE) - NCT ID: NCT06304064 - Study ID: CAP-1002-DMD-03 - Status: COMPLETED - Start Date: 2018-06-21 - Completion Date: 2019-03-06 - Lead Sponsor: Capricor Inc. ### Study Description This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up.The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months. ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Allogeneic Cardiosphere-Derived Cells (CAP-1002) ### Outcomes Primary Outcomes - Number of Participants Experiencing Acute Respiratory Decompensation - Number of Participants With Hypersensitivity Reactions - All-cause Mortality - Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs) - Number of Participants With Immune Sensitization Syndrome Secondary Outcomes ### Location - Facility: University of Florida, Gainesville, Florida, 32610, United States @@
## Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage - NCT ID: NCT06304051 - Study ID: Naochuxue-IOE - Status: COMPLETED - Start Date: 2023-01-17 - Completion Date: 2023-06-01 - Lead Sponsor: Muhammad ### Study Description This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.Participants will be divided into two groups randomly, with different nutritional support respectively. ### Conditions - Intracerebral Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding ### Outcomes Primary Outcomes - Number of cases of successful extubation Secondary Outcomes - Body mass index - Serum albumin level - Hemoglobin level - Clinical Pulmonary Infection Score ### Location - Facility: Hongkong central Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome - NCT ID: NCT06304038 - Study ID: 2018 - Status: COMPLETED - Start Date: 2017-10-16 - Completion Date: 2019-11-14 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days. ### Conditions - Influenza Vaccine - Cost-Benefit Analysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Flu Vaccine ### Outcomes Primary Outcomes - Effectiveness of the quadrivalent vaccine - Economic impact of the quadrivalent vaccine Secondary Outcomes - Expected economic savings for each one percentage point increase in vaccination coverage - Non-economic incentives for healthcare personnel who decide to vaccinate ### Location - Facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Rome, N/A, 00168, Italy @@
## Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment - NCT ID: NCT06304025 - Study ID: GvHD 01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-08 - Lead Sponsor: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle ### Study Description Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib. ### Conditions - Graft Versus Host Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wharton's jelly mesenchymal stem cells (WJ-MSCs) ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events: safety and tolerability - Efficacy clinic profile: response of acute GVDH - Efficacy clinic profile : duration of response - Efficacy clinic profile: decrease in treatments - Efficacy biological profile: secretion pattern of soluble factors - Efficacy biological profile: cell populations - Efficacy biological profile: ocrrelation of the biological markers with the clinical response Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury - NCT ID: NCT06304012 - Study ID: IOE-TBI lao - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-06-01 - Lead Sponsor: Muhammad ### Study Description This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nasogastric tube feeding - Intermittent Oro-esophageal Tube Feeding - Rehabilitation therapy ### Outcomes Primary Outcomes - Concentration of hemoglobin - Concentration of albumin - Concentration of prealbumin - Nutritional status-body mass index Secondary Outcomes - Complications-Pulmonary Infections - Complications-Gastroesophageal Reflux - Complications- Gastrointestinal Bleeding - Complications-Gastric Retention - Complications-Diarrhea - Complications-Constipation - Decannulation of tracheostomy tube-placement duration - Level of consciousness ### Location - Facility: Jiansheng Hos., Yilan, N/A, N/A, Taiwan @@
## Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease - NCT ID: NCT06303999 - Study ID: IOE-Small lao - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-06-15 - Lead Sponsor: Muhammad ### Study Description Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach. ### Conditions - Cerebral Small Vessel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intermittent Oro-esophageal Tube - Nasogastric tube ### Outcomes Primary Outcomes - Functional Oral Intake Scale Secondary Outcomes - Body mass index - Serum albumin - Hemoglobin - Pneumonia - Activities of daily living - World Health Organization Quality of Life Assessment Instrument Brief Version ### Location - Facility: Huimin Hos., Pengfu, N/A, N/A, Taiwan @@
## Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process - NCT ID: NCT06303986 - Study ID: NAS-002 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-06-30 - Lead Sponsor: Rekovar Inc. ### Study Description Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments. ### Conditions - Neonatal Abstinence Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neomonki ### Outcomes Primary Outcomes - Training/validation data collection Secondary Outcomes - Continuous Monitoring ### Location - Facility: John Hopkins University, Baltimore, Maryland, 21224, United States @@
## Effect of Oral Enteral Nutrition in Pierre Robin Syndrome - NCT ID: NCT06303973 - Study ID: IOE-PRS - Status: COMPLETED - Start Date: 2022-01-10 - Completion Date: 2023-06-15 - Lead Sponsor: Muhammad ### Study Description This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. ### Conditions - Pierre Robin Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - IOE - PNG ### Outcomes Primary Outcomes - Number of patients diagnosed as the pulmonary infection "Positive". Secondary Outcomes - Nutritional status-total protein - Nutritional status-hemoglobin - Nutritional status-albumin - Nutritional status-prealbumin - Body weight - Swallowing function ### Location - Facility: Renai Hospital, Yilan, N/A, N/A, Taiwan @@
## Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation - NCT ID: NCT06303960 - Study ID: Cerebellar DBS for stroke - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-03-07 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bilateral Cerebellar deep brain stimulation - Unilateral Cerebellar deep brain stimulation ### Outcomes Primary Outcomes - safety and feasibility of bilateral cerebellar DBS Secondary Outcomes - FM-UE scores between bilateral and unilateral cerebellar DBS - Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS - the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS - the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS - Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS - the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS - the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS - nerve conduction velocity between bilateral and unilateral cerebellar DBS ### Location - Facility: Chao Zhang, Jinan, Sichuan, 250100, China @@
## Effect of Oral Enteral Nutrition Feeding in Parkinson Disease - NCT ID: NCT06303947 - Study ID: IOE-PKS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: Muhammad ### Study Description The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intermittent Oro-esophageal Tube - Nasogastric tube - Comprehensive rehabilitation training ### Outcomes Primary Outcomes - Serum albumin level - Hemoglobin Secondary Outcomes - Modified Barthel Index - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia - NCT ID: NCT06303934 - Study ID: IOE-NT - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-06-30 - Lead Sponsor: Muhammad ### Study Description This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding , n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - systemic therapy - Intermittent Oro-Esophageal Tube Feeding - Persistent Nasogastric Tube Feeding ### Outcomes Primary Outcomes - The Oral Motor Assessment Scale Secondary Outcomes - Pneumonia - Hemoglobin - Total Protein - Albumin - Prealbumin - body weight - Penetration-Aspiration Scale - Functional Oral Intake Scale for Infants - Feeding amount ### Location - Facility: River First Hos., Pingdong, N/A, N/A, Taiwan @@
## Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503 - NCT ID: NCT06303921 - Study ID: 854681 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2029-02 - Lead Sponsor: University of Pennsylvania ### Study Description The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites. ### Conditions - Tauopathies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 11C-M503 PET - Brain MRI - Amyloid PET - Neurological assessments ### Outcomes Primary Outcomes - Organ Biodistribution or Dosimetry - PET Uptake of Tracer Secondary Outcomes - Adverse Events ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## How Traditional Chinese Medicine Exercise Improves Parkinson Disease - NCT ID: NCT06303908 - Study ID: Commu-PKS - Status: NOT_YET_RECRUITING - Start Date: 2024-11 - Completion Date: 2024-12 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Simple Gymnastics Training ### Outcomes Primary Outcomes - Unified Parkinson's Disease Rating Scale Secondary Outcomes - The Berg Balance Scale - Patient Health Questionnaire-9 - Generalized Anxiety Disorder-7 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients - NCT ID: NCT06303895 - Study ID: Acu-PKS-new - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description This study is focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine rehabilitation training - Swallowing rehabilitation training - Acupuncture therapy ### Outcomes Primary Outcomes - Penetration-Aspiration Scale-liquid - Penetration-Aspiration Scale-paste Secondary Outcomes - Swallowing time - body mass index - Serum Albumin - Prealbumin - Hemoglobin - Swallowing Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke - NCT ID: NCT06303882 - Study ID: AI-Dysphagia - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - routine rehabilitation treatment - Computer-assisted Cognitive Function Training - conventional cognitive training ### Outcomes Primary Outcomes - Montreal Cognitive Assessment Secondary Outcomes - The coordination of swallowing - Penetration-Aspiration Scale - Swallowing duration - Swallowing reflex ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke - NCT ID: NCT06303869 - Study ID: STUDY22070043 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-10 - Lead Sponsor: Jorge Gonzalez-Martinez ### Study Description The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life. ### Conditions - Stroke - Brain Disease - Central Nervous System Diseases - Nervous System Diseases - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Deep Brain Stimulation (DBS) of the Motor Thalamus ### Outcomes Primary Outcomes - Adverse Events - Discomfort and Pain Secondary Outcomes - Dysphagia - Hand dexterity - Muscle weakness - Dexterity of Articulation AMRs - Dexterity of Articulation SMRs - Intelligibility of Speech - Spasticity - Range of Motion (ROM) ### Location - Facility: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States @@
