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## A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders - NCT ID: NCT06339359 - Study ID: 2024-02-014 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-31 - Lead Sponsor: Bundang CHA Hospital ### Study Description This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis. ### Conditions - ASD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments ### Outcomes Primary Outcomes - K-BSID-Ⅲ - ADI-R - M-CHAT - ADOS-2 - K-WPPSI-Ⅳ - K-CARS-2 - CBCL - SCQ - GMFM - HFT - BOT-2 - VMI-6 - SP - Eye Tracking - Motion Analysis Secondary Outcomes ### Location - Facility: CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, 463-712, Korea, Republic of @@
## Analysis of Histopathological Factors Predictive of Lymph Node Involvement and Management Practices in pT1 Colorectal Cancers Treated by Primary Endoscopic Resection: a Retrospective Population-based Study (PROMOT1) - NCT ID: NCT06339346 - Study ID: 29BRC24.0028 - PROMOT1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-01 - Completion Date: 2024-04-30 - Lead Sponsor: University Hospital, Brest ### Study Description Colorectal cancers (CRC) extending beyond the muscularis mucosae and invading the submucosa without extending beyond it are classified as pT1.Among these, a number of lesions presenting pejorative criteria, notably histopathological, have a significant risk of lymph node invasion, and are therefore candidates for partial colectomy with lymph node dissection. Tumors deemed to be at low risk of lymph node involvement can be treated by endoscopy alone.It should be noted that further surgical intervention is not without comorbid consequences, and that a significant proportion of post-surgical surgical specimens are free of cancerous lesions.The aim of this study is therefore to analyze the current histopathological criteria predictive of lymph node invasion, in order to more accurately select candidates for surgical management. ### Conditions - Colorectal Cancer - Colorectal Adenocarcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Analysis of lymph node invasion rates as a function of tumor characteristics Secondary Outcomes - Population demographics - lesion characteristics - management - recurrence - survival ### Location - Facility: Chu Brest, Brest, N/A, 29609, France @@
## Evaluation of ACT Now GAIN Later - NCT ID: NCT06339333 - Study ID: RRECB0523EC - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: University College Dublin ### Study Description The goal of this Randomised Control Trial is to evaluate a Psychologist Guided Self Help Video Parenting Programme based on principles of Acceptance and Commitment Therapy (ACT)The main questions it aims to answer are:Primary Objectives1. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in increasing parental psychological flexibility (measured by Psy-Flex, tool which measures psychological flexibility)? Please find attached.2. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in decreasing child challenging behaviour (measured by the Eyberg Child Behavior Inventory)? Please find attached.Secondary Objectives1. Is ACT Now GAIN Later: an ACT based Parenting Programme, effective in improving parent-child relationships (measured by the Child-Parent Relationship Scale)? Please find attached.2. Does ACT Now GAIN Later increase parental well-being as measured by (Depression Anxiety Stress Scale, Parenting Stress Index and Goal Based Outcome Tool)? Please find attached.3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.Participants will complete a 7 week psychologist guided parenting intervention. Researchers will compare waitlist groups to see if there are differences in psychological flexibility, child behaviour, parent-child relationships, parental well-being or parental self-efficacy. ### Conditions - Psychological Flexibility - Child Behavior - Relationship, Parent Child - Well-Being, Psychological - Self-efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ACT Now GAIN Later - Control Group ### Outcomes Primary Outcomes - Parental Psychological Flexibility - Child Behaviour Secondary Outcomes - Parent-Child Relationships - Parental Well-Being - Parental Self-Efficacy - Parental Self-Efficacy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity - NCT ID: NCT06339320 - Study ID: PRO00037835 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2033-10 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS). ### Conditions - Endoscopic Sleeve Gastroplasty - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endoscopic Sleeve Gastroplasty (ESG) - Apollo OverStitch endoscopic suturing device ### Outcomes Primary Outcomes - Number of participants with technically successful completion of the ESG procedure - Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Secondary Outcomes - Change in body mass index (BMI) measured by kg/m2 - Change in hemoglobin A1C (%) ### Location - Facility: Houston Methodist Hospital, Houston, Texas, 77030, United States @@
## A Prospective Clinical Study to Validate a Preoperative Risk Scoring Model for LNM in GC Patients - NCT ID: NCT06339307 - Study ID: DJY004 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability. ### Conditions - Predictive Cancer Model - Gastric Cancer - Lymph Node Metastasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - lymph node metastasis Secondary Outcomes ### Location - Facility: Cancer Hospital of Tianjin Medical University, Tianjin, Tianjin, N/A, China @@
## Efficacy of Pyodine Soaked Gelfoam vs Single Topical Application of Clotrimazole in Otomycosis Treatment - NCT ID: NCT06339294 - Study ID: ZShabbir - Status: COMPLETED - Start Date: 2023-06-16 - Completion Date: 2023-12-31 - Lead Sponsor: Rawalpindi Medical College ### Study Description Background and Objectives To compare the efficacy of gel foam-soaked pyodine with a single topical application of clotrimazole ointment.Subjects and Methods This randomized controlled trial will include 90 patients presenting to ENT OPD with complaints of earache, watery ear discharge, pruritis, and ear blockage and will be clinically diagnosed as a case of otomycosis on otoscopy. The external auditory canal of the patient will be cleared of fungal debris via suction before treatment In Group A ear canal will be filled with 1% clotrimazole ointment by using an IV catheter and syringe and in Group B pyodine-soaked gel foam will be placed in the external auditory canal. The patients will be followed up on post-treatment days 7 and 14. ### Conditions - Otomycosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clotrimazole Cream - Povidone-Iodine ### Outcomes Primary Outcomes - Treatment Response Based on Otoscopy Secondary Outcomes - Condition of External Auditory Canal ### Location - Facility: Benazir Bhutto Hospital, Rawalpindi, Punjab/46000, 46000, Pakistan @@
## A Multicenter Clinical Study of Apatinib Mesylate Combined With Doctor's Choice for Advanced Breast Cancer - NCT ID: NCT06339281 - Study ID: 2023YJZ87 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12 - Lead Sponsor: Li Huiping ### Study Description Previous studies have found good efficacy of (investigator's choice of chemotherapy, or endocrine drug) in combination with apatinib mesylate in the treatment of her-2 negative, chest wall metastatic advanced breast cancer, and the present study proposes to further explore the efficacy of apatinib mesylate in her-2 negative, HR-positive advanced breast cancer. ### Conditions - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - apatinib mesylate+Capecitabine Tablets - apatinib mesylate+Fulvestrant injection ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection - NCT ID: NCT06339268 - Study ID: MMABelgrade - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-03-01 - Lead Sponsor: Military Medical Academy, Belgrade, Serbia ### Study Description Postoperative cognitive deficit and its connection with surgery and general anesthesia were first mentioned in the literature in 1955 by Bradford. Cognitive disorders in the postoperative period are postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). POD is an acute dysfunction in cognition, which did not exist preoperatively. Attention deficit disorder is the main symptom of POD and refers to the inability to direct, focus, maintain, or shift attention. Memory impairment, disorientation, or perceptual disturbances may also be present. Cognitive capacity changes in POD patients develop and fluctuate in the first few days after surgery. Unlike POD, there is no formal definition for POCD. Based on data from the existing literature, it is defined as newly diagnosed cognitive deterioration that occurs after surgery. The diagnosis of POCD should be based on pre- and postoperative screening with appropriate psychometric tests. Risk factors for the development of POCD include those related to the surgical procedure, anesthesia, or the patient himself. Compared to less invasive and shorter operations, there is a higher risk of developing POCD after major, invasive, and long-term operations. Additional risk factors are intraoperative (intraoperative bleeding, perioperative transfusion treatment, hypotension) and postoperative complications (respiratory insufficiency, pneumonia, atelectasis, bronchospasm, bronchopleural fistula, and pulmonary edema). Presurgical optimization (Prehabilitation) is a widespread concept that aims to improve the general condition of the patient or optimize comorbidities before major surgery. Prehabilitation is primarily focused on improving physical ability and nutritional status, but it is developing in the direction of a multimodal approach that includes measures to reduce stress and anxiety. Psychological factors are increasingly recognized as an essential element of prehabilitation and are often added to prehabilitation programs.Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasinglyundergoing lung resection. These complications can affect the outcome and speed of postoperative recovery. ### Conditions - Prehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cognitive training, CogniFit App ### Outcomes Primary Outcomes - Postoperative cognitive dysfunction - Perioperative depression and anxiety - Postoperative delirium - Functional status and postoperative recovery - Functional status and postoperative recovery - Postoperative recovery - Functional status and postoperative recovery Secondary Outcomes - Overall outcome: Complication rate - Overall outcome: Morbidity - Overall outcome: Mortality ### Location - Facility: Military Medical Academy, Belgrade, N/A, 11000, Serbia @@
## Italian Observational Study on CAR-T Therapy for Lymphoma - NCT ID: NCT06339255 - Study ID: INT 180/19 - Status: RECRUITING - Start Date: 2019-10-30 - Completion Date: 2029-12-31 - Lead Sponsor: Paolo Corradini ### Study Description The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity. ### Conditions - Diffuse Low Grade B-Cell Lymphoma - Primary Mediastinal Large B-cell Lymphoma (PMBCL) - Mantle Cell Lymphoma - Follicular Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice - Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice Secondary Outcomes - Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria. - Evaluation of Outcome: Overall survival (OS), according to Lugano criteria. - Evaluation of Outcome: Progression free survival (PFS) - Evaluation of Outcome: duration of response (DoR) - Evaluation of Outcome: Overall Response rate (ORR) - Evaluation of Outcome: Overall survival (OS) - Evaluation of Outcome: non-relapse mortality (NRM) - Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications - Evaluation of bridging therapy: safety - Evaluation of bridging therapy: efficay - Evaluation of salvage therapy after CAR-T failure - Evaluation of salvage therapy after CAR-T failure - Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety) - Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products ### Location - Facility: Fondazione IRCCS Istituto Nazionale Tumori, Milan, N/A, 20133, Italy @@
## A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis - NCT ID: NCT06339242 - Study ID: 2024-01-NSCLC - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-31 - Lead Sponsor: Jiangsu Province Nanjing Brain Hospital ### Study Description Leptomeningeal metastasis is a fatal complication of advanced lung cancer. There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs. The Furmonertinib prototype persists longer in brain tissue, and its metabolites can also penetrate the blood-brain barrier. Ommaya cystlateral ventricle chemotherapy can quickly control the progression of intracranial lesions. The aim of this study is to evaluate the LM progression-free survival (LM-PFS) of Furmonertinib combined with lateral ventricular chemotherapy in the treatment of leptomeningeal metastatic NSCLC after third-generation EGFR-TKIs resistance. ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Furmonertinib ### Outcomes Primary Outcomes - LM-PFS（progression-free survival） - LM-ORR（Objective response rate） Secondary Outcomes - LM-OS - Incidence of Treatment-Emergent Adverse Events - PFS ### Location - Facility: Nanjing Brain Hospital, Nanjing, Jiangsu, 210029, China @@
## Postoperative New-onset Proteinuria and Adverse Outcomes. - NCT ID: NCT06339229 - Study ID: FSYYY-2024-12 - Status: COMPLETED - Start Date: 2000-01-01 - Completion Date: 2023-11-01 - Lead Sponsor: Yaozhong Kong ### Study Description We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate. ### Conditions - Surgery - Proteinuria - Mortality ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - proteinuria ### Outcomes Primary Outcomes - mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of Adebrelimab Combined With Apatinib and Paclitaxel in Patients With Advanced Gastric Cancer. - NCT ID: NCT06339216 - Study ID: OBU-BJ-GC-II-011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-11-30 - Lead Sponsor: Chinese PLA General Hospital ### Study Description Phase II Clinical Study of Adebrelimab Combined with Apatinib and Paclitaxel for Injection(Albumin Bound) as Second-line Therapy in Patients with Advanced Gastric Cancer Previously Treated with Immunotherapy ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound) ### Outcomes Primary Outcomes - ORR Secondary Outcomes - PFS - DCR - OS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intraoperative Wound Irrigation in Cesarean Section - NCT ID: NCT06339203 - Study ID: 5240002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Loma Linda University ### Study Description This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery. ### Conditions - Cesarean Section Complications - Cesarean Section; Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Irrisept - Normal Saline ### Outcomes Primary Outcomes - Composite wound evaluation after caesarean delivery Secondary Outcomes ### Location - Facility: Loma Linda University, Loma Linda, California, 92354, United States @@
## Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis - NCT ID: NCT06339190 - Study ID: E21-006-72840 - Status: RECRUITING - Start Date: 2021-08-01 - Completion Date: 2027-12 - Lead Sponsor: Monash University ### Study Description This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.Participants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample. ### Conditions - Neurodegenerative Diseases - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Venepuncture ### Outcomes Primary Outcomes - Nfl correlation with neurodegeneration Secondary Outcomes - Change in speech processing - Change in language processing - Change in Direct Magnitude Estimation ### Location - Facility: Box Hill Hospital, Box Hill, Victoria, 3128, Australia @@
## Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study - NCT ID: NCT06339177 - Study ID: 10001899 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-04-01 - Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) ### Study Description Background:Hemophagocytic lymphohistiocytosis (HLH) is a disease caused by disrupted immune function. People with HLH are prone to fevers and illnesses, which can be fatal. Some people develop a genetic form of this disease (pHLH), but researchers do not understand why some other people develop a nongenetic form (sHLH). They also do not have good ways to diagnose and treat sHLH.Objective:To learn about sHLH and why some people get it and others do not.Eligibility:Adults aged 18 years and older with sHLH.Design:Participants will be admitted to the study based on a review of their medical records. Those who join will have at least 3 clinical evaluations over 9 to 12 months. These may occur during an inpatient hospitalization if they require medical care or in the outpatient clinic.Participants will also have a physical exam at each visit. Up to half a cup of blood will be drawn at each visit. Participants may also have their blood drawn by their own doctors, who will send the samples to the researchers. Researchers may also contact these participants by telephone or video calls.The blood will be used for clinical tests as well as research. No new treatments will be administered as part of this study; however, standard medications and treatments may be recommended.Participants may opt to continue their visits once a year for 3 more years. Participants may also opt for an extra clinial evaluation 1 week after starting a new treatment.... ### Conditions - Lymphohistiocytosis, Hemophagocytic - Secondary Hemophagocytic Lymphohistiocytosis - Macrophage Activation Syndrome - Hyperinflammatory Syndromes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions. Secondary Outcomes - Prospectively define acute and longitudinal clinical profiles that predict key clinical outcomes. - Compare clinical and immune profiles between the classically defined HLH subgroups. - Improve the understanding of the pathogenesis of sHLH. - Characterize risk factors to identify populations at risk for developing sHLH. ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Breech Delivery Skills. Resident Learning Program - NCT ID: NCT06339164 - Study ID: ObGynEASC006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-06-30 - Lead Sponsor: G. d'Annunzio University ### Study Description Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation ### Conditions - Breech Presentation; Before Labor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - skills and learning quality in breech delivery ### Outcomes Primary Outcomes - Skills capacities - Skills capacities Secondary Outcomes - learning qualities ### Location - Facility: Claudio Celentano, Pescara, PE, 65100, Italy @@
## Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA - NCT ID: NCT06339151 - Study ID: TUH multiple dexamethasone TKA - Status: RECRUITING - Start Date: 2024-03-23 - Completion Date: 2025-10-31 - Lead Sponsor: Thammasat University Hospital ### Study Description The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.The main question\[s\] it aims to answer \[is/are\]:Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?Researchers will compare double dose of dexamethasone group to see if \[insert effects\].Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\]. ### Conditions - Osteo Arthritis Knee - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexamethasone before surgery - Dexamethasone before and 12 hours after surgery - Dexamethasone before and 24 hours after surgery ### Outcomes Primary Outcomes - Pain at rest and motion Secondary Outcomes - Nausea and vomiting - Morphine consumption - Blood sugar level - CRP level - Range of motion - Length of hospital stay - Complication ### Location - Facility: Thammasat University Hospital, Khlong Luang, Pathum Thani, 12120, Thailand @@
