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## Subtypes and Prognostic Factors in Erdheim-Chester Disease - NCT ID: NCT06317246 - Study ID: ECDSUB - Status: RECRUITING - Start Date: 2020-09-15 - Completion Date: 2024-12-15 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease. ### Conditions - Erdheim-Chester Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Investigation of BRAF mosaicism ### Outcomes Primary Outcomes - Clinical characteristics of patients with Erdheim-Chester Disease - Prognostic factors of patients with Erdheim-Chester Disease Secondary Outcomes ### Location - Facility: Meyer Children's Hospital IRCCS, Florence, Firenze, N/A, Italy @@
## Outcomes of a Multidisciplinary Program for the Treatment of Chronic Pelvic Pain - NCT ID: NCT06317233 - Study ID: STUDY00007131 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: Medstar Health Research Institute ### Study Description The goal of this clinical trial is to test the impact of a detailed treatment handbook and follow-up schedule on women seeking care for chronic pelvic pain in a gynecology office-based practice. The main questions it aims to answer are:* How does the handbook and follow-up impact patient satisfaction?* How does the handbook and follow-up impact patient pain and quality of life scores? Participants will be randomized to receive the office standard of care, or standard of care plus a printed handbook customized to highlight their diagnosis, treatment plan and follow-up schedule. ### Conditions - Chronic Pelvic Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chronic Pelvic Pain Treatment Guide ### Outcomes Primary Outcomes - Patient Satisfaction Secondary Outcomes - Pain Catastrophizing - Pelvic Pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vedolizumab for the Treatment of Collagenous Gastritis - NCT ID: NCT06317220 - Study ID: 2024P000152 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-04-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are:* Whether vedolizumab can reduce CG symptoms* Whether vedolizumab is safe to take for patients with CGParticipants in this study will:* Receive vedolizumab through an IV ("infusion")* Complete a survey at each infusion visit* Have blood collected at each infusion visit* Undergo an endoscopy with biopsy ### Conditions - Collagenous Gastritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Vedolizumab ### Outcomes Primary Outcomes - Change in symtpoms Secondary Outcomes - Response durability - Histologic response - Incidence of treatment-emergent adverse events (safety) ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Evaluation of the Safety of Reoperation for Ipsilateral Recurrent Tumors After Nephron-sparing Partial Nephrectomy - NCT ID: NCT06317207 - Study ID: PJ2024-01-44 - Status: COMPLETED - Start Date: 2013-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: The First Affiliated Hospital of Anhui Medical University ### Study Description To evaluate the safety of reoperation in patients with renal tumors who have ipsilateral tumor recurrence after nephron-sparing partial nephrectomy. ### Conditions - Renal Cell Carcinoma - Robotic Surgical Procedures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Operation time Secondary Outcomes - Estimated blood loss ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients - NCT ID: NCT06317194 - Study ID: Magnetic Tides - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-15 - Completion Date: 2027-08-30 - Lead Sponsor: Magnetic Tides ### Study Description Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - kTMP - Sham kTMP ### Outcomes Primary Outcomes - Fugl- Meyer Assessment (Upper Extremity) Secondary Outcomes - Action Research Arm Test (ARAT) - Modified Ashworth Scale (MAS) - Trial to Trial Variability (T2TV) - Range of Joint Motion (ROM) - Grasp to Lift Time - Transport Time ### Location - Facility: Magnetic Tides, El Cerrito, California, 94530, United States @@
## Assessment of Liver Diseases Using a Deep-Learning Approach Based on Ultrasound RF-Data - NCT ID: NCT06317181 - Study ID: DifLivSPECTRUS - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Technische Universität Dresden ### Study Description The goal of this clinical trial is to test the performance of neuronal networks trained on ultrasonic raw Data (=radiofrequency data) for the assessment of liver diseases in patients undergoing a clinical ultrasound examination. The general feasibility is currently evaluated in a retrospective cohort.The main questions the study aims to answer are:* Can a neuronal network trained on RF Data perform equally good as elastography in the assessment of diffuse liver diseases?* Can a neuronal network trained on RF Data perform better than a neuronal network trained on b-mode images in the assessment of diffuse liver diseases?* Can a neuronal network trained on RF Data distinguish focal pathologies in the liver from healthy tissue?To answer these questions participants with a clinically indicated fibroscan will undergo:* a clinical elastography in Case ob suspected diffuse liver disease* a reliable ground truth (if normal ultrasound is not sufficient e.g. contrast enhanced ultrasound, biopsy, MRI or CT) in case of focal liver diseases, depending on the standard routine of the participating center* a clinical ultrasound examination during which b-mode images and the corresponding RF-Data sets are captured ### Conditions - Artificial Intelligence - Ultrasonography - Elasticity Imaging Techniques - Liver Diseases - Metastasis to Liver ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Collection of elastography data - Collection of ultrasonic raw data ### Outcomes Primary Outcomes - Performance analysis of the trained model Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SIMPLifying Elements of Standardized Automated Office Blood Pressure Measurements (Pilot Study) - NCT ID: NCT06317168 - Study ID: SIMPLE-AOBP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-31 - Lead Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal ### Study Description This study aims to assess whether removing single elements of the standardized office BP measurement procedure will affect the accuracy towards the mean awake ambulatory BP. Four arms are planned in a randomized order: 1) full standardized procedure, 2) standardized procedure but with cuff placed on a sleeve, 3) standardized procedure but arm resting vertically, 4) standardized procedure but with non-validated device.This is a pilot study to inform on the sample size required to perform adequately powered large scale studies. ### Conditions - Blood Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - Mean awake ambulatory BP measurements ### Outcomes Primary Outcomes - Difference with mean awake ambulatory systolic BP Secondary Outcomes - Difference with mean awake ambulatory diastolic BP ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Occupational Therapy for Children and Young People Who Self-harm: A Qualitative Study - NCT ID: NCT06317155 - Study ID: BournemouthU-AS - Status: NOT_YET_RECRUITING - Start Date: 2024-12 - Completion Date: 2025-12 - Lead Sponsor: Bournemouth University ### Study Description The goal of this qualitative observational study is to explore the experiences of children and their carers, receiving occupational therapy for self-harm and the experiences of health professionals delivering these interventions. The child cohort within the study will have a history of self-harm and have been under the care of Children and Adolescent Mental Health Services.The main questions it aims to answer are:* What are the experiences of children and their carers who have received occupational therapy interventions as either a standalone, or adjunct, treatment for self-harm, whilst under the care of Tier 4 CAMHS service.* What are the experiences of healthcare professionals delivering occupational therapy interventions working within a T4 CAMHS service.* To understand the participants views on whether occupational therapy interventions are a viable and effective approach to address self-harm amongst young people.Participants will be asked to complete a questionnaire and take part in a single semi-structured interview. 25% of participants may be asked to take part in a further in depth semi-structured interview. ### Conditions - Self Harm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Occupational therapy ### Outcomes Primary Outcomes - What was the participants experience of receiving or delivering an occupational therapy informed intervention? - What was the participants experience of receiving or delivering an occupational therapy informed intervention? - Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm? - Did the participants feel the occupational therapy informed interventions were effective in supporting young people who self-harm or effective in reducing self-harm? Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Glucose and Glycogen Dynamics in Prediabetes - NCT ID: NCT06317142 - Study ID: NL84574.068.23 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-07 - Lead Sponsor: Maastricht University Medical Center ### Study Description The goal of this observational study is to investigate changes in nocturnal and postprandial glucose and glycogen metabolism in individuals with impaired fasting glucose and impaired glucose tolerance compared to healthy, non-diabetic, overweight participants (15 per group). In addition, it will be investigated if reducing gluconeogenesis, by using the challenge agent Acipimox, in people with prediabetes can increase glucose tolerance and fat oxidation by increased reliance on hepatic glycogen. The main questions this project aims to answer are:* whether there are differences in nocturnal glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.* whether there are differences in postprandial glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls.Participants will visit the university for a screening visit and a visit with overnight stay for measurements of gluconeogenesis, glycogen, and substrate oxidation. A subgroup will receive \[18F\]-FDG to assess tissue-specific postprandial glucose uptake. Thereafter, 20 prediabetic individuals will follow a 4-day treatment with acipimox to decrease gluconeogenesis, followed by a second overnight visit with similar measurements as mentioned for the first visit. ### Conditions - Pre Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Acipimox 250 mg Oral Capsule ### Outcomes Primary Outcomes - Hepatic and muscle glycogen measured by 13Carbon-Magnetic resonance spectroscopy (13C-MRS) - Whole body gluconeogenesis determined by deuterated water - Postprandial hepatic and muscle glucose uptake determined by Fluorodeoxyglucose-Positron emission tomography ([18F]-FDG-PET) combined with oral glucose tolerance test (OGTT) Secondary Outcomes - Oral glucose tolerance after acipimox treatment measured by OGTT - Hepatic glycogen after acipimox treatment measured by 13C-MRS - Whole body gluconeogenesis after acipimox treatment determined by deuterated water ### Location - Facility: Maastricht University, Maastricht, Limburg, 6229ER, Netherlands @@
## Clinical Feasibility Study of the BariTon™ System in Obese Patients - NCT ID: NCT06317129 - Study ID: CP000005 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2026-01-31 - Lead Sponsor: BariaTek Medical ### Study Description Safety evaluation of BariaTek Medical gastric restriction and biliodigestive diversion device. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endoscopic gastric restriction and biliodigestive diversion ### Outcomes Primary Outcomes - Safety of the BariTon™ - Safety of the BariTon™ Secondary Outcomes - Safety of the BariTon™ - Safety of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ - Efficacy of the BariTon™ ### Location - Facility: Republican Specialized Scientific and Practical Medical Center of Surgery named after V. Vakhidov, Tashkent, N/A, N/A, Uzbekistan @@
## Examining the Relationship Between Core Muscles and Bladder Issues in Children - NCT ID: NCT06317116 - Study ID: 2023/09-14 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-29 - Completion Date: 2025-03-01 - Lead Sponsor: Izmir Bakircay University ### Study Description The goal of this observational study is to learn about functional bladder problems in children. The main questions it aims to answer are:* Does bladder symptoms in children have an effect on core muscles?* How do core muscles change based on an increase or decrease in these symptoms? ### Conditions - Lower Urinary Tract Symptoms - Skeletal Muscle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Dysfunctional Voiding and Incontinence Scoring System (DVAISS) - Bladder and Bowel Dysfunction Questionnaire (BBDQ) - Childhood Bladder and Bowel Dysfunction Questionnaire (CBBDQ) - Bladder Diary - Bowel Diary Secondary Outcomes - Superficial Electromyography (EMG) - Ultrasonography (USG) ### Location - Facility: Ege University Hospital Pediatric Urology Outpatient Clinic, İzmir, N/A, N/A, Turkey @@
## A Clinical Trial to Evaluate the Sensitivity and Specificity of "WAYMED Endo" Compared to the Endoscopists in Classifying Early Gastric Cancer (EGC) Based on the Depth of Invasion in Endoscopic Images - NCT ID: NCT06317103 - Study ID: WAY-CTP-WME01-MSM - Status: COMPLETED - Start Date: 2023-08-22 - Completion Date: 2023-08-22 - Lead Sponsor: WAYCEN Inc ### Study Description The purpose of this clinical trial is to prove that the prediction capability of 'WAYMED endo' is superior to that of the endoscopists in classifying EGC based on the depth of invasion categories in gastro-endoscopic images.The computer-aided detection·diagnosis software is an Artificial Intelligence (AI) software used to assist medical specialists in diagnostic decisions by automatically classifying EGC based on the depth of invasion categories in gastro-endoscopic images and displaying the results and possibilities on the User Interface (UI). ### Conditions - Early Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - WADYMED endo - Control group (the endoscopists) ### Outcomes Primary Outcomes - Clinical Sensitivity in classifying early gastric cancer (EGC) based on the depth of invasion (%) - Clinical Specificity in classifying early gastric cancer (EGC) based on the depth of invasion (%) Secondary Outcomes - Accuracy in classifying the depth of invasion categories ("Mucosa" or "Submucosa") for early gastric cancer (%) ### Location - Facility: Yonsei University Gangnam Severance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Vertical GBR LPRF Block vs. Autogenous Bone With DBBM - NCT ID: NCT06317090 - Study ID: S59813-2 - Status: COMPLETED - Start