Datasets:

hackint0sh
/

md_dataset

Dataset card Data Studio Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## The Effect of Trunk and Upper Extremity Exercises Added to the Otago Exercise Program - NCT ID: NCT06267833 - Study ID: MSKUSBFFTR01 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-06-01 - Lead Sponsor: Muğla Sıtkı Koçman University ### Study Description This study is designed to investigate the effect of adding trunk and upper extremity exercises in traditional and mobile game formats to the Otago exercise program on balance performance, fall risk, and fear in older adults. A randomized controlled, cross-sectional, single-blind (evaluator) study will be conducted with 36 older adults aged 65 and older enrolled at Muğla Sıtkı Koçman University (MSKÜ) Elderly Studies Application and Research Center. Participants will be divided into three randomized groups: control group (12 individuals receiving the Otago exercise program), study group 1 (12 individuals receiving additional trunk and upper extremity exercises with traditional methods added to the Otago exercise program), and study group 2 (12 individuals receiving additional trunk and upper extremity exercises with mobile game method added to the Otago exercise program). Participant demographics informations will be recorded in Form 1. Participants' cognitive functions , levels of independence in activities of daily living, fall risk , and fear of falling will be evaluated. Balance performance will be assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest), portable computerized kinetic balance measurement (SportKAT 650-TS), "5 Times Sit-to-Stand" and "Four-Stage Balance Test" from the Otago Exercise Program. Participants' body sway will be assessed simultaneously with the second part of the Mini-BESTest using a mobile application. All assessments will be conducted by a researcher blinded to the exercises, both before and after the exercises, in a one-on-one face-to-face setting. In the exercise protocol, a personalized, home-based, 30-minute Otago exercise program consisting of strength, balance, and walking exercises performed three times a week will be implemented for 8 weeks with home visits and telerehabilitation sessions (via Videoconferencing) under the supervision of the responsible researcher. In addition to the Otago exercise program, trunk and upper extremity exercises (totaling 45 minutes) will be implemented in study group 1 using traditional methods and in study group 2 using the mobile game method. Telerehabilitation sessions will be conducted via an Android-based tablet if the study is supported by Tübitak 1002 A Rapid Support Module. Individual smartphones of participants will be used if the study is not supported. All questionnaires, scales, and tests used in the initial assessments will be repeated at the end of the 8-week exercise protocol for all participants. ### Conditions - Geriatrics - Balance - Exercise - Fall Prevention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - exercise ### Outcomes Primary Outcomes - Mini BESTest Secondary Outcomes - Functional Reach Test - International Falls Efficacy Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Postoperative Pain Control by Adding Ketorolac to Bupivacaine in Transversus Abdominis Plane Block in Children - NCT ID: NCT06267820 - Study ID: 2010 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-12-10 - Lead Sponsor: Sohag University ### Study Description Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) ### Conditions - Postoperative Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Bupivacain - Ketorolac ### Outcomes Primary Outcomes - 1st analgesic requirement - Number of patients who requested analgesia Secondary Outcomes - heart rate - Total rescue analgesia - Satisfaction of the parents regarding their children analgesia - Number of children in each group who required analgesia in the first 24 h postoperatively - blood pressure ### Location - Facility: Fouad Ibrahim Soliman, Sohag, N/A, 52514, Egypt @@
## Lymphatic Phenotype in Noonan Syndrome Spectrum Disorders - NCT ID: NCT06267807 - Study ID: 114369 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-06-01 - Lead Sponsor: Radboud University Medical Center ### Study Description To get a better insight into the central conducting lymphatic system in adult volunteers with Noonan Syndrome (NS) without clinical symptoms or signs of lymphatic disease compared to NS and CardioFacioCutaan syndrome patients with severe lymphatic disease ### Conditions - Lymphatic System Disorders Congenital - Lymphatic Diseases - Noonan Syndrome - Lymphatic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Dynamic contrast-enhanced lymphangiography ### Outcomes Primary Outcomes - Central lymphatic system anatomy and flow descriptive parameters. - Diameter Thoracic duct - Lymph flow velocity Secondary Outcomes ### Location - Facility: Radboudumc, Nijmegen, Gelderland, 6500 HB, Netherlands @@
## Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis. - NCT ID: NCT06267794 - Study ID: ODISEA Study - Status: COMPLETED - Start Date: 2015-06-26 - Completion Date: 2023-03-24 - Lead Sponsor: Jorge L Poo ### Study Description This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov. ### Conditions - Liver Fibrosis - Cirrhosis, Liver - Chronic Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pirfenidone 1200 mg - Pirfenidone 1800 mg - Placebo ### Outcomes Primary Outcomes - Change in liver fibrosis - Clinical side effects Secondary Outcomes - Improvement in Child Pugh score - Improvement in MELD score - Improvement in bilirrubin and albumin - Improvement in prothrombin time - Improvement in liver enzymes - Improvement in EuroQol Visual analog scales - Improvement in EuroQol five dimensions Scale - Improvement in modified fatigue impact scale (MFIS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies - NCT ID: NCT06267781 - Study ID: TRANSPLANT-PRO - Status: RECRUITING - Start Date: 2022-09-02 - Completion Date: 2027-09-02 - Lead Sponsor: IRCCS San Raffaele ### Study Description To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of fading/disappearing paramagnetic rim lesions (PRLs) Secondary Outcomes - Surrogate biomarkers of disease progression (MSFC) - Surrogate biomarkers of disease progression (sNfL) - Surrogate biomarkers of disease progression (RNFL) - Surrogate biomarkers of disease progression (cortical lesions) - Surrogate biomarkers of disease progression (atrophy) - Changes in myeloid landscape ### Location - Facility: IRCCS San Raffaele, Milan, N/A, 20132, Italy @@
## The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke - NCT ID: NCT06267768 - Study ID: REC Reference No.:HE-OT2023/13 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-11-30 - Lead Sponsor: Hong Kong Metropolitan University ### Study Description This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Various intensities of inspiratory muscle training ### Outcomes Primary Outcomes - Diaphragmatic thickening fraction Secondary Outcomes - Muscle activation of the sternocleidomastoid muscle - Perceived Exertion Borg scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain - NCT ID: NCT06267755 - Study ID: P.T.REC/012/004884 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-08-30 - Lead Sponsor: Cairo University ### Study Description this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal Shockwave therapy - Traditional physical therapy ### Outcomes Primary Outcomes - muscle thickness - hypoechoic area intensity Secondary Outcomes - neck disability - pressure pain threshold - cervical range of motion - pain intensity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Trial to Evaluate MDW for Early Detection of Sepsis - NCT ID: NCT06267742 - Study ID: CHN097 - Status: RECRUITING - Start Date: 2022-06-23 - Completion Date: 2024-09-30 - Lead Sponsor: Beckman Coulter, Inc. ### Study Description This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China. ### Conditions - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Complete Blood Count (CBC) with Differential ### Outcomes Primary Outcomes - sensitivity, specificity Secondary Outcomes ### Location - Facility: Peking Union Medical College Hospital, Beijing, N/A, N/A, China @@
## Study of AZD0754 in Participants With Metastatic Prostate Cancer - NCT ID: NCT06267729 - Study ID: D9660C00001 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2027-05-24 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer. ### Conditions - Metastatic Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AZD0754 ### Outcomes Primary Outcomes - Incidence of participants with Dose-limiting Toxicity (DLTs)/DLT-like events, Adverse Events (AEs), including Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs). - Presence of replication-competent lentivirus (RCL) in peripheral blood samples Secondary Outcomes - Prostate-specific antigen (PSA) response rate - PSA50 - PSA response rate - PSA90 - Duration of PSA Response (DoPSA50, DoPSA90) - Durable PSA Response Rate (DRRPSA50, DRRPSA90) - Time to PSA Response (TTPSA50, TTPSA90) - Time to PSA Progression (TTPSAP50, TTPSAP90) - Best Overall Response (BOR) - Objective Response Rate (ORR) - Time to Response (TTR) - Duration of Response (DoR) - Durable Response Rate (DRR) - Disease Control Rate (DCR) - Percentage change in tumor size - Radiographic Progression-free Survival (rPFS) - Overall Survival (OS) - Time from AZD0754 Infusion to the first Symptomatic Skeletal-related Events (SSRE) - Pharmacokinetics - maximum observed serum concentration (Cmax) of AZD0754 - Pharmacokinetics - time taken to reach maximum serum concentration (Tmax) of AZD0754 - Pharmacokinetics - Last measurable serum concentration (Clast) of AZD0754 - Pharmacokinetics - time of last measurable serum concentration (Tlast) of AZD0754 - Pharmacokinetics - Exposure of AZD0754 - Biomarker - STEAP2 expression in Tumor ### Location - Facility: Research Site, Duarte, California, 91010, United States @@
## Pericapsular Nerve Block and Iliopsoas Fascial Plane Block in Hip Surgery - NCT ID: NCT06267716 - Study ID: 274-2023 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2024-08-30 - Lead Sponsor: Haseki Training and Research Hospital ### Study Description This prospective randomized interventional study aims to compare the effects of two peripheral nerve blocks, the periencapsular nerve block (PENG) and iliopsoas block (IPB), on analgesia and motor function after hip surgery.The main questions it aims to answer are the effectivity of postoperative pain management the preservation of motor movement.Participants will receive standardized general anesthesia and postoperative PENG or IPB in either Group.Researchers will compare the total amount of rescue analgesia and numeric rating scale with accompanying evaluating motor function at the same time intervals within 24 hour. ### Conditions - Hip Fractures - Peripheral Nerve Block ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PENG block - IPB ### Outcomes Primary Outcomes - postoperative motor block Secondary Outcomes - pain scores - total analgesia, intraoperative - total rescue analgesia ### Location - Facility: Haseki Training and Research Hospital, Istanbul, Sultangazi, 34000, Turkey @@
## Multi-omics Analyses on Etiology and Early Detection of Stomach Cancer Precursor Lesions - NCT ID: NCT06267703 - Study ID: 2023-01939_VR - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Karolinska Institutet ### Study Description The overall aim is to utilize multi-omics approach to identify novel etiopathogenesis and early detection biomarkers for stomach cancer precursor lesions. To achieve this aim, first the investigators will use stored serum samples to perform metabolomics profiling among 12,599 twin subjects, among whom 1034 were deemed to have chronic atrophic gastritis based on measured pepsinogen I and II levels. Logistic regression will be used to search for metabolites related to the risk of chronic atrophic gastritis. Second, the investigators will further measure serum proteome by using two quantitatively precise proteomics assays, among the above-mentioned twin subjects. Identified protein biomarkers will be combined with metabolomics biomarkers to create a prediction model for chronic atrophic gastritis. The results will hopefully improve our understanding of the etiological factors and provide promising early detection biomarkers for stomach cancer precursor lesions. ### Conditions - Chronic Atrophic Gastritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Metabolomic profiling ### Outcomes Primary Outcomes - Chronic atrophic gastritis Secondary Outcomes ### Location - Facility: Karolinska Institutet, Solna, Stockholm, 17165, Sweden @@
## A CT-based Radiomics Model to Predict Survival-graded Fibrosis in PDAC - NCT ID: NCT06267690 - Study ID: SYSUFAH2021025 - Status: COMPLETED - Start Date: 2021-01-13 - Completion Date: 2023-08-31 - Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University ### Study Description Tumor fibrosis plays an important role in chemotherapy resistance in pancreatic ductal adenocarcinoma (PDAC), however there remains a contradiction in the prognostic value of fibrosis. We aimed to investigate the relationship between tumor fibrosis and survival in patients with PDAC, classify patients into high- and low-fibrosis groups, and develop and validate a CT-based radiomics model to non-invasively predict fibrosis before treatment. ### Conditions - Pancreatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - surgery ### Outcomes Primary Outcomes - fibrosis Secondary Outcomes ### Location - Facility: Shi Siya, Guangzhou, Guangdong, 510000, China @@
## Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery - NCT ID: NCT06267677 - Study ID: 2007/3928 - Status: COMPLETED - Start Date: 2008-01-02 - Completion Date: 2009-03-06 - Lead Sponsor: Hospital Clinic of Barcelona ### Study Description The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications.Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:* Analytical determination* Nitrogen balance by determining urea N2 in 24-hour urine* Anthropometric determinations* Body composition determined by impedanciometry* Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.* Energy, protein and hydration intake.* Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery. ### Conditions - Body Composition - Obesity - Protein Supplementation - Bariatric Surgery Candidate - Weight Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High protein liquid formula ### Outcomes Primary Outcomes - protein intake - evaluate nutritional deficiencies - Tolerance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP) - NCT ID: NCT06267664 - Study ID: PI-GR-23-3263 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2024-12-01 - Lead Sponsor: Hospital Clínico Universitario de Valladolid ### Study Description Migraine is the third most prevalent disease and the leading reason of years lived with disability in the most productive years of the life. Migraine associated disability can be alleviated by acute and preventive treatment. The migraine landscape has changed recently, with the approval of novel acute treatments, including oral Calcitonin gene-related peptide antagonists, the gepants (Rimegepant, Ubrogepant, Zavegepant) and 5-HT-1F antagonists, the Ditans (Lasmiditan). These have joined Triptans as acute "migraine-specific" drugs.The TRIDIGEP study will be an open-label, multiple attack, prospective cohort study.This study aims to describe 1) the effectiveness of the acute treatments of migraine attacks in routine clinical practice, 2) the tolerability of the drugs, and 3) to explore potential response and tolerability predictors.The endpoints recommended by the International Headache Society will be employed, including: 1) Pain freedom; 2) Absence of the most bothersome symptom; 3) Sustained pain freedom; 4) Total freedom from migraine; 5) Headache relief; 6) Duration of attacks; 7) Time lost due to an attack; 8) Need of rescue medication. The study endpoints will be assessed at 2, 8 and 24 hours after the acute drug use. Data will be collected by the patients themselves, with a validated data collection instrument within a RedCap questionnaire, using QR codes. ### Conditions - Migraine - Migraine Disorders - Migraine With Aura - Headache Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients with migraine treated with triptans, Lasmiditan or Gepants ### Outcomes Primary Outcomes - Pain freedom at 2 hours - Absence of the most bothersome symptom Secondary Outcomes - Pain freedom at 8 hours - Pain freedom at 24 hours - Sustained pain freedom - Total freedom from migraine at 2 hours - Total freedom from migraine at 8 hours - Total freedom from migraine at 24 hours - Headache relief at 2 hours - Headache relief at 8 hours - Headache relief at 24 hours - Time to meaningful relief - Time to pain freedom - Time to migraine freedom - Need of rescue medication at 2 hours - Need of rescue medication at 8 hours - Need of rescue medication at 24 hours - Tolerability of the drugs - Response predictors at 2 hours - Response predictors at 24 hours - Tolerability predictors - Time lost due to an attack ### Location - Facility: Hospital Clínico Universitario de Valladolid, Valladolid, N/A, 47010, Spain @@
## Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals - NCT ID: NCT06267651 - Study ID: Steroid in ulcerative colitis - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-01 - Lead Sponsor: Assiut University ### Study Description 1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups ) ### Conditions - Early Detection of Complication of Ulcerative Colitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Early prevention of complication of ulcerative colitis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia - NCT ID: NCT06267638 - Study ID: Chomthong hospital, Thailand - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-12-31 - Lead Sponsor: Ministry of Health, Thailand ### Study Description The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketamine group - Placebo group ### Outcomes Primary Outcomes - Postoperative pain score at rest and movement Secondary Outcomes - First time to receive intravenous analgesic drug - Morphine consumption - Length of hospital stay - side effect and complication from ketamine and opioid ### Location - Facility: Chomthong hospital, Chiangmai, N/A, 50160, Thailand @@
## Physical Impairments in Elderly Individuals - NCT ID: NCT06267625 - Study ID: Elderly Individuals - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-15 - Lead Sponsor: Izmir Democracy University ### Study Description There are no studies in the literature reporting the dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals. The aims of this observational study are; 1) to evaluate dyspnea, posture, strength, physical activity, functional mobility and balance in elderly individuals, 2) to reveal the relationships between these parameters of research group. ### Conditions - Aging Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physical Evaluations of individuals ### Outcomes Primary Outcomes - Dyspnea score Secondary Outcomes - Posture score - Cough strength - Handgrip strength - Functional mobility score - Physical activity score - Functional Mobility score - Balance score - Cognitive function score ### Location - Facility: Izmir Democracy University, İzmir, N/A, 35140, Turkey @@
## Corheart 6 LVAS Long-term Follow-up Study - NCT ID: NCT06267612 - Study ID: KY20231109-11 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-10 - Completion Date: 2030-06-30 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Corheart 6 Left Ventricular Assist System ### Outcomes Primary Outcomes - Device implantaion success rate at 24 months post-implantation Secondary Outcomes - Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) - Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire - Functional status as measured by the Six Minute Walk Test (6MWT) - Functional status as measured by the New York Heart Association (NYHA) Classification - Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score - Stroke severity as assessed by the modified Rankin Scale (mRS) score - Adverse events - Device-related re-operations - Device-related re-hospitalizations - Overall survival ### Location - Facility: Nanjing First Hospital, Nanjing, Jiangsu, N/A, China @@
## Bladder Suture in Uterus-Sparing Surgery and Hysterectomy for Placenta Percreta - NCT ID: NCT06267599 - Study ID: ACAR-Style Bladder Suture - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-01-01 - Lead Sponsor: Necmettin Erbakan University ### Study Description This study aimed to evaluate the short-term and long-term complications of placenta percreta with bladder invasion. This evaluation focuses on cases where bladder dissection and ACAR-style bladder sutures were applied in cases of placenta percreta with bladder invasion that underwent uterine-sparing surgery or hysterectomy. ### Conditions - Placenta Percreta - Bladder Injury - Sutures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ACAR-Style Bladder Suture ### Outcomes Primary Outcomes - Comparison of intraoperative bleeding and complication rates of the two groups - Comparison of postoperative bleeding between two groups - Comparison of complication rate between two groups Secondary Outcomes ### Location - Facility: Cemre Alan, Konya, N/A, N/A, Turkey @@
## Effects of PeptiSleep in Healthy Males and Females With Mild to Moderate Sleep Impairment - NCT ID: NCT06267586 - Study ID: PN23.007 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-02-20 - Lead Sponsor: Nuritas Ltd ### Study Description Examining the effects of PeptiSleep, a plant-based sleep aid, in healthy males and females with mild to moderate sleep impairment ### Conditions - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - PeptiSleep - Placebo MCC micro-crystalline cellulose ### Outcomes Primary Outcomes - Safety and Tolerability of a dose range of PeptiSleep via adverse event reporting Secondary Outcomes - Safety via electrolytes and liver function tests - Sleep Quality via Leeds Sleep Evaluation Questionnaire - Insomnia severity via the Insomnia Severity Index Questionnaire - Sleep onset time via self-reported recording in a Sleep Diary - Sleep pattern via self-reported recording in a Sleep Diary - Daytime Sleepiness via the Epworth Sleepiness Scale - Stress via the Perceived Stress Scale - Stress via self reported Profile of Mood States Questionnaire - Anxiety via self-reported Beck Anxiety Inventory questionnaire - Stress via Salivary cortisol test - Alertness via Reaction Time Test - Circadian cycles via melatonin and serotonin via blood test - Markers associated with inflammation via blood test - Sleep onset latency via wearable sleep tracker - Total sleep time spent in sleep phases via wearable sleep tracker - Blood pressure via blood pressure machine - Heart rate via blood pressure machine - Body Temperature via wearable sleep tracker - BMI via height and weight measurements ### Location - Facility: RDC Clinical, Brisbane, Fortitude Valley Queensland, 4006, Australia @@
## Thoracoabdominal Aortic Aneurysms - NCT ID: NCT06267573 - Study ID: Kerolos protocol - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-09-10 - Lead Sponsor: Assiut University ### Study Description Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA ### Conditions - Thoracoabdominal Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fenestrated and branched endovascular devices for TAAA ### Outcomes Primary Outcomes - Successful cannulation of the target vessels with complete in-line flow to target organs. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD - NCT ID: NCT06267560 - Study ID: CTQJ230A12303 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-27 - Completion Date: 2027-06-21 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c. QM in US Black/African American and Hispanic participants with established ASCVD and elevated levels of Lp(a) who are treated for cardiovascular (CV) risk factors according to local practice/guidelines for the reduction of cardiovascular risk. ### Conditions - Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TQJ230 - Placebo ### Outcomes Primary Outcomes - Change in log-transformed Lp(a) concentration from baseline at week 52 Secondary Outcomes - Incidence proportion of study discontinuations due to TEAEs - Incidence proportion of Treatment emergent adverse events (TEAEs) of special interest ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Healthy Activities Improve Lives (HAIL) - NCT ID: NCT06267547 - Study ID: 2023P003522 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2027-02-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description The investigators have developed an online platform to support the 8-week, F\&S! exercise program called the Healthy Activity Improves Lives (HAIL) online platform. The aim of this study is to perform a cluster randomization of four racially diverse churches or senior centers to either the standard F\&S! program, or the combined HAIL Online Platform + F\&S! program to examine the efficacy of the HAIL online platform + F\&S! program for older adults in black communities. ### Conditions - Physical Activity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HAIL Online Platform - Fit and Strong! Program ### Outcomes Primary Outcomes - Feasibility and Retention - Acceptability - Acceptability (Feedback Form) - Acceptability (Exit Interviews) Secondary Outcomes - Changes in Physical Activity (Steps) - Changes in Physical Activity (MVPA) - Changes in Aerobic Capacity - Changes in Physical Strength - Motivation to Change - Utilization of Healthcare Resources - Fall History - Chronic Conditions - Changes in Overall Wellbeing - Changes in Depression - Changes in Anxiety - Changes in Physical Functioning - Changes in Social Isolation - Changes in Confidence in Exercises ### Location - Facility: Roslindale Baptist Church, Boston, Massachusetts, 02131, United States @@
## Mindfulness-based Mobile Applications Program - NCT ID: NCT06267534 - Study ID: YCH - Status: COMPLETED - Start Date: 2022-09-09 - Completion Date: 2022-09-22 - Lead Sponsor: Yu-Chien Huang ### Study Description The goal of this type of study: quasi-experimental clinical trial . The purpose of this study is to explore the effects of applying mindfulness-based mobile applications program to maintaining mental health of emergency nurses during providing care to COVID-19 patients. The main question\[s\] it aims to answer are:1. To explore the effect of mindfulness-based mobile device-assisted program on care stress of emergency nurses caring for COVID-19 patients.2. To explore the impact of mindfulness-based mobile device-assisted programs on the psychological distress of emergency nurses caring for COVID-19 patients.3. To explore the impact of a mindfulness-based mobile device-assisted program on compassion fatigue in emergency nurses caring for COVID-19 patients.Participants will Mindfulness-based mobile device is provided to experimental group as assistance for 2 weeks. In the contrary, no intervention measure was assigned in the control group. Scale exam was performed before and after the program in both groups at the same time. ### Conditions - COVID-19 - Cell Phone Use - Nurse - Mental Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - mindfulness-based mobile applications program ### Outcomes Primary Outcomes - The impact of mindfulness-based mobile device assistance program on the care stress of emergency nursing staff caring for COVID-19 patients - Effects of mindfulness-based mobile device assistance program on psychological distress among emergency nursing staff caring for COVID-19 patients - Effects of a mindfulness-based mobile device-assisted program on compassion fatigue among emergency nursing staff caring for COVID-19 patients Secondary Outcomes ### Location - Facility: Yu-Chien Huang, Taipei, Zhongzheng District, 100, Taiwan @@
## The STRENGTHEN Study - NCT ID: NCT06267521 - Study ID: 2023-1473 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2025-02 - Lead Sponsor: University of Wisconsin, Madison ### Study Description This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled and can expect to be on study for up to 9 months. ### Conditions - Cognitive Flexibility - Emotional Regulation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Healthy Minds Program - Sham Meditation Didactic Material - Sham Stimulation in Lab - Stimulation in Lab - MRI Scanner ### Outcomes Primary Outcomes - Change in Patient Health Questionnaire-9 (PHQ-9) Score - Change in General Anxiety Disorder (GAD-7) Score - Change in Single-item Suicide Question - Change in Healthy Minds Index (HM Index) - Change in the Perceived Stress Scale (PSS) Score - Change in Emotional Styles Questionnaire (ESQ) Score - Change in Cognitive Flexibility Inventory (CFI) Score: Alternatives Subscale - Change in Cognitive Flexibility Inventory (CFI) Score: Control Subscale - Change in Difficulties in Emotion Regulation Scale-18 (DERS-18) Score - Change in PROMIS Sleep Disturbance Score - Change in PTSD Checklist for DSM-5 (PCL-5) - Change in World Health Organization-5 (WHO-5) - Change in Restorative Sleep Questionnaire (RSQ) Score - Change in Sleep Depth Question (SDQ) Score - Change in Pittsburgh Sleep Quality Index (PSQI) Score - Change in Suicide Risk Survey - Change in Brief Suicide