## How Active Breathing Training Improves Dysphagia in Elderly People - NCT ID: NCT06303856 - Study ID: ABE-OLDer - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Active Breathing Exercises ### Outcomes Primary Outcomes - Eating Assessment Tool-10 Secondary Outcomes - Time consumed in eating - Swallowing-Related Quality of Life Questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre - NCT ID: NCT06303843 - Study ID: 13.04.2023 - Status: COMPLETED - Start Date: 2023-05-02 - Completion Date: 2024-02-15 - Lead Sponsor: Uşak University ### Study Description The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.Translated with DeepL.com (free version) ### Conditions - Anxiety - Preoperative Anxiety - Pediatric Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Transfer with an electric ride-on car ### Outcomes Primary Outcomes - Perioperative anxiety Secondary Outcomes ### Location - Facility: Usak University Training and Research Hospital, Usak, N/A, 64100, Turkey @@
## Bariatric Surgery and Cardiovascular Responses to Sodium Nitrate - NCT ID: NCT06303830 - Study ID: BACA2019 - Status: COMPLETED - Start Date: 2019-04-16 - Completion Date: 2021-10-01 - Lead Sponsor: University of Sao Paulo ### Study Description Inorganic nitrite and nitrate can be reduced to NO and NO-related species such as S-nitrosothiols via the nitrate-nitrite-NO pathway. This is due to the reduction of nitrate to nitrite by the action of bacteria in the mouth and the reduction of nitrite to NO depending on the acidic pH on the stomach or by enzymes with nitrite-reductase activity. The acidic environment of the stomach is very important to the formation of NO and S-nitrosothiols and several studies suggest that changes in gastric pH can affect this conversion. In this context, bariatric surgery, by altering the anatomy of the stomach and increasing gastric pH, can affect the nitrate-nitrite-NO pathway and change the antihypertensive and antioxidant effect of sodium nitrate. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sodium nitrate ### Outcomes Primary Outcomes - Assess changes in s-nitrosothiols Secondary Outcomes - Assess changes in blood pressure - Assess changes in endotelial function - Assess changes in Vascular stiffness - Assess changes in nitrate concentration - Assess changes in nitrite concentration ### Location - Facility: Usp - Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão, Ribeirão Preto, São Paulo, 14.048-900, Brazil @@
## Double Knots Versus Triple Knots Facia Closure Method; is There a Difference in Pain Sensation or Cosmetic Satisfaction? - NCT ID: NCT06303817 - Study ID: 1812 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-01-01 - Lead Sponsor: Adana City Training and Research Hospital ### Study Description The study included women who were scheduled for an elective or had an emergency cesarean section. Age, body mass index (BMI), obstetric history, education status, smoking status and C-section indications of the patients were recorded. Patients with a previous suprapubic scar, medical conditions affecting wound healing (such as diabetes or chronic corticosteroid use), those needing a vertical incision (e.g., placenta previa), individuals with postoperative wound infection or under 18 years old were excluded. Data were collected in standardized data form by a research assistant. Pre- and post-surgery treatments and/or interventions were standardized. All patients received antimicrobial prophylaxis with cefazolin before the operation. The abdomen was entered via a transverse suprapubic skin incision and the surgical steps up to the point of facia closure were accomplished in a standard fashion. Technical differences such as blunt and sharp dissection, uterus exteriorization vs in situ, or parietal peritoneum closure were left to the surgeon's discretion. The procedures for facia closure are as follows; in Group I (Double knots group), the edge of the fascia was determined with a Kocher clamp. The fascia was closed starting from the opposite side with a synthetic absorbable multifilament suture in a continuous fashion up to the Kocher clamp and tied the knots with the same single suture (Figure 2; a-b). In Group II (Triple knots group), the edge of the fascia was fixed with the same suture material instead of the Kocher clamp, and the fascia was closed similarly, starting from the opposite corner via the second loop. Then the loops from the first suture were tied to the second suture (Figure 2; c-d). After the incision was irrigated with sterile saline solution, the subcutaneous space was closed if the thickness was 2 cm or more. Skin closure was accomplished with a subcuticular technique using a non-absorbable monofilament suture, which was removed on the 10th day postoperatively. A closed subcutaneous suction drain was not used in any of the patients. Postoperative pain at and around the incision line was measured on the 1st, and 10th days postoperatively on the NRS (Numeric Rating Scale), with "0" being "no pain" and "10" being "the worst pain imaginable." The 1st measurements were made face-to-face, and the 10th-day evaluation was made via telephone interviews by the same research assistant. ### Conditions - Cesarean Section - Pain - Cosmetics Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Double knots facia closure method during cesarean section - Triple knots facia closure method during cesarean section ### Outcomes Primary Outcomes - Change from baseline in pain on NRS (Numeric Rating Scale) at 10 days - Change from baseline in aesthetic results at 3 months Secondary Outcomes ### Location - Facility: Adana Şehir Eğitim ve Araştırma Hastanesi, Adana, Yüreğir, 01120, Turkey @@
## Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective - NCT ID: NCT06303804 - Study ID: HSC-SPH-23-0837 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-31 - Lead Sponsor: The University of Texas Health Science Center, Houston ### Study Description The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores ### Conditions - Opioid Misuse ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Educational videos ### Outcomes Primary Outcomes - Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire - Changes in opioid related knowledge as assessed by a questionnaire Secondary Outcomes ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders - NCT ID: NCT06303791 - Study ID: 1905517 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-07 - Completion Date: 2024-12 - Lead Sponsor: University of Valencia ### Study Description The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support (randomized and with a control group) that will be conducted virtually and synchronously to families of children with autism spectrum disorder (ASD) and families of children with Attention Deficit with hyperactivity Disorder (ADHD). The main questions it aims to answer are:1. Will the program impact on different variables in the parents' domain (parental stress variables, quality of life/social support and coping skills),2. Will the program impact on different variables in the children's domain (daily life functioning, social behavioral variables, and executive functioning).3. Treatment outcomes will be assessed at pre-test, post-test, and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress, coping skills, social support, and children's dysfunctional outcomesParents and teachers will complete different questionnaires to see if there are improvements on parent's and children outcomes.Researchers will compare intervention group and control group to see if there are improvements on parent's domains (parenting stress, coping skills, social support) and children's dysfunctional outcomes (daily life functioning, social behavioral variables, and executive functioning). ### Conditions - Autism Spectrum Disorder - Attention Deficit Hyper Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Digital Psychosocial intervention ### Outcomes Primary Outcomes - Parental stress in The Parenting Stress Index - Short Form (PSI-SF) Spanish adaptation - Social support: The Social Functional Support Questionnaire Duke-UNC - Coping Skills using The Brief COPE - Children's social problems using Strengths and Difficulties Questionnaire (SDQ) - Daily life executive functioning using the BRIEF Secondary Outcomes - Children Sleep problems: using The Sleep Disturbance Scale for Children (SDSC) - Behavioral problems using The Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P) - Children Learning Behavior using Learning behavior scale (LBS) ### Location - Facility: University of Valencia, Valencia, N/A, 46010, Spain @@