Date: 2018-07-02 - Completion Date: 2023-03-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description split-mouth RCT, 25 months follow up. GBR protocol with LPRF as grafting material in the test group and autogenous bone with DBBM as grafting material in the control group. ### Conditions - Alveolar Bone Resorption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - guided bone regeneration ### Outcomes Primary Outcomes - bone volume as measured on CBCT scans Secondary Outcomes - Buccal bone thickness around the implants - Buccal bone thickness around the implants - Cumulative survival rate of the implants - rates and types of complications ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks - NCT ID: NCT06317077 - Study ID: I5-R1-C-FA - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-05-15 - Lead Sponsor: Löwenstein Medical Technology GmbH & Co. KG ### Study Description Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing events. For this purpose, breathing events of different classes are detected, counted and identified.This clinical investigation aims to evaluate the performance of prismaLINE devices based on the accuracy of the apnea-hypopnea index (AHI) recorded in the devices. During the PAP titration night, the AHI is similarly detected via polysomnography (PSG) device and a subsequent manual scoring of the recorded PSG data. The validation of the device AHI accuracy refers to the alignment with the manually scored AHI.Further goals of this clinical investigation are the confirmation of safety of the prismaLINE devices, the confirmation of performance and safety of LM full face masks (full face masks of the manufacturer Löwenstein Medical Technology), as well as the investigation of the influence of LM full face masks on therapy quality.The most relevant inclusion criteria are diagnosis of a sleep-related breathing disorder and indication for therapy with continuous positive airway pressure (CPAP). Treatment takes place with prismaLINE PAP therapy devices in combination with LM full face masks. ### Conditions - Sleep Apnea Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PAP therapy setting - exclusive use of Löwenstein Medical full face masks ### Outcomes Primary Outcomes - Delta AHI [n/h]= Difference of device AHI (prismaLINE devices of the type WM100TD) and the manual scored AHI of polysomnographic data identified in the Matlab-based SOMNOmat tool Secondary Outcomes - N_AE device [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration - Mask fit score= Leakage, pressure points, stable pressure level, comfort determined via questionnaire - N_AE mask [n]= number and severity of occurred (predictable) adverse events and (predictable) adverse device effects, counted during study duration - Delta AI [n/h]= difference of apnea-indices (obstructive/central/mixed) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat - Delta HI [n/h]= difference of hypopnea-indices (obstructive/central) between the therapy device and the manually evaluated PSG data identified in the Matlab-based tool SOMNOmat - Delta Event_individual [n]= difference of the number (with time, duration, type) of residual breathing events (apneas/hypopneas) device vs. PSG identified in the Matlab-based tool SOMNOmat - N_influenced phases [n]= number (with time, duration, type) of phases with significant deviations between the synchronized device and PSG files identified in the Matlab-based tool SOMNOmat - Delta AHI_1A [n/h]= difference between apnea indices using scoring rule 1A from AASM manual version 3.0 - Delta AHI_1B [n/h]= difference between apnea indices using scoring rule 1B from AASM manual version 3.0 - Delta AHI_mean [n/h]= difference between apnea indices using mean of scoring rule 1A and 1B from AASM manual version 3.0 (AHI_1A + AHI_1B)/2 - Delta AHI_Routine [n/h]= difference between unmachined apnea indices of device and PSG - N_impact factors [n]= number and type of factors that can increase the risk for sleep related breathing disorders like comorbidities and smoking - corr_flow-sleep= correlation between flow signal and sleep state - corr_marker= correlation between diagnostic sleep apnea syndrom markers with medical history data, biomarkers of the diagnostic night, therapy pressure and sleep stage ### Location - Facility: Krankenhaus Bethanien, Solingen, NRW, 42699, Germany @@
## Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea - NCT ID: NCT06317064 - Study ID: LMRC-Aprepitant-Pain-01 - Status: COMPLETED - Start Date: 2023-01-15 - Completion Date: 2024-01-31 - Lead Sponsor: Lahore Medical Research Center, LLP ### Study Description Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses. Substance P (SP) and NK1R mediate the symptoms of various pain disorders with chronic and/or neuropathic pain. Objective: To evaluate diagnostic and therapeutic potential of Substance P/ NK1R receptor in primary dysmenorrhea. Study Design: This was a randomized controlled trial which took place at Lahore Medical Research Center from April 2023 to August 2023. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. The study comprised of three phases, Phase 1 (Before medication), Phase 2 (NSAIDs) and Phase 3(Dexamethasone + Aprepitant). 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles. 20 dysmenhorric and 6 controls were analyzed for NK1R levels. Several assessment tools were also used in the study, ### Conditions - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ibuprofen and Aprepitant ### Outcomes Primary Outcomes - Visual Analogue Scale Score (Pain scale) - Mini Nutritional Assessment (MNA) Score - DASS-21 (Depression Anxiety Stress Scale) - Pictorial Blood Loss Assessment Chart (PBAC) Secondary Outcomes ### Location - Facility: Prof. Dr. Riffat Mehboob, Lahore, Punjab, 54000, Pakistan @@
## Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) - NCT ID: NCT06317051 - Study ID: OPTIMAR - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-12 - Lead Sponsor: Kirby Institute ### Study Description People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART. ### Conditions - HIV Infections - Weight Gain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10mg Tab - Pitavastatin 4 Mg Oral Tablet - Rosuvastatin and Ezetimibe - Placebo ### Outcomes Primary Outcomes - To assess the impact of dapagliflozin vs. placebo on weight reduction - To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration Secondary Outcomes - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^2 - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem. - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) - To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events. - To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L) - To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem. - To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples) - To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Evaluate the Performance of Total 30 (Lehifilcon A) Contact Lenses in Patients Using Digital Devices for Greater Than 8 Hours Per Day 5 Days Per Week Based on Subjective Reported Data. - NCT ID: NCT06317038 - Study ID: 89814415 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2025-01 - Lead Sponsor: Tauber Eye Center ### Study Description To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data. ### Conditions - Eye Strain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Total 30 Contact Lens ### Outcomes Primary Outcomes - Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear). Secondary Outcomes - Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear. - Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire. - Report on total daily wear time and digital device usage. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Design and Development of Multi-modal Intelligent Anesthesia Monitoring System - NCT ID: NCT06317025 - Study ID: SHOUFA2022-2Z-2039 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Beijing Chao Yang Hospital ### Study Description This project integrates the characteristics of electroencephalo-graph（EEG）, cerebral oxygen, blood pressure, heart rate, etc., based on nonlinear theory and neural oscillation, large sample data and machine learning theory, to develop a multi-modal monitoring system suitable for domestic patients, taking into account changes in sedation, analgesia, cerebral hemodynamics and other factors, regardless of patient age and type of general anesthesia drugs. ### Conditions - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Multi-modal Intelligent Anesthesia Monitoring System ### Outcomes Primary Outcomes - the depth of anesthesia (too deep or too shallow) Secondary Outcomes - EEG characteristics of loss of consciousness induced by different general anesthesia drugs - Characteristics of perioperative neurovascular coupling ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery - NCT ID: NCT06317012 - Study ID: 0407-03/2022 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2023-06-30 - Lead Sponsor: Hams Hamed Abdelrahman ### Study Description Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month. ### Conditions - Le Fort; I ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate ### Outcomes Primary Outcomes - Change in pain - change in edema - Change in post operative osteotomy position Secondary Outcomes ### Location - Facility: Alexandria Faculty of Dentistry, Alexandria, N/A, N/A, Egypt @@
## Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis - NCT ID: NCT06316999 - Study ID: 23-012169 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-06 - Lead Sponsor: Mayo Clinic ### Study Description Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA). ### Conditions - Ulcerative Colitis - Pouchitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Intestinal Ultrasound ### Outcomes Primary Outcomes - Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis Secondary Outcomes ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care. - NCT ID: NCT06316986 - Study ID: 2023-A02294-41 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Fondation Hôpital Saint-Joseph ### Study Description In the ICU, scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray. ### Conditions - Intensive Care - Nutrition ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - pH indication with NGPOD ### Outcomes Primary Outcomes - Ability of the NGPOD device to detect correct positioning of the gastric tube. Secondary Outcomes - Probe malpositioning - Time to validate correct positioning of gastric tube - Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system - x-ray manipulators time - Adverse events occurring during the study period - Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients ### Location - Facility: Hôpital Marie Lannelongue, Le Plessis-Robinson, N/A, 92350, France @@
## A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants - NCT ID: NCT06316973 - Study ID: CS-1103-01 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-07 - Lead Sponsor: Clear Scientific, Inc. ### Study Description The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants. ### Conditions - Substance Use Disorders - Methamphetamine Abuse - Methamphetamine Intoxication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CS-1103 - Sterile Saline ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events (AEs) assessed by physical examinations - Number of participants with treatment-related adverse events (AEs) assessed by vital signs - Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs) - Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters Secondary Outcomes - Time course of CS-1103 blood and urine concentrations ### Location - Facility: Dr. Vince Clinical Research, Overland Park, Kansas, 66212, United States @@
## Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation - NCT ID: NCT06316960 - Study ID: AVACBFKIT - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Children's Hospital of Soochow University ### Study Description The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation. ### Conditions - AML, Childhood - Relapse/Recurrence - Refractory AML - Core Binding Factor Acute Myeloid Leukemia - C-KIT Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Avapritinib - Azacitidine Injection - Decitabine Injection - Idarubicin Hydrochloride - Cytarabine - Granulocyte Colony-Stimulating Factor ### Outcomes Primary Outcomes - Composite remission rate (CRc) Secondary Outcomes - Overall survival - Progression-free survival ### Location - Facility: First Affiliated Hospital Of University of Science and Technology of China, Hefei, Anhui, 230000, China @@
## Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes - NCT ID: NCT06316947 - Study ID: FMCH-2024-32723 - Status: NOT_YET_RECRUITING - Start Date: 2025-02-01 - Completion Date: 2026-01-01 - Lead Sponsor: University of Minnesota ### Study Description Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans.This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules. ### Conditions - Shisha ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - CHW-delivered intervention ### Outcomes Primary Outcomes - Recruitment rate - Retention rate measure - pre-/post- survey completion rates - pre-/post- biospecimen completion rates Secondary Outcomes - shisha use changes - tobacco product use changes - smoke-free home rules - the cotinine levels of parents and children. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy - NCT ID: NCT06316934 - Study ID: IRB202302181 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-08 - Lead Sponsor: University of Florida ### Study Description Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo. ### Conditions - Anxiety - Pain, Procedural ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Lavandula angustifolia, Aura Cacia - Placebo ### Outcomes Primary Outcomes - Determine the change in pain scores from baseline to immediate post-procedure. - Determine change in anxiety scores from baseline to immediate post-procedure. - Determine level of satisfaction after the procedure Secondary Outcomes ### Location - Facility: University of Florida, Gainesville, Florida, 32610, United States @@