## Identification of Novel High Quality Methylated DNA Markers in Renal Tumors: Whole Methylome Discovery, Tissue Validation, and Feasibility Testing In Blood and Urine, The INQUIRE Study - NCT ID: NCT06339138 - Study ID: 17-010944 - Status: RECRUITING - Start Date: 2018-02-20 - Completion Date: 2027-01-31 - Lead Sponsor: Mayo Clinic ### Study Description This study is being done to collect blood, tissue and urine samples to identify a novel high quality methylated DNA marker in patients with renal tumors. ### Conditions - Chromophobe Renal Cell Carcinoma - Clear Cell Papillary Renal Tumor - Clear Cell Renal Cell Carcinoma - Kidney Oncocytoma - Papillary Renal Cell Carcinoma - Urothelial Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Identify novel methylated DNA markers in tissue for malignant renal and urothelial tumors Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Predictive Analytics and Computer Visualization Enhances Patient Safety to Prevent Falls - NCT ID: NCT06339125 - Study ID: 2023p003637 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-07 - Lead Sponsor: Massachusetts General Hospital ### Study Description Annually, in the United States there are 700,000 - 1,000,000 inpatient falls reported, and one-third of patients sustain an injury. The average estimated cost per fall is $6,694, resulting in over $1.4 -1.9 billion dollars in losses each year (AHRQ, 2017). This study aims to compare the impact of different fall prevention strategies on the rate of occurrence of falls and falls with injury in an academic medical center on three adult medical units. While maintaining the usual standard of care for fall prevention, each unit will add one of the following: (1) use of a fall risk alert to nurses using an algorithm based on electronic health record data or (2) computerized camera visualization or (3) a combination of both. ### Conditions - Falls and Falls With Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Fall prevention algorithm - Inspiren camera visualization ### Outcomes Primary Outcomes - Falls - Falls with injury Secondary Outcomes - Nurse perceptions - Nurse perceptions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children - NCT ID: NCT06339112 - Study ID: 2024/10 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Tarsus University ### Study Description This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G\Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data. ### Conditions - Fear - Anxiety - Inhalant Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Playing with toy nebulizer - Cartoon ### Outcomes Primary Outcomes* - fear - anxiety Secondary Outcomes ### Location - Facility: Tarsus State Hospital, Mersin, N/A, N/A, Turkey @@
## Loaded Gait Training on Gross Motor Function in Cerebral Palsy - NCT ID: NCT06339099 - Study ID: P.T.REC/012/002489 - Status: COMPLETED - Start Date: 2023-02-26 - Completion Date: 2024-03-15 - Lead Sponsor: Cairo University ### Study Description A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional physical therapy program - Loaded gait training ### Outcomes Primary Outcomes - Gross motor function - knee extensor strength Secondary Outcomes ### Location - Facility: Faculty of Physical Therapy, Cairo University, Giza, Cairo, 12613, Egypt @@
## Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes - NCT ID: NCT06339086 - Study ID: BPR-201-I-III-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12-30 - Lead Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd. ### Study Description The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar. ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Semaglutide Injection - Semaglutide Injection(Ozempic®) - Metformin ### Outcomes Primary Outcomes - Change in HbA1c Secondary Outcomes - Change in HbA1c - Change in FPG - Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% - Proportion of participants who achieved HbA1c<7.0%，HbA1c≤6.5% with no hypoglycemic event - Change in Body Weight - Proportion of participants with Weight Loss≥5%, ≥10% and ≥15% - Change in Diastolic and Systolic Blood Pressure - Changes in Blood Lipids - Incidence and severity of Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma - NCT ID: NCT06339073 - Study ID: 2021NZKY-045-01 - Status: COMPLETED - Start Date: 2023-10-01 - Completion Date: 2024-02-05 - Lead Sponsor: Jinling Hospital, China ### Study Description Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients. ### Conditions - Wounds and Injuries - Ventilation Therapy; Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mechanical ventilation ### Outcomes Primary Outcomes - Prolonged mechanical ventilation Secondary Outcomes ### Location - Facility: the General Surgical Department of Jinling Hospital, Nanjing, Jiangsu, 210002, China @@
## An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3). - NCT ID: NCT06339060 - Study ID: RTS-022 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-03-01 - Lead Sponsor: Ruijin Hospital ### Study Description Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group).The 3-year overall survival rate is the primary outcome. ### Conditions - Esophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Arm 1 Organ preservation - Active Comparator: Arm 2 Surgery ### Outcomes Primary Outcomes - 3-year overall survival rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Projector Kaleidoscope and Cartoons on Anxiety, Fear, and Pain in Children - NCT ID: NCT06339047 - Study ID: 2024/09 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Tarsus University ### Study Description The research will be conducted with children hospitalized in Tarsus State Hospital Children's Clinics and who meet the sampling criteria.The population of the study, which is planned as a randomized controlled experimental study, will consist of children aged 4-10 years old who are admitted to the pediatric surgery service of Tarsus State Hospital and will undergo outpatient surgical intervention.In collecting research data; the Introductory Information Form, Child Anxiety Scale, Child Fear Scale, Wong-Baker Pain Scale and Vital Signs Follow-up Form will be used. ### Conditions - Anxiety and Fear - Pain - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Projector Kaleidoscope - Cartoon ### Outcomes Primary Outcomes - Anxiety - Fear - Pain after surgery Secondary Outcomes ### Location - Facility: Tarsus State Hospital, Mersin, N/A, N/A, Turkey @@
## Repurposing Lithium for Parkinson's Disease: a RCT - NCT ID: NCT06339034 - Study ID: STUDY - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-10 - Lead Sponsor: State University of New York at Buffalo ### Study Description This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lithium - Placebo ### Outcomes Primary Outcomes - MRI-derived free water (FW) levels. - Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression - Serum neurofilament light chain (NfL) Secondary Outcomes - PBMC superoxide dismutase type-1 (SOD-1) mRNA expression - PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio - PBMC pThr308 and pS473/total protein kinase B (Akt) ratios - Serum interleukin-6 - Serum glial fibrillary acidic protein (GFAP) - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) - Montreal Cognitive Assessment (MoCA) - Parkinson's Anxiety Scale - Geriatric Depression Scale-15 - Fatigue Severity Scale - Insomnia Severity Index - Parkinson's Disease Questionnaire-8 - Levodopa equivalent daily dose (LEDD) ### Location - Facility: UBMD Neurology, Williamsville, New York, 14221, United States @@
## OCT or Angiography Guided De-escalation of DAPT - NCT ID: NCT06339021 - Study ID: DAPT-OCT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-01 - Lead Sponsor: Shenyang Northern Hospital ### Study Description Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation. ### Conditions - Optical Coherence Tomography - Dual Antiplatelet Therapy - Antiplatelet De-escalation - Neointimal Coverage - ST Elevation Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OCT-guided PCI - Conventional angiography-based PCI - DAPT de-escalation - default DAPT regimen ### Outcomes Primary Outcomes - Neointimal thickness after DES implantation Secondary Outcomes - Major adverse cardiovascular and cerebrovascular events (MACCE) - BARC types 2-5 bleeding - In-stent thrombosis ### Location - Facility: Northern Hospital, Shenyang, Liaoning, N/A, China @@
## A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) - NCT ID: NCT06339008 - Study ID: 18789 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2026-05-01 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months ### Conditions - Perennial Allergic Rhinitis (PAR) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LY3650150 - Placebo - Standard therapy for INCS ### Outcomes Primary Outcomes - Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16 Secondary Outcomes - Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16 - Mean CFBL in RQLQ(S) at week 56 - Mean CFBL in TNSS at Week 4 - Mean CFBL in TNSS at Week 56 - Mean CFBL in Postnasal drip score at Week 16 ### Location - Facility: Southern California Research, California City, California, 92691, United States @@
## A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) - NCT ID: NCT06338995 - Study ID: 18790 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2026-10-25 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months. ### Conditions - Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LY3650150 - Placebo - Standard therapy for INCS ### Outcomes Primary Outcomes - Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity - Mean CFBL in Endoscopic Nasal Polyp Score (NPS) Secondary Outcomes - Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK) - Mean