## Combining a Smartphone App With Medications to Manage Heavy Drinking - NCT ID: NCT06303778 - Study ID: IIR 22-141 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-01 - Lead Sponsor: VA Office of Research and Development ### Study Description One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally. ### Conditions - Alcohol Use Disorder (AUD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Stand Down mobile app - Standard Care ### Outcomes Primary Outcomes - Change in Percent Heavy Drinking Days - Semi-structured qualitative interview data from patients, providers, clinical leaders Secondary Outcomes - Change in Short Inventory of Problems - Revised version (SIP-R) - Change in World Health Organization (WHO) Risk Levels - Change in Client Satisfaction Questionnaire (CSQ) Scores - Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores - Change in PTSD Checklist for DSM-5 (PCL-5) Scores - Change in Veterans RAND 12 Item Health Survey Scores - Change in Percent Heavy Drinking Days - Change in Short Inventory of Problems - Revised version (SIP-R) - Change in World Health Organization (WHO) Risk Levels - Change in Patient Health Questionnaire Depression Screen (PHQ-9) Scores - Number of Participants Receiving VA Outpatient Substance Use Disorder Treatment - Number of Participants Receiving VA Emergency Department Services - Change in PTSD Checklist for DSM-5 (PCL-5) Scores - Change in Veterans RAND 12 Item Health Survey Scores ### Location - Facility: Central Alabama Veterans Health Care System West Campus, Montgomery, AL, Montgomery, Alabama, 36109, United States @@
## Evaluating the Practice Resource for Driving After Stroke - NCT ID: NCT06303765 - Study ID: 13Nov2023PReDAS Study - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-08-31 - Lead Sponsor: Western University, Canada ### Study Description After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning. ### Conditions - Stroke, Acute - Driving - Occupational Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Practice Resource for Driving After Stroke (PReDAS) ### Outcomes Primary Outcomes - clinical reasoning - self-efficacy Secondary Outcomes ### Location - Facility: Western University, London, Ontario, N6G 1H1, Canada @@
## Tissue Therapy of Transsphincteric Anal Fistula - NCT ID: NCT06303752 - Study ID: 260-2021-NQ - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-04-30 - Lead Sponsor: University of Southern Denmark ### Study Description This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics. ### Conditions - Anal Fistula ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ADRC injection - ADRC001 injection ### Outcomes Primary Outcomes - Healing rate (percentage) Secondary Outcomes - QoL - Fecal Incontinence - Risk factors for recurrence of fistula. - Radiological healing. - Treatment efficacy. - Cellular composition - Transplantation-related alloantibodies ### Location - Facility: Odense University Hospital, Odense, N/A, 5000, Denmark @@
## Psilocybin-Assisted Therapy in Treatment-Resistant Depression - NCT ID: NCT06303739 - Study ID: 22-1421 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2026-09 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are:* Does psilocybin with assisted therapy help improve symptoms for people with depression?* How long do the effects of this treatment last?Participants will:* Take part in a couple of screening and preparation visits.* Be given psilocybin in one or two treatment sessions.* Attend a series of follow-up sessions over the following year.* Complete forms and surveys to test how their symptoms have changed and what they thought of their experience.Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants. ### Conditions - Refractory Depression - Treatment Resistant Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - psilocybin ### Outcomes Primary Outcomes - Change in HAM-D-17 Scores between Baseline and 2 Weeks after Treatment - Change in QIDS SR-16 Scores between Baseline and 2 Weeks after Treatment - Number of Participants Achieving Remission 2 Weeks after Treatment - Number of Participants Achieving Response 2 weeks after treatment Secondary Outcomes - Number of Participants Achieving Remission at 6 Weeks - Number of Participants Achieving Response at 6 Weeks - Number of Participants Achieving Remission at 3 Months - Number of Participants Achieving Response at 3 Months - Number of Participants Achieving Remission at 6 Months - Number of Participants Achieving Response at 6 Months - Number of Participants Achieving Remission at 9 Months - Number of Participants Achieving Response at 9 Months - Number of Participants Achieving Remission at 12 Months - Number of Participants Achieving Response at 12 Months - Time to Relapse in Participants Who Showed Remission at 2 weeks - Time to Relapse in Participants Who Showed Response at 2 Weeks - Change in HAM-D-17 Scores between Baseline and 6 Weeks after Treatment - Change in HAM-D-17 Scores between Baseline and 3 Months after Treatment - Change in HAM-D-17 Scores between Baseline and 6 Months after Treatment - Change in HAM-D-17 Scores between Baseline and 9 Months after Treatment - Change in HAM-D-17 Scores between Baseline and 12 Months after Treatment - Change in QIDS SR-16 Scores between Baseline and 6 Weeks after Treatment - Change in QIDS SR-16 Scores between Baseline and 3 Months after Treatment - Change in QIDS SR-16 Scores between Baseline and 6 Months after Treatment - Change in QIDS SR-16 Scores between Baseline and 9 Months after Treatment - Change in QIDS SR-16 Scores between Baseline and 12 Months after Treatment ### Location - Facility: UNC Chapel Hill Medical Center, Chapel Hill, North Carolina, 27514, United States @@
## Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06303726 - Study ID: IRP-2021/02-19 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-04-25 - Completion Date: 2024-06-25 - Lead Sponsor: University Medical Centre Maribor ### Study Description The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).The main question it aims to answer are:* which surgery gives better outcome in patients (short- and long-term results)?* are there any sings of osteoarthritis in an injured knee compared to a healthy knee?Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery. ### Conditions - Anterior Cruciate Ligament Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ACL reconstruction single bundle - ACL reconstruction double bundle ### Outcomes Primary Outcomes - IKDC SUBJECTIVE SCORE - TEGNER SCORE - LYSHOLM SCORE - OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS - OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior) Secondary Outcomes ### Location - Facility: University Clinical Center Maribor, Maribor, N/A, 2000, Slovenia @@
## LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer - NCT ID: NCT06303713 - Study ID: 23-693 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-07-19 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer.The names of the study drugs used in this research study are:* Carboplatin (A type of chemotherapy)* 177Lu-PSMA-617 (A type of radioligand therapy) ### Conditions - Prostate Cancer - Metastatic Prostate Cancer - Metastatic Castration-resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Carboplatin - 177Lu-PSMA-617 ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) or the Recommended Phase 2 dose (RP2D) of carboplatin administered in combination with 177Lu-PSMA-617 Secondary Outcomes - PSA response rate (PSA reduction by ≥50% from baseline). - Overall Response Rate (ORR) - Radiographic Progression-Free Survival (rPFS) - Overall Survival (OS) ### Location - Facility: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States @@
## Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups - NCT ID: NCT06303700 - Study ID: Quality of life - Status: COMPLETED - Start Date: 2022-05-10 - Completion Date: 2024-01-31 - Lead Sponsor: Amira Hussin Hussin Mohammed ### Study Description To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. ### Conditions - Public Health ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the severity of dyspnea - the level of fear of falling through daily life activities - quality of life and public health Secondary Outcomes ### Location - Facility: Amira Hussin Mohammed, Gamasa, N/A, 35712, Egypt @@
## VR-PAT and fNIRS to Identify CNS Biomarkers of Pain - NCT ID: NCT06303687 - Study ID: STUDY00003496 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Nationwide Children's Hospital ### Study Description This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR). ### Conditions - Acute Pain - Pediatric ALL - Procedural Pain - Burns ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - VR-PAT ### Outcomes Primary Outcomes - Change in brain activity Secondary Outcomes - Procedural pain during burn dressing changes - Change in procedural anxiety - Self-reported VR experience ### Location - Facility: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States @@
## Effects of Brain Breaks on Educational Achievement in Laboratory Settings: The Break4Brain Project - NCT ID: NCT06303674 - Study ID: 301CER22 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-27 - Completion Date: 2025-09 - Lead Sponsor: University of the Balearic Islands ### Study Description Advancement in teaching methods, together with the frenetic change in the lifestyles of the school population, provides a unique opportunity to advance scientific knowledge. The current project, called "The Break4Brain Project", aims to examine the acute (transient) effects of physical activity on brain function, cognition, and academic performance in children with and without Attention Deficit Hyperactivity Disorder (ADHD). Specifically, a total of 60 children between 10 and 12 years old will be included with (n=30) and without (n=30) ADHD. The study will use an intra-subject design of isolated conditions with four measurement moments where the children will perform three different experimental conditions lasting 10 minutes, which will be randomized in a counterbalanced manner. These experimental conditions will be based on physical activity engaging cognitively, physical activity without engaging cognitively, and cognitively engaging control condition. This project could have a significant impact in the educational field, since, if brain function, cognition, and academic performance prove to be favorably stimulated, acutely, by physical activity through active breaks, these could be prescribed as an effective teaching strategy for children with and without ADHD in the school setting. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Physical activity with engaging cognitively - Physical activity without engaging cognitively ### Outcomes Primary Outcomes - Academic achievement - Inhibition - Working memory - Sustained attention - Brain function Secondary Outcomes - Physical fitness and body composition - Physical activity levels and sleep - Self-reported sedentary patterns - Motor proficiency - Biological maturation - ADHD symptoms - IQ - Socioeconomic levels - Educational levels ### Location - Facility: University of the Balearic Islands, Palma, Balearic Islands, 07122, Spain @@
## Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease - NCT ID: NCT06303661 - Study ID: 74001323.3.0000.5544 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2026-06 - Lead Sponsor: Centro de Atenção ao Assoalho Pélvico ### Study Description The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question\[s\] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy. ### Conditions - Peyronie Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Non-ablative Radiofrequency - Low-intensity Shock Wave Therapy ### Outcomes Primary Outcomes - It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to sexual function. - It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to pain. - It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a safe technique that leads to a satisfactory clinical response in relation to penile erection. Secondary Outcomes - It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on quality of life and psycho-emotional aspects of anxiety and depression. - It is estimated that non-ablative RF associated with low-intensity SWT in patients with Peyronie Disease is a technique that promotes a positive impact on psycho-emotional aspects of anxiety and depression. ### Location - Facility: Centro de Atenção ao Assoalho Pelvico, Salvador, Ba, 40.290-000, Brazil @@