## Epidural PCA on Pain Relief After L-spine Surgery - NCT ID: NCT06316921 - Study ID: TCHIRB-11003008-E - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2021-12-31 - Lead Sponsor: Taipei City Hospital ### Study Description This study aimed to evaluate the effect of epidural patient-controlled analgesia (PCA) on postoperative pain relief after lumbar spine surgeries. The eligible patients received two types of postoperative pain management: PCA and standard pain treatment. Comparisons between the two groups were made in terms of postoperative pain level. ### Conditions - Pain, Postoperative - Lumbar Spine Degeneration - Analgesia, Patient-Controlled - Epidural Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Epidural patient-controlled analgesia - Standard postoperative pain management ### Outcomes Primary Outcomes - Pain degree Secondary Outcomes - The number of morphine injections ### Location - Facility: Taipei City Hospital, Taipei, N/A, N/A, Taiwan @@
## Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach - NCT ID: NCT06316908 - Study ID: ERC-2019/A187 - Status: COMPLETED - Start Date: 2020-02-25 - Completion Date: 2023-03-15 - Lead Sponsor: Sindh Institute of Urology and Transplantation ### Study Description The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.The main questions it aimed to answer are:1. Whether unilateral or bilateral NCPB technique has a better pain relief2. Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.Pain scores and adverse events at multiple time points post-procedure were recorded. ### Conditions - Abdominal Cancer - Cancer Pain - Cancer of Pancreas ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol - Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol ### Outcomes Primary Outcomes - Pain Score using the Visual Analog Scale Secondary Outcomes - Change in Mean Arterial Pressure - Incidence of Patient-Reported Nausea Feeling - Incidence of Vomiting ### Location - Facility: Sindh Institute of Urology and Transplantation, Karachi, Sindh, 74200, Pakistan @@
## The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma - NCT ID: NCT06316895 - Study ID: S2023-706 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-12-31 - Lead Sponsor: Chinese PLA General Hospital ### Study Description 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma; ### Conditions - Papillary Thyroid Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - thyroid surgery - ultrasound-guided thermal ablation ### Outcomes Primary Outcomes - rate of disease progression Secondary Outcomes - Rate of complications - Rate of tumor disappearance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Opportunistic Gastric Cancer Screening - NCT ID: NCT06316882 - Study ID: ROCGAS 01 - Status: RECRUITING - Start Date: 2023-02-03 - Completion Date: 2024-12-31 - Lead Sponsor: Unidade Local De Saúde Do Norte Alentejano ### Study Description Endoscopic screening of gastric cancer combined with screening colonoscopy ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Screening endoscopy ### Outcomes Primary Outcomes - number of gastric adenocarcinoma Secondary Outcomes - number of pre-malignant lesions - Costs of screening endoscopy - Socio-demographic characteristics of population in screening program ### Location - Facility: ULSNA, Portalegre, N/A, 7300-853, Portugal @@
## Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography - NCT ID: NCT06316869 - Study ID: STVi - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-31 - Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University ### Study Description The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows:* What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)?* Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated.* To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator.The HVPG is considered as the gold standard in our study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH. ### Conditions - Portal Hypertension - Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - STVi index Secondary Outcomes ### Location - Facility: the First Affiliated Hospital the First Affiliated Hospital, Wenzhou, Zhejiang, 325006, China @@
## CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia - NCT ID: NCT06316856 - Study ID: BJGBYY-IIT-LCYJ-2024-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-06-30 - Lead Sponsor: Beijing GoBroad Hospital ### Study Description This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10\^6 (±20%) to dose level 2: 2×10\^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10\^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled. ### Conditions - T-Cell Acute Lymphocytic Leukemia - Acute Lymphoblastic Leukemia, in Relapse - Refractory Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Autologous CD5 CAR T-cells - Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells - Newly matched donor-derived CD5 CAR T-cells ### Outcomes Primary Outcomes - Phase 1-The incidence and type of dose-limiting toxicity (DLT) - Phase 1-The incidence and severity of adverse events (AEs) - Phase 2-Antitumor effect Secondary Outcomes - Phase 1-Objective response rate (ORR) - Phase 1-Pharmacokinetics of CD5 CAR T cells - Phase 1-The incidence and severity of adverse events (AEs). - Phase 1-Best overall response (BOR) rate. - Phase 2-Objective response rate (ORR) - Phase 2- The incidence and severity of AEs - Phase 2- Progression free survival (PFS) - Phase 2- Overall survival (OS). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Valacyclovir Plus Celecoxib for Post-Acute Sequelae of SARS-CoV-2 - NCT ID: NCT06316843 - Study ID: BHC202 v2.1 - Status: RECRUITING - Start Date: 2023-10-15 - Completion Date: 2024-10 - Lead Sponsor: Bateman Horne Center ### Study Description To explore the safety and efficacy of daily doses of celecoxib + valacyclovir in the treatment of patients with prolonged symptoms caused by COVID-19. ### Conditions - Long COVID - PASC Post Acute Sequelae of COVID 19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Valacyclovir celecoxib dose 1 - Valacyclovir celecoxib dose 2 - Placebo ### Outcomes Primary Outcomes - Fatigue assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Instrument Secondary Outcomes ### Location - Facility: Bateman Horne Center, Salt Lake City, Utah, 84102, United States @@
## Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose - NCT ID: NCT06316830 - Study ID: STUDY00000075 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-30 - Lead Sponsor: Rhode Island Hospital ### Study Description The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), decreased use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (secondary outcome). ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Buprenorphine ### Outcomes Primary Outcomes - Treatment Engagement Secondary Outcomes - Use of non-prescribed opioids - Control of Opioid Cravings - Rate of Non-fatal or Fatal Opioid Overdose - Use of non-prescribed opioids ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## FloPatch for Prevention of Hypotension After Induction of General Anesthesia - NCT ID: NCT06316817 - Study ID: 23-0184-E - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03-02 - Lead Sponsor: Mount Sinai Hospital, Canada ### Study Description This study is being conducted to find out if a special device called FloPatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. The investigators will be testing this in adults who are having elective non-heart surgery. Basically, the goal is to see if this device can help predict who might have low blood pressure during surgery.Hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury. Myocardial injury after non-cardiac surgery (MINS) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development.In the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. For surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. Optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. Since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it.The hypothesis is that the corrected Flow Time (cFT) measured by the FloPatch will help predict hypotension after the induction of general anesthesia. ### Conditions - Hypotension on Induction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FloPatch ### Outcomes Primary Outcomes - Prognostic ability of preoperative common carotid artery corrected Flow Time (cFT) measurement to predict Post Induction Hypotension(PIH). Secondary Outcomes - Passive leg raising (PLR) in predicting Post Induction Hypotension(PIH). - Thresholds of common carotid artery corrected Flow Time (cFT) change during Passive Leg Raising (PLR) in predicting Post Induction Hypotension (PIH). - Thresholds of common carotid artery corrected Flow Time (cFT) change after Passive Leg Raising(PLR) in predicting Post Induction Hypotension (PIH). - Time required to get common carotid artery corrected Flow Time(cFT) data. - Common carotid artery corrected Flow Time (cFT) during induction correlation with Post Induction Hypotension(PIH). ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada @@
## Mobile Mental Health Stigma Reduction Intervention Among Black Adults - NCT ID: NCT06316804 - Study ID: 2022P000580 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-07-31 - Lead Sponsor: Massachusetts General Hospital ### Study Description Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety. ### Conditions - Anxiety - Depression - Health Knowledge, Attitudes, Practice - Stigmatization - Mobile Phone Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Video Intervention 1 - Video Intervention 2 - Video Intervention 3 ### Outcomes Primary Outcomes - Treatment Inventory of Costs in Patients with Psychiatric Disorders - Release of Information Form Secondary Outcomes - Reported and Intended Behavior Scale - Internalized Stigma of Mental Illness - The Group Based Medical Mistrust Scale - Group Help Seeking Questionnaire ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases - NCT ID: NCT06316791 - Study ID: HY001007 - Status: RECRUITING - Start Date: 2021-12-14 - Completion Date: 2025-12-13 - Lead Sponsor: Juventas Cell Therapy Ltd. ### Study Description Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care. ### Conditions - Lupus Erythematosus, Systemic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - single dose of CNCT19 ### Outcomes Primary Outcomes - Percentage of Subjects Experiencing Treatment-Emergent Adverse Events（TEAE） Secondary Outcomes - Overall survival (OS) - SELENA-SLEDAI - The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period - To evaluate disease related biomarkers - To evaluate disease related biomarkers - To evaluate disease related biomarkers - To evaluate disease related biomarkers ### Location - Facility: The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, N/A, China @@
## Pelvic Floor Muscle Training for Women With Myotonic Dystrophy - NCT ID: NCT06316778 - Study ID: 2023-038 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-11 - Completion Date: 2024-12-01 - Lead Sponsor: Université de Sherbrooke ### Study Description Myotonic dystrophy type 1 (DM1) is a neuromuscular disease characterized by multisystem manifestations. DM1 can affect the urinary system through the impact of the pelvic floor muscles (PFM). Urinary incontinence can occur in this situation and is often offset with compensatory measures without restoring the PFM function (e.g. sanitary pads). PFM training have already been shown to be effective in reducing or even eliminating urinary incontinence in the general population. However, no study has been the subject of this modality in people with DM1. Having recently shown that it is possible to gain strength with DM1, a strengthening protocol targeting PFM could prove effective in treating urinary incontinence. The objectives of this study are i) to assess the feasibility and acceptability of PFM training and ii) to investigate the effects of PFM training in women with DM1 with adult phenotype. A quasi-experimental study will be conducted with 12 women having a confirmed diagnosis of DM1 with urinary incontinence. Participants will follow a 12-week PFM training program, comprising weekly sessions with an experienced physiotherapist as well as a home exercise program. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, frequency of urinary incontinence, urogynecological symptoms and their impact on quality of life, morphometry and function of PFM, and the perceived improvement following the treatments. This study has the potential to improve the management of urinary incontinence and support the implementation of pelvic floor rehabilitation services in this population. ### Conditions - Myotonic Dystrophy Type 1 - Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pelvic floor muscle training ### Outcomes Primary Outcomes - Percentage of attended treatment sessions - Percentage of home exercises performed - Retention rate - Recruitment rate - Intervention Acceptability Questionnaire Secondary Outcomes - Change in the frequency of urinary incontinence episodes - Change in urinary incontinence symptoms - Change in pelvic floor disorder symptoms - Change in pelvic floor disorder symptoms related impact on quality of life - Change in pelvic floor muscles morphometry - Change in pelvic floor muscles function - Patient's satisfaction - Patient's global impression of change - Patient's estimated improvement ### Location - Facility: Clinique des maladies neuromusculaires, Jonquière, Quebec, G7X 7X2, Canada @@
## A Stylet Use May be Beneficial for Elective and Rescue Intubation of Prematurely Born Infants - NCT ID: NCT06316765 - Study ID: 118/10 - Status: COMPLETED - Start Date: 2016-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Charles University, Czech Republic ### Study Description Contrary to recent findings suggesting that stylets offer no advantage in general infant intubations, this study focuses on their potential benefits for premature infants undergoing elective or rescue intubation in the delivery room. The goal is to compare the safety and efficiency of intubations with or without a stylet. ### Conditions - Neonatology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intubation with stylet ### Outcomes Primary Outcomes - The primary outcome was defined as successful initial intubation attempt. Secondary Outcomes - Secondary outcomes was defined as the duration of intubation courses until successful placement of the endotracheal tube. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Natural History of Sialidosis Type I - NCT ID: NCT06316752 - Study ID: 202107158RINB - Status: RECRUITING - Start Date: 2022-03-15 - Completion Date: 2024-12-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description Sialidosis type 1 is an autosomal recessive disorder caused by bialleic NEU1 gene mutations. Patients with sialidosis type I present variable neurological and eye dysfunction and the progression rate is variable. The goal of this protocol is to assess the neurological and ophthalmological status of these patients and characterize the clinical and laboratory abnormalities in order to determine the natural history of the disease. Patients will be followed every 6 month with comprehensive clinical, neurological and ophthalmological examinations combined with neuropsychological, blood, radiological and electrophysiological tests. ### Conditions - Observational Study ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational study ### Outcomes Primary Outcomes - Scale for the Assessment and Rating of Ataxia (SARA) - Unified Myoclonus Rating Scale (UMRS) Secondary Outcomes - MRI of the brain - Blood test for alpha-N -acetyl neuraminidase activity and neruofilamment light chain - Electrophysyiology test on peripheral nerves - Opathalmology examinations for cherry-red spots - Montreal cognitive assessment score ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City - NCT ID: NCT06316739 - Study ID: R34DA057166 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: North Jersey AIDS Alliance dba North Jersey Community Research Initiative (NJCRI) ### Study Description The goal of this pilot clinical trial is to learn if an intervention that trains Gancheros (people who provide injection services in exchange for drugs or money) to conduct risk-reduction outreach could help lower risk for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and overdose among migrant Puerto Rican people who inject drugs (PWID) in New York City. The main questions it aims to answer are:* Can the Ganchero intervention be carried out successfully and will Gancheros and their clients like it?* Could the Ganchero intervention help Puerto Rican PWID who are clients of Gancheros use sterile syringes and carry naloxone (a medication to reverse opioid overdoses) more often?Gancheros who participate in the trial will be asked to attend a 6-session training on HIV, HCV, and overdose prevention and then to share key prevention messages and supplies (e.g., naloxone, sterile syringes and other injection equipment) with their clients during 4 months of outreach. The intervention will be carried out with Gancheros and their clients in two Bronx neighborhoods, one after the other, so the investigators can see if clients in the neighborhood that received the intervention first have better outcomes than clients in the neighborhood that did not yet receive the intervention. ### Conditions - HIV Infections - HCV - Overdose ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Ganchero intervention ### Outcomes Primary Outcomes - sterile syringe use Secondary Outcomes - naloxone carriage ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Two Nursing Programs on the Surgery-related Pressure Injury - NCT ID: NCT06316726 - Study ID: 202100409A3 - Status: COMPLETED - Start Date: 2021-12-15 - Completion Date: 2023-08-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description Introduction: This study was to compare the differences in the incidence, grade, and time of surgery-related pressure injuries between the two interventions; and describe the locations of surgery-related pressure injuries between the two interventions.Methods: This study adopted a true experimental research design with a convenience sampling method from the operating rooms of a teaching hospital in a northern region. The experimental group was randomly assigned by block to receive intervention A (full bed silicone mattress plus other measures), and the control group received intervention B (full bed silicone mattress plus usual care). Measurements include basic personal attributes, risk factors, grade, time, and location of occurrence related to surgery-related pressure injuries. ### Conditions - Pressure Injury - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - full bed silicone mattress plus other measures ### Outcomes Primary Outcomes - the occurrence of surgery-related pressure injuries Secondary Outcomes ### Location - Facility: Taoyuan Chang Gung Memorial Hospital, Taoyuan, N/A, 333, Taiwan @@
## One MORE for Chronic Pain in Latinos - NCT ID: NCT06316713 - Study ID: IRB_00166637 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12-31 - Lead Sponsor: University of Utah ### Study Description This study will be a single-site, two-arm randomized controlled trial conducted among Spanish-speaking chronic pain patients. Chronic pain patients will be randomized by a computer-generated randomization schedule with simple random allocation (1:1) to either One MORE or a wait-list control condition (WLC). One MORE will be delivered individually either in-person or via a HIPAA compliant virtual meeting platform. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - One MORE (Spanish Adaptation) ### Outcomes Primary Outcomes - Pain Intensity & Interference Secondary Outcomes - Acute Pain - Acceptability ### Location - Facility: University of Utah, Salt Lake City, Utah, 84112, United States @@
## A Pharmacokinetic Study of a Novel Nutritional Product on Healthy Men and Women - NCT ID: NCT06316700 - Study ID: AG-02-0124 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Athletic Greens International ### Study Description This study is a randomized, double-blind, placebo-controlled study of N=16 apparently healthy men and women. The purpose of this study is to examine the bioavailability of a health and wellness supplement. ### Conditions - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Nutritional supplement - Placebo ### Outcomes Primary Outcomes - Plasma concentration of zinc following consumption of study products - Plasma concentration of Vitamin C following consumption of study products - Plasma concentration of Folate following consumption of study products - Plasma concentration of calcium following consumption of study products Secondary Outcomes ### Location - Facility: Center for Applied Health Sciences, Canfield, Ohio, 44046, United States @@
## Prevalence of Dental Caries in a Group of Egyptian Children - NCT ID: NCT06316687 - Study ID: prevalence of dental caries - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Cairo University ### Study Description Prevalence of Dental Caries in a group of Egyptian children and its relation to TV and other screens time and sugar consumption (Observational cross-sectional study) ### Conditions - Prevalence of Dental Caries and Its Relation to Screen Time and Sugar Consumption - Prevalence,Patient ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaire for food consumption frequency ### Outcomes Primary Outcomes - Prevalence of dental caries Secondary Outcomes - Dental neglect Dental neglect Dental neglect - Screen time evaluation - A sugar consumption evaluation ### Location - Facility: Cairo University, Cairo, Al Manial, N/A, Egypt @@
## The Malleability of Body Representation in Anorexia Nervosa: the Sixth Finger Illusion - NCT ID: NCT06316674 - Study ID: 03C304 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Body representation can be explored using behavioural tasks such as motor imagery tasks as well as body illusions.In both cases, evidence from studies on healthy individuals as well as patients with lesions to the central nervous system show that body representation is not set in stone: how we imagine our bodies is a dynamic and continuously updated process, to reflect changes in our own body as well as the environment.In anorexia nervosa the representation of the body is very different from that of healthy individuals: the representation is more malleable, and easier to manipulate, while at the same time being more detached from physical constraints. These features of body representation in anorexia nervosa might contribute to the persistence of symptoms and to relapses too. Body representation has clear implications for treatment of anorexia nervosa too.The study aims at evaluating the presence of differences in the malleability of the body representation, explored through the illusion of the sixth finger, between a group of people with AN and a group of normal weight people, taking into account the biomechanical constraints that characterize the physical and mentally represented body. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - sixth finger illusion ### Outcomes Primary Outcomes - Sixth finger illusion questionnaire Secondary Outcomes ### Location - Facility: Istituto Auxologico italiano IRCSS, Milan, N/A, N/A, Italy @@
## CMR Assessment of Cardiac Microvascular Dysfunction in Patients With HFpEF - NCT ID: NCT06316661 - Study ID: 09C921 - Status: RECRUITING - Start Date: 2019-03-01 - Completion Date: 2024-12-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients. ### Conditions - Microvascular Coronary Artery Disease - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - stress perfusion cardiac magnetic resonance - cardiopulmonary exercise test ### Outcomes Primary Outcomes - Peak stress perfusion - Extracellular volume Secondary Outcomes ### Location - Facility: IRCCS Istituto Auxologico Italiano, Milan, N/A, 20149, Italy @@
## Whey Intake Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery - NCT ID: NCT06316648 - Study ID: 210366 - Status: COMPLETED - Start Date: 2021-04-20 - Completion Date: 2021-07-20 - Lead Sponsor: TC Erciyes University ### Study Description Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery ### Conditions - Elective Hip Fracture Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - whey intake group - control group ### Outcomes Primary Outcomes - blood glucose Secondary Outcomes - Fasting, Thirst - Nausea and Vomiting ### Location - Facility: Erciyes University, Kayseri̇, Talas, 38000, Turkey @@
## Microplastics in Otitis Media With Effusion Material - NCT ID: NCT06316635 - Study ID: 2023/209 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-04-20 - Lead Sponsor: Kerem Kökoğlu ### Study Description Microplastic rate is increasing ib athmosphere. They can be found in lung, kidney, heart, even placenta. Otitis media with effusion (OME) is a clinical condition that is ver common in children. Biofilms are blamed in the pathogenesis of OME. Microplastics can include biofilms. Importance of microplastics for potential pathogens and their toxicity aspects should be enlighted with studies. This study aims to investigate presency of microplastics in middle ear fluid of patients with OME. ### Conditions - Microplastics - Otitis Media With Effusion - Biofilms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ventilation tube insertion ### Outcomes Primary Outcomes - Microplastic presence Secondary Outcomes ### Location - Facility: Erciyes University Medical School, Kayseri, N/A, 38039, Turkey @@
## Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance - NCT ID: NCT06316622 - Study ID: 2021/08/42 - Status: COMPLETED - Start Date: 2021-03-08 - Completion Date: 2022-10-01 - Lead Sponsor: Dokuz Eylul University ### Study Description Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG. ### Conditions - Anesthesia Awareness ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ultrasound ### Outcomes Primary Outcomes - We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound. Secondary Outcomes ### Location - Facility: Dokuz Eylul Unicersity, İzmir, Narlidere, 35150, Turkey @@
## Prenatal Exposure to Emerging Contaminants and Children's Atopic Dermatitis - NCT ID: NCT06316609 - Study ID: AD2016-2027 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2016-06 - Completion Date: 2027-12-31 - Lead Sponsor: Children's Hospital of Fudan University ### Study Description This prospective cohort study aims to investigate the association between prenatal blood levels of Emerging Contaminants and the five-year incidence of atopic dermatitis (AD) in offspring. ### Conditions - Atopic Dermatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gestational Exposure to Emerging Contaminants (ECs) ### Outcomes Primary Outcomes - atopic dermatitis: Infant atopic dermatitis incidence Secondary Outcomes - atopic dermatitis - atopic dermatitis - atopic dermatitis - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at early pregnancy - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at mid pregnancy - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at late pregnancy - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at first trimester - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at second trimester - prenatal exposure to Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) at third trimester - Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) in Umbilical cord whole blood - Umbilical cord serum Perfluoroalkyl and Polyfluoroalkyl Substances (PFASs) - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at early pregnancy - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at mid pregnancy - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at late pregnancy - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at first trimester - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at second trimester - prenatal exposure to Organophosphate Flame Retardants (OPFRs) at third trimester - Organophosphate Flame Retardants (OPFRs) in Umbilical cord whole blood - Umbilical cord serum Organophosphate Flame Retardants (OPFRs) - Infant skin barrier function (Transepidermal Water Loss, TEWL） - Infant skin barrier function (Transepidermal Water Loss, TEWL） - Infant skin barrier function (Transepidermal Water Loss, TEWL） - Infant skin barrier function (Stratum corneum hydration, SCH) - Infant skin barrier function (Stratum corneum hydration, SCH) - Infant skin barrier function (Stratum corneum hydration, SCH) - Infant skin barrier function (sebum content) - Infant skin barrier function (sebum content) - Infant skin barrier function (sebum content) - Infant skin barrier function (skin surface pH) - Infant skin barrier function (skin surface pH) - Infant skin barrier function (skin surface pH) - prenatal exposure to Microplastics at early pregnancy - prenatal exposure to Microplastics at mid pregnancy - prenatal exposure to Microplastics at late pregnancy - prenatal exposure to Microplastics at first trimester - prenatal exposure to Microplastics at second trimester - prenatal exposure to Microplastics at third trimester - Microplastics in Umbilical cord whole blood - Umbilical cord serum Microplastics - Allergic rhinitis - Asthma - Infantile hemangioma ### Location - Facility: Children Hospital of Fudan University, Shanghai, Shanghai, 201102, China @@
## Brain Oxygenation in Newborns Due to Neuroaksial Methods - NCT ID: NCT06316596 - Study ID: 2011-KAEK-25 2023/09-16 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-05-01 - Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital ### Study Description Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS). ### Conditions - Cesarean Section - Pregnancy Related - Cerebral Hypoxia - Anesthesia, Regional - Oxygen Saturation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Spinal Anesthesia - Epidural Anesthesia ### Outcomes Primary Outcomes - Near İnfrared Spectroscopi Secondary Outcomes - Maternal mean arterial pressure - Newborn vitalty - Newborn vitalty ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study on Dry Needling for Primary Dysmenorrhea and Its Preliminary Correlation With Acupoints - NCT ID: NCT06316583 - Study ID: BJH-001 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Beijing Hospital ### Study Description Primary dysmenorrhea refers to menstrual pain not caused by pelvic organic lesions, commonly seen in young women, significantly affecting patients' quality of life. Dry needling therapy targeting myofascial trigger points for primary dysmenorrhea has been preliminarily applied in clinical settings. However, related research is limited with questionable quality, hindering its widespread clinical application. Furthermore, is there a connection between myofascial trigger points in dry needling and acupuncture acupoints in terms of selection and mechanism of action? Could this be a new interpretation of acupuncture theory? These are important questions that have garnered widespread attention. This study employs a randomized patient-blinded controlled design, enrolling primary dysmenorrhea patients aged 18 to 30 years. They are randomly divided into three groups: the trigger point dry needling group, traditional acupuncture treatment group, and trigger point sham needle (placebo) group. Changes in pain levels, quality of life scores, inflammatory factor levels, and local blood flow before and after treatment among the three groups are observed. The aim is to assess the therapeutic effects of dry needling trigger points and acupuncture treatments on primary dysmenorrhea and explore their potential mechanisms of action. By comparing the differences and similarities between dry needling trigger points and acupuncture treatments in terms of acupoint selection, treatment effects, and potential mechanisms of action, this study seeks to preliminarily explore the feasibility of integrating trigger point theory into the meridian 'acupoint' theory, laying the foundation for a modern interpretation of acupuncture ### Conditions - Trigger Point Pain, Myofascial - Acupuncture - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TrP-DN and Acupuncture ### Outcomes Primary Outcomes - mean intensity of pain Secondary Outcomes - mean intensity of painscale during period a 100mm horizontal line, with the ends of the line representing the extreme expressions of pain (no pain to maximum pain).The mean intensity of all days with menstrual pain is used for the analysis - Short Form Health Survey - Global Rating of Change Scale - the amount of NSAIDs used - the frenquecy of NSAIDs used - inflammatory factors - local uterine blood flow：Doppler Systolic/Diastolic (S/D) Ratio - local uterine blood flow：Pulsatility Index (PI) - local uterine blood flow：The Resistance Index (RI) - Number of Participants with adverse effects with treatment ### Location - Facility: Yanxia Sun, Beijing, Beijing, 100730, China @@
## Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke - NCT ID: NCT06316570 - Study ID: HX-A-2023044 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-01 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke. ### Conditions - Ischemic Stroke, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early Dual Antiplatelet Therapy - Placebo ### Outcomes Primary Outcomes - Excellent functional outcome Secondary Outcomes - mRS score of 0-2 points - Distribution of mRS score - Neurologic improvement - Quality of life (EQ-5D scale) - Activity of daily living (Barthel index ≥95 points) - Recurrent ischemic stroke - Symptomatic intracranial hemorrhage (ECASS-III) - Symptomatic intracranial hemorrhage (ECASS-III) - Parenchymal hematoma type 2 (SIST-MOST) - Parenchymal hematoma type 2 (SIST-MOST) - Bleeding events (GUSTO) - Adverse events - Severe adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment - NCT ID: NCT06316557 - Study ID: HX-A-2022063 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days. ### Conditions - Post-stroke Cognitive Impairment - Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - rTMS group - control group ### Outcomes Primary Outcomes - The efficacy of rTMS in improving cognitive function of post-stroke cognitive impairment Secondary Outcomes - The safety of rTMS in improving cognitive function of post-stroke cognitive impairment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## China Elderly Comorbidity Medical Database - NCT ID: NCT06316544 - Study ID: CECMed - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-11-30 - Lead Sponsor: Beijing Friendship Hospital ### Study Description The objective of this observational cohort study is to provide comprehensive evaluation and early warning for elderly patients with chronic diseases. The main question it aims to answer is: How to explore effective evaluation methods for diseases in elderly patients based on the coexistence of multiple diseases and high individual heterogeneity? How to explore the key indicators and influencing factors of adverse events in elderly patients.. Participants will be followed up at 1, 3, 6, 9, and 12 months to obtain adverse event information. ### Conditions - Coronary Artery Disease - Hypertension - Diabetes Mellitus - Osteoporosis - COPD Chronic Obstructive Pulmonary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Pneumonia/pulmonary infection - respiratory failure - pulmonary encephalopathy - acute exacerbation of chronic obstructive pulmonary disease - unstable angina pectoris - acute myocardial infarction - acute hemorrhagic stroke - acute ischemic stroke - acute heart failure/acute exacerbation of chronic heart failure - malignant ventricular arrhythmia - sudden death - falls - fractures - gastrointestinal bleeding - pulmonary embolism - deep vein thrombosis - diabetes ketoacidosis - diabetes hyperosmolar coma - rehospitalization - admission to ICU Secondary Outcomes ### Location - Facility: Beijing Friendship Hospital, Beijing, Beijing, 100050, China @@
## A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer - NCT ID: NCT06316531 - Study ID: BL-M07D1-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab. ### Conditions - HER2-positive Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-M07D1 - T-DM1 ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Anti-drug antibody (ADA) ### Location - Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, N/A, China @@
## The Effect of Mindfulness-Based Web-Based Stress Reduction Program Applied to Primigravidas on Perceived Stress Level in Pregnancy, Birth Self-Efficacy and Prenatal Attachment - NCT ID: NCT06316518 - Study ID: AIBU-HF-YS-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-01 - Lead Sponsor: Ataturk University ### Study Description The aim of this study is to investigate the effect of a mindfulness-based web-based stress reduction program applied to primigravidas on perceived stress level in pregnancy, birth self-efficacy and prenatal attachment. ### Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - mindfulness group ### Outcomes Primary Outcomes - Pregnancy Stress Assessment Scale (PSAS) - Self-Efficacy Scale for Normal Childbirth - Prenatal Attachment Inventory (PAI) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Photographs of Patients on Oral Hygiene Motivation - NCT ID: NCT06316505 - Study ID: 11/2023-58 - Status: COMPLETED - Start Date: 2023-12-01 - Completion Date: 2024-03-01 - Lead Sponsor: Didem OZKAL EMINOGLU ### Study Description Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters. ### Conditions - Periodontal Diseases - Motivation - Hygiene ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Oral hygiene motivation with individual oral photograps ### Outcomes Primary Outcomes - Clinical periodontal parameters / plaque index (PI) - Clinical periodontal parameters / gingival index (GI) - Clinical periodontal parameters / probing pocket depth (PPD). - Clinical periodontal parameters / bleeding on probing (BOP) Secondary Outcomes ### Location - Facility: Atatürk University, Erzurum, N/A, 25240_, Turkey @@
## A Study Done by a Demonstrator and Two Professors in Public Health and Community Medicine Department in Faculty of Medicine in Assiut and New Valley University to Assess Knowledge, Attitude ,and Practice of Rural Population in a Remote Governorate ( New Valley ) Towards Hepatitis B and C Viruses - NCT ID: NCT06316492 - Study ID: 101919039932 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-06-01 - Lead Sponsor: Assiut University ### Study Description This study is a research aiming to identify knowledge , attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be orally answered by the participants to be recorded in papers by the researcher. ### Conditions - Hepatitis B - Hepatitis C ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assess proportion of adequate knowledge , attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate Secondary Outcomes - Assess proportion of high risk groups of viral hepatitis B and C in these population thus behaviours made them candidates for viral hepatitis B and C infection - 2- Proportion of health-seeking behaviour of cases ( confirmation of diagnosis, treatment, and follow up ) and proportion of high risk group seeking for screening ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Performance of PTMC Dermal Filler - NCT ID: NCT06316479 - Study ID: CI-001-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-12 - Lead Sponsor: Aqpha Medical B.V. ### Study Description The goal of this clinical trial is to assess the safety and performance of the PTMC Dermal filler for treating moderate to severe nasolabial folds in adult men and women.The main questions it aims to answer are:* Does the PTMC dermal filler maintain its performance for a minimum of 6 months?* Is the treatment considered safe for participants?Participants will:* Before treatment, the investigator will assess your medical history, medication usage, and satisfaction with your wrinkles/folds.* You'll receive one injection of the PTMC Dermal filler during your initial visit.* For 30 days post-injection, you'll keep a diary to note any reactions like pain, redness, or swelling at the injection site.* At the 1-month follow-up, you can request a 'touch-up' of the filler, extending your participation in the study.* Participants will visit the clinic a total of 8 times, including the initial treatment and 7 follow-up visits, spanning up to 18 months.* Each visit will last approximately 60-90 minutes. The visits will be conducted in person. ### Conditions - Moderate to Severe Nasolabial Fold ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PTMC Dermal Filler ### Outcomes Primary Outcomes - Nasolabial fold severity Secondary Outcomes - Safety (Adverse events) - Nasolabial fold severity - Responder rate - Overall aesthetic improvement (by the investigator) - Overall aesthetic improvement (by the subject) - Subject satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lipoprotein a is an Independent Risk Factor for Overall Survival in Patients With Pancreatic Cancer: a Propensity Score Matching Analysis - NCT ID: NCT06316466 - Study ID: QYFYWZLL28521 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-03-30 - Lead Sponsor: jingxue ### Study Description Background: This study aims to assess the prognostic significance of serum lipoprotein (a) \[Lp (a)\] levels on overall survival (OS) and progression free survival (PFS) in individuals diagnosed with pancreatic cancer through the utilization of propensity score matching (PSM).Methods: A retrospective analysis was conducted on the clinicopathological data of 364 patients diagnosed with pancreatic cancer at the Affiliated Hospital of Qingdao University from January 2019 to December 2022. The cut-off value for Lp (a) was determined based on one-year survival rates after diagnosis. Patients were then categorized into the high and low Lp (a) groups. We applied PSM analysis to minimize selection bias. The study compared OS and PFS between two groups by Kaplan-Meier method and analyzed differences using the log-rank test. Additionally, univariate and multivariate Cox-regression analyses were performed to identify prognostic factors among patients. ### Conditions - Pancreatic Carcinoma; Lipoprotein a; Overall Survival; Prognosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lp(a) ### Outcomes Primary Outcomes - OS Secondary Outcomes - PFS ### Location - Facility: Affiliated Hospital of Qingdao University, Qingdao, Shandong, N/A, China @@
## Prospective Assessment of Atherosclerotic Cardiovascular Disease (ASCVD) Risk - NCT ID: NCT06316453 - Study ID: PARADISE-PK-09-03-2024 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12 - Lead Sponsor: Advanced Education & Research Center ### Study Description This study aims to conduct a 10-year follow-up to assess ASCVD risk in Pakistan among individuals aged 30 years and above without a known history of ASCVD. The focus will be on evaluating ASCVD risk over this specific 10-year timeframe. The study will also validate risk assessment scores for identifying high-risk individuals and examine the incidence rate of ASCVD events during long-term follow-up. ### Conditions - Atherosclerotic Cardiovascular Diseases (ASCVD) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Evaluating ASCVD risk over 10 and 30 year and lifetime ### Outcomes Primary Outcomes - 10-year ASCVD risk Categorization - 30-year ASCVD risk Categorization - Lifetime ASCVD risk evaluation - Genetic Risk Assessment of ApoB Secondary Outcomes ### Location - Facility: Advanced Education Institute and Research Center, Karachi, Sindh, 75270, Pakistan @@
## Effect of Noise Isolation on the Incidence of Moderate to Severe Postoperative Pain - NCT ID: NCT06316440 - Study ID: noise and postoperative pain - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-12 - Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University ### Study Description To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wear noise-cancelling earphones ### Outcomes Primary Outcomes - The incidence of moderate to severe postoperative pain Secondary Outcomes - Patient controlled analgesia pump analgesic consumption - Patient controlled analgesia pump analgesic consumption - The incidence of additional analgesic requirements - Maximum pain score (NRS score) at 0-48 hours postoperatively - The incidence of moderate to severe postoperative pain - Accumulative postoperative pain NRS ### Location - Facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, Chongqing, 400010, China @@
## Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma - NCT ID: NCT06316427 - Study ID: BJGBYY-IIT-LCYJ-2024-003 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2028-03-30 - Lead Sponsor: Beijing GoBroad Hospital ### Study Description This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled. ### Conditions - T-cell Acute Lymphoblastic Leukemia - Acute Lymphoblastic Leukemia, in Relapse - Refractory Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Autologous CD7 CAR T-cell - Prior-HSCT donor-derived CD7 CAR T-cell - New donor-derived CD7 CAR T-cell ### Outcomes Primary Outcomes - Dose-Limiting Toxicity (DLT) in phase I - Overall Response Rate (ORR) in phase II Secondary Outcomes - Overall Response Rate (ORR) in phase I - Safety in phase II - Progression-Free Survival (PFS) in phase II - Duration of Remission (DOR) in phase II - Overall Survival (OS) in phase II - Levels of CD7 CAR-T Cells in phase II - Levels of CAR transgene in phase II - Levels of immune cells in phase II - Levels of cytokines in phase II ### Location - Facility: Beijing GoBroad Hospital, Beijing, Beijing, 102206, China @@