change in Forced Expiratory Volume in 1 Second (FEV1) - Mean CFBL in Severity of Loss of Smell - Mean CFBL in Postnasal Drip ### Location - Facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS, Mandeville, Louisiana, 70448, United States @@
## Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars - NCT ID: NCT06338982 - Study ID: N-20230059 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2030-10-31 - Lead Sponsor: Kimie Bols Østergaard ### Study Description The goal of this clinical trial is to investigate the hypothesis that there are none difference in the treatment result of orthognathic surgery on the lower jaw, with interoperative wisdom tooth removal rather than preoperative wisdom tooth removal. In patients with severe dental malocclusion combined with a dentofacial deformity. The main question it aims to answer are:• Is there a difference in the degree of complication and the patient's perception, with inter-operative wisdom tooth removal rather than pre-operative wisdom tooth removal.Participants will be will be divided into two groups, with one group having their wisdom teeth removed 6 months before their jaw moving surgery and the other group having their wisdom teeth removed in connection with their jaw moving surgery. ### Conditions - Impacted Third Molar Tooth - Osteotomy - Orthognathic Surgery - Mandibular Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Interoperative wisdom tooth removal in conjunction with BSSO ### Outcomes Primary Outcomes - Fracture pattern following BSSO with or without impacted third molars - Condylar segment position following BSSO with or without impacted third molars - Oral Health Impact Profile-14 (OHIP-14) - The Modified Dental Anxiety Scale (MDAS) - Short Form-36 (SF-36) - PROMs Secondary Outcomes - Length of the surgical procedure - Intraoperative bleeding - Frequency of intra- and postoperative complications ### Location - Facility: Aalborg universitets hospital, Aalborg, N/A, 9000, Denmark @@
## The Impact of Different Carbohydrate Restriction After a Gastric Bypass on the Ketosis and Ketoacidosis - NCT ID: NCT06338969 - Study ID: PostBariKetosis - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-08-01 - Lead Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan ### Study Description Background:Ketosis after bariatric surgery is a metabolic process that occurs when the body breaks down fat for energy because of not getting enough carbohydrates.Insufficient production of ketone bodies reduces the rate of weight loss, and excessive amounts of ketones can lead to ketoacidosis or liver failure in patients with nonalcoholic steatohepatitis (NASH).The investigators hypothesize that weight loss is directly related to calorie intake, and a significant reduction in carbohydrate content leads to increased ketosis and the risk of ketoacidosis.Objectives:The study aimed to compare the incidence of ketoacidosis and liver failure in patients with NASH with different intakes of carbohydrates in the early postoperative period after gastric bypass. In addition, the investigators want to find out how carbohydrate restriction will affect weight loss for up to 1 year. ### Conditions - Obesity, Morbid - NASH - Ketosis - Keto Acidosis - Carbohydrate Metabolism Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Carbohydrate Restriction after a Gastric Bypass ### Outcomes Primary Outcomes - Cases of ketosis and incidence of ketoacidosis - Cases of liver failure Secondary Outcomes - Change in body mass index (Δ BMI) ### Location - Facility: Oral Ospanov, Astana, Aqmola, 010000, Kazakhstan @@
## Optimal Attained LDL-Cholesterol Levels in Patients Who Achieved ≥50% LDL Reduction After PCI - NCT ID: NCT06338956 - Study ID: Lipid-PCI - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description For the management of low-density lipoprotein-cholesterol (LDL-C), some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in LDL-C levels. High-intensity or maximally tolerated intensity can be maintained without a target goal. However, the European guideline recommends less than 55 mg/dL of LDL-C after PCI. ### Conditions - Coronary Artery Disease - Hyperlipidemias ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LDL reduction therapy ### Outcomes Primary Outcomes - MACCE Secondary Outcomes - Cardiovascular death - Spontaneous myocardial infarction - Repeat revascularization - Ischemic stroke ### Location - Facility: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of @@
## Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction - NCT ID: NCT06338943 - Study ID: 02-02/24 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-01 - Lead Sponsor: National Medical Research Center for Therapy and Preventive Medicine ### Study Description Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?Objectives1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.Study population - 45-60 year-old women with the history of pregnancy (\>20 weeks) in the absence of low left ventricle ejection fraction (\<50%)Primary endpoint: The prevalence of HFpEF in patients with the history of APOs. ### Conditions - Heart Failure Preserved Ejection Fraction - Pregnancy Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography - Questionnaire ### Outcomes Primary Outcomes - HFpEF incidence - APOs incidence Secondary Outcomes ### Location - Facility: National Medical Research Center for Therapy and Preventive Medicine, Moscow, N/A, N/A, Russian Federation @@
## Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy - NCT ID: NCT06338930 - Study ID: ROADMAP - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-03-30 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Routine follow-up of patients with inflammatory bowel disease (IBD) under stable doses of maintenance therapy or no IBD-related therapy at all, consists of intensive monitoring with prescheduled outpatient visits every six or twelve months. However, many of these patients do not require additional interventions from the IBD specialist during these visits. In addition, patients in long-term remission, often request a less frequent follow-up in the hospital and in consequence a less frequent absence from school or work. In conclusion, these routinely follow-up visits might put unnecessary burden on both healthcare providers and IBD patients, as well as on healthcare resources.Until now, no clear standard was set for how to organize a remote monitoring programme that is feasible and safe in a large patient population. Despite the possible added value of remote monitoring for IBD patients on stable or no therapy and who are in remission, they are seldomly the targeted population in clinical trials analysing the effects of remote monitoring in IBD. Secondly, a significant reduction in outpatient clinic visits, is often not actively included in the programme, but more an outcome result. Finally, to compose a safe remote monitoring programme, subjective and objective parameters of disease activity should be collected.With the ROADMAP study, the main objective is to evaluate the safety and feasibility of remote monitoring in IBD patients that are stable on their current therapy or receive no IBD-related therapy. Secondly, a health economic evaluation will be conducted. Patients will be randomised to either the remote monitoring group or control group. The remote monitoring group will visit the outpatient clinic after two years. During this two-year period, patients will be monitored remotely via three-monthly questionnaires (PRO-2, IBD disk, WPAI, EQ-5D-5L) and faecal calprotectin measures. An IBD nurse will evaluate all incoming data and act in case of red flags. ### Conditions - Crohn Disease - Colitis, Ulcerative - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Remote monitoring ### Outcomes Primary Outcomes - Patient safety measured as the number of patients not requiring unplanned IBD related hospital visits (outpatient clinic, emergency department, hospitalization, or surgery) or rescue therapy with steroids within two years. Secondary Outcomes - Costs and cost savings for hospital, RIZIV, employer, patient, … in the intervention group versus the control group. - Time saving for patients in the intervention group versus the control group will be measured using a "timing questionnaire". - Number of telephone/email contacts with the IBD team within one year and within two years. - Number of contacts with the general practitioner for IBD related reasons within one year and within two years. - Absence at work or school within one year and within two years in the intervention group versus the control group will be measured using the WPAI IBD questionnaire. - Quality of life in the intervention group versus the control group will be measured using the European Quality of Live Five Dimension Five Level Scale. - Number of patients refusing to participate in this trial and the reason why. - Reasons to stop remote monitoring. - Patient's compliance, measured via missing data in the intervention versus the control group - Satisfaction with the program in the intervention group. - System usability in the intervention group. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mental Health and Vigorous-intensity Physical Activity - NCT ID: NCT06338917 - Study ID: File 2022 DI 61 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-10 - Completion Date: 2026-01-31 - Lead Sponsor: University of Vic - Central University of Catalonia ### Study Description People with severe mental illness have unhealthy lifestyles and habits, such as sedentary behavior and physical inactivity. Which are associated with a higher prevalence of premature mortality and chronic comorbidities.The aim of this study is to evaluate the efficacy of a physical activity program, which pretends to increase the number of vigorous-intensity physical activity bouts in their daily life, as a habit, combining High Intensity Interval Training (HIIT) and Vigorous Intensity Life-Style Physical Activity (VILPA). Secondary aims are to evaluate the efficacy of the program on fitness, physical activity and sedentary behavior level and patron; depressive, mania and psychotic symptomatology, functionality and cognitive functioning; quality of life and mood. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Vigorous-intensity physical activity program ### Outcomes Primary Outcomes - Psychotic symptomatology - Depression symptomatology - Depression severity - Mania symptomatology - Mania severity - Disability - Quality of life - Cognitive functioning - Mood Secondary Outcomes - Subjective physical activity patron - Subjective sedentary behaviour patron - Perception of physical fitness - Objective physical activity patron - Objective sedentary behavior patron - Cardiorespiratory endurance - Velocity - Agility - Lower limb strength ### Location - Facility: University of Vic, Vic, Barcelona, 08500, Spain @@
## Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50 - NCT ID: NCT06338904 - Study ID: PID2022-141225OB-I00 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2026-05-31 - Lead Sponsor: University of Santiago de Compostela ### Study Description Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups. ### Conditions - Suicide ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Problem-solving-based psychological intervention ### Outcomes Primary Outcomes - Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. - Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. Secondary Outcomes - Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months - Treatment adherence - Satisfaction with the service received ### Location - Facility: Research Group on Mental Health and Psychopatology, Santiago de Compostela, A Coruña, 15782, Spain @@
## Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks - NCT ID: NCT06338891 - Study ID: ACPM34 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: University of Palermo ### Study Description Familial Mediterranean Fever (FMF) is a chronic hereditary autoinflammatory disease caused by mutations in the MEditerranean FeVer (MEFV) gene which codes for pyrin. Dysfunction of this protein determines an inappropriate response to inflammatory stimuli. The clinical course of the disease is characterized by recurrent episodes of fever and inflammation of the serous membranes, which manifest with chest, abdominal and joint pain. Several studies suggest a possible association between acute FMF attacks and dietary triggers, including wheat. However, it is still unclear to what extent wheat is responsible for the reactivation of FMF and if, between one acute attack and another, patients with FMF experience other symptoms, both gastrointestinal and extraintestinal, characteristic of gluten/wheat sensitivity not linked to celiac disease or immunoglobulin E (IgE)-mediated wheat allergy (i.e. Non-Celiac Wheat Gluten/Sensitivity, NCGS/NCWS).Therefore, this study aims to evaluate the appearance of symptoms compatible with an acute attack of FMF following the ingestion of wheat or other foods, and the prevalence of self-perceived gluten/wheat sensitivity in patients with FMF. ### Conditions - Familial Mediterranean Fever - Non-celiac Gluten Sensitivity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Main questionnaire - Secondary questionnaire ### Outcomes Primary Outcomes - Prevalence of the self-perception of wheat as a potential trigger of acute attack in patients with familial Mediterranean fever (FMF) - Prevalence of the self-perception of other foods, other than wheat, as potential triggers of an acute attack in patients with FMF - Prevalence of self-reported NCGS/NCWS in patients with FMF Secondary Outcomes - Genetic differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Genetic differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Genetic differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Ethnic group differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Ethnic group differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Ethnic group differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Education level differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Education level differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Education level differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Working activity differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Working activity differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Working activity differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Gastrointestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Gastrointestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Extraintestinal symptoms differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Extraintestinal symptoms differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Extraintestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Extraintestinal symptoms duration between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Gastrointestinal symptoms duration differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Gastrointestinal symptoms duration differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - FMF specific drugs intake differences between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - FMF specific drugs intake differences between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - FMF specific drugs intake differences between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Differences in number/year of FMF attacks between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Differences in number/year of FMF attacks between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Differences in FMF specific drugs intake adherence between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Differences in FMF specific drugs intake adherence between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Differences in marital status between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Differences in marital status between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Differences in marital status between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Differences in age at FMF diagnosis between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Differences in age at FMF diagnosis between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. - Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of wheat and those who do not identify this specific food as a potential trigger of the disease flares. - Differences in age at FMF symptom's onset between FMF patients who perceive a trigger effect of foods other than wheat and those who do not identify foods other than wheat as a potential trigger of disease flares. - Differences in age at FMF symptom's onset between patients with FMF who self-report NCGS/NCWS and those who do not self-report it. ### Location - Facility: University Hospital of Palermo, Palermo, Sicily, 90127, Italy @@
## PAtient Treatment Analysis: Hospital and Wide-ranging Out-of-hospital Care Assessment Yields Insights Into Heart Failure Outcomes - NCT ID: NCT06338878 - Study ID: 2023PI087 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-01 - Lead Sponsor: Pr. Nicolas GIRERD ### Study Description This is a monocentric cohort study conducted in the cardiology department of Nancy hospital. The main purpose of the study is to document the global management strategy of patients hospitalized for heart failure and evaluate the association between patient's care and post-hospitalization outcome. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause post-hospitalization mortality - Rehospitalization for heart failure Secondary Outcomes - Percentage of maximum dose of each cardiotropic treatment indicated in heart failure according to ESC recommendations - Influenza and pneumococcal vaccination status - Evolution of renal function - All-cause Rehospitalization - All-cause mortality ### Location - Facility: CHRU de Nancy, Nancy, N/A, N/A, France @@
## Short Title: Standard vs. Lower Pressure Pneumoperitoneum - NCT ID: NCT06338865 - Study ID: Study00003146 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Cedars-Sinai Medical Center ### Study Description This study aims to investigate the effect of varying insufflation pressures on post-operative pain and adequacy of surgical field visualization among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. ### Conditions - Laparoscopic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Carbon dioxide - Bupivacaine - Oxycodone ### Outcomes Primary Outcomes - Maximum documented pain score in post-anesthesia care unit (PACU) (numerical rating scale, 0-10) Secondary Outcomes - First reported pain score in PACU (numerical rating scale, 0-10) - Last reported pain score in PACU prior to discharge (numerical rating scale, 0-10) - Inpatient morphine milligram equivalents - Total number of 5mg oxycodone pills taken in the 2 weeks following discharge - Need for insufflation pressure increase intra-operatively due to inadequate visualization - Operative time - Estimated blood loss - Intraoperative complications - Conversion to laparotomy - Postoperative length of stay - Surgeon-reported adequacy of assigned insufflation pressure - Need for adjustment of insufflation pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse - NCT ID: NCT06338852 - Study ID: 4347 - Status: COMPLETED - Start Date: 2023-03-03 - Completion Date: 2023-07-03 - Lead Sponsor: Cairo University ### Study Description The aim of this study will be to detect if there is awareness of gynecologists about the role of physical therapy in genital prolapse.Physical therapy plays an important role in assessment, prevention and treatment of pelvic floor dysfunction and genital prolapse, it helps to stimulate and strength pelvic floor muscle.Physical therapy treatments for the pelvic floor may include bladder training, pelvic floor muscles training with or without biofeedback, vaginal cones, electro stimulation or other adjuncts to training. ### Conditions - Genital Prolapse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Socio demographic and evaluation questionnaires ### Outcomes Primary Outcomes - Socio demographic and evaluation questionnaires Secondary Outcomes ### Location - Facility: Faculty of physical therapy cairo university, Cairo, N/A, 37617692, Egypt @@
## Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia - NCT ID: NCT06338839 - Study ID: D8450R00006 - Status: RECRUITING - Start Date: 2023-12-28 - Completion Date: 2024-11-30 - Lead Sponsor: AstraZeneca ### Study Description A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice.The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis ### Conditions - Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of ATTR-CM in patients with HFpEF in routine clinical practice in the Russian Federation Secondary Outcomes - demographic and clinical characteristics, and test results ### Location - Facility: Research Site, Akhtubinsk, N/A, N/A, Russian Federation @@