## A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects - NCT ID: NCT06303648 - Study ID: TSND201-PK-101 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-05-11 - Lead Sponsor: Transcend Therapeutics ### Study Description This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects. ### Conditions - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Methylone ### Outcomes Primary Outcomes - Cmax: Maximum Observed Plasma Concentration for methylone - AUC: Area under the plasma concentration-time curve for methylone Secondary Outcomes - Incidence and frequency of adverse events - Change overtime in Visual Analog Scales ### Location - Facility: CMAX Clinical Research, Adelaide, South Australia, 5000, Australia @@
## Safety of UFRJvac, Trivalent COVID-19 Vaccine - NCT ID: NCT06303635 - Study ID: UFRJvac-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-24 - Completion Date: 2025-11-25 - Lead Sponsor: Azidus Brasil ### Study Description Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine. ### Conditions - Healthy People ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluate the safety and reactogenicity of the UFRJvac COVID-19 vaccine booster Secondary Outcomes - Evaluate the safety and reactogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 - Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 - Evaluate the humoral immunogenicity of the vaccine booster the trivalent UFRJvac COVID-19 - Evaluate the humoral immunogenicity of the vaccine booster with the trivalent UFRJvac - Evaluate the humoral immunogenicity of the vaccine booster trivalent UFRJvac - Evaluate the cellular immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial - NCT ID: NCT06303622 - Study ID: CRE-2023.610 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-03-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - MRI-USG fusion approach - Cognitive-guided approach ### Outcomes Primary Outcomes - Proportion of men with clinically significant Prostate cancer(csPCa) Secondary Outcomes - Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm - Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m - The proportion of men with a diagnosis of csPCa only in targeted biopsy - Proportion of men with a diagnosis of csPCa only in systemic biopsy - Proportion of men with a diagnosis of clinically insignificant PCa, - Procedure time - Pain score on a scale of 0-10 taken after biopsy - Proportion of men with post-biopsy adverse events within 30 days after biopsy ### Location - Facility: Prince of Wales Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder - NCT ID: NCT06303609 - Study ID: 61102222.5.0000.5544 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-07-20 - Lead Sponsor: Centro de Atenção ao Assoalho Pélvico ### Study Description The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress. ### Conditions - Pelvic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - nonablative radiofrequency - Vaginal dilator - Sham nonablative radiofrequency ### Outcomes Primary Outcomes - Penetration capacity with reduced vaginal pain Secondary Outcomes - Sexual function - Quality of sexual life - Stress perception ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hippotherapy in Patients With Schizophrenia - NCT ID: NCT06303596 - Study ID: Hippotherapy in Schizophrenia - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-10-01 - Lead Sponsor: Erzurum Technical University ### Study Description This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention. ### Conditions - Equine-Assisted Therapy - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Hippotherapy - Standard psychiatric treatment ### Outcomes Primary Outcomes - The Positive and Negative Syndrome Scale (PANSS) - State-Trait Anxiety Inventory (STAI) - The Quality of Life Scale (QLS) - UCLA Loneliness Scale Secondary Outcomes ### Location - Facility: Erzurum Technical University, Erzurum Community Mental Health Center, Erzurum, N/A, 25010, Turkey @@
## Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma - NCT ID: NCT06303583 - Study ID: IRB- 2022-213 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-06-01 - Completion Date: 2026-12-31 - Lead Sponsor: Qiu Guoqin ### Study Description The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer ### Conditions - Esophageal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - paclitaxel - carboplatin - tislelizumab - radiotherapy ### Outcomes Primary Outcomes - Complete pathological response rate Secondary Outcomes - R0 resection rate - 2-year Disease-free survival rate - 2-year overall survival rate - Safety will be analyzed through the incidence of adverse events, serious adverse events ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310000, China @@
## A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas - NCT ID: NCT06303570 - Study ID: CBL-0202DD - Status: NOT_YET_RECRUITING - Start Date: 2024-06-28 - Completion Date: 2025-05-23 - Lead Sponsor: Caliway Biopharmaceuticals Co., Ltd. ### Study Description This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas. ### Conditions - Dercum's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CBL-514 injection - 0.9% Sodium chloride ### Outcomes Primary Outcomes - To estimate the treatment effect, as measured by Complete Response (CR), between CBL-514 and placebo at Week 12 in participants with Dercum's disease (DD). Secondary Outcomes - To estimate the treatment effect, as measured by pain, between CBL-514 and placebo at Week 12 in participants with DD. - To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. - To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. - To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. - To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. - To estimate the treatment effect, as measured by CR, between CBL-514 and placebo, at Weeks 4, 8, 16, 20, and 24. - To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To estimate the treatment effect, as measured by partial response, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To evaluate the treatment effect, as measured by change in volume, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To evaluate the treatment effect, as measured by pain, between CBL-514 and placebo, at Weeks 4, 8, 12, 16, 20, and 24. - To evaluate the incidence of adverse events of special interests (AESI) as defined in the protocol. - To evaluate the incidence of clinically significant abnormal findings as defined in the protocol as defined in the protocol. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of ESPB on Intraoperative Remifentanil Consumption - NCT ID: NCT06303557 - Study ID: AEŞH-EK1-2023-797 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-12-30 - Lead Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital ### Study Description In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB. ### Conditions - Lumbar Spine Surgery - Erector Spinae Plane Block - Remifentanil Consumption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Preoperative Erector Spinae Plane Block - Postperative Erector Spinae Plane Block ### Outcomes Primary Outcomes - Intraoperative remifentanil consumption Secondary Outcomes - Mean arterial pressure - Heart rate - Pain scores ### Location - Facility: Ankara Etlik City Hospital, Yenimahalle, Ankara, 06170, Turkey @@
## More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers - NCT ID: NCT06303544 - Study ID: R01HL168853 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2028-05-30 - Lead Sponsor: Alaska Native Tribal Health Consortium ### Study Description The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention. ### Conditions - Child Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Wedge 1 ### Outcomes Primary Outcomes - BMI - Physical activity - Outdoor time - Sleep quality - Fingernail nitrogen & carbon stable isotope ratios Secondary Outcomes ### Location - Facility: Alaska Native Tribal Health Consortium, Anchorage, Alaska, 99508, United States @@
## Efficacious Iron for Iron Deficiency Anemia in Adults Aged ≥18 Years - NCT ID: NCT06303531 - Study ID: Efficacious Iron - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-24 - Completion Date: 2025-02 - Lead Sponsor: Dr. Anil K. Gupta Medicine Professional Corporation ### Study Description Iron deficiency anemia (IDA) is a widespread condition affecting many people globally. Despite the many cases of IDA, there are few studies that compare the effectiveness of different types of iron supplements with a greater emphasis on the cost of supplements and their tolerability. This study aims to conduct a comparison between different iron supplements to determine the superiority of the iron supplements Ferrous Ascorbate (EBMfer) and Ferrous Fumarate (Eurofer) over polysaccharide iron (FeraMax). This comparison will be conducted by determining the change in hemoglobin levels for participants in this trial over a 3-month period. ### Conditions - Iron Deficiency Anemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ferrous Fumarate - Polysaccharide Iron - Ferrous Ascorbate ### Outcomes Primary Outcomes - Change in Hemoglobin Levels Secondary Outcomes - Change in Serum Ferritin - Tolerability of Study Medication - Discontinuation Rate ### Location - Facility: Albion Finch Medical Centre, Etobicoke, Ontario, M9V 4B4, Canada @@
## End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children - NCT ID: NCT06303518 - Study ID: H23-03546 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12-31 - Lead Sponsor: University of British Columbia ### Study Description Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children.During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are.The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment. ### Conditions - Anesthesia - Hypercapnia - Hypocapnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - High normal ETCO2: ETCO2 50 mmHg (+/- 3mmHg) - Normal ETCO2: ETCO2 40 mmHg (+/- 3mmHg) - Low Normal ETCO2: ETCO2 30 mmHg (+/- 3mmHg) ### Outcomes Primary Outcomes - To determine the effect of end-tidal carbon dioxide concentration (EtCO2) on the depth of anesthesia in children, as measured by BIS. Secondary Outcomes - Patient movement as detected clinically by the surgical or anesthetic team. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC - NCT ID: NCT06303505 - Study ID: NAPISTAR 1-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-01 - Lead Sponsor: Tubulis GmbH ### Study Description The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects. ### Conditions - Ovarian Cancer - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TUB-040 ### Outcomes Primary Outcomes - Determination of MTD Secondary Outcomes - Maximum plasma/serum concentration (Cmax) - Through plasma/serum concentration (Cmin) - The time taken to reach the maximum concentration (Tmax) - Area Under Curve (AUC) - Half life (T1/2) - Determination of immunogenicity - Determination of efficacy ### Location - Facility: Christ Hospital, Cincinnati, Ohio, 45219, United States @@
## Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study - NCT ID: NCT06303492 - Study ID: CTO 4096 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital ### Study Description Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries. ### Conditions - Pulmonary Aspiration - Emergency Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - GUS ### Outcomes Primary Outcomes - Proportion of change in Anesthetic Plan Secondary Outcomes - Percentage change in the three-category risk assessment before and after GUS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity - NCT ID: NCT06303479 - Study ID: Voldyne_Tele - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09-29 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;* Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,* It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment.In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly.Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants.Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated. ### Conditions - Breathing Exercises - Telerehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Non-Instrumental breathing exercise group - Instrumental breathing exercise group ### Outcomes Primary Outcomes - Pulmonary Function Test for FEV1 - Pulmonary Function Test for PEF - Pulmonary Function Test for FEV1/FVC - Pulmonary Function Test for FVC Secondary Outcomes - International Physical Activity Questionnaire-Short Form (IPAQ-SF) ### Location - Facility: University of Health Sciences, Istanbul, N/A, N/A, Turkey @@
## Real World Evidence Study of Danish Fabry Patients - NCT ID: NCT06303466 - Study ID: R-23053109 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-12-31 - Lead Sponsor: Caroline Michaela Kistorp ### Study Description Fabry is a rare X-linked metabolic lysosomal disorder caused by deficiency in the enzyme α-galactosidase A (alpha-Gal A) by mutations in the GLA gene, encoding the alpha-Gal A enzyme, which catalyses glycosphingolipids, namely globotriaosylceramide (Gb3). Reduced or absent alpha-Gal A activity leads to accumulation of Gb3 in various organs as well as cellular dysfunction and inflammation causing phsyical symptoms and eventual organ failure. Treatment has been available since 2001 for Fabry patients - first enzyme replacement therapy and since 2016, an oral chaperone therapy, Migalastat. Although the initial trials of Migalastat had some both short and extended outcome treatment comparisons, the overall evidence of clinical efficacy is based on too small numbers considering the heterogeneity of the Fabry patient population as well as the very slow progression of the disease. Though the body of real-world evidence is growing, there is a need for more publications of real-world long-term data on clinical outcomes with a focus on treatment with Migalastat.Research Question:Is the incidence and prevalence of Fabry associated clinical events (FACEs) (cardiac, renal, and cerebrovascular) associated with sex, genotype, phenotype at time of diagnosis, biomarkers, and Fabry specific therapy?Objectives:* To investigate time to first Fabry associated clinical events (FACE) (cardiac, renal, and cerebrovascular) with particular focus on Migalastat clinical outcomes and treatment outcomes preceding Migalastat therapy.* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.* To describe FACEs in accordance with different geno- and phenotypic groups.* To investigate the incidence and time to a first fatal or non-fatal cardiac, renal, and cerebrovascular clinical event, separated by each category.Primary outcomes - Time to first FACE (cardiac, renal, and cerebrovascular) with particular focus on Migalastat on clinical outcomes and treatment outcomes preceding Migalastat therapy.Secondary outcomes* To investigate the incidence and prevalence of FACEs with respect to Fabry specific treatment, Migalastat, ERT or no treatment.* To describe FACEs in accordance with different geno- and phenotypic groups To investigate the incidence and time to a first fatal or non-fatal cardiac, renal and cerebrovascular clinical event, separated by each category.Exploratory outcomes- To describe disease progression with focus on organ involvement.The study design is a retrospective clinical and paraclinical follow-up of the Danish National Fabry cohort in the period 01.01.2001-31.12.2022. Patient followed a structured yearly monitoring program as part of routine clincal care. ### Conditions - Fabry Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time to first individual FACE since confirmed diagnosis (Composite endpoint) - Time to first FACE after initiation of Migalastat treatment (Composite endpoint) Secondary Outcomes - Time to first individual FACE since confirmed diagnosis (cardiac) - Time to first individual FACE after initiation of Migalastat treatment (cardiac) - Time to first individual FACE since confirmed diagnosis (renal) - Time to first individual FACE after initiation of Migalastat treatment (renal) - Time to first individual FACE after initiation of Migalastat treatment (cerebrovascular) - Time to first individual FACE since confirmed diagnosis (cerebrovascular) - Prevalence of FACE since confirmed diagnosis - Prevalence of FACE after initiation of Fabry-specific treatment - Incidence of FACE since confirmed diagnosis - Incidence of FACE after initiation of Fabry-specific treatment - Incidence of cardiac events since confirmed diagnosis - Incidence of renal events since confirmed diagnosis - Incidence of cerebrovascular events since confirmed diagnosis - Incidence of cardiac events after initiation of Fabry-specific treatment - Incidence of renal events after initiation of Fabry-specific treatment - Incidence of cerebrovascular events after initiation of Fabry-specific treatment - Annualized rate of change in eGFR by CKDEPI-formula since initiation of treatment - Annualized rate of change in eGFR by CKDEPI-formula after initiation of Fabry-specific treatment - Rapid renal progression of disease since confirmed diagnosis - Rapid renal progression of disease after initiation of Fabry-specific treatment - Incidence of albuminuria since confirmed diagnosis - Incidence of albuminuria after initiation of Fabry-specific treatment - Prevalence of albuminuria since confirmed diagnosis - Prevalence of albuminuria after initiation of Fabry-specific treatment ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy. - NCT ID: NCT06303453 - Study ID: REC/RCR&AHS/23/0291 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy. ### Conditions - Diabetic Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Balance exercises - Resisted exercises ### Outcomes Primary Outcomes - Michigan neuropathy screening instrument - De Morton mobility index test - PainDETECT Tool Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Effects of Virtual Reality Training Versus Motor Imagery in Children With Cerebral Palsy - NCT ID: NCT06303440 - Study ID: REC/RCR&AHS/23/0288 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-25 - Lead Sponsor: Riphah International University ### Study Description Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine Physical Therapy+ Balance Training - Virtual Reality+ Routine Physical Therapy - Motor Imagery+ Routine Physical Therapy ### Outcomes Primary Outcomes - Gross Motor Function Classification System(GMFCS) - Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) - WeeFIM scale Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy - NCT ID: NCT06303427 - Study ID: REC/RCR & AHS/23/0292 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy. ### Conditions - Erb's Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified constraint-induced movement therapy - Electrical stimulation ### Outcomes Primary Outcomes - Standard universal goniometer - Medical Research Council (MRC) Scale - Active Movement Scale Secondary Outcomes ### Location - Facility: Riphah International University, Lahore, Punjab, 54660, Pakistan @@
## Revascularization for Symptomatic Non-acute Carotid Artery Occlusion - NCT ID: NCT06303414 - Study ID: RESCO - Status: RECRUITING - Start Date: 2016-06-17 - Completion Date: 2028-12-30 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery. ### Conditions - Non-acute Carotid Artery Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Carotid Endarterectomy (CEA) - Carotid Artery Stenting (CAS) - Hybrid Surgery ### Outcomes Primary Outcomes - Stroke or death whthin 30 days or recurrent ischemic stroke related of qualifying artery beyond 30 days through 12 months - MMSE within 30 and 90 days after procedure - MoCA scale within 30 and 90 days after procedure Secondary Outcomes - Technical success rate - Procedural success rate - Any stroke within 30 days, 90 days and 12 months after procedure - Death within 30 days, 90 days and 12 months after procedure - Cranial nerve injury - Carotid artery or internal carotid artery reocclusion - Functional outcome - Other major complications ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100005, China @@
## Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain - NCT ID: NCT06303401 - Study ID: REC/MS-PT/01787 Gullalay - Status: RECRUITING - Start Date: 2023-09-27 - Completion Date: 2024-08-30 - Lead Sponsor: Riphah International University ### Study Description compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain. ### Conditions - Low Back Pain, Post Partum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SI joint thrust manipulation - pelvic stabilization exercises ### Outcomes Primary Outcomes - Numeric pain rating scale (NPRS) - Modified Oswestry Disability Index (ODI) Secondary Outcomes ### Location - Facility: Lady Reading Hospital and Shahab Orthopedic & General Hospital, Peshawar, KPK, 25000, Pakistan @@