Cognitions Scale (B-SCS) Score - Change in Passive and Active Suicidal Ideation Scale (PASIS) Score - Change in NIH Toolbox Loneliness Score - Change in Five Facet Mindfulness Questionnaire (FFMQ) Score - Change in Drexel Defusion Scale (DDS) Score - Change in PROMIS Meaning and Purpose Score - Change in Digital Working Alliance Inventory (D-WAI) Score - Change in Perseverative Thinking Questionnaire (PTQ) Score - Change in Experiences Questionnaire's Decentering subscale (EQ-D) Score - Change in Experience Sampling / Ecological Momentary Assessment - Change in Death Implicit Association Test Score - Change in Reversal Learning Task Score - Change in Multi-Source Interference Task Score - Change in Emotional Stroop Score: Reaction Time - Change in Emotional Stroop Score: Percent Correct - Change in Meteor Mission Score: Mean Reaction Time - Change in Meteor Mission Score: Coefficient of Variation - Change in Meteor Mission Score: Percent Correct - Change in Emotional Persistence Task Score - Change in Change Your Mind Task Score: Mean Change - Change in Change Your Mind Task Score: Accuracy - Change in Change Your Mind Task Score: Response Time Secondary Outcomes - Change in Spectral Power Density During Stimulation-Free Sleep - Resting-state fMRI Connectivity Z-Scores ### Location - Facility: Center for Healthy Minds, Madison, Wisconsin, 53703, United States @@
## Increasing Neonatal HIV Test and Treat to Maximize the Long-Term Impact on Infant Health and Novel Infant Antiretroviral Treatment - NCT ID: NCT06267508 - Study ID: LMU-IMPH-LIFE2Scale - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Michael Hoelscher ### Study Description This study aims to improve HIV healthcare services for mothers living with HIV and their newborns in Tanzania and Mozambique. The main questions it aims to answer are: 1) does enhancing screening with maternal HIV viral load monitoring at delivery identify more mother-child pairs at high-risk for HIV vertical transmission? and 2) are high-risk infants linked to appropriate prevention and care? The study will expand access to HIV testing services to more rural settings using a hub-and-spoke referral system. ### Conditions - Vertical Human Immunodeficiency Virus Transmission - HIV Infection Pediatric - Infant Death - Infant Morbidity - Infant, Newborn, Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Maternal HIV viral load testing at delivery for VHT risk assessment ### Outcomes Primary Outcomes - Proportion of HIV-exposed infants correctly identified as low- or high-risk and receiving birth EID testing and ePNP or ART as appropriate within 7 days of life Secondary Outcomes - Turnaround times for EID testing at birth, 4-6 weeks, and 14 weeks (time from sample collection to receipt of results by the health facility and communication of results to the mother/caregiver) and maternal PoC VL testing at delivery and 14 weeks - Proportion and rate of VHT at birth, week 4-8, and week 14 - Risk-factors associated with VHT - Adherence to PNP and ePNP - Proportion and rate of clinical endpoints (mortality, morbidity) among HIV-positive infants at week 14, month 6, and month 12 - Age at ART initiation among HIV-positive infants - Risk factors for poor ART adherence among high-risk mothers and infants - Proportion of HIV-positive infants virally suppressed at week 14, month 6, and month 12 - Risk factors for poor viral suppression among HIV-positive infants - Proportion of HIV-positive infants on ART that experience grade III or greater laboratory ART toxicity - Retention to HIV EID and infant health care services - Proportion of pregnant women presenting with criteria considered high-risk for VHT at delivery - Proportion of mothers virally suppressed at week 14 post-partum - Proportion and rate of post-partum mothers newly fulfilling high-risk criteria based on socio-behavioural criteria (i.e., adherence issues) - Characteristics of transmitted viral strains (lineages, subtypes, resistance mutations) among HIV-positive infants and in comparison to their mothers viral sequences - Proportion of HIV-positive infants who develop acquired drug resistance mutations during the study - Characteristics of infant and maternal HIV strains to be neutralized against a panel of known broadly neutralizing antibody candidates (e.g., VRC07, 10-1074) and maternal autologous antibodies at time of transmission - Average public healthcare and healthcare-related expenditures - Average health worker time needed to care for mothers and infants per clinic visit, including for enhanced counselling sessions - Cost per HIV-exposed infant fulfilling the primary outcome - Empirical cost-effectiveness (incremental cost-effectiveness ratio) relating intervention costs to life-years saved among HIV-positive infants - Average global and dimensional patient satisfaction ### Location - Facility: Centro de Investigacao Operacional de Beira (CIOB), Instituto Nacional de Saúde (INS), Ministério da Saúde,, Beira, N/A, N/A, Mozambique @@
## Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus - NCT ID: NCT06267495 - Study ID: EOCXLFE - Status: COMPLETED - Start Date: 2017-01-01 - Completion Date: 2024-01-31 - Lead Sponsor: Assiut University ### Study Description Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists.The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only. ### Conditions - Keratoconus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Epithelium-on corneal cross-linking (epi-on CXL) ### Outcomes Primary Outcomes - Steep keratometry value - Maximum keratometry value Secondary Outcomes - Corrected distance visual acuity ### Location - Facility: Tiba Eye Center, Assiut, N/A, 71516, Egypt @@
## Using ROSA for Challenging The TKA Standard of Care - NCT ID: NCT06267482 - Study ID: 122311 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2025-06 - Lead Sponsor: Lawson Health Research Institute ### Study Description This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.1. Standard of care medial parapetallar approach (Control)2. ROSA PSA medial parapetallar approach3. ROSA PSA medial subvastus approach Participants will be followed for 1 year post surgery with a combination of perioperative parameters, imaging, patient reported outcomes, functional outcomes, blood and tissue sampling for inflammatory information and activity levels. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - ROSA PSA Parapatellar Approach - ROSA PSA Subvastus Approach ### Outcomes Primary Outcomes - Functional Outcome - Weight-bearing CT scan - Functional Outcome - 3D Ultrasound - Functional Outcome - Timed Up and Go test - Patient health status - Knee Society Score - Patient health status - EuroQuol Survey - Patient health status - Knee Injury and Osteoarthritis Outcome Score - Patient health status - Western Ontario and McMaster Universities Arthritis Index - Patient health status - Global Assessment Secondary Outcomes - Health Ecominics ### Location - Facility: University Hospital, London, Ontario, N/A, Canada @@
## Boutonniere Deformity Effectiveness of Thermoplastic and Fabricated Orthoses - NCT ID: NCT06267469 - Study ID: Boutonniere deformity - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2024-09-30 - Lead Sponsor: Magdalena Kolasińska ### Study Description The goal of this study is to present the author's thumb orthosis with a butonier deformity and its effect on hand function, strength, dexterity and pain levels in relation to patients wearing factory-made orthopedic supplies. It is planned to include about 60 people in the study (30 people each in the group with thermoplastic orthoses and 30 participants with factory-made orthoses)The main questions it aims to answer are:1. How much improvement in dexterity will the patient wearing the orthosis get? 2. By how much will the grip strength of the whole hand and pincer grip strength improve with the orthosis? 3. How will wearing the orthosis affect the pain associated with the disease? Participants will1. measurement of grip strength of the right and left hands with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the appointed times.2. measurement of pincer grip strength with a dynamometer in an orthosis and without an orthosis, at the time of the test conducted and at the designated times.4. completion of the DASH questionnaire 6. assessment of the NRS pain scale in relation to the period of 6 months before the start of the study 7. Likert scale - evaluation of satisfaction with the use of the orthosis 8. the Kapandji scale Researchers will compare patients with thermoplastic orthosis and patients with fabric orthosis to see which is more functional. ### Conditions - Orthotic Devices ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Thermoplastic orthosis ### Outcomes Primary Outcomes - Grip strength - DASH -Disabilities of the Arm, Shoulder and Hand - Likert scale - Kapandji score - NRS - Numerical Rating Scale - pinch strength Secondary Outcomes ### Location - Facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher, Warsaw, Mazowieckie, 02-637, Poland @@
## The Reliability of ULRT in Overhead Athletes and Its Relationship With Selected UEPT - NCT ID: NCT06267456 - Study ID: HÜ- FTR- BD- 01 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-01-10 - Lead Sponsor: Hacettepe University ### Study Description Upper Extremity Rotation Test is a new test the evaluates 90-90 position, which is one of the requirements for overhead throwing. The aim of the study was to evaluate the reliability of the Upper Extremity Rotation Test in overhead athletes and the relationship between the Closed Chain Upper Extremity Stability Test and the Upper Quarter Y Balance Test. ### Conditions - Upper Limb Asymmetry ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: DIAGNOSTIC ### Interventions - Upper Limb Rotation Test - Closed Kinetic Chain Upper Extremity Stability Test - Upper Quarter Y Balance Test ### Outcomes Primary Outcomes - The reliability of Upper Extremity Rotation Test Secondary Outcomes - The Relationship Assessment of the Upper Extremity Rotation Test ### Location - Facility: Birgül Dıngırdan, Kocaeli, İzmit, N/A, Turkey @@
## Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries - NCT ID: NCT06267443 - Study ID: 2023/337 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-01 - Lead Sponsor: TC Erciyes University ### Study Description Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas. ### Conditions - Postoperative Pain - Postoperative Atelectasis - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Comparison of erector spina plane block, parasternal block plus local infiltration to the tube sides for postoperative analgesia ### Outcomes Primary Outcomes - postoperative analgesia - postoperative atelectasia Secondary Outcomes - postoperative mechanical ventilation duration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With a Severe CHD - NCT ID: NCT06267430 - Study ID: NL85141.078.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-04-30 - Lead Sponsor: Erasmus Medical Center ### Study Description Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome. ### Conditions - Congenital Heart Disease - Executive Dysfunction - Attention Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Kleuter Extra training program ### Outcomes Primary Outcomes - Kleuter Extra test battery Secondary Outcomes - EF functioning - Information processing - Executive functioning in daily life - completed by the parent(s) - Behavioral and emotional difficulties of the child - completed by the parent(s) - Quality of the child's life - completed by the parent(s) - Emotional distress parent - completed by the parent(s) - Parental trauma - Parenting behavior and quality parent-child relationship - completed by the parent(s) - Child demographics teacher's perspective - Behavioral and emotional difficulties teacher's perspective - Executive functioning child in daily life teacher's perspective ### Location - Facility: University Medical Center - Beatrix children's hospital Groningen, Groningen, N/A, 9713GZ, Netherlands @@
## Laser Therapy Effect as Preventive Measure for Oral Mucositis in Children With Hematological Malignancies - NCT ID: NCT06267417 - Study ID: CCHE-AML-4/2023 - Status: RECRUITING - Start Date: 2023-04-10 - Completion Date: 2024-12-31 - Lead Sponsor: Children's Cancer Hospital Egypt 57357 ### Study Description Introduction:Among the most drastic complications of chemotherapy is oral mucositis(OM). It is a painful inflammatory, often ulcerative condition and may increase risk for systemic infections leading to prolonged hospital stays and interruptions of treatment protocol. Many treatment modalities have been introduced for the prevention and treatment of oral mucositis , of which low level laser therapy(LLLT) is gaining popularity. The use of LLLT as a prophylactic treatment for chemotherapy induced oral mucositis in pediatric cancer patients is still lacking robust evidence. Also, the parameters used have not been optimized and no standard method has yet been established. Based on this point, this study will compare photobiomodulation to the conventional preventive program of oral mucositis applied in 57357 children's cancer hospital foundation to determine which will be optimal for the prophylaxis of chemotherapy-induced OM.Aim:To assess the effectiveness of low level laser therapy in the prophylaxis of oral mucositis in pediatric patients diagnosed with Hematological cancers.Methods:This study is a randomized, prospective, double-blinded trial that will include acute Myeloid leukemia patients admitted to receive chemotherapy cycle between the age of 3 and 18years. These patients will be randomized into two groups: group 1 will receive low level laser therapy and group 2 will receive mock treatment. Patient will be followed to asses the development of oral mucositis on prespecified time points. ### Conditions - Oral Mucositis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Laser therapy - Mock treatment ### Outcomes Primary Outcomes - To measure incidence of oral mucositis in Laser arm versus Placebo arm. - To measure grade of oral mucositis in patients receiving laser arm placebo arm. Secondary Outcomes ### Location - Facility: Children Cancer Hospital 57357, Cairo, N/A, 11617, Egypt @@
## Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain. - NCT ID: NCT06267404 - Study ID: IShamsi - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-02-25 - Lead Sponsor: University of Karachi ### Study Description Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability ### Conditions - Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Iliopsoas Positional release therapy - Conventional exercises ### Outcomes Primary Outcomes - VAS Visual Analogue Scale VAS Visual Analogue Scale - Modified Schober's test Secondary Outcomes - Roland-Morris Disability Questionnaire ### Location - Facility: Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Sindh, N/A, Pakistan @@
## Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes - NCT ID: NCT06267391 - Study ID: 898 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-01 - Lead Sponsor: Endogenex, Inc. ### Study Description This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications. ### Conditions - Type 2 Diabetes Mellitus - Type2diabetes - Diabetes Mellitus, Type 2 - Diabetes - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ReCET Treatment - Sham Procedure ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - HbA1c - HbA1c ≤7.0% without requiring rescue medication - Time-in Range (TIR) - Total body weight loss (%TBWL) - Incidence of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery - NCT ID: NCT06267378 - Study ID: 1174/2022/NCTS - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2029-12-01 - Lead Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust ### Study Description The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future. ### Conditions - Bowel Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Frailty measure ### Outcomes Primary Outcomes - The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events - The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events - The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events Secondary Outcomes - Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events) - Adverse events related to surgery assessed CTCAE classifications - Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events) - Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events) - Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0. - Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L - Overall survival at 3 months and 5 years (the latter via cancer registry returns) ### Location - Facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, South Yorkshire, DN2 5LT, United Kingdom @@
## Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis - NCT ID: NCT06267365 - Study ID: 23-00766 - Status: RECRUITING - Start Date: 2023-11-27 - Completion Date: 2025-09-01 - Lead Sponsor: NYU Langone Health ### Study Description This is an observational prospective study to develop predictive biomarkers for pain response in participants with chronic pancreatitis scheduled for endoscopic therapy. Participants will undergo baseline assessments including electroencephalography (EEG), quantitative sensory testing (QST), and psychosocial questionnaires. Response to endoscopic therapy will be assessed at approximately 3, 6, 12 and 18 months post-procedure using questionnaires. ### Conditions - Chronic Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change from Baseline in Brief Pain Inventory (BPI) Score at Month 3 Post-Operation Secondary Outcomes - Change from Baseline in BPI Score at Month 6 Post-Operation - Change from Baseline in BPI Score at Month 12 Post-Operation - Change from Baseline in BPI Score at Month 18 Post-Operation - Change from Baseline in Patient Reported Outcome System (PROMIS) - Physical Function - Short Form 6b Score at Month 3 Post-Operation - Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 6 Post-Operation - Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 12 Post-Operation - Change from Baseline in PROMIS - Physical Function - Short Form 6b Score at Month 18 Post-Operation - Number of Participants who use Opioids at Baseline - Number of Participants who use Opioids at Month 3 - Number of Participants who use Opioids at Month 6 - Number of Participants who use Opioids at Month 12 - Number of Participants who use Opioids at Month 18 - Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 3 Post-Procedure - Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 6 Post-Procedure - Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 12 Post-Procedure - Change from Baseline in PROMIS - Depression - Short Form 4a Score at Month 18 Post-Procedure - Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 3 Post-Procedure - Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 6 Post-Procedure - Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 12 Post-Procedure - Change from Baseline in PROMIS - Anxiety- Short Form 4a Score at Month 18 Post-Procedure - Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 3 Post-Procedure - Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 6 Post-Procedure - Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 12 Post-Procedure - Change from Baseline in PROMIS - Neuropathic Pain Quality 5a Score at Month 18 Post-Procedure - Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 3 Post-Procedure - Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 6 Post-Procedure - Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 12 Post-Procedure - Change from Baseline in PROMIS - Sleep Disturbance - Short Form 6a Score at Month 18 Post-Procedure - Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 3 Post-Procedure - Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 6 Post-Procedure - Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 12 Post-Procedure - Change from Baseline in PROMIS - Fatigue - Short Form 6a Score at Month 18 Post-Procedure - Change from Baseline in Pain Catastrophizing Scale (PCS) Score at Month 3 Post-Procedure - Change from Baseline in PCS Score at Month 6 Post-Procedure - Change from Baseline in PCS Score at Month 12 Post-Procedure - Change from Baseline in PCS Score at Month 18 Post-Procedure - Change from Baseline in Sleep Duration at Month 3 Post-Procedure - Change from Baseline in Sleep Duration at Month 6 Post-Procedure - Change from Baseline in Sleep Duration at Month 12 Post-Procedure - Change from Baseline in Sleep Duration at Month 18 Post-Procedure - Change from Baseline in Tobacco, Alcohol, Prescription medications, and other Substance (TAPS) Score at Month 3 Post-Procedure - Change from Baseline in TAPS Score at Month 6 Post-Procedure - Change from Baseline in TAPS Score at Month 12 Post-Procedure - Change from Baseline in TAPS Score at Month 18 Post-Procedure - Change from Baseline in Patient Global Impression of Change (PGIC) Score at Month 3 Post-Procedure - Change from Baseline in PGIC Score at Month 6 Post-Procedure - Change from Baseline in PGIC Score at Month 12 Post-Procedure - Change from Baseline in PGIC Score at Month 18 Post-Procedure - Change from Baseline in Patient Health Questionnaire-2 (PHQ-2) Score at Month 3 Post-Procedure - Change from Baseline in PHQ-2 Score at Month 6 Post-Procedure - Change from Baseline in PHQ-2 Score at Month 12 Post-Procedure - Change from Baseline in PHQ-2 Score at Month 18 Post-Procedure - Change from Baseline in Generalized Anxiety Disorder 2 (GAD-2) Score at Month 3 Post-Procedure - Change from Baseline in GAD-2 Score at Month 6 Post-Procedure - Change from Baseline in GAD-2 Score at Month 12 Post-Procedure - Change from Baseline in GAD-2 Score at Month 18 Post-Procedure - Change from Baseline in Pain, Enjoyment of Life and General Activity (PEG) Scale at Month 3 Post-Procedure - Change from Baseline in PEG Scale at Month 6 Post-Procedure - Change from Baseline in PEG Scale at Month 12 Post-Procedure - Change from Baseline in PEG Scale at Month 18 Post-Procedure ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Epidemiology and Genomic Surveillance of Staphylococcus Aureus in ICU Neonatology - NCT ID: NCT06267352 - Study ID: 230097 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: University Hospital, Caen ### Study Description Newborns hospitalized in Neonatology are particularly vulnerable to infections, in particular healthcare associated infection (HAI). Staphylococcus aureus represents the 2nd microorganism responsible for sepsis, this infection is particularly serious and like any HAI, it increases the length of hospitalization of newborns and neonatal morbidity.In September 2020, the CDC published recommendations for the prevention and control of Staphylococcus aureus infections in neonatal intensive care unit/ICU. They specify the indications for implementing a MSSA surveillance strategy as well as the screening and management methods.Despite the absence of a defined strategy at the national level, our establishment chose to initiate management measures several years ago following serious infections and MSSA epidemics in neonatal intensive care unit/ICU.With the aim of improving the efficiency of care and evaluating the strategy chosen at the establishment, it is necessary to describing* the epidemiology of MSSA carriage and infections* cross-transmission of MSSA strains between patients* the success rate of decolonization* the sensitivity of detection of digestive carriage by stool swabbing in order to limit the number of samples from newborns. ### Conditions - the Aim of This Study is to Describe Genomic Epidemiology of MSSA in Neonatal ICU ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - frequency of MSSA cross transmission as assessed by WGS Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents - NCT ID: NCT06267339 - Study ID: TD_tRNS - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-08-31 - Lead Sponsor: Burke Medical Research Institute ### Study Description The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation. ### Conditions - Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - transcranial random noise stimulation - Sham stimulation ### Outcomes Primary Outcomes - Change in Grasp score - Change in Reach score Secondary Outcomes - Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP) - Change in score on second reaching task ### Location - Facility: Burke Neurological Institute, White Plains, New York, 10605, United States @@
## World Health Organization (WHO) , COVID19 Case Series of Post Covid 19 Rhino Orbito Cerebral Mucormycosis in Egypt - NCT ID: NCT06267326 - Study ID: Nasser institute - Status: COMPLETED - Start Date: 2021-05-23 - Completion Date: 2023-08-21 - Lead Sponsor: Nasser Institute For Research and Treatment ### Study Description Objectives: identify and recognize clinical Characteristics, Pathophysiology, and management of a group of patients with rhino Rhino-Orbito-Cerebral Mucormycosis infection associated with Covid 19 viral infection ### Conditions - Mucormycosis; Rhinocerebral (Etiology) - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - debridment ### Outcomes Primary Outcomes - 35 patients suffering from mucormycosis infection post covid 19 - 25 patients were cured with comorbidity and 10 pateints died - pain Secondary Outcomes - Visual Analog Score for pain ### Location - Facility: Omar Elmonofy, Cairo, N/A, N/A, Egypt @@
## Attention Training for COVID-19 Related Distress - NCT ID: NCT06267313 - Study ID: 2023-078-PAU - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2027-02-19 - Lead Sponsor: Palo Alto University ### Study Description The study aims to test whether attention training (attention bias modification or attention control training) reduces distress or COVID-19 related anxiety compared to a neutral condition. ### Conditions - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Attention Bias Modification - Attention Control Training - Neutral training ### Outcomes Primary Outcomes - COVID-19 Anxiety Syndrome Scale - COVID-19 Anxiety Syndrome Scale - COVID-19 Anxiety Syndrome Scale - COVID-19 Anxiety Syndrome Scale Secondary Outcomes ### Location - Facility: Palo Alto University, Palo Alto, California, 94304, United States @@
## Treatment of Post-COVID-19 With Hyperbaric Oxygen Therapy: a Randomized, Controlled Trial - NCT ID: NCT06267300 - Study ID: N/A - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2026-04-01 - Lead Sponsor: Erasmus Medical Center ### Study Description The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action.The main questions it aims to answer are:* What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID?* What are the changes in absence from work after treatment with HBOT?* What is the cost-effectiveness of treatment with HBOT?* What are possible mechanisms of action of HBOT?Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months. ### Conditions - Post-COVID-19 Syndrome - Post-COVID Syndrome - Post COVID-19 Condition - Post-COVID Condition - Post COVID-19 Condition, Unspecified - Long COVID - Long Covid19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Hyperbaric oxygen ### Outcomes Primary Outcomes - Physical and mental component scores of the 36-item Short Form Survey (SF-36) Secondary Outcomes - Euroqol-5D (EQ-5D) - Activity tracking (through wrist band), monitoring heart rate, step count and sleep patterns - Biochemical parameters - Absence from work - Cost-effectiveness ### Location - Facility: Da Vinci Clinic, Amersfoort, N/A, N/A, Netherlands @@
## Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period - NCT ID: NCT06267287 - Study ID: 2023-4 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty ### Study Description Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods. ### Conditions - Joint Infection - Periprosthetic Left Knee Joint Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Microbiological examination of the patient's biological material and determination of antibiotic resistance ### Outcomes Primary Outcomes - Structure of isolated pathogens of periprosthetic infection - Structure of isolated pathogens of periprosthetic infection Secondary Outcomes - Antibiotic resistance of isolated pathogens of periprosthetic infection - Antibiotic resistance of isolated pathogens of periprosthetic infection ### Location - Facility: Federal Center for Traumatology, Orthopedics and Endoprosthetics, Cheboksary, Chuvashia, 429500, Russian Federation @@
## A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes - NCT ID: NCT06267274 - Study ID: MW230021 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Amneal Pharmaceuticals, LLC ### Study Description A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study ### Conditions - Open-angle Glaucoma - Ocular Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bimatoprost Ophthalmic Solution, 0.01% - LUMIGAN® (bimatoprost ophthalmic solution) 0.01% ### Outcomes Primary Outcomes - Primary Endpoint Secondary Outcomes - Secondary Endpoint ### Location - Facility: West Coast Eye Institute, Bakersfield, California, 93308, United States @@
## Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber - NCT ID: NCT06267261 - Study ID: KOL-001 - Status: COMPLETED - Start Date: 2021-06-07 - Completion Date: 2021-10-25 - Lead Sponsor: Alyatec ### Study Description There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs. ### Conditions - Allergic Asthma - Allergic Rhinitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - KOLMI® surgical face mask (OP-Air) ### Outcomes Primary Outcomes - Time to early asthma response (EAR) Secondary Outcomes - Frequency of EAR and late asthma response (LAR) - Severity of EAR and LAR - Nasal Symptoms ### Location - Facility: ALYATEC, Strasbourg, N/A, N/A, France @@