## Study Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses - NCT ID: NCT06338826 - Study ID: ANRS0250s-BI-LIGHT - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-02-28 - Lead Sponsor: ANRS, Emerging Infectious Diseases ### Study Description The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy ### Conditions - HIV Infections - HBV Coinfection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI - Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR) ### Outcomes Primary Outcomes - The proportion of participants with HBV virological failure at 96 weeks. Secondary Outcomes - • HBV virological success rate at 48 weeks - • HIV virological success rate at 48 and 96 weeks - • Time to virological failure (rebound HBV and/or HIV viral load) - • The rate of participants with at least one HBV viral load blip until W48 and until W96 - • Selection of HBV resistance mutations at the time of virological failure - • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96 - • Evolution of CD4 from W0 to W48 and W96 - • Evolution of total cholesterol from W0 to W48 and W96 - • Evaluation of the adherence by self-reported questionnaire - • Evaluation of quality of life using the Pro-Qol self-questionnaire - Evolution of CD8 T lymphocytes from W0 to W48 and W96 - Evolution of the CD4/CD8 ratio from W0 to W48 and W96 - Evolution of LDL-c from W0 to W48 and W96 - Evolution of HDL-c from W0 to W48 and W96 - Evolution of triglycerides from W0 to W48 and W96 - Evolution of fasting blood sugar from W0 to W48 and W96 - HBV virological success rate at 96 weeks between arms ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Digital Manometry for Intra-Abdominal Pressure Measurement in Ileus - NCT ID: NCT06338813 - Study ID: Merve Unutmaz - Status: COMPLETED - Start Date: 2022-10-30 - Completion Date: 2023-03-01 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Although many measurement techniques have been tried for intra-abdominal pressure, the Kron technique is currently the gold standard method. However, the search for other methods continues due to its long application time, the need for more equipment, and impracticality. Consequently, the investigators sought to investigate a quicker and more accessible method suitable for successful intra-abdominal pressure measurement in the emergency department. This study aimed to compare intra-abdominal pressure measurements in patients diagnosed with ileus using a digital manometer and the Kron Technique. ### Conditions - Ileus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SCREENING ### Interventions - Digital Manometry ### Outcomes Primary Outcomes - Digital manometer measuring for Intraabdominal Pressure Secondary Outcomes ### Location - Facility: Ankara City Hospital, Ankara, N/A, 06100, Turkey @@
## One Session Virtual Reality During Ongoing Treatment for Anxiety: Feasibility in Children and Adolescents - NCT ID: NCT06338800 - Study ID: PSY-2324-S-0134 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Accare ### Study Description The goal of this study is to evaluate one session with exposure with Virtual Reality (VR) in in children and adolescents, aged 8-18 years with an anxiety disorder. The main questions it aims to answer are:1. What are the expectations of children and adolescents and therapists with VR exposure?2. What is the acceptability of the VR session (positive and negative effects)?3. What are possible working mechanisms of VR exposure? During ongoing treatment, participants will receive a session of exposure with VR. ### Conditions - Anxiety Disorders - Exposure - Social Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - One session exposure with Virtual Reality ### Outcomes Primary Outcomes - Willingness to participate in exposure in vivo Secondary Outcomes - Idiosyncratic expectations - Anxiety - Expectations of Virtual Reality - Acceptability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Novel Iron-Based Supplement for Athletes Aged 14-17 - NCT ID: NCT06338787 - Study ID: 23-0826.2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: University of Calgary ### Study Description Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females. ### Conditions - Iron Deficiencies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FeSC ### Outcomes Primary Outcomes - Iron Status - Hemoglobin - Lower Gut microbiome Secondary Outcomes - Exercise Capacity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive Control to Boost Physical Activity Adherence - NCT ID: NCT06338774 - Study ID: 202310129 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-11-30 - Lead Sponsor: University of Iowa ### Study Description This trial is designed to develop and test the efficacy of cognitive training strategies to improve self-regulatory capacities for middle-aged adults to adopt and sustain a physically active lifestyle. The main questions it aims to answer are:* Can cognitive training designed to improve cognitive control improve physical activity adherence?* What are the psychological, physiological, cognitive, and sociodemographic factors that affect the impact of cognitive control on physical activity adherence?Participants will* Complete a 6-week home-based, computerized cognitive training program* Complete a 6-week home-based, aerobic exercise training program with supervision of a health coach and trainer* Complete a 6-week home-based, aerobic exercise training program prescribed by a health coach and trainer* Visit the laboratory before and after cognitive training, and before and after physical training, to complete assessments of cognition and aerobic fitness ### Conditions - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Cognitive training - Exercise ### Outcomes Primary Outcomes - Physical Activity Adherence Secondary Outcomes ### Location - Facility: Psychological and Brain Sciences Building, Iowa City, Iowa, 52242, United States @@
## Switching to E-cigarette After PCI - NCT ID: NCT06338761 - Study ID: E-cigarette PCI - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description Despite the increasing popularity of electronic cigarettes (E-cigarettes), the prognostic impact of switching to E-cigarettes in smokers with coronary artery disease (CAD) who underwent percutaneous coronary intervention (PCI) remains uncertain. ### Conditions - Coronary Artery Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Smoking cessation - Switching to E-cigarette ### Outcomes Primary Outcomes - MACE Secondary Outcomes - Cardiovascular death - All-cause death - Spontaneous myocardial infarction - Repeat revascularization ### Location - Facility: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of @@
## Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery - NCT ID: NCT06338748 - Study ID: 24-157 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: The Cleveland Clinic ### Study Description This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated. ### Conditions - Continuous Glucose Monitoring ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Continuous glucose monitor (CGM) Dexcom G7 used in blinded mode ### Outcomes Primary Outcomes - Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU - Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors Secondary Outcomes ### Location - Facility: The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States @@