## Effects of Bruegger's Exercises Versus Egoscue Exercise on Lower Cross Syndrome - NCT ID: NCT06303388 - Study ID: REC/MS-PT/01721 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description This study aims to find effects of Bruegger's Exercise versus Egoscue exercise on pain and hyperlordosis on patient with lower cross syndrome. This is interventional study which recruits 34 participants ,14 in each group. ### Conditions - Lower Cross Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bruegger,s Exercise - Egoscue Exercise ### Outcomes Primary Outcomes - Flexicurve Ruler - Pelvic Inclinometer - NPRS Secondary Outcomes - Modified Thomas Test - Visual Assessment through toe touching - Prone Hip Extension Co-ordination Test - Trunk Flexion Co-ordination and Strength Test ### Location - Facility: Pakistan Railway General Hospital, Rawalpindi, Federal, 44000, Pakistan @@
## Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome - NCT ID: NCT06303375 - Study ID: REC/MS-PT/01718 Nida Kausar - Status: RECRUITING - Start Date: 2023-10-13 - Completion Date: 2024-08-30 - Lead Sponsor: Riphah International University ### Study Description Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome. ### Conditions - Lower Cross Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kinesio taping - Conventional physical therapy ### Outcomes Primary Outcomes - Visual analog scale (VAS) - Anterior pelvic tilting - Oswestry Disability Index (ODI) - Muscle Length Secondary Outcomes ### Location - Facility: Railway hospital Rawalpindi, Rawalpindi, Punjab, 46060, Pakistan @@
## Effects of Elastic Band Excercises on Chest Expansion - NCT ID: NCT06303362 - Study ID: REC/MS-PT/014258 Sumbal Nawaz - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-01-30 - Lead Sponsor: Riphah International University ### Study Description • To determine the effects of Elastic Band Exercises on Chest Expansion, Forward Head Posture and disability ### Conditions - Forward Head Posture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Elastic band excercise - strengthening with conventional physical therapy ### Outcomes Primary Outcomes - Cloth tape measurement - Neck Disability Index - Craniovertebral angle Secondary Outcomes ### Location - Facility: Railway hospital Rawalpindi, Rawalpindi, Punjab, 46060, Pakistan @@
## Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers. - NCT ID: NCT06303349 - Study ID: CHUBX 2023/45 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University Hospital, Bordeaux ### Study Description The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage.Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier.Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient.The measurement of biomarkers and cerebral vasospasm will be blinded to each other. ### Conditions - Cerebral Vasospasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Samples collection ### Outcomes Primary Outcomes - Occurrence of cerebral vasospasm Secondary Outcomes - Biomarkers measurements - WFNS (World Federation of Neurologic Surgeons) score - Glasgow score - Medical Research Council (MRC) score - PtiO2 (oxygen pressure in the cerebral tissue) - Transcranial Doppler - Modified Fisher score - Non-significant angiographic vasospasm - Non-significant perfusion anomaly - Glasgow Outcome Scale -Extended (GOS-E) - Cerebral ischemic lesions - Occurrence of symptomatic vasospasm ### Location - Facility: CHU de Bordeaux, Bordeaux, N/A, N/A, France @@
## Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP - NCT ID: NCT06303336 - Study ID: REC/0258 Ayesha Ashraf - Status: RECRUITING - Start Date: 2023-12-30 - Completion Date: 2024-05-14 - Lead Sponsor: Riphah International University ### Study Description The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy ### Conditions - Diplegic Spastic Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NMES with Dynamic Bracing - NMES without Dynamic Bracing - Dynamic Bracing Only ### Outcomes Primary Outcomes - Modified Ashworth Scale - Observable Movement Quality Scale - Physicians Rating Scale Secondary Outcomes ### Location - Facility: Children Hospital, Faisalābad, Punjab, 54000, Pakistan @@
## Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan in CVD Risk Individuals - NCT ID: NCT06303323 - Study ID: Nawal Fatima - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08 - Lead Sponsor: Riphah International University ### Study Description To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing ### Conditions - Cardiovascular Diseases - Risk Behavior, Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Qigong Exercise - Wu Dang Tai Chi ### Outcomes Primary Outcomes - Exercise Capacity - Stress Secondary Outcomes ### Location - Facility: Pakistan Railway General Hospital, Rawalpindi, Punjab, 4600, Pakistan @@
## Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction - NCT ID: NCT06303310 - Study ID: REC/RCR&AHS/23/0296 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-05-15 - Lead Sponsor: Riphah International University ### Study Description This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities. ### Conditions - Vestibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gaze Stability Exercises - Optokinetic Exercises - Routine Physical Therapy ### Outcomes Primary Outcomes - Dizziness Handicap Inventory - Mini-Bestest - Modified-Clinical Test of Sensory Interaction on Balance - Vestibular Disorders Activities of Daily Living Scale Secondary Outcomes ### Location - Facility: Bahawal Victoria Hospital, Bahāwalpur, Punjab, 63100, Pakistan @@
## Effects of Reflexology and Generalized Stretching in Postmenopausal Females. - NCT ID: NCT06303297 - Study ID: REC/RCR&AHS/23/0576 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2024-09-01 - Lead Sponsor: Riphah International University ### Study Description To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females ### Conditions - Postmenopausal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - REFLEXOLOGY - GENERALIZED STRETCHING ### Outcomes Primary Outcomes - Insomnia severity index score - Menopause Rating Scale - Menopause Specific Quality of Life Secondary Outcomes ### Location - Facility: Akhtar Saeed trust hospital,, Lahore, Punjab, 05499, Pakistan @@
## Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT - NCT ID: NCT06303284 - Study ID: Pending - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2027-06-01 - Lead Sponsor: University of Calgary ### Study Description As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs.There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications.The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed.This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population. ### Conditions - Ankle Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - subcutaneous Teriparatide injection - placebo ### Outcomes Primary Outcomes - Participant recruitment rate Secondary Outcomes - Incidence of composite measure of complications - Adverse events - modified Radiological Union Scale for Tibia [RUST] score), - Olerud Molander Score - EuroQol five dimensions [EQ-5D] - short form-12 [SF-12] - pain visual analogue score [VAS] - time-to-fracture union - 90 day mortality - Bone mineral density - Total cost and QALYs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population - NCT ID: NCT06303271 - Study ID: MUHAMMAD NISAR - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Riphah International University ### Study Description The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks ### Conditions - Vestibular Hypofunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey - Caw Thorne Cooksey ### Outcomes Primary Outcomes - The Dix-Hall pike test - Berg Balance Scale - The Dizziness Handicap Inventory (DHI) - Dynamic Gait Index (DGI) - Modified Clinical Test of sensory interaction & Balance (MCTSIB) Secondary Outcomes ### Location - Facility: ENT dept. of DHQ Mirpur AJK, Kashmir, N/A, N/A, Pakistan @@
## Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain - NCT ID: NCT06303258 - Study ID: RiphahIU Sharmeen Kanwar - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-06-30 - Lead Sponsor: Riphah International University ### Study Description Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain. ### Conditions - Low Back Pain - Pelvic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Core Stabalization Exercises - Generalized Antenatal Exercises ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) - Visual Analogue Scale (VAS) - Pregnant women's quality of life questionnaire (QOL-GRAV) - Pregnant women's quality of life questionnaire (QOL-GRAV) Secondary Outcomes ### Location - Facility: Tehsil Headquarter Hospital Raiwind, Lahore, Punjab, 55150, Pakistan @@
## Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section - NCT ID: NCT06303245 - Study ID: REC/RCR&AHS/23/0579 - Status: RECRUITING - Start Date: 2023-02-23 - Completion Date: 2024-09-01 - Lead Sponsor: Riphah International University ### Study Description To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section ### Conditions - Cesarean Section; Complications, Wound, Dehiscence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ABDOMINAL BINDERS - TENS ### Outcomes Primary Outcomes - o Numeric Pain rating Scale - o Symptom Distress scale - o PAC-SYM Questionnaire Secondary Outcomes ### Location - Facility: PAF hospital, Lahore, N/A, 05499, Pakistan @@
## Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement - NCT ID: NCT06303232 - Study ID: REC/RCR&AHS/23/0578 - Status: RECRUITING - Start Date: 2023-02-23 - Completion Date: 2024-09-01 - Lead Sponsor: Riphah International University ### Study Description To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women. ### Conditions - Postpartum Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MANUAL LYMPHATIC DRAINAGE - THERAPEUTIC ULTRASOUND ### Outcomes Primary Outcomes - Visual Analogue Scale - VAS - Six Point Engorgement Scale - SPE - Breastfeeding Self-Efficacy Scale - BSES Secondary Outcomes ### Location - Facility: Innovative Health Concepts Clinic, Lahore, N/A, 05499, Pakistan @@
## Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome - NCT ID: NCT06303219 - Study ID: REC/RCR&AHS/23/0577 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2024-09-01 - Lead Sponsor: Riphah International University ### Study Description To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome ### Conditions - Polycystic Ovarian Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RADITIONAL MODERATE INTENSITY TRAINING - HIGH INTENSITY INTERVAL TRAINING ### Outcomes Primary Outcomes - Hamilton Anxiety Rating scale (HAM-A) - The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) - The Fatigue Impact Scale (FIS) Secondary Outcomes ### Location - Facility: Gynecological Department of Fatima Memorial Hospital, Lahore, N/A, 05499, Pakistan @@
## TEC4Home Blood Pressure Randomized Controlled Trial - NCT ID: NCT06303206 - Study ID: H23-00623 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-01-01 - Lead Sponsor: University of British Columbia ### Study Description The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED).The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED?Secondary research questions will address:1. How do these interventions (telemonitoring and case management) improve medication adherence?2. Do these interventions reduce physician and ED visits?3. Are these interventions safe?4. How do these interventions influence patient experience?Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM) ### Outcomes Primary Outcomes - Systolic blood pressure controlled Secondary Outcomes - Impact of intervention on other blood pressure measures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms - NCT ID: NCT06303193 - Study ID: 10001554 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2035-01-01 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description Background:Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed.Objective:To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN.Eligibility:Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN.Design:Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone.Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants.Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years.Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics. ### Conditions - Myelodysplastic Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - pacritinib ### Outcomes Primary Outcomes - Recommended phase 2 dose of pacritinib in participants 12-17 years of age - Efficacy as measured by Objective Response Rate (ORR) per each risk-based cohort Secondary Outcomes - Pharmacokinetic (PK) properties of pacritinib - Extended safety of pacritinib ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## NIDCD Otolaryngology Clinical Protocol Biospecimen Bank - NCT ID: NCT06303180 - Study ID: 10001560 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2033-12-30 - Lead Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD) ### Study Description Background:Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.Objective:To collect biological samples for a repository that will be used for research.Eligibility:People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.Design:Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.Samples may be used for genetic testing. ### Conditions - Hearing Loss - Head and Neck Neoplasms - Hearing Disorders - Laryngeal Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To create a biorepository of diseased and normal tissue specimens for research purposes. Secondary Outcomes - To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Testing AZD9291 as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH-Subprotocol E) - NCT ID: NCT06303167 - Study ID: NCI-2024-01150 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2015-08-06 - Completion Date: 2024-05-26 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MATCH treatment trial evaluates the effectiveness of osimertinib (AZD9291) in treating patients with cancer that has certain genetic changes called EGFR mutations. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of mutant forms of the EGFR protein, which play a key role in tumor cell growth. Osimertinib may cause tumor cell death and inhibit tumor growth in EGFR-overexpressing tumor cells, thereby stopping or slowing the spread of tumor cells. ### Conditions - Advanced Lymphoma - Advanced Malignant Solid Neoplasm - Hematopoietic and Lymphoid Cell Neoplasm - Refractory Lymphoma - Refractory Malignant Solid Neoplasm - Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Echocardiography - Multigated Acquisition Scan - Osimertinib - Radiologic Examination ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Overall survival - Progression free survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment - NCT ID: NCT06303154 - Study ID: EC45 MOBIBRA - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2025-09 - Lead Sponsor: Thuasne ### Study Description The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment. ### Conditions - Breast Cancer Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mobiderm Intimate Bra group ### Outcomes Primary Outcomes - Evolution of breast edema severity Secondary Outcomes - Comparison of methods to follow changes in the severity of breast edema - TDC measurement - Comparison of methods to follow changes in the severity of breast edema - Clinical assessment - Comparison of methods to follow changes in the severity of breast edema - Ultrasound measurement - Time to edema onset - Time to edema disappearance - Symptoms and quality of life changes associated with breast edema - Breast edema hypersensitivity - Breast pain - Skin changes associated with breast edema - Physical activity - Healing time - Safety of the device - Compliance to the device - Patient's satisfaction ### Location - Facility: Groupe Hospitalier Paris Saint Joseph - Groupement FEHAP, Paris, Paris 14, 75014, France @@
## Comparative Effects of Neuromuscular Training and Mobilization With Movement in Professional Athletes With Ankle Sprain - NCT ID: NCT06303141 - Study ID: LUC/CPGS/PGS/20230405/001 - Status: COMPLETED - Start Date: 2023-04-05 - Completion Date: 2023-09-10 - Lead Sponsor: Riphah International University ### Study Description The study aims to compare the effects of neuromuscular training and mobilization with movement on pain, range of motion, function, and disability in professional athletes with ankle sprain. Neuromuscular training focuses on improving neuromuscular control and stability, while mobilization with movement aims to restore joint mobility and function. By investigating the outcomes of these two interventions, the study seeks to provide insights into their effectiveness for managing ankle sprains in professional athletes. ### Conditions - Ankle Injuries - Musculoskeletal Manipulations ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Closed Chain exercises - Neuromuscular Training - Mobilization with Movement ### Outcomes Primary Outcomes - Numerical Pain Rating Scale for Pain - Goniometer for Range of Motion - Star balance excursion test for Balance - Foot and ankle ability Measure for Functional Performance - Cumberland Ankle Instability Secondary Outcomes - Agility T-test - Speed (20m sprint test) ### Location - Facility: Pakistan Sports Board, Lahore, Punjab, N/A, Pakistan @@
## Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge - NCT ID: NCT06303128 - Study ID: IRB-FY2024-61 - Status: RECRUITING - Start Date: 2024-02-03 - Completion Date: 2025-05 - Lead Sponsor: James Tarbox, MD ### Study Description The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is:- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction. ### Conditions - Penicillin Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Amoxicillin 250 MG - Placebo - Amoxicillin 62.5mg - Amoxicillin 187.5mg ### Outcomes Primary Outcomes - Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups Secondary Outcomes - Analysis of adverse reactions - Analysis of medical and allergic history - Validation of penicillin allergy delabeling - Analysis of demographic data ### Location - Facility: Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States @@