## Omalizumab in Severe Asthmatics With Food Allergy - NCT ID: NCT06316414 - Study ID: 1501/17 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2023-03-31 - Lead Sponsor: Bambino Gesù Hospital and Research Institute ### Study Description A prospective assessment of the impact of Omalizumab in terms of efficacy, safety, and quality of life (FA-QoL) in patients with moderate/severe asthma and history of anaphylaxis to peanut, tree nuts, fish, egg, milk, and/or wheat. Evaluation of the trend of total and specific IgE during Omalizumab treatment. ### Conditions - Food; Allergy, Anaphylactic Shock - Asthma in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Omalizumab ### Outcomes Primary Outcomes - Milligram tolerated food allergen (gms) of raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T1. Secondary Outcomes - Proportion of negative OFCs at T1 - NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T2. - NOAEL for raw and baked milk, raw and baked egg, hazelnut, peanut, wheat, and/or fish at T3. - Change in number of anaphylactic events - Rate of severity of anaphylactic events - Asthma Control Test (ACT) - Quality of Life score - Total IgE - Specific IgE for milk, egg, hazelnut, peanut, wheat, and/or fish ### Location - Facility: Pediatric Hospital Bambino Gesù IRCCS - Allergy Dpt, Roma, N/A, 00145, Italy @@
## Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia - NCT ID: NCT06316401 - Study ID: 03-2024 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2024-03-03 - Lead Sponsor: Azienda USL Modena ### Study Description The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). ### Conditions - Colorectal (Colon or Rectal) Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ESD of large LSTs under SA ### Outcomes Primary Outcomes - Technical success of ESD under SA - Safety of ESD under SA Secondary Outcomes - Intra- and post-procedural need for additional opioid or other analgesic drug administration - ESD- and colonoscopy-related AEs - Length of hospital stay - Median ESD duration ### Location - Facility: Mauro Manno, Carpi, MO, 41012, Italy @@
## Outcomes After Vitrectomy in Eyes With Tractional Diabetic Macular Edema - NCT ID: NCT06316388 - Study ID: TDME - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-03-11 - Lead Sponsor: Rehab Azzam ### Study Description 1. assessment the outcomes of vitrectomy on retinal function by mf-ERG (multifocal electroretinogram) and anatomy by OCT (optical coherence tomography) in patients with tractional diabetic macular edema (TDME) .2. To correlate the postoperative corrected distance visual acuity (CDVA) with the mf-ERG and OCT findings following vitrectomy surgery for TDME. ### Conditions - Diabetic Macular Edema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - vitrectomy ### Outcomes Primary Outcomes - assessment the outcomes of vitrectomy on retinal function in patients with tractional diabetic macular edema - assessment the outcomes of vitrectomy on retinal anatomy in patients with tractional diabetic macular edema Secondary Outcomes - correlation CDVA with mf-ERG and OCT finding ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## STUMBL Score as a Risk Stratification Tool for Management of Blunt Chest Trauma Patients - NCT ID: NCT06316375 - Study ID: STUMBL blunt chest trauma - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-30 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to assess validity of the STUMBL score in EGYPT for complications of blunt chest trauma without multi-trauma and immediate life-threatening injuries and identify patients at risk of in- hospital mortality or ICU admission and predict survival in both Assiut \& Suez Canal University Hospitals. ### Conditions - Blunt Injury of Thorax ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary outcome was to assess the validity of the STUMBL score for all complications of chest blunt trauma, originally defined by the STUMBL authors Secondary Outcomes - Secondary outcomes validated the STUMBL score using a composite of early and delayed complications. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of SMOF Lipid in the Management of Acute Poisoning With Carbamazepine - NCT ID: NCT06316362 - Study ID: SMOF in carbamazepine toxicity - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-02-28 - Lead Sponsor: Alexandria University ### Study Description The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute, moderate-to-severe carbamazepine poisoning. ### Conditions - Acute Poisoning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SMOF lipid 20% ### Outcomes Primary Outcomes - Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS) Secondary Outcomes - Assessment of Intubation Requirement Using GCS and APACHE - Length of Intensive Care Unit (ICU) Stay - length of hospital stay ### Location - Facility: Faculty of Medicine, Alexandria, N/A, N/A, Egypt @@
## Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump. - NCT ID: NCT06316349 - Study ID: CAAE: 75727323.3.0000.0068 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-10-01 - Lead Sponsor: University of Sao Paulo General Hospital ### Study Description The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.* Evaluating the strength of the femoral quadriceps muscle* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs The protocol will have a total duration of 35 days, with an initial intervention period of 21 days (5 days per week), followed by a 14-day follow-up period. ### Conditions - Heart Failure - Physical Therapy - Neuromuscular Electrical Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Isolated Resistance Training Program - Neuromuscular electrical stimulation ### Outcomes Primary Outcomes - To investigate echo intensity of the rectus femoris muscle Secondary Outcomes - To investigate cross-sectional area of the rectus femoris muscle - To investigate pennation angle of the rectus femoris muscle - To investigate changes in quadriceps femoral muscle strength - To investigate changes in arterial blood pressure during the protocol - To investigate changes in heart rate during the protocol - To investigate changes in peripheral oxygen saturation during the protocol - To investigate changes in the veno-arterial difference in carbon dioxide partial pressure ### Location - Facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Sao Paulo, N/A, 05403-000, Brazil @@
## Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions - NCT ID: NCT06316336 - Study ID: BE24-005 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-10 - Completion Date: 2024-06-28 - Lead Sponsor: Pharma Nueva ### Study Description Objectives:To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulationsStudy Design:An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2. ### Conditions - Healthy Vollunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Alfuzosin Hydrochloride 10 mg - Xatral® XL 10 mg ### Outcomes Primary Outcomes - Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets - Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish - NCT ID: NCT06316323 - Study ID: REC/09/2021 (FB/51) - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-01-26 - Lead Sponsor: Universiti Teknologi Mara ### Study Description Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management. ### Conditions - Early Childhood Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Silver diamine fluoride - Sodium fluoride ### Outcomes Primary Outcomes - comparison of salivary pH - comparison of salivary counts of Streptococcus mutans - comparison of salivary counts of Lactobacillus Secondary Outcomes - Detection and comparison of salivary counts of Lactobacillus acidophilus ### Location - Facility: University Technology MARA, Sungai Buloh, Selangor, 47000, Malaysia @@
## Effect of Acupoint Thread Embedding on Obesity - NCT ID: NCT06316310 - Study ID: XSF20240312 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-31 - Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine ### Study Description The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - acupoint thread embedding ### Outcomes Primary Outcomes - Body Mass Index (BMI) Secondary Outcomes - Change in body weight - Changes in body circumference - Body composition analysis - Abdominal visceral fat tissue thickness - Fasting blood glucose (FPG) - Blood lipid profile - Impact of Weight on Quality-of-Life Scale (IWQOL-Lite) - Well-Being Index (WHO-5) - Visual analog scale (VAS) of appetite - Hamilton Anxiety Scale (HAMA) - Adverse effects ### Location - Facility: Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, Shanghai, 200071, China @@
## Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne - NCT ID: NCT06316297 - Study ID: VBE00001 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2027-12-23 - Lead Sponsor: Sanofi Pasteur, a Sanofi Company ### Study Description The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of one or two intramuscular injections of the Acne mRNA vaccine candidate at three dose levels in adult participants aged 18 to 45 years with moderate to severe acne in the US. ### Conditions - Acne ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Acne mRNA vaccine - Placebo ### Outcomes Primary Outcomes - Number of participants with unsolicited systemic AEs - Number of participants with solicited injection site and systemic reactions - Number of participants with unsolicited AEs - Number of participants with MAAEs - Number of patients with SAEs - Number of patients with related SAEs, fatal SAEs and AESIs - Change in grade from baseline in biological test results - Absolute change from baseline in the number of inflammatory acne lesions on face - Percentage change from baseline in the number of inflammatory acne lesions on face - Absolute change from baseline in the number of non-inflammatory acne lesions on face - Percentage change from baseline in the number of non-inflammatory acne lesions on face - At least two-grade improvement in IGA scores Secondary Outcomes - Assessment of vaccine-antigen-specific serum antibody titers ### Location - Facility: True Blue Clinical Research Site Number : 8400016, Brandon, Florida, 33511, United States @@
## miRNA in Chronic Kidney Diseases - NCT ID: NCT06316284 - Study ID: miRNA-CKD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Josip Juraj Strossmayer University of Osijek ### Study Description Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Systemic microvascular function - Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase - Detecton of miRNA of interest Secondary Outcomes - Body fluid compartments ### Location - Facility: Faculty of Medicine Osijek, Osijek, N/A, 31000, Croatia @@
## Endothelial Function in Prehypertension - NCT ID: NCT06316271 - Study ID: PreHT 2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Josip Juraj Strossmayer University of Osijek ### Study Description In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established. ### Conditions - Hypertension,Essential ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Systemic microvascular function - Systemic macrovascular function - Aortic stiffness - Left ventricle global longitudinal strain Secondary Outcomes - Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α) - Activity of renin-angiotensin system (RAS) - Endothelial progenitor cells (EPCs) - Endothelial extracellular vesicles (eEVs) - Systemic peripheral vascular resistance - Autonomic nervous system (ANS) activity - Matrix metalloproteinase 9 ### Location - Facility: Faculty of Medicine Osijek, Osijek, N/A, 31000, Croatia @@
## Evaluating a CFT Group for Adults With Acquired Brain Injury - NCT ID: NCT06316258 - Study ID: 333112 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-30 - Lead Sponsor: King's College London ### Study Description Emotional difficulties such as anxiety and depression are common after experiencing a brain injury. The compassion focused therapy (or CFT) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. Several studies have shown that therapy groups using CFT techniques are helpful, but there has only been one previous study of a CFT group with people with acquired brain injury. This study aims to evaluate a new CFT group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. The group will have six weekly sessions with 4-6 people in each group. The group will be run at the inpatient neuro-rehabilitation unit. As this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. The study will evaluate whether the group can be run as planned and how many people attend. The investigators will also interview people who attended the group to find out what they thought of the group.The study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. Group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group.This project is being completed as part of a Doctorate in Clinical Psychology at King's College London, and will be recruiting patients from an inpatient neurorehabilitation setting. ### Conditions - Acquired Brain Injury Including Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Compassion focused therapy group ### Outcomes Primary Outcomes - Demand - patients referred and screened for the group - Demand - patients recruited - Demand - attendance - Implementation - patients per group - Implementation - group sessions completed - Implementation - practice sessions completed - Practicality - delivery of intervention - Acceptability - end of session ratings scores - Acceptability - patient interview feedback Secondary Outcomes - Change in emotional distress questionnaire score - Change in mental well-being questionnaire score - Change in self-compassion questionnaire score - Change in quality of life questionnaire