## Spine Registration Using 3D-Scanning - NCT ID: NCT06267248 - Study ID: T05100 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02 - Completion Date: 2024-11 - Lead Sponsor: Advanced Scanners Inc. ### Study Description The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period. ### Conditions - Spine Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Optical 3D Scanner ### Outcomes Primary Outcomes - Spine Registration Secondary Outcomes - Vertebral Shift Measurement - Determination Of Bony Exposure Requirements ### Location - Facility: Mass General Bringham, Hale Building for Transformative Medicine, Boston, Massachusetts, 02115, United States @@
## Dietary Protein Restriction and Health - NCT ID: NCT06267235 - Study ID: lowprotein - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2024-01-31 - Lead Sponsor: University of Copenhagen ### Study Description The incidence of type 2 diabetes worldwide has increased significantly over the past decades, which is associated with changing dietary habits and physical inactivity. According to the diet, so far there has been a great focus on the quality of carbohydrates and fat in relation to metabolic health, while the importance of protein has been neglected. The Danes' average protein intake is 1.5 g/kg/day, which is at the high end of the recommendations (0.8-1.5 g/kg/day) from the Nordic Nutrition Recommendations (NNR 2023). Recent studies in rodents have shown that protein restriction has positive effects on health, including improved glucose and insulin homeostasis and reduced fat mass, while a high intake of protein has a negative effect on insulin sensitivity. Previously the investigators have shown, in healthy young men, that consuming a diet low in protein (0.9 g/kg/day), compared to the participants usual diet (1.5 g/kg/day), over 7 days, resulted in an increased insulin sensitivity as well as a marked increase in the plasma fibroblast growth factor 21 (FGF21) concentration. The increased insulin sensitivity is thought to be mediated by the increase in plasma FGF21 concentration. However, the effect is not yet fully understood. It is also not clear whether the increase in plasma FGF21 concentration, as well as the mentioned metabolic effects on insulin and glucose homeostasis, will take place if the participants are kept weight stable on a eucaloric diet. ### Conditions - Protein - Healthy - Diet ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary protein restriction ### Outcomes Primary Outcomes - Energy balance - Insulin sensitivity Secondary Outcomes - Adipose tissue proteomics - Plasma FGF21 ### Location - Facility: University of Copenhagen, Copenhagen, N/A, 2100, Denmark @@
## Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia - NCT ID: NCT06267222 - Study ID: SCATDCS23 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-04 - Completion Date: 2024-07-31 - Lead Sponsor: Laura Alice Santos Oliveira ### Study Description The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are:* If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol.* If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions. * Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges. * Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6). ### Conditions - SCA - Postural Balance - Gait Ataxia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TRANSCRANIAL DIRECT CURRENT STIMULATION + exercises ### Outcomes Primary Outcomes - Postural control - Mobility - Gait performance Secondary Outcomes - The subjective experience of the participants regarding the protocol. ### Location - Facility: Anna Fontes Baptista, Rio de Janeiro, RJ, 21032-060, Brazil @@
## Conditioned Pain Modulation in Patients With Hemophilia - NCT ID: NCT06267209 - Study ID: He-Modulation - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-04-20 - Lead Sponsor: Investigación en Hemofilia y Fisioterapia ### Study Description Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables ### Conditions - Hemophilia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational group ### Outcomes Primary Outcomes - Assess the Conditioned Pain Modulation Index Secondary Outcomes - Assess the kinesiophobia with Tampa Scale of Kinesiophofia - Assess the catastrophizing with Pain catastrophizing scale - Assess the catastrophizing with State-Trait Anxiety Inventory - Assess the joint damage with Haemophilia Joint Health Score - Assess the joint pain with visual analog scale - Assess the pressure pain threshold with pressure algometer - Assess the functional capacity with the 6-Minute Walking test ### Location - Facility: University of Oviedo, Oviedo, Asturias, 33006, Spain @@
## The Effect of the Stress Ball Used During Spinal Anesthesia on Pain and Anxiety - NCT ID: NCT06267196 - Study ID: CemilTascıogluERHO-AYAN - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2024-03-15 - Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization ### Study Description The aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels ### Conditions - Pain - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - The use of a stress ball ### Outcomes Primary Outcomes - stress ball and anxiety - stress ball and pain Secondary Outcomes - Stress ball and blood pressure - Stress ball and pulse - Stress ball and saturation ### Location - Facility: Özge Sayın Ayan, Istanbul, Eyup, 34065, Turkey @@
## A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers. - NCT ID: NCT06267183 - Study ID: SV001-101 - Status: RECRUITING - Start Date: 2024-01-12 - Completion Date: 2025-03-30 - Lead Sponsor: Shanghai Synvida Biotechnology Co.,Ltd. ### Study Description The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers. ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SV001 - Placebo ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events Secondary Outcomes - Peak Plasma Concentration (Cmax) - Peak time（Tmax） - Area under the plasma concentration versus time curve (AUC) - half-life（T1/2） - Immunogenicity ### Location - Facility: Shanghai Xuhui District Central Hospital, Shanghai, N/A, N/A, China @@
## A Multicenter, Real-world Study of Adebrelimab in the Treatment of Extensive Stage Small Cell Lung Cancer - NCT ID: NCT06267170 - Study ID: SCLC-RWS-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2026-02-25 - Lead Sponsor: Henan Cancer Hospital ### Study Description This study collected data on patients with extensive stage small cell lung cancer treated with Adebrelimab to investigate its safety and efficacy ### Conditions - SCLC,Extensive Stage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Adebrelimab ### Outcomes Primary Outcomes - Safety (Occurrence of ≥ Grade 3 AE) Secondary Outcomes - PFS - ORR - OS - DCR ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Breastfeeding Consultant Training in the Metvaverse Universe - NCT ID: NCT06267157 - Study ID: 2023/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-02 - Lead Sponsor: Gulhane School of Medicine ### Study Description Although breastfeeding is an important and natural process in infant development, mothers may fail to manage the process. Nurses, who have an important place in helping to physically initiate and maintain breastfeeding, provide an in-depth knowledge of breast anatomy and breastfeeding physiology, practice and process breastfeeding techniques. Must have extensive management skills. Although the World Health Organization recommends that breastfeeding issues should be addressed in medical, nursing and midwifery schools, there is a lack of nurses' training curricula and breastfeeding training given in hospitals. Due to this deficiency, mothers have low self-confidence and insufficient knowledge about breastfeeding.The aim of this project is to develop a breastfeeding counseling model in the metaverse universe and to determine the effect of this model on nursing students' breastfeeding counseling skills, knowledge level and empathy skills. Giving breastfeeding education with the metaverse application compared to the application on real patients includes much less risk for the patient and the ability to practice until the right skill is acquired. In the project, it is expected that the breastfeeding counseling education model (LactaVerse), which is structured on virtual reality developed in the metaverse universe, is compared to the existing deficient and non-standardized breastfeeding education practice, enabling nurses to practice more and without errors during the undergraduate education, and to gain more effective skills in breastfeeding counseling. In this context, the project will support the ability of multiple users in the metaverse universe to examine the anatomy of the breast and apply breastfeeding counseling to the mother by transmitting their voices and movements with virtual glasses.In the preparation phase of the training to be developed in the virtual universe within the scope of the project, the breast anatomical modeling and the breastfeeding mother-baby duo project scenario will be developed and virtual glasses will be transferred. At this stage, expert opinions of the questionnaires to be used in the evaluation of educational effectiveness will be taken. Pre-application of data collection tools and LactaVerse training will be made. Experiment (n=40) and control (n=40) groups will be determined from the students by randomization. "Descriptive Characteristics Data Collection Form", "Breastfeeding Information Form", "Basic Empathy Level Scale", "Nursing Counseling Skill Scale" and "Presence Scale" will be applied to both groups. During the application phase, Lactaverse training method with virtual glasses will be applied to the experimental group, and a 2-hour theoretical classical training method will be applied to the control group. After 4 weeks of the training, the post-tests will be applied to the experimental group and the control group and they counseling will be given to the patient who plays the role of a nursing mother in the laboratory, and measurements will be made with the Breastfeeding Counseling Skill List and statistical analyzes will be applied.With the training developed in connection with the project, it is expected that nurses will have a high level of empathy development and breastfeeding counseling skills in a complex healthcare environment such as breastfeeding counseling before they graduate. In this way, the professional knowledge, counseling skills and empathy skills of nurses, who have an important role in breastfeeding, will increase, helping our society to increase the breastfeeding rates to the desired level. ### Conditions - Breast Feeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - virtual reality training - theoretical breastfeeding training ### Outcomes Primary Outcomes - Introductory Features Data Collection Form - Breastfeeding Information Form - Basic Empathy Level Scale - Breastfeeding Teaching Skill Evaluation Form - Presence Scale Secondary Outcomes ### Location - Facility: Gulhane Faculty of Nursing, Ankara, N/A, N/A, Turkey @@
## Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer - NCT ID: NCT06267144 - Study ID: 23K237-001 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2025-12-17 - Lead Sponsor: The First Hospital of Jilin University ### Study Description Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sintilimab plus chemotherapy ### Outcomes Primary Outcomes - Event free survival(EFS) Secondary Outcomes - Overall Survival (OS) - Objective Response Rate (ORR) - Disease-Control Rate (DCR) - Pathological complete response rate（PCR） - Major pathological response rate (MPR) ### Location - Facility: The First Hospital Of Jilin University, Changchun, Jilin, 130000, China @@
## Transcutaneous Pulse Oximetry Brain Monitoring Study (US) - NCT ID: NCT06267131 - Study ID: IRB 22-1286 - Status: RECRUITING - Start Date: 2023-10-27 - Completion Date: 2024-11 - Lead Sponsor: Cyban Pty Ltd ### Study Description This is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. The purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain. ### Conditions - Acute Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Brain Pulse Oximeter ### Outcomes Primary Outcomes - Agreement of the brain oximeter levels compared with invasive ICP levels Secondary Outcomes - Optical signal changes associated with periods of brain hypoxia and surrogate ICP waveform - Optical signal changes associated with non-convulsive seizures via EEG monitoring (Alpha, Beta, Theta) ### Location - Facility: Cleveland Clinic, Neurological Institute, Cleveland, Ohio, 44195, United States @@
## Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis - NCT ID: NCT06267118 - Study ID: Treatment of Bronchiolitis - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-05-31 - Lead Sponsor: Combined Military Hospital, Pakistan ### Study Description The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis2. Length of Hospitalization ### Conditions - Acute Bronchiolitis Due to Respiratory Syncytial Virus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hypertonic Saline Solution, 1 Ml - Adrenaline ### Outcomes Primary Outcomes - Wood-Downes-Ferres clinical score calculation Secondary Outcomes - total length of hospitalization ### Location - Facility: Combined Military Hospital, Nowshera, KPK, 24110, Pakistan @@