## CSD231005 Nicotine Pouch Biomarkers of Exposure - NCT ID: NCT06303115 - Study ID: CSD231005 BoE - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2025-01-15 - Lead Sponsor: RAI Services Company ### Study Description This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence. ### Conditions - Tobacco Use - Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Nicotine Pouch P1312914, 4 mg nicotine - Nicotine Pouch P1312915, 8 mg nicotine - Nicotine Pouch P1013215, 8 mg nicotine - Nicotine Pouch P1013218, 10 mg nicotine - Nicotine Pouch P1012919, 12 mg nicotine - Smoking Abstinence - Continued UB cigarette smoking ### Outcomes Primary Outcomes - 4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL] Secondary Outcomes - 4Aminobiphenyl [4ABP] - 1Aminonaphthalene [1AN] - 2Aminonaphthalene [2AN] - 2Cyanoethyl mercapturic acid [CEMA] - 3Hydroxypropyl mercapturic acid [3HPMA] - 3Hydroxy1methylpropylmercapturic acid [HMPMA] - 3hydroxybenzo[a]pyrene [3-OH-B[a]P] - 1hydroxypyrene [1OHP] - Monohydroxybutyl mercapturic acid [MHBMA] - Nnitrosonornicotine [NNN] + glucuronides [Total NNN] - SPhenyl mercapturic acid [SPMA] - Total nicotine equivalents (molar sum of nicotine, cotinine, 3hydroxycotinine and their glucuronides) [TNneq] - Carboxyhemoglobin [COHb] - Nnitrosonornicotine [NNN] + glucuronides [Total NNN] ### Location - Facility: Pillar Bentonville, Bentonville, Arkansas, 72712, United States @@
## Effects of Segmental and Pursed Lip Breathing Exercises on Upper Cross Syndrome - NCT ID: NCT06303102 - Study ID: REC/RCR&AHS/23/0356 - Status: COMPLETED - Start Date: 2023-05-23 - Completion Date: 2024-02-15 - Lead Sponsor: Riphah International University ### Study Description Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross ### Conditions - UPPER CROSS SYNDROME ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manual PT/ Conventional PT Treatment + Segmental and Pursed Lip Breathing Exercise - Manual PT/Conventional PT Treatment ### Outcomes Primary Outcomes - NPRS - Quality of Life (SF-36 questionnaire) - Neck Disability Index (NDI) Secondary Outcomes ### Location - Facility: Ismail Medicare, Jhang, Punjab, 35200, Pakistan @@
## Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients - NCT ID: NCT06303089 - Study ID: zzwee-quit (CKD) 23152 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Sun Yat-sen University ### Study Description The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation. ### Conditions - Smoking Cessation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires set ### Outcomes Primary Outcomes - Prevalence of current smokers - Abstinence rates Secondary Outcomes - Nicotine dependence - Perceptions of tobacco harm - knowledge of tobacco-related diseases - Smoking related attitudes - Self-efficacy level - Withdrawal symptoms ### Location - Facility: XIAW, Guangzhou, Guangdong, 510080, China @@
## Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial - NCT ID: NCT06303076 - Study ID: 134 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-12 - Lead Sponsor: Sultan Qaboos University ### Study Description The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia. ### Conditions - Depressive Disorder, Major ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tizanidine Hcl 4Mg Tab - Zolpidem Tartrate 10 mg ### Outcomes Primary Outcomes - Pittsburgh Sleep Quality Index Secondary Outcomes - Frequency and Severity of Side Effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms - NCT ID: NCT06303063 - Study ID: SNSC-IAS-202301 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2025-12-30 - Lead Sponsor: Sinomed Neurovita Technology Inc. ### Study Description The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms. ### Conditions - Intracranial Aneurysm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SINOMED IAS Stent System - Neuroform Atlas Stent System ### Outcomes Primary Outcomes - Success aneurysm occlusion at 6 month post procedure Secondary Outcomes - Technical success - Success aneurysm occlusion immediately after the procedure - Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure - Complete aneurysm occlusion at 6 months post procedure - Retreatment Rate at 6 months and 1 year post procedure - In-Stent Stenosis at 6 months post procedure - Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure - Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure - All-cause mortality at 30 days, 6 months and 1 year post procedure - Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure - In-stent thrombosis at 6 months post procedure - Rate of Device defect ### Location - Facility: Beijing Tiantan Hospital, Capital Medical University, Beijing, N/A, N/A, China @@
## Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke - NCT ID: NCT06303050 - Study ID: Urooj Amir - Status: RECRUITING - Start Date: 2023-12-07 - Completion Date: 2024-06-07 - Lead Sponsor: Riphah International University ### Study Description The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks. ### Conditions - Stroke, Cardiovascular ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mental Imagery with task Oriented training group - Task Oriented training group ### Outcomes Primary Outcomes - Berg And Balance scale - Tempa scale for kinesiophobia - Ten-meter walk test - Dynamic gate index - Time Up and Go Test Secondary Outcomes ### Location - Facility: Khyber Medical University, Peshawar, KPK, 2500, Pakistan @@
## Effect of Esketamine on 95% Induction Dose of Remimazolam - NCT ID: NCT06303037 - Study ID: SAHoWMU-CR2024-03-105 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University ### Study Description As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children. ### Conditions - Pediatric - Gastroscopy - ED95 - Sedation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Remimazolam besylate and low-dose Esketamine - Remimazolam besylate and Medium dose Esketamine ### Outcomes Primary Outcomes - Sedation induction time Secondary Outcomes - Modified observer's assessment of alertness#sedation#MOAA/S#scale - Recovery times - VAS(The difficulty of gastroscope insertion) - Number of children with adverse effects ### Location - Facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, N/A, China @@
## Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis - NCT ID: NCT06303024 - Study ID: RELIABLE Clinical Study - Status: RECRUITING - Start Date: 2023-06-14 - Completion Date: 2026-03-01 - Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus ### Study Description Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy. ### Conditions - Multiple Sclerosis, Relapsing-Remitting ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - personalized combined physical and cognitive intervention ### Outcomes Primary Outcomes - Symbol Digit Modalities Test (SDMT) - California Verbal Learning Test second edition (CVLT-II) - Brief Visuo-Spatial Memory Test- Revised (BVMT-R) - Word list generation (WLG) - Stroop test - Test Intelligenza Breve (TIB) - 9 hole peg test (9HPT) - The Hospital Anxiety and Depression Scale (HADS) - Beck Depression Inventory second edition - The Modified Fatigue Impact Scale (MFIS) - The Multiple Sclerosis Walking Scale (MSWS-12) - Multiple Sclerosis Impact Scale (MSIS-29-V2) - Multiple Sclerosis Quality of Life-54 (MSQOL-54) - six minutes walking test (6MWT) - Romberg test - handgrip test - cognitive-motor interference - Timed 25-foot walk - brain MRI scan - International Physical Activity Questionnaire (IPAQ) Secondary Outcomes ### Location - Facility: IRCCS Fondazione Don Carlo Gnocchi ONLUS, Firenze, N/A, 50143, Italy @@
## Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females. - NCT ID: NCT06303011 - Study ID: S22C14G92003 - Status: COMPLETED - Start Date: 2023-03-15 - Completion Date: 2024-03-15 - Lead Sponsor: Riphah International University ### Study Description Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales. ### Conditions - Constipation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Electrical Nerve Stimulator - TENS on para sacral area with Abdominal Massage ### Outcomes Primary Outcomes - PAC-SYM Questionnaire - PAC-QOL Questionnaire Secondary Outcomes ### Location - Facility: Jinnah Hospital, Lahore, Punjab, 44000, Pakistan @@
## Dexmedetomidine and Vasopressin in Septic Shock - NCT ID: NCT06302998 - Study ID: MS.111 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-01 - Lead Sponsor: Mansoura University ### Study Description Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality. ### Conditions - Sepsis - Septic Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DEX-PRESSIN - Standard of Care ### Outcomes Primary Outcomes - in-hospital mortality Secondary Outcomes - survival analysis - Norepinephrine Equivalent Dose (NED) - Duration of vasopressor infusion in survivors - Initiation of invasive mechanical ventilation (IMV) - Duration of IMV - Early acute kidney injury (AKI) - Late acute kidney injury (AKI) - Acute Physiology and Chronic Health Evaluation (APACHE-II) - Simplified Acute Physiology Score (SAPS) II score - ICU length of stay - Hospital length of stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Atomized Inhalation ICG for Treatment of Congenital Lung Malformations - NCT ID: NCT06302985 - Study ID: ICG-CLMs - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2050-12-31 - Lead Sponsor: Jiexiong Feng ### Study Description To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children. ### Conditions - Pulmonary Sequestration - Congenital Pulmonary Airway Malformation - Indocyanine Green - Thoracoscopic Surgery - Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - atomized inhalation ICG before thoracoscope pneumonectomy ### Outcomes Primary Outcomes - rate residual Secondary Outcomes - peak volume ratio - length of hospital stay - peak time ratio ### Location - Facility: Tongji Hospital, Wuhan, Hubei, 430030, China @@
## Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome. - NCT ID: NCT06302972 - Study ID: RCRAHS-ISB/REC/MS-PT/01771 - Status: RECRUITING - Start Date: 2023-10-30 - Completion Date: 2024-06-30 - Lead Sponsor: Riphah International University ### Study Description This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results. ### Conditions - Upper Cross Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional treatment - IASTM and CCEP ### Outcomes Primary Outcomes - Range of motion Cervical (Flexion) - ROM Cervical (Extension) - ROM Cervical (Left Lateral Flexion) - ROM Cervical( Right Lateral Flexion) - ROM Cervical ( Right Rotation) - ROM Cervical ( Left Rotation) Secondary Outcomes - Numeric Pain Rating Scale (NPRS) - Flexicurve Ruler and Photogrammetry for posture ### Location - Facility: Maroof international Hospital and Railway Hospital, Islamabad, Federal, 44000, Pakistan @@
## Clock Proteins as Prognostic Markers - NCT ID: NCT06302959 - Study ID: 36-232 ex 23/24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Medical University of Graz ### Study Description Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study the investigators will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment. ### Conditions - Severe Eosinophilic Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Correlation between clock expression, exacerbation rate and lung function. Secondary Outcomes - Correlation between clock expression, symptoms and quality of life. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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