## Ultra-High Frequency Ultrasonography in Sjögren's Syndrome - NCT ID: NCT06338735 - Study ID: 14540 - Status: RECRUITING - Start Date: 2016-01-11 - Completion Date: 2030-12 - Lead Sponsor: University of Pisa ### Study Description Patients diagnosed with a diagnosis of Sjogren's syndrome performed according to the ACR/EULAR criteria will be included in the study. Sjogren's syndrome diagnosis will be performed following a complete diagnostic work-up involving rheumatologic assessment, glandular functional tests, and blood testing for anti-Ro(SSA) antibodies. Conventional ultrasonography of major salivary glands and ultra-high frequency ultrasonography (70 MHz) of minor salivary glands will be performed, and the scans assessed using the Outcome Measures in Rheumatology (OMERACT) scoring system (Score 0 normal glandular tissue, Score 1 mild glandular alteration, fine echogenicity or diffuse hypo-echogenicity, Score 2 moderate glandular alteration and focal hypoechoic areas with partial conservation of normal parenchyma, Score 3 diffuse presence of hypoechoic areas in the absence of normal glandular parenchyma with glandular fibrosis. Focus Score will be assessed following biopsy of minor salivary glands. ### Conditions - Sjogren's Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Ultra-High Frequency Ultrasound scan of minor salivary glands ### Outcomes Primary Outcomes - OMERACT score - Correspondence between ultrasonography and histology Secondary Outcomes ### Location - Facility: University of Pisa, Pisa, N/A, 56126, Italy @@
## Making it Work Program for Systemic Sclerosis - NCT ID: NCT06338722 - Study ID: 23-397 - Status: RECRUITING - Start Date: 2023-12-08 - Completion Date: 2024-09-30 - Lead Sponsor: University of New Mexico ### Study Description The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time. ### Conditions - Scleroderma, Systemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Making it Work Systemic Sclerosis ### Outcomes Primary Outcomes - Job Related Self-efficacy Scale - Job Self-Efficacy Scale Secondary Outcomes - Work Productivity and Activity Impairment Questionnaire Specific Health Problem Subscale - The Work Instability Scale ### Location - Facility: University of New Mexico, Albuquerque, New Mexico, 87131-0001, United States @@
## Clinical Study Protocol for the Assessment of Safety and Efficacy of the BARICLIP® - NCT ID: NCT06338709 - Study ID: 11-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2026-08 - Lead Sponsor: Advanced Bariatric Technology ### Study Description Overweight and obesity are at epidemic proportions in the world population as well as in the United States, where nearly 42% of the adult population(1) is considered to meet the definition of obesity, namely a body mass index ("BMI") ≥ 30 kg/m2. Well-established links between obesity and increased morbidities and mortality make treatment of the utmost importance; however, there continues to be a significant unmet need for more effective treatments for obesity. Bariatric surgery is recognized as an effective treatment for obese patients, particularly in more severe cases where surgical restriction of the stomach's capacity and outlet size are considered necessary. The BariClip® is a laparoscopically implanted device for treatment of obesity and serves as an alternative to current existing technology for use in bariatric surgery. The BariClip® is a medical device, non-adjustable, resembling a clip that is placed parallel to the greater curvature of the stomach, causing restriction of the gastric lumen in a vertical fashion. This multi-center, randomized, moderate-lifestyle (program of diet and exercise) controlled pivotal study of the BariClip® device is intended to gather data to objectively support its safety and effectiveness for the treatment of obesity in adults and to ultimately support marketing authorization of this device as a viable alternative to existing bariatric surgical procedures. Specifically, this study aims to look at efficacy of the BariClip® device with regards to weight loss metrics and secondary health metrics and safety of the BariClip® device with regards to serious adverse events. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BariClip® Device Treatment ### Outcomes Primary Outcomes - Achieving ≥ 5% total body weight loss (TBWL) in 50% of treated subjects - Achieving ≥ 5% superiority margin for weight loss in the treated group as compared to the control group Secondary Outcomes - Weight and Height will be combined to report BMI in kg/m^2 - Blood Pressure (BP) in mmHg, both systolic and diastolic - Diagnosis and/or Change in Severity of Diabetes Mellitus (DM) - Weight in kilograms - Height in meters - Waist Circumference in centimeters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Thailand ATTR-CM Registry - NCT ID: NCT06338696 - Study ID: COA-CREC070/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2030-06-30 - Lead Sponsor: Mahidol University ### Study Description The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand. ### Conditions - Transthyretin Amyloid Cardiomyopathy (ATTR-CM) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Rate of death - Rate of heart failure hospitalization Secondary Outcomes - Transthyretin (ATTR) amyloidosis medication ### Location - Facility: Faculty of Medicine at Chulalongkorn University, Bangkok, N/A, N/A, Thailand @@
## Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer - NCT ID: NCT06338683 - Study ID: QRCH-2024001 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2028-03-20 - Lead Sponsor: Qinghai Red Cross Hospital ### Study Description This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival. ### Conditions - Advanced Cancer - Olanzapine - Progression Free Survival ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Olanzapine 2.5 MG - Standard anti-tumor treatment - Nutritional advice ### Outcomes Primary Outcomes - Comparing the difference in Median PFS between the two groups Secondary Outcomes - Comparing the difference in Median OS between the two groups - Comparing the difference in ORR between the two groups - Comparing the difference in the incidence of ≥3% weight loss between the two groups - Comparing the difference in BMI between the two groups - Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups - Comparing the difference in Quality of life in the overall stage between the two groups - neutrophil-to-lymphocyte ratio - platelet-to-lymphocyte ratio - C-reactive protein (CRP) concentration - concentration of albumin - Level of interleukin (IL)-6 and IL-8 - Comparing the difference in the side effects of olanzapine treatment between the two groups ### Location - Facility: Qinghai Red Cross Hospital, Xining, Qinghai, 810000, China @@
## Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Users - NCT ID: NCT06338670 - Study ID: CLTD5839 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-11-22 - Lead Sponsor: Cochlear ### Study Description This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors. ### Conditions - Hearing Loss, Mixed Conductive-Sensorineural - Hearing Loss, Conductive ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cochlear Osia 3 Sound Processor - Cochlear™ Osia® 2 Sound Processor ### Outcomes Primary Outcomes - Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL - Change (within subject) in word recognition score in quiet measured at 65 dB SPL - Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz - Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips - Percentage of participants who preferred Osia 3 over Osia 2 sound processor Secondary Outcomes ### Location - Facility: The HEARing CRC, Melbourne, Victoria, 3053, Australia @@
## FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer - NCT ID: NCT06338657 - Study ID: 7H-23-5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2027-04-04 - Lead Sponsor: University of Southern California ### Study Description This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Computed Tomography - Magnetic Resonance Imaging - PEOX-based Polymer Encapsulated Paclitaxel FID-007 - Tumor Resection ### Outcomes Primary Outcomes - Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007 Secondary Outcomes - Incidence of adverse events (AEs) - Major pathologic response rate - Complete pathologic response rate - Rate of locoregional recurrence - Rate of distant metastasis ### Location - Facility: Los Angeles General Medical Center, Los Angeles, California, 90033, United States @@
## Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients. - NCT ID: NCT06338644 - Study ID: HelwanUY - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-09-01 - Lead Sponsor: Helwan University ### Study Description Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies ### Conditions - Hormone-receptor-positive Breast Cancer - Human Epidermal Growth Factor 2 Negative Carcinoma of Breast - Metastatic Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Palbociclib ### Outcomes Primary Outcomes - 1-year Progression free survival (PFS) Secondary Outcomes - Neutropenia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess" - NCT ID: NCT06338631 - Study ID: 43C301 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk.It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients.The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity.The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diet ### Outcomes Primary Outcomes - Glomerular filtration rate - Microalbuminuria - Glycemia - Body mass index Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Città Studi ICANS, Milano, N/A, 20100, Italy @@