score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Functional Capacity and Days Alive Out of Hospital at 30 Days - NCT ID: NCT06316245 - Study ID: 2024/178 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-12-19 - Lead Sponsor: Istanbul University ### Study Description This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor. ### Conditions - Gastrointestinal Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DASI questionnaire ### Outcomes Primary Outcomes - Days alive and out of hospital at 30 days (DAOH-30) Secondary Outcomes - Days alive and out of hospital at 90 days (DAOH-90) - Postoperative complications - The Postoperative Morbidity Survey (POMS) defined morbidity - Mortality - Intensive care unit (ICU) stay - Length of hospital stay after index surgery - Rehospitalization ### Location - Facility: Istanbul University Istanbul Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, Fatih, 34093, Turkey @@
## DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease - NCT ID: NCT06316232 - Study ID: DBS-FOG 2023 - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2026-12-31 - Lead Sponsor: IRCCS Istituto delle Scienze Neurologiche di Bologna ### Study Description Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa. ### Conditions - Freezing of Gait - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - STIM ON plus - MED ON plus ### Outcomes Primary Outcomes - Time spent with FOG during protocol Secondary Outcomes - Gait performance - MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III - Patient global impression of change (PGI-C) - Trail Making test A and B - Phonemic/Semantic alternate Fluency test ### Location - Facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, N/A, 40139, Italy @@
## The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation - NCT ID: NCT06316219 - Study ID: ZOEPREP - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Palermo ### Study Description The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Nomegestrol Acetate/Estradiol, in rapid preparation of endometrium for hysteroscopic polypectomy. ### Conditions - Endometrial Polyp - Endometrial Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nomegestrol Acetate/Estradiol 2.5mg/1.5mg ### Outcomes Primary Outcomes - Quality of endometrial preparation Secondary Outcomes ### Location - Facility: Andrea Etrusco, Palermo, N/A, 90123, Italy @@
## The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation - NCT ID: NCT06316206 - Study ID: EFFIPREP - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Palermo ### Study Description The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy. ### Conditions - Endometrial Polyp - Endometrial Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ethinylestradiol/Dienogest 0.03mg/2mg ### Outcomes Primary Outcomes - Quality of endometrial preparation Secondary Outcomes ### Location - Facility: Andrea Etrusco, Palermo, N/A, 90123, Italy @@
## The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel. - NCT ID: NCT06316193 - Study ID: DiaPaNeo - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10-15 - Lead Sponsor: IRCCS Ospedale San Raffaele ### Study Description The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population:* Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital.* Health workers of the O.U. of Neonatal Pathology. ### Conditions - Experience, Life - Stress - Depression, Postpartum - Support, Family ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diary ### Outcomes Primary Outcomes - The objective of the qualitative phase is to provide a description of the experience of the parents of infants admitted to Neonatal Pathology and the healthcare personnel who participated in the compilation of the diary. Secondary Outcomes - The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The instruments will be administered by one of the appropriately trained nurses. - The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Stressor Scale (PSS). - The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. Edinburgh Postnatal Depression Scale (EPDS). - The quantitative phase includes as data collection tools a set of instruments validated in the Italian context and selected in relation to the variables to be measured. The Nurse Parental Support Tool (NPST). ### Location - Facility: IRCCS Ospedale San Raffaele, Milano, MI, 20132, Italy @@
## The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation - NCT ID: NCT06316180 - Study ID: DROVPREP - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: University of Palermo ### Study Description The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy. ### Conditions - Endometrial Polyp - Endometrial Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - drospirenone/estetrol 3mg/14.2mg ### Outcomes Primary Outcomes - Quality of endometrial preparation Secondary Outcomes ### Location - Facility: Andrea Etrusco, Palermo, N/A, 90123, Italy @@
## Mandatory Hiatoplasty in Sleeve Gastrectomy for Gastro-Esophageal Reflux Disease - NCT ID: NCT06316167 - Study ID: Hiatoplasty-2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-31 - Lead Sponsor: Instituto Mexicano del Seguro Social ### Study Description The goal of this observational study is to learn about incidence of postoperative gastroesophageal reflux disease in mandatory hiatoplasty performed during gastric sleeve surgery.The main question\[s\] it aims to answer are:* Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty* Comparison of postoperative complication rates, including GERDParticipants will answer a follow-up questionnaire, about postoperative quality of life ### Conditions - Postgastrectomy Syndromes - Gastroesophageal Reflux ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of participants without postoperative GERD Secondary Outcomes - Comorbidities in patients undergoing gastric sleeve with hiatoplasty - Incidence of postoperative GERD in patients undergoing gastric sleeve with mandatory hiatoplasty - Comparison of postoperative complication rates, including GERD - Postoperative quality of life analysis ### Location - Facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico, Guadalajara, Jalisco, 44329, Mexico @@
## Presentation of Protoscolexes and Acephalocysts in the Fibrous Capsule Area of the Liver With Echinococcosis - NCT ID: NCT06316154 - Study ID: 12032024 - Status: RECRUITING - Start Date: 2023-10-22 - Completion Date: 2024-12-22 - Lead Sponsor: Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov ### Study Description The objective of the study is to determine the presence of germinal elements of echinococcosis in the liver parenchyma next to and in the thickness of the fibrous capsule of hydatid cysts. ### Conditions - Echinococcosis, Hepatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echinococcectomy ### Outcomes Primary Outcomes - Presence of viable germinal elements of echinococcosis Secondary Outcomes - Recurrence of liver echinococcosis ### Location - Facility: Republican specialized scientific and practical medical center of surgery named after academician V.Vakhidov, Tashkent, N/A, 100115, Uzbekistan @@
## Effects of Aquatic vs Land Based Jogging in Overweight - NCT ID: NCT06316141 - Study ID: REC/RCR&AHS/23/0352 - Status: COMPLETED - Start Date: 2023-05-23 - Completion Date: 2024-02-15 - Lead Sponsor: Riphah International University ### Study Description Obesity raises the risk of chronic illnesses in adults, especially heart disease, type II diabetes, and osteoarthritis. One way to combat obesity is by physical activity, and water-based exercise (hydrotherapy) is recognized as an enhancement of the more common on land physical activity. Obesity is associated with several negative health outcomes, including cardiovascular disease (CVD), cardiac enlargement, gallbladder disease, diabetes, several cancers, osteoarthritis, and sleeping disorders .In addition to being a significant predictor of coronary heart disease and heart failure. obesity is indirectly related to cardiovascular health through its association with several other CVD risk factors, including hypertension, high cholesterol, low high-density lipoprotein (HDL) cholesterol, high triglycerides, and diabetes Therefore, obesity is a primary target for interventions to decrease overall cardiovascular risk. It is a randomized clinical trial conducted at the University OF Central Punjab Lahore. Convenience sampling technique will be used .Participants will be recruited through simple random sampling by sealed opaque envelope method into two Groups .Group A and Group B. Group A:Aqua jogging group: This group will perform aqua jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Group B: Land based jogging group: This group will perform land jogging for 60 minutes consisting of 10 minutes warming up, 40 minutes aqua jogging or land jogging and 10 minutes cooling down. Assessment tools for this study will be cooper's 1.5 miles run test for cardiorespiratory endurance and health related quality of life questionnaire for Quality of life. The study will be completed within 10 months after synopsis approval from ethical Committee of RCRS \& AHS .Data will be entered and analysed by SPSS version 25. After assessing the normality of data, it will be decided either parametric or non-parametric test will be use within a group or between two groups. ### Conditions - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aqua Jogging - Land based Jogging ### Outcomes Primary Outcomes - Cardiorespiratory Endurance(cooper; s1.5 miles run) - Quality of life (health related QOL SF 36 Questionnaire) - BMI Secondary Outcomes ### Location - Facility: University of Central Punjab (sports complex) Lahore., Lahore, Punjab, 42000, Pakistan @@
## EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian CCUs - NCT ID: NCT06316128 - Study ID: K26 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-03-29 - Lead Sponsor: Heart Care Foundation ### Study Description This registry has the aim to assess the use of different antithrombotic therapies, including untested drug combinations, routinely used during the hospitalization phase, with their timing, route and dose of administration, in consecutive patients discharged with a diagnosis NSTEMI or STEMI in Italian Cardiac care Units (CCUs) during a four-week study period. ### Conditions - Acute Coronary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Antithrombotic therapies Secondary Outcomes ### Location - Facility: Ospedale Santo Spirito - Sc Cardiologia, Casale, AL, 15033, Italy @@
## Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement - NCT ID: NCT06316115 - Study ID: HRRU-KMY-FA-01 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-04-10 - Lead Sponsor: Harran University ### Study Description Diabetic foot ulcer; It is a disease used to describe a series of lower extremity complications that may occur together with infection, ulceration or gangrene in individuals with diabetes and is coded as S91.3 and S91.8 in the International Classification of Diseases (ICD). Sharp debridement, one of the treatments for diabetic foot ulcers, is a short-term application performed with a sharp scalpel or scissors at the patient's bed or in outpatient clinic conditions. It should be performed by a skilled clinician with wound training. To our knowledge, no study has been found in the literature regarding the use of a stress ball as an intervention to prevent pain and anxiety during sharp debridement. In line with this information, this study will examine the effect of stress ball use on the pain and anxiety levels of patients with diabetic foot ulcers during wound debridement. ### Conditions - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - In Patıents Wıth Dıabetıc Foot Ulcer, Effect On Paın And Anxıety Of Stress Ball Use Durıng Sharp Debrıdement ### Outcomes Primary Outcomes - Introductory Information Form Secondary Outcomes - Meggit-Wagner classification of diabetic foot ### Location - Facility: Harran Universitesi, Şanlıurfa, N/A, N/A, Turkey @@
## Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo - NCT ID: NCT06316102 - Study ID: 22-3282 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-14 - Completion Date: 2025-01-01 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description This study includes an adapted multilevel intervention, Abriendo Puertas (Opening Doors), including individual counseling, peer navigation, and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process. Prior to this randomized controlled trial, feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV (no control group) and documented positive trends in antiretroviral therapy use (70% to 85%, p=0.03), missed care appointments (35% to 20%, p=0.39) and antiretroviral therapy adherence (86% to 96%, p=0.50). Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem. Limited trust and cohesion among trans women, however, inhibited more extensive engagement with peer navigation and community activities. In response, the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV: 1) integrate more gender affirming content, including with providers and 2) focus on building trust among transfeminine people through sequential implementation of individual and then community components. The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention. In Aim 1, the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed. The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention (n=60) (individual counseling, peer navigation, provider training, and community support building) or control group (n=60). There will be baseline, 6, and 12-month surveys and viral load assessments to assess differences across study arms. In Aim 2, the study team will examine pathways of influence (e.g. decreased stigma, increased cohesion) and experiences with the intervention to identify specific areas for improvement and scale up. Longitudinal qualitative interviews will be conducted at baseline, 6, and 12 months with 20 intervention participants. Together with surveys, the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma, cohesion, and HIV outcomes. The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 (n=2) and 12 months (n=2). ### Conditions - HIV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gender Affirming Abriendo Puertas (Opening Doors) (GAP) ### Outcomes Primary Outcomes - Viral Suppression (HIV), 6 months - Viral Suppression (HIV), 1 year - Retention in HIV care, 6 months - Retention in HIV care, 1 year - Antiretroviral therapy adherence, 6 months - Antiretroviral therapy adherence, 1 year - Antiretroviral therapy interruption, 6 months - Antiretroviral therapy interruption, 1 year Secondary Outcomes - Depression, 6 months - Depression, 1 year - Anxiety, 6 months - Anxiety, 1 year - Substance use, 6 months - Substance use, 1 year - Binge drinking, 6 months - Binge drinking, 1 year - Self-esteem, 6 months - Self-esteem, 1 year ### Location - Facility: Instituto Dermatológico y Cirugía de Piel (IDCP), Santo Domingo, N/A, N/A, Dominican Republic @@