## A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin. - NCT ID: NCT06267105 - Study ID: A1-LORT - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-03 - Lead Sponsor: Corporacion Parc Tauli ### Study Description Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery. ### Conditions - Functional Disturbance as Result ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Longitudinal incision - Transverse incision ### Outcomes Primary Outcomes - Functional improvement of the patient after surgery Secondary Outcomes - Surgeon comfort - Resolution - Flushed - Pain feeling - Contracture - Infection - Nerve injury - Return to work - Reincorporation to activities - Sensitivity Test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of How CagriSema Works on Appetite in People With Excess Body Weight - NCT ID: NCT06267092 - Study ID: NN9838-4944 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-01-19 - Lead Sponsor: Novo Nordisk A/S ### Study Description Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months.Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine. ### Conditions - Overweight - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - No treatment given - Cagrilintide and Semaglutide - Placebo ### Outcomes Primary Outcomes - Change in mean postprandial appetite score based on visual analogue scale (VAS) Secondary Outcomes - Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption - Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score - Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score - Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score - Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas - Relative change in total energy intake during ad libitum lunch, evening meal and snackbox - Change in percent energy intake of high fat, sweet food in total ad libitum energy intake in the evening snack box - Change in total energy intake during ad libitum lunch, evening meal and snackbox - Change in total amount of food consumed during ad libitum lunch, evening meal and snackbox - Change in body weight ### Location - Facility: Charité Research Organisation GmbH, Berlin, N/A, 10117, Germany @@
## Core Stability, Symmetrical Weight-bearing Stroke - NCT ID: NCT06267079 - Study ID: core stability - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-01-01 - Lead Sponsor: Cairo University ### Study Description To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients? ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - core stability exercise ### Outcomes Primary Outcomes - Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales - Each patient was assessed by Digital weight scale pre treatment and repeated Measurements were taken after treatment. Secondary Outcomes ### Location - Facility: faculty of physical therapy Cairo university, Cairo, N/A, N/A, Egypt @@
## Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus - NCT ID: NCT06267066 - Study ID: MD-232-2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-30 - Lead Sponsor: Cairo University ### Study Description The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.Participants will:* Be assessed clinically by doctor* Biopsies will be taken from them by doctor* Receive treatment as laser or topical steroids or both* Fill in depression questionnaire.Researchers will divide and compare groups as follows:Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.* Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.* Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.* Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.to see if:1. Pruritus severity scale.2. Scaling, erythema, lichenification excoriation scores3. Visual analogue scale.4. Investigator's Global Assessment.5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)6. Depressionimprove more in which group of patients after treatment. ### Conditions - Lichen Simplex Chronicus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Betamethasone Valerate 0.1% Cream - SmartXide® fractional carbon dioxide laser - Vaseline Topical Product ### Outcomes Primary Outcomes - Comparison between 2 groups regarding change in Pruritus severity scale - Comparison between 2 groups regarding change in Visual analogue scale - Comparison between 2 groups regarding change in Investigator's Global Assessment. - Comparison between 2 groups regarding change in Scaling score - Comparison between 2 groups regarding change in Erythema score - Comparison between 2 groups regarding change in Lichenification score - Comparison between 2 groups regarding change in Excoriation score Secondary Outcomes - change of depression score in both groups. - change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups - Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls ### Location - Facility: Lobna Alieldin, Cairo, N/A, 11562, Egypt @@
## Relationship Between Vitamins and Radiologic Stage in Knee Osteoarthritis - NCT ID: NCT06267053 - Study ID: 2023/469 - Status: COMPLETED - Start Date: 2023-12-01 - Completion Date: 2024-01-20 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description The aim of this study is to investigate the relationship between folic acid, vitamin B12 and 25-OH vitamin D levels and radiographic staging in patients diagnosed with primary gonarthrosis. ### Conditions - Knee Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Direct digital radiography - 25-OH Vitamin D - Vitamin B12 - Folic acid ### Outcomes Primary Outcomes - 25-OH Vitamin D (25(OH)D) and Kellgren Lawrence Grade - Vitamin B12 and Kellgren Lawrence Grade - Folic acid and Kellgren Lawrence Grade Secondary Outcomes ### Location - Facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital, Istanbul, N/A, N/A, Turkey @@
## Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS) - NCT ID: NCT06267040 - Study ID: 17 Al-KindyCM - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-04-30 - Lead Sponsor: Al-Kindy College of Medicine ### Study Description The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis.The main questions it aims to answer are:* Do the questions of the Arabic-ACSS have sufficient clarity?* Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician.Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract. ### Conditions - Cystitis Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Linguistic validity - Clinical reliability Secondary Outcomes ### Location - Facility: Al-Elwiya Maternity Teaching Hospital, Baghdad, N/A, 10064, Iraq @@
## Comparison of Different Physical Therapy Modalities in Lateral Epicondylitis - NCT ID: NCT06267027 - Study ID: 2022/125 - Status: COMPLETED - Start Date: 2023-02-07 - Completion Date: 2023-12-15 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study ### Conditions - Lateral Epicondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Kinesiotaping - High intensity laser therapy ### Outcomes Primary Outcomes - Patient Rated Tennis Elbow Evaluation (PRTEE) Secondary Outcomes - Visual Analogue Scale (VAS) - Quick Disabilities of the Arm, Shoulder and Hand (qDASH) - Jamar's handheld dynamometer ### Location - Facility: BakirkoySadiKonuk, Bakırköy, İstanbul, 34147, Turkey @@
## Use of a Virtual Reality Cognitive Stimulation Programme for Breast Cancer Patients Wishing to Restart or Maintain a Professional Activity - NCT ID: NCT06267014 - Study ID: 2023-A02163-42 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Centre Francois Baclesse ### Study Description The study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation.Patients will follow the Virtual Reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks. ### Conditions - Breast Cancer - Cancer-related Cognitive Difficulties ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality sessions ### Outcomes Primary Outcomes - Proportion of patients adhering to the Virtual Reality program Secondary Outcomes ### Location - Facility: Centre François Baclesse, Caen, N/A, N/A, France @@
## A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy - NCT ID: NCT06267001 - Study ID: GO45006 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2039-06-30 - Lead Sponsor: Hoffmann-La Roche ### Study Description The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy. ### Conditions - Non-small Cell Lung Cancer (NSCLC) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atezolizumab - Tiragolumab - Placebo ### Outcomes Primary Outcomes - Disease-free Survival (DFS) Secondary Outcomes - Percentage of Participants With Adverse Events (AEs) - Overall Survival (OS) - DFS Rate - Percentage of Participants Who Maintained or Meaningfully Improved from Baseline in Patient-reported Role, Emotional, and Physical Functioning and Global Health Status (GHS)/Quality of Life (QoL) - Serum Concentration of Tiragolumab - Serum Concentration of Atezolizumab - Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab - Percentage of Participants With ADAs to Atezolizumab ### Location - Facility: The Oncology Institute of Hope and Innovation; Cerritos, Cerritos, California, 90703, United States @@
## A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions - NCT ID: NCT06266988 - Study ID: SCVL-TFZ-1010 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-08 - Lead Sponsor: Viatris Inc. ### Study Description Primary objective is to is to evaluate the bioequivalence of two formulations ### Conditions - Chronic Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Sacubitril and Valsartan Tablets 97mg/103mg - Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) ### Outcomes Primary Outcomes - Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software) - Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chronic Kidney Disease Patient in Chronic Myloied Leukemia - NCT ID: NCT06266975 - Study ID: CKD pts in CML - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-11 - Lead Sponsor: Sahar Mohammed Gad ### Study Description To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia . ### Conditions - Chronic Myeloid Leukemia in Remission ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biobsy from kidney ### Outcomes Primary Outcomes - Chronic Kidney Disease Patient in Chronic Myloied Leukemia Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome - NCT ID: NCT06266962 - Study ID: 3/24 - Status: COMPLETED - Start Date: 2020-07-01 - Completion Date: 2022-09-30 - Lead Sponsor: University Hospital Olomouc ### Study Description Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine. ### Conditions - Intraoperative Floppy Iris Syndrome - Cataract - Age-related Cataract - Adrenergic Receptor Antagonist Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 1% Atropine drops - Epinephrine ### Outcomes Primary Outcomes - Development of IFIS - Severity of IFIS - Incidence of intraoperative complications Secondary Outcomes ### Location - Facility: Department of Ophthalmology, University Hospital Olomouc, Olomouc, N/A, N/A, Czechia @@
## Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors - NCT ID: NCT06266949 - Study ID: 11362 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: University Medical Center Groningen ### Study Description The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour. ### Conditions - Pituitary Tumor - Visual Fields Hemianopsia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SONDA ### Outcomes Primary Outcomes - Convert validity - Test-retest reliability Secondary Outcomes - Experience ### Location - Facility: UMCG, Groningen, N/A, 9713 GZ, Netherlands @@
## Smart Life Smart Living Intercontinental - Medical Students' Cohort - NCT ID: NCT06266936 - Study ID: EssaiClinique_SL2i-MSC - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2044-12 - Lead Sponsor: University Hospital, Grenoble ### Study Description The question of the well-being, quality of life and mental health of care students is unanimously considered to be a central issue among young adults. According to the French Ministry of Higher Education and Research, there will be 194,752 care students in France in 2021-2022. The quality of life and well-being of health students can be affected at several levels. The first is mental health. In France, the mental health of these students has deteriorated considerably in recent years. According to a 2017 survey of 21,768 French medical students, 66% of them had an anxiety disorder and 27% a depressive syndrome. In addition, a number of risk factors have been identified for the mental health of health students.The aim of the study is to carry out a longitudinal evaluation of the mental health status of care students during their university studies in France through anxiety, depression and perceived stress. ### Conditions - Mental Health Issue - Student Burnout ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Synthetic score on standardized assessment scale of anxiety Secondary Outcomes - Synthetic score on standardized assessment scale of mental health - Synthetic score on standardized assessment scale of stress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors. - NCT ID: NCT06266923 - Study ID: SPH6516-101 - Status: COMPLETED - Start Date: 2022-01-20 - Completion Date: 2023-11-01 - Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd ### Study Description To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SPH6516 tablets ### Outcomes Primary Outcomes - MTD（Maximum tolerated dose） Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events - Peak Plasma Concentration (Cmax） - Peak time（Tmax） - Area under the plasma concentration versus time curve (AUC) - half-life（T1/2） - Objective response rate(ORR) - Progression-free survival (PFS) ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, N/A, N/A, China @@
## Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes - NCT ID: NCT06266910 - Study ID: 2023KYPJ320 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-10-10 - Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University ### Study Description This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Visual training video ### Outcomes Primary Outcomes - Accommodative facility - Vergence facility Secondary Outcomes - Negative and positive fusional vergence - Accommodative response - negative and positive relative accommodation - Near point of convergence - Accommodation amplitude - Electroencephalogram (EEG) node efficiency - Functional near-infrared spectroscopy (fNIRS) ### Location - Facility: Zhongshan Opthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, 510060, China @@
## A Study on the Correlation Between Endometriosis and Intra-tissue Microbiota - NCT ID: NCT06266897 - Study ID: ZhujiangEM - Status: RECRUITING - Start Date: 2023-06-18 - Completion Date: 2026-12 - Lead Sponsor: Zhujiang Hospital ### Study Description Endometriosis (EM) is a common gynecological condition, but the pathogenesis of it has not yet been clarified. Here, the investigators wanted to investigate the correlation between endometriosis and the intra-tissue microbiota. The investigators planed to collect serum, vaginal swabs, cervical mucus, feces, peritoneal fluid, and endometrial tissue for sequencing and experiments. ### Conditions - Endometriosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Metagenomics Next Generation Sequencing of the Intra-tissue Microbiota Composition Secondary Outcomes ### Location - Facility: Zhujiang Hospital, Guangzhou, Guangdong, 510280, China @@
## The Effect of Kangaroo Care on Father-Baby Attachment - NCT ID: NCT06266884 - Study ID: AgriIbrahimCecen - Status: COMPLETED - Start Date: 2022-12-15 - Completion Date: 2023-11-15 - Lead Sponsor: Agri Ibrahim Cecen University ### Study Description The aim of the research is to evaluate the attachment level of fathers who received kangaroo care training in the antenatal period and applied kangaroo care in the postpartum period to their babies in the first and fourth months.The research will be conducted in a randomized controlled experimental type with educational intervention. The research will be conducted at Islahiye State Hospital with 25 experimental and 25 control group fathers who meet the inclusion criteria. Fathers in the experimental group will be given kangaroo care training during the antenatal period and postpartum kangaroo care will be applied. No intervention will be made to the control group fathers. The Paternal-Infant Attachment Questionnaire (PPAQ) will be applied to fathers in both groups in the first and fourth months and the results will be compared. ### Conditions - Kangaroo Care - Attachment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Kangaroo care ### Outcomes Primary Outcomes - Fathers' Attachment Level Secondary Outcomes ### Location - Facility: Agri Ibrahim Cecen University, Agri, N/A, N/A, Turkey @@
## SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer - NCT ID: NCT06266871 - Study ID: WCH-2023-1625 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2026-07-30 - Lead Sponsor: West China Hospital ### Study Description Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SOX+Tislelizumab+LDRT ### Outcomes Primary Outcomes - pCR rate Secondary Outcomes - R0 resection rate - MPR rate - ORR - 2-year disease-free survival (DFS) rate - 2-year OS rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multimodality Imaging Assessment of the Severity of Mitral Regurgitation - NCT ID: NCT06266858 - Study ID: SYSKY-2022-407-02 - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2024-06-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description To investigate to assess the severity of mitral regurgitation by multimodality imaging. ### Conditions - Mitral Regurgitation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - rehydration - UCG - CMR - fasting ### Outcomes Primary Outcomes - effective regurgitant orifice area (EROA) - mitral regurgitant volume (RVol) - mitral regurgitant fraction (RF) Secondary Outcomes ### Location - Facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China @@
## Efficacy of Gamification With Escape-Room for Arrhythmia Identification in Critical Patients - NCT ID: NCT06266845 - Study ID: 76082423.1.0000.8093 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-12-31 - Lead Sponsor: University of Brasilia ### Study Description Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing. ### Conditions - Arrythmia - Health Education - Escape-Room ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - In-person Escape Room - Virtual Escape-Room ### Outcomes Primary Outcomes - Evaluate the feelings of stress and anxiety among nursing students after experiencing the in-person and virtual escape-room combined with an interactive lecture - Perceived Gains Scale - Student Satisfaction and Self-Confidence in Learning Secondary Outcomes ### Location - Facility: Alberto Augusto Martins Paiva, Brasília, DF, 71938360, Brazil @@
## The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma - NCT ID: NCT06266832 - Study ID: 20230727 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-12-31 - Lead Sponsor: Sir Run Run Shaw Hospital ### Study Description To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma. ### Conditions - Rectal Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab - Oxaliplatin - Capecitabine - Short-course Radiation - Biopsy ### Outcomes Primary Outcomes - Organ retention rate Secondary Outcomes - Total mesorectal excision rate - Total mesorectal excision rate after recurrence - Tumor regression grade - Overall survival - Disease free survival - TRAEs - QoL ### Location - Facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China @@
## The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum - NCT ID: NCT06266819 - Study ID: OU-HEM-LE-01 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-07-01 - Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ ### Study Description In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women. ### Conditions - Hyperemesis Gravidarum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - chewing gum ### Outcomes Primary Outcomes - Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) - Visual Analog Scale (VAS) Secondary Outcomes - Stress Coping Styles Scale (SCSS) - State-Trait Anxiety Inventory (STAI) ### Location - Facility: Özel Şar Hospital, Rize, N/A, 53100, Turkey @@
## The Effect of Breastfeeding Counseling on Social Support Perception, Breastfeeding Self-Efficacy and Outcomes - NCT ID: NCT06266806 - Study ID: OndokusMU55 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-12-31 - Lead Sponsor: Ondokuz Mayıs University ### Study Description The purpose of this study is to examine the effects of the Breastfeeding Self-Efficacy Resources Development Nurse Consultancy Program (EMÖZGEDAP), based on Dennis's Breastfeeding Self-Efficacy Theory along with the hypno-breastfeeding philosophy given to mothers and family relatives, on social support perception, breastfeeding self-efficacy and outcomes. The study will involve pregnant women and close others assigned randomly to the intervention (n=50) or control (n=50) groups in a state hospital in Turkey. Individual counseling will be provided to the intervention group within the scope of the EMÖZGEDAP, based on Denis's Breastfeeding Self-Efficacy theory and hypnobreastfeeding philosophy. EMÖZGEDAP, which will be applied to pregnant women and their family relatives, will consist of 5 sessions lasting 7.5 hours (2 sessions with the woman and her family relatives, two sessions with the woman alone, and one with her family relatives alone). The Antenatal Breastfeeding Self-Efficacy Scale will be evaluated before the counseling program is given in the antepartum period. Breastfeeding and Nutrition Results, Postpartum Breastfeeding Self-Efficacy Scale, Breastfeeding Self-Efficacy Scale for Fathers, Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy and Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy will be evaluated at the 1st, 3rd, and 6th months postpartum. ### Conditions - Breastfeeding, Exclusive - Nurse's Role - Self Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Nurse Consultancy Program to Develop Breastfeeding Self-Efficacy Resources ### Outcomes Primary Outcomes - Breastfeeding and Nutrition Results - Antenatal Breastfeeding Self-Efficacy Scale Short Form - Postpartum Breastfeeding Self-Efficacy Scale-Short Form - Breastfeeding Self-Efficacy Scale for Fathers Short Form - Assessment Scale for Perceived Support of Close Others in Relation to Breastfeeding Self-Efficacy - Scale of Perception of Close Others' Support For Breastfeeding Self-Efficacy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Holmium Laser and Thulium Laser for Mini PCNL - NCT ID: NCT06266793 - Study ID: 2072488-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-06-01 - Lead Sponsor: MaineHealth ### Study Description This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting. ### Conditions - Nephrolithiasis - Percutaneous Nephrolithotomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Holmium Laser - Thulium Laser ### Outcomes Primary Outcomes - Laser Treatment Time Secondary Outcomes - Retreatment rate - Total Operative Time - Stone-Free Rate ### Location - Facility: Maine Medical Center, Portland, Maine, 04102, United States @@
## Impact Evaluation of a Targeted mHealth Intervention to Improve Uptake of Postpartum Contraception in Kenya - NCT ID: NCT06266780 - Study ID: P1473-2023 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2024-12-31 - Lead Sponsor: Jacaranda Health ### Study Description The goal of this study is to explore approaches to improve postpartum contraceptive counseling, information, and uptake through a collaboration between the Harvard Chan School, Rutgers School of Public Health, Jacaranda Health, Jhpiego, and IPSOS, leveraging an existing mobile health platform for intervention delivery and Jacaranda's established partnership with the Kenyan Ministry of Health, county health offices and public maternity hospitals.Jacaranda's PROMPTS mHealth platform has reached over two million pregnant women and new mothers, providing them with needed, tailored information about prenatal and postpartum health along with access to a mobile helpdesk to triage users' questions. Using a targeted human-centered-design process with early postpartum mothers, we developed targeted messaging around family planning and contraceptive method options, with the goal of integrating this new content into Jacaranda's PROMPTS platform. We will conduct a randomized controlled trial with pregnant women engaged with the PROMPTS platform to determine the impact of the intervention package on information and utilization of postpartum contraception. If proven effective, the results of this intervention will be integrated into Jacaranda's PROMPTS system at full scale. ### Conditions - Postpartum Family Planning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - PROMPTS Enhanced Family Planning Counselling ### Outcomes Primary Outcomes - Use of postpartum family planning at 3 months - Use of postpartum family planning at 6 months Secondary Outcomes - Knowledge of return to fertility - Knowledge of safe birth spacing - Knowledge of lactational amenorrhea (LAM) method - Intention to continue family planning method - Intended duration of continued family planning method use - Desired pregnancy spacing of two years or more - Short interpregnancy interval - Method satisfaction - Uptake of most effective family planning methods - Time to take-up of most effective methods - Discussion of FP at any prenatal visit - Discussion of FP at any postnatal visit - Reproductive empowerment: health care provider communication ### Location - Facility: Jacaranda Health, Nairobi, N/A, 00000, Kenya @@
## Programmed Intermittent Epidural Bolus (PIEB) Techniques for Labour Analgesia - NCT ID: NCT06266767 - Study ID: MRC-01-18-157 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-04-30 - Lead Sponsor: Hamad Medical Corporation ### Study Description Epidural Analgesia remains the most effective form of pain relief in labour. After initiating epidural analgesia, there are many epidural drug regimens that can be employed to maintain analgesia for the duration of labour using an epidural catheter. Due to recent advances in medical technology, new epidural pumps, which allow both patient controlled epidural analgesia boluses (PCEA, a common standard of care in many hospitals) and programmed intermittent epidural boluses (PIEB, automatic boluses given in addition to the PCEA bolus), are now available. In this randomized double-blind trial, we aim to evaluate the effects of different combinations of PIEB (epidural bolus volume) and PIEB (bolus volume and time interval) on labour patient-controlled epidural analgesia (PCEA) usage. In theory, the more effective the PIEB combination (the ideal drug volume and ideal time interval), the less PCEA boluses (extra epidural drug) will be used as well as less clinician boluses and less lower limb weakness (motor block) as assessed by the Bromage Score. ### Conditions - Labor Pain - Obstetric Pain - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Levobupivacaine and Fentanyl ### Outcomes Primary Outcomes - The volume of local anaesthetic mixture for breakthrough pain (PCEA + clinician bolus) + the Bromage Score Secondary Outcomes - Pain score - Total local anesthetic consumption - Need for supplementary epidural analgesia - Bromage score (lower limb weakness score) - Type of delivery - Sensory block - Fetal Outcome ### Location - Facility: Hamad Medical Corporation (HMC), Doha, N/A, 3050, Qatar @@
## The Non-Specific Immunological Effects of Providing Oral Polio Vaccine to Seniors in Guinea-Bissau - NCT ID: NCT06266754 - Study ID: OPV-IMMUNO-ADULT - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-29 - Completion Date: 2024-12-31 - Lead Sponsor: Bandim Health Project ### Study Description OPV is the live attenuated vaccine against polio virus. OPV has been key in almost eradicating polio infection. Intriguingly, OPV has been associated with lower all-cause mortality and morbidity. These beneficial OPV effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of OPV against polio infection. They have been coined "non-specific effects" (NSEs). Such NSEs have also been observed for other live attenuated vaccines such as BCG vaccine and measles vaccine. The underlying immunological mechanisms are unknown. Other live vaccines with beneficial NSEs have been shown to induce epigenetic changes leading to "trained immunity". They have also been associated with decreased inflammation. In the present study it will be investigates whether OPV can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in Guinea-Bissau. ### Conditions - Vaccine Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Oral polio vaccine - Placebo ### Outcomes Primary Outcomes - Levels of in vitro proinflammatory cytokines such as IL1-beta, TNF-alfa and IFN-gamma after stimulation of peripheral blood mononuclear cells with non-OPV antigens and mitogens - Levels of plasma markers of systemic inflammation such as TNF ligand superfamily member 12 (TWEAK) and sirtuin 2 (SIRT2) - Amount of pseudo-bulk ATACseq and RNAseq - indicating chromatin accessibility of interferon-stimulated genes associated with the interferon response pathway in PBMCs. - Proportions of immune cell subsets Secondary Outcomes ### Location - Facility: Bandim Health Project, Apartado 861, Bissau, N/A, N/A, Guinea-Bissau @@
## The Predictive Value of Lubricin in Patients With Infective Endocarditis - NCT ID: NCT06266741 - Study ID: NCT093509350936 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-11 - Completion Date: 2026-02-20 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description The main goal of this study is to evaluate the predictability of the disease by measuring the serum lubricin levels in patients with infective endocarditis and in non-patients ### Conditions - Infective Endocarditis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lubricin ### Outcomes Primary Outcomes - Valve damage indicative sign in infective endocarditis Secondary Outcomes ### Location - Facility: Sevil Gulasti, Aydın, Zafer, 09010, Turkey @@
## T30 for Astigmatism in Digital Device Users - NCT ID: NCT06266728 - Study ID: IRB00006733 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-08-18 - Lead Sponsor: Southern College of Optometry ### Study Description This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users. ### Conditions - Contact Lens Complication - Astigmatism - Refractive Errors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Total30 for Astigmatism Contact Lenses ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) Comfort Scores