## An Intervention to Improve HIV Pre-exposure Prophylaxis Initiation, Adherence and Linkage to Care for Recently Incarcerated Men Who Inject Drugs. - NCT ID: NCT06316089 - Study ID: K23DA054003 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-06 - Lead Sponsor: Rhode Island Hospital ### Study Description Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection among people who inject drugs (PWID) yet studies suggest that its use is low among this population which is particularly vulnerable to HIV infection. The criminal justice (CJ) system, at the intersection of increased risk of HIV infection and substance use, presents a unique opportunity to engage PWID in HIV prevention care that incudes PrEP. The study will characterize the facilitators and barriers to PrEP initiation, adherence and linkage to care among male PWID that are experiencing incarceration and develop the "PrEPare-for-Release" intervention to promote PrEP initiation, adherence and linkage to care upon release from incarceration into the community. ### Conditions - Hiv - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - PrEPared for Release ### Outcomes Primary Outcomes - PrEP initiation Secondary Outcomes - Adherence to PrEP - Linkage to PrEP care in the community ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases - NCT ID: NCT06316076 - Study ID: RJMty19-AID001 - Status: RECRUITING - Start Date: 2023-10-30 - Completion Date: 2026-06 - Lead Sponsor: RenJi Hospital ### Study Description To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases ### Conditions - Systemic Lupus Erythematosus - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Idiopathic Inflammatory Myopathies - Systemic Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CD19-CAR-DNT cells ### Outcomes Primary Outcomes - DLT - MTD - Incidence of abnormalities Secondary Outcomes - Pharmacokinetics (PK) indicator (Cmax) - Pharmacokinetics (PK) indicator (AUC) - Pharmacokinetics (PK) indicator (Tmax) - Pharmacokinetics (PK) indicator (T1/2) - Disease response rate at 6 months - Duration of Response ### Location - Facility: Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University, Shanghai, N/A, N/A, China @@
## Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery - a Randomised Study - NCT ID: NCT06316063 - Study ID: 2023- - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2026-03-25 - Lead Sponsor: Region Stockholm ### Study Description During apnoeic oxygenation there is a continuous raise in carbon dioxide with subsequent respiratory acidosis. The hypercapnia and respiratory acidosis have several dose-related effects on both the systemic and the pulmonary circulation and the heart that ultimately, if unrecognised, can result in cardiovascular collapse and fatal arrhythmias. In our knowledge, no studies have investigated the haemodynamic effects of apnoeic oxygenation with HFNO.The general purpose of this project is to investigate haemodynamic alternations during apnoeic oxygenation with HFNO compared to mechanical ventilation in relatively healthy patients under general anaesthesia during laryngeal surgery. ### Conditions - Laryngeal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Apnoeic oxygenation with high-flow nasal oxygen - Mechanical ventilation ### Outcomes Primary Outcomes - Significant haemodynamic effects during apnoeic oxygenation with HFNO Secondary Outcomes - Alterations in FloTrac derived central haemodynamic parameters - Alterations in Electrocardiogram - Alterations in arterial carbon dioxide, oxygen and pH - Alterations in blood catecholamines and cardiac biomarkers ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrovertion Assesment and Study in Elderly Patients With Reverse Total Shoulder Arthroplasty - NCT ID: NCT06316050 - Study ID: cst - Status: COMPLETED - Start Date: 2018-08-01 - Completion Date: 2023-06-28 - Lead Sponsor: Consorci Sanitari de Terrassa ### Study Description Determine the optimal degree of retroversion (0-30º) to obtain the best rotational mobility, both internal and external, of the shoulder after implanting a reversed sghoulder arthroplasty (Comprehensive system), and analyze the functional and radiologic results based on humeral retroversion. ### Conditions - Rotator Cuff Tears - Rotator Cuff Tear Arthropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - humeral retroversion ### Outcomes Primary Outcomes - INTERNAL ROTATION - INTERNAL ROTATION Secondary Outcomes - EXTERNAL ROTATION - FORWARD ELEVATION - Simple shoulder test - Constant test - ASES test - Glenoid inclination angle - glenoid retroversion angle - abduction - center of rotation - lateralizaiton offset ### Location - Facility: JM MORA, Terrassa, Barcelona, 08227, Spain @@
## Adaptation of Work in a Hospital and Assessment of Feelings of Quality of Life at Work, Teleworking and Face-to-face - NCT ID: NCT06316037 - Study ID: 2024 DUTHEIL ADAPTAWORK_2 - Status: COMPLETED - Start Date: 2023-09-12 - Completion Date: 2024-01-20 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description The ADAPTAWORK_2 study is a follow-up to the first qualitative study, to evaluate the feelings of hospital workers in all occupations about teleworking. This involves measuring the variation between three periods: before the COVID-19 pandemic, during the first lockdown an after the pandemic.Secondary objectives were: 1) to evaluate wich factors were associated to the feelings towards teleworking, 2) to assess musculo-squeletal disorders among teleworkers and the other participants, 3) to assess psycho-social risks among teleworkers and the oher participants, and 4) to evaluate teleworking costs ### Conditions - Work-Related Stress - Work-Related Condition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Feeling about teleworking Secondary Outcomes - Musculo-squeletic pain - psychosocial risks - purchases ### Location - Facility: CHU de Clermont-Ferrand, Clermont-Ferrand, N/A, N/A, France @@
## Early Oral Intake of Different Types of Diets Affecting Gastrointestinal Function - NCT ID: NCT06316024 - Study ID: IRB2023056 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Chiayi Christian Hospital ### Study Description The percentage of cesarean deliveries is on the rise, accounting for 30-40% of all deliveries in Taiwan. Following a cesarean delivery, a few doctors in Taiwan still adheres to the progressive eating regimen of "nothing per mouth" for 24 hours or until the patient passes flatus or hears bowel sounds. However, a meta-analysis has shown that early oral intake (6-8 hours) significantly reduces the time required for the restoration of gastrointestinal function and hospital stay compared to delayed oral intake. Furthermore, early oral intake has not shown to increase the likelihood of gastrointestinal complications. While several food types have been adopted for early oral intake, no study has investigated the effect of different food types on clinical outcomes regarding gastrointestinal function and hospital stay for cesarean delivery. Therefore, the objective of this study is to investigate the effect of different food types on clinical outcomes for cesarean delivery through a randomized controlled trial. The subjects of this study are pregnant women who come to Chiayi Christian Hospital to schedule cesarean deliveries. They are randomly assigned to one of four groups: nothing by mouth, water, juice/sports drink, or chewing gum. The relevant clinical outcomes, such as time to first bowel sound or readiness for discharge, are recorded. One-way analysis of variance or Chi-square test is used to compare the differences among the four groups. Our expected results could provide valuable information on the type of food that could be used to improve the recovery of mothers after cesarean delivery and increase the quality of breastfeeding. ### Conditions - Cesarean Section ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - water - juice/sport drink group - Chewing gum group ### Outcomes Primary Outcomes - first time to bowel sound - beginning of breastmilk lactation - length of hospital stay Secondary Outcomes - time to first drink - time to first solid food intake - duration of IV hydration - IV cannulae removal - first ambulation - first stool - satisfaction VAS (0-100) regarding the early intake ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MCG for Risk Stratifications of Patients With Chest Pain - NCT ID: NCT06316011 - Study ID: MCG-chestpain - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-08-31 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome （ACS） using Magnetocardiography （MCG）. ### Conditions - Acute Coronary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetocardiography ### Outcomes Primary Outcomes - Efficacy of MCG for the detection and risk stratification in patients with chest pain Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diagnosis of Structural Heart Disease Using MCG - NCT ID: NCT06315998 - Study ID: MCG-Structural - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-09-30 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard. ### Conditions - Structural Heart Abnormality ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Magnetocardiography ### Outcomes Primary Outcomes - The efficacy of the MCG in identifying structural heart disease Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Classical Turkish Music for Pregnant Women With Preeclampsia - NCT ID: NCT06315985 - Study ID: GAksoy - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-03-20 - Lead Sponsor: Tarsus University ### Study Description Stress and Sleep of Classical Turkish Music in Pregnant Women Diagnosed with Preeclampsia in Clinics The study to be carried out to determine the effect on quality is a randomized controlled experimental research. All patients who comply with the limitations of the study and volunteer will be included in the study. When the studies in the literature are examined, there are a limited number of studies on the effects of music on pregnant women diagnosed with preeclampsia, and no studies have been found on the effects of music on stress and sleep quality in pregnant women with preeclampsia. This research aimed to determine the effect of Classical Turkish Music on stress and sleep quality in pregnant women diagnosed with Preeclampsia in clinics. ### Conditions - Pre-Eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia ### Outcomes Primary Outcomes - Perceived Stress Secondary Outcomes - Sleep Quality ### Location - Facility: Gülay Aksoy, Mersin, N/A, 33080, Turkey @@
## Combining Clemastine and Aerobic Exercise to Treat Cognitive Dysfunction in Schizophrenia by Targeting Myelin Plasticity - NCT ID: NCT06315972 - Study ID: 2022-000054-28 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: LMU Klinikum ### Study Description Schizophrenia (SZ) is a broad clinical entity characterized by different subjective symptoms,behavioural signs, and disease course. Research has pointed to numerous biological indicators tentatively associated with neurocognitive dysfunction, brain structural and neurochemical alterations. Cognitive deficits occur as early as the prodromal phase of the illness and significantly determine its outcome. Pathophysiologically, SZ is regarded as a disconnectome disorder in which frontal and temporal brain regions are functionally disconnected, which contributes substantially to the development of cognitive dysfunction.Impaired connectivity is related to synaptic (microconnectivity) and myelin (macroconnectivity) plasticity. With design-based stereology, a decreased number of oligodendrocytes (OLs) in the CA4 hippocampal subregion as the basis for disturbed myelination and impaired cognition, but also a decrease in the prefrontal cortex were observed. Animal studies demonstrated that clemastine enhances remyelination by increasing the differentiation of oligodendrocyte precursor cells (OPCs) and showed that aerobic exercise increases the rate of remyelination and proliferation of OPCs; this clinically meaningful effect of aerobic exercise is stronger in combination with clemastine. Furthermore, aerobic exercise improves everyday functioning, measured by the Global Assessment of Functioning (GAF) scale, and cognitive dysfunction in SZ and increases hippocampal volume, especially the volume in the hippocampal CA4 subregion. This regional volume change correlates negatively with global and cell-specific polygenic risk scores (PRSs), indicating that OPCs are involved in the genetic risk mechanisms and disturbed plasticity underlying SZ. In patients with multiple sclerosis, 90 days' administration of clemastine fumarate 10.72 mg/day, corresponding to clemastine 8 mg/day, significantly decreased the P100 latency delay of visual evoked potentials (VEPs) as a sign of myelin repair. In a bicentric, randomized, double-blind, controlled phase IIb clinical trial with a 2-arm parallel group design in patients with SZ, the study will compare the effects of aerobic exercise training plus clemastine vs. aerobic exercise training plus placebo over a period of 3 months on 1) everyday functioning and 2) working memory as primary outcomes. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - clemastine (8 mg/day) - Placebo ### Outcomes Primary Outcomes - change in Global Assessment of Functioning - change in working memory performance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery - NCT ID: NCT06315959 - Study ID: ESPCHRONIC2023 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-15 - Lead Sponsor: Ondokuz Mayıs University ### Study Description The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale. ### Conditions - Chronic Pain - Cardiac Surgery - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bilateral ultrasound guided erector spinae plane block - morphine PCA - Control group - morphine PCA ### Outcomes Primary Outcomes - Chronic pain status Secondary Outcomes - Postoperative opioid consumption in the first 24 Hours - Postoperative pain scores - The incidences of post-operative nausea and vomiting (PONV) - The number of patient requiring rescue analgesic - Time to extubation - The number of patients with complications - Chronic pain status at 6 months. - Length of stay in the ICU ### Location - Facility: Ondokuz Mayis University, Samsun, Atakum, 55139, Turkey @@

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