Secondary Outcomes ### Location - Facility: Kannar Eye Care, Pittsburg, Kansas, 66762, United States @@
## Improvement of Depression With Use of ATP - NCT ID: NCT06266715 - Study ID: NFEC-2024-070 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-12-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus normal saline(NA)) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Scale（HAMD-24）, cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ATP Group - Placebo Group ### Outcomes Primary Outcomes - HAMD-24 Secondary Outcomes - Diffusion Tensor Imaging - Diffusion Spectral Imaging - Quantitative susceptibility mapping - Monetary Incentive Delay Task - Emotional faces processing task - Resting state functional connectivity - Hamilton Anxiety Scale - Clinical Global Impression - Snaith-Hamilton Pleasure Scale - Insomnia Severity Index - Columbia-Suicide Severity Rating Scale - Antidepressants Side Effects - C-reactive protein - Tumor Necrosis Factor α - Interleukin- 6 - N-back task - Attention network test - Psychomotor vigilance task - Hamilton Depression Scale - Montgomery and asberg Depression Rating Scale - Beck Depression Inventory ### Location - Facility: Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China @@
## Evaluation of a Nutritional Technology for Vitamin D Absorption - NCT ID: NCT06266702 - Study ID: BL71 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Abbott Nutrition ### Study Description This is a prospective, 2-group crossover, randomized, double-blind study to evaluate nutrient absorption. ### Conditions - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Experimental Oil with Phospholipids - Control Polyunsaturated Oil Blend ### Outcomes Primary Outcomes - Vitamin D Absorption Secondary Outcomes - Vitamin D Absorption - Peak - Vitamin D Absorption - AUC ### Location - Facility: Walsh University, North Canton, Ohio, 44720, United States @@
## Project humAn dieTary daTa rEtuRN - NCT ID: NCT06266689 - Study ID: Pro00112671 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Duke University ### Study Description This study is designed to test the effects of diet data return on human dietary patterns. The investigators' working hypothesis is that returning diet data, collected via an empirical biomarker-based assessment method, will promote participant eating behavior changes towards a more healthful diet, and that these dietary patterns may also be reflected in the structure and function of the gut microbiome and in participant health outcomes. Here, the investigators will explore this hypothesis with participants supplying stool (poop) samples that will be used to assess their diet using the investigators' DNA-biomarker based method. Participants will have their diet data returned to them, and will then supply post-intervention stool samples for dietary assessment to investigate the efficacy of diet data return in impacting subject dietary patterns and health. It is anticipated that the investigators will enroll infants, children, and adults across the age span, including infants that are currently participating in Project HOPE 1000, a longitudinal observational study of mothers and infants from pregnancy through early childhood (Pro00100000). This study represents a minimal risk to subjects; namely, the potential loss of privacy involved with study participation. ### Conditions - Diet Habit ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Personalized Diet Information ### Outcomes Primary Outcomes - Number of participants with diet improvement - Number of participants with increased dietary diversity Secondary Outcomes - Number of participants with changes in the composition and function of the gut microbiome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mobile Micro-course Impact on Perioperative RNs in Heart Surgery Nursing. - NCT ID: NCT06266676 - Study ID: 202301775B1 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-12-31 - Lead Sponsor: Ting-Fang Yeh ### Study Description The goal of this clinical trialis to compare in learning effectiveness of nurses. The main questions it aims to answer are:1. Can the "Micro-course" teaching enhance the awareness of cardiac surgery nursing among operating room nurses?2. Can the "Micro-course" teaching boost the learning motivation and engagement of operating room nurses?3. What is the satisfaction level of nurses regarding the use of "Micro-course" in cardiac surgery nursing?4. What are the relevant factors influencing the effectiveness of the "Micro-course" teaching intervention?Participants will be divided into two groups. The control group will receive online presentations, while the experimental group will engage in mobile learning combined with micro-courses. Both groups of participants will undergo instruction through asynchronous online courses. ### Conditions - periOperative - Cardiac Surgical Procedures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - micro-course - slide presentation ### Outcomes Primary Outcomes - Cognitive scale - motivation scale - Engagement Scale Secondary Outcomes - learning satisfaction ### Location - Facility: ChangGungMH, Taoyuan City, N/A, 33305, Taiwan @@
## Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease - NCT ID: NCT06266663 - Study ID: 2022-13788 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Montefiore Medical Center ### Study Description Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - IBD medication adherence - Health-related quality of life (HRQoL) Secondary Outcomes ### Location - Facility: Montefiore Hutchinson Campus, Bronx, New York, 10461, United States @@
## Unilateral vs Bilateral Application of Muscle Energy Techniques in Pelvic Somatic Dysfunction - NCT ID: NCT06266650 - Study ID: 19485 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-09-30 - Lead Sponsor: The Touro College and University System ### Study Description The goal of this clinical trial is to compare the efficacy of pelvic muscle energy technique online against the traditional full length osteopathic pelvic treatment protocol. The main question it aims to answer are• Can one single pelvic muscle energy technique can correct all pelvic somatic dysfunctions (SD)?Participants will* be positioned by the physician into the area of treatment into a position of resistance, which is the restrictive barrier.* be instructed to use the targeted muscles for 3-5 seconds in the direction of ease while the physician provides a counterforce.* be instructed to stop contracting their muscles and evaluate the area for decreased tension, then repositions the patient into their new restrictive barrier.* These steps are repeated three to five times and then the dysfunction is reevaluated.Subjects diagnosed with pelvic SD will be divided into two groups. One group will be treated with traditional one and be compared with the pelvic muscle energy group. ### Conditions - Pelvic Somatic Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osteopathic Treatment Technique- Muscle Energy Treatment ### Outcomes Primary Outcomes - Resolution of pelvic somatic dysfunction Secondary Outcomes - Anterior anatomical landmarks assessment - Posterior anatomical landmarks assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics - NCT ID: NCT06266637 - Study ID: P.T.REC/012/004999 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-12 - Completion Date: 2024-03-15 - Lead Sponsor: Delta University for Science and Technology ### Study Description PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trialBACKGROUND:Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.HYPOTHESES:Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.RESEARCH QUESTION:What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.? ### Conditions - Scoliosis Idiopathic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional Physical Therapy Program - Physiotherapeutic Scoliosis-Specific Exercise (Schroth) ### Outcomes Primary Outcomes - Cobb's angle - Coronal balance - length of the the tibia and femur - tibiofemoral angle - knee joint line convergence angle - lower limb mechanical axis; and mechanical axis deviation Secondary Outcomes ### Location - Facility: Delta university for science and technology, Gamasa, Dakahleya, 7731168, Egypt @@
## Tourniquet-Test in HHT - NCT ID: NCT06266624 - Study ID: Tourniquet in HHT - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-09-25 - Completion Date: 2024-07-30 - Lead Sponsor: University Hospital, Essen ### Study Description The Tourniquet test is used as a diagnostic procedure for thrombocytopathies and vascular diseases. Currently, there is no evidence whether this test is also positive in hereditary haemorrhagic telangiectasia (HHT), a vasculopathy. The aim of this study was to investigate whether this non-invasive test could also be used as an additional diagnostic criterion in patients with HHT. ### Conditions - HHT ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Tourniquet Test ### Outcomes Primary Outcomes - number of positive Tourniquet Test results in HHT patients Secondary Outcomes ### Location - Facility: University Hospital Essen, Essen, Nordrhein Westphalen, 45122, Germany @@
## Cannabis for Palliative Care in Cancer - NCT ID: NCT06266611 - Study ID: 23-0982 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-07-31 - Lead Sponsor: University of Colorado, Boulder ### Study Description Many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. Cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. In this endeavor, the present study seeks to compare the use of hemp-derived CBD (Cannabidiol) with and without THC (Delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients. ### Conditions - Sleep - Anxiety - Depression - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fsCBD Cannabidiol - Placebo - bsCBD Cannabidiol ### Outcomes Primary Outcomes - Pain Interference - Pain Intensity - Pain Inventory - Sleep Disturbance - Sleep-Related Impairment - Depression/Anxiety - Fatigue - Health Related Quality of Life - Cognitive Function - Cognitive Function - Cognitive Function - Cognitive Function - Plasma Cannabinoids - PROMIS Pain Intensity (Right Now) - Drug Effects - Drug Effects - Drug Effects - Mood - Drug Effects - Cognitive - Drug Effects - Cognitive - Drug Effects - Cognitive - Drug Effects - Blood Cannabinoids Secondary Outcomes - Polypharmacy - Polypharmacy - Polypharmacy ### Location - Facility: Anschutz Health Sciences Building, Aurora, Colorado, 80045, United States @@
## Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity - NCT ID: NCT06266598 - Study ID: EU-TF-HA-01 - Status: COMPLETED - Start Date: 2019-11-17 - Completion Date: 2021-10-27 - Lead Sponsor: HÜMEYRA ACIKAN ### Study Description In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests. ### Conditions - Childhood Obesity - Insulin Resistance ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Metformin ### Outcomes Primary Outcomes - Insulin resistance (HOMA-IR) level - Weight loss rate Secondary Outcomes ### Location - Facility: Erciyes University, Kayseri̇, Melikgazi, 38030, Turkey @@
## Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study - NCT ID: NCT06266585 - Study ID: HX-B-2023090 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation ### Conditions - Cerebral Venous Thrombosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of Participants with CVT deteriorated on radiology - Number of Participants with altered neurological function - Number of Participants with altered consciousness Secondary Outcomes - Neurological function at 30th day after onset (mRS) - Emergency surgery rates ### Location - Facility: Capital Medical University Affiliated Beijing Tiantan Hospital, Beijing, Beijing, N/A, China @@
## Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment - NCT ID: NCT06266572 - Study ID: 1R43DA055182-01 - Status: COMPLETED - Start Date: 2021-09-30 - Completion Date: 2023-09-29 - Lead Sponsor: Center for Social Innovation, Massachusetts ### Study Description C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:1. Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.2. Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) ### Outcomes Primary Outcomes - Open Minds Scale for Health Care Providers - Brief Opioid Stigma Scale - Perceived Stigma of Addiction Scale - Knowledge Check - System Usability Scale - Internalized Stigma of Mental Illness Scale - Recovery Empowerment Scale - Mental Health Seeking Attitudes Scale Secondary Outcomes ### Location - Facility: West Haven VA Medical Center, West Haven, Connecticut, 06516, United States @@
## Efficacy Evaluation of Chang Geng Healthy Drink on Patients With Non-alcoholic Fatty Liver Disease - NCT ID: NCT06266559 - Study ID: 202101896A3 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-12-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description For non-alcoholic fatty liver disease, there is currently no effective treatment options. Traditional Chinese medicine (TCM) has a long history of treating liver diseases. However, TCM treatment methods are diverse, and there is currently a lack of high-quality clinical research to confirm the efficacy of Chinese herbal medicine. Thereafter, Chang-Gung Healthy Drink which is a TCM based healthy drink may be used to alleviate the clinical adverse event of non-alcoholic fatty liver disease patients. ### Conditions - Non-Alcoholic Fatty Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chang Geng Healthy Drink ### Outcomes Primary Outcomes - Fatigue Visual Analogue Scale - Current fatigue level - Fatigue Visual Analogue Scale - Other daily specific task fatigue level - Laboratory Data (Linver Function Index) - Liver stiffness measurement (kPa) - Controlled attenuation parameter (dB/m) Secondary Outcomes - Number of Participants With Clinical Significant Adverse Avent (Safety Measures) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy - NCT ID: NCT06266546 - Study ID: CRYOTXA - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Ascension Via Christi Hospitals Wichita, Inc. ### Study Description Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy. ### Conditions - Hemorrhage Lung - Endobronchial Mass ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Tranexamic acid ### Outcomes Primary Outcomes - Major Hemorrhage Secondary Outcomes - Early termination of the procedure due to bleeding - Rate of intermediate hemorrhage - Rate of minor hemorrhage - Inadequate tissue sampling due to bleeding - Graded use of other measures to control bleeding (not prophylactic) - Unplanned hospital admission for bleeding complications - Acute cardiovascular side effects - All cause 28 day mortality ### Location - Facility: Ascension Via Christi, Wichita, Kansas, 67214, United States @@

Subsets and Splits