## Manual Therapy in Metabolic Liver Disease - NCT ID: NCT06338618 - Study ID: 1532-N-23 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-08 - Lead Sponsor: University of Seville ### Study Description Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver. ### Conditions - NAFLD, Non-alcoholic Fatty Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - liver treatment protocol ### Outcomes Primary Outcomes - Hepatic steatosis index Secondary Outcomes - FIB-4 index - NAFLD-fibrosis index - HOMA index - TyG index - Change from baseline in algometry - Visual analogue Scale ### Location - Facility: Universitary Hospital Juan Ramón Jiménez, Huelva, N/A, 21005, Spain @@
## Evaluating the Incidence of Pseudo-Acute Kidney Injuries in Patients With Metastatic Breast Cancer on CDK4/6 Inhibitors Trough Cystatin C Analysis - NCT ID: NCT06338605 - Study ID: MEC-2023-0715 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-12 - Completion Date: 2024-06-01 - Lead Sponsor: Erasmus Medical Center ### Study Description CDK4/6 inhibitors have led to an improvement of both progression free survival (PFS) and overall survival (OS) in patients with advanced estrogen positive (ER+)/HER2- breast cancer when applied in the first or second line of treatment. Despite the advantages of CDK4/6 inhibitors, these medications can lead to adverse effects. One of the adverse events observed across all types of CDK4/6 inhibitors is an elevation in creatinine levels. An elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. This phenomenon is known as pseudo acute kidney injury (pseudo-AKI).The incidence of pseudo-AKI in patients using CDK4/6 inhibitors is currently unknown. A method to distinguish pseudo-AKI from AKI is measuring the level of an alternative filtration marker in blood, for example cystatin C. Cystatin C is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. Also, there is no affection by muscle mass or diet. In this study the investigators will explore the incidence of both AKI and pseudo-AKI in patients who are treated with CDK4/6 inhibitor treatment by assessing both creatinine and cystatin C in plasma. ### Conditions - Advanced Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention, observational study of AKI under CDK4/6 inhibitor treatment ### Outcomes Primary Outcomes - Pseudo-AKI in patients on CDK4/6 inhibitors Secondary Outcomes - Pseudo-AKI in patients on CDK4/6 inhibitors per drug - AKI in patients - Influencing factors cystatin C levels ### Location - Facility: Erasmus Medical Center, Rotterdam, N/A, N/A, Netherlands @@
## The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale - NCT ID: NCT06338592 - Study ID: UUtah_00153806 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-12-31 - Lead Sponsor: University of Utah ### Study Description Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making. ### Conditions - Lung Cancer - Lung Neoplasms/Diagnosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - MyLungHealth - DecisionPrecision+ ### Outcomes Primary Outcomes - Study 1 primary outcome: Percentage of participants identified as eligible for LCS. - Study 2 primary outcome: Percentage of participants for whom LDCT was ordered. Secondary Outcomes - Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered. - Study 1 secondary outcome: Percentage of participants for whom LDCT was completed. - Study 2 secondary outcome: Percentage of participants for whom LDCT was completed. - Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed. ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Overview of Self-medication Among French Navy Personnel - NCT ID: NCT06338579 - Study ID: 2023PPRC04 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Direction Centrale du Service de Santé des Armées ### Study Description The goal of this cross-sectional descriptive observational study is to assess the extent of self-medication among the crews of surface ships at the Toulon naval base. This study could include healthy volunteers, or participants with well-controlled chronic pathologies enabling them to be fit for embarkation, who are currently being deployed for at least 4 weeks on a surface ship at the naval base.Participants will tick and complete a questionnaire (between 15 and 30 minutes) after 4 consecutive weeks on the ship. ### Conditions - Self Medication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - percentage of patients who have self-medication Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle - NCT ID: NCT06338566 - Study ID: 2021PPRC10 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-04 - Lead Sponsor: Direction Centrale du Service de Santé des Armées ### Study Description The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting.Patients will be asked to complete a questionnaire during follow-up consultations. ### Conditions - Ankle Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Follow-up ### Outcomes Primary Outcomes - bony outcome of transcalcaneal nailing Secondary Outcomes - functional result of the procedure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab - NCT ID: NCT06338553 - Study ID: 231620 - Status: RECRUITING - Start Date: 2024-06 - Completion Date: 2027-03 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under three different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The first meal test is pre-teplizumab, followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population. ### Conditions - Type 1 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - Semaglutide (Rybelsus®) ### Outcomes Primary Outcomes - Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study - Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study - Determine the impact of GLP-1Ra on endothelial function in a pilot study Secondary Outcomes ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States @@
## Relation of Caries Color to Caries Severity and Its Microbial Load - NCT ID: NCT06338540 - Study ID: A26020822 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-07-01 - Lead Sponsor: Mansoura University ### Study Description This study is to find the relation of caries color to caries severity and its microbial load in primary molars. ### Conditions - Relation of Caries Color ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Black color of caries - dark brown color of caries - light brown color of caries - yellow color of caries ### Outcomes Primary Outcomes - Caries color related to history of pain - Caries color related to ICDAS - Caries color related to pulp exposed - Caries color related to microbial load Secondary Outcomes ### Location - Facility: Mansoura university, Mansoura, Dakahlia, 35511, Egypt @@
## Effects of Aromatherapy on Patients Undergoing Chemotherapy for Breast Cancer - NCT ID: NCT06338527 - Study ID: 2024YX321 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-06-15 - Lead Sponsor: Weifang Medical University ### Study Description The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer. ### Conditions - Sleep Quality - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aromatherapy - No intervention ### Outcomes Primary Outcomes - Sleep quality - Anxiety Secondary Outcomes ### Location - Facility: Weifang People's Hospital, Weifang, Shangdong, 261000, China @@
## The Effectiveness of Dry Needling Treatment in Patients Diagnosed With Dorsal Myofascial Pain Syndrome. - NCT ID: NCT06338514 - Study ID: KutahyaHSU-DRYNEEDLE-dorsalgia - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-06-25 - Lead Sponsor: Kutahya Health Sciences University ### Study Description Back pain is commonly seen in the working-age population, with the peak occurrence around the age of 40. Its frequency does not increase with age and is not associated with age-related degenerative changes in the spine. Especially when the underlying cause is conditions such as myofascial pain syndrome (MPS), where regional muscle sensitivity in the rhomboid and trapezius areas is prominent, dry needling treatment has become increasingly popular and the subject of numerous studies in recent years. In the diagnosis of MPS, two valuable findings include the detection of a taut band upon palpation and the presence of trigger points in muscle fibers with mild finger pressure. The study we are planning involves a double-blind efficacy trial where real and sham dry needling procedures will be performed under ultrasound guidance, ensuring that both the patient and the evaluator are blinded. This study design has the potential to make a significant contribution to the literature in this field. ### Conditions - Myofascial Trigger Point Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Real dry needling - Sham dry needling ### Outcomes Primary Outcomes - Visual Analog Scale - Patient-Specific Functional Scale - Pressure Pain Threshold Measurement Secondary Outcomes - What does Oswestry stand for? The Oswestry Disability Index (ODI) - The 12-item Short-Form Health Survey version 2 (SF-12v2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Heart Rate Variability, Performance and Dehydration in Muay Thai Athletes - NCT ID: NCT06338501 - Study ID: 77325224.4.0000.5235 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-06-30 - Lead Sponsor: Centro Universitário Augusto Motta ### Study Description Known as "Thai boxing," Muay Thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." It is practiced worldwide and is a prominent discipline in many mixed martial arts (MMA) training camps. In this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. In the context of combat sports, such as Muay Thai, heart rate variability (HRV) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. Additionally, HRV can also serve as a tool for assessing recovery after training or competition. If HRV does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. Due to the absence of studies in the literature that have assessed a possible association between HRV and dehydration and rehydration processes in amateur Muay Thai athletes, it becomes essential to evaluate this correlation. Given the growing interest in practicing Muay Thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. Therefore, the aim of this study is to investigate the relationship between dehydration indicators, HRV parameters, and performance in the frequency speed kick test (FSKT). Participants will be assessed before and after an eight-week training program, conducted three times a week. Assessments will include resting HRV measurement and FSKT; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. It is expected that the results will reveal changes in HRV, performance, and body composition of the athletes after training. ### Conditions - Nervous System Diseases - Dehydration ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Specifical Functional Training Exercises ### Outcomes Primary Outcomes - HRV during specifical physical test Secondary Outcomes - Correlation with BIA analysis, HRV and Specific Physical Test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Dry Needling Treatment in Patients With Shoulder Myofascial Pain Syndrome - NCT ID: NCT06338488 - Study ID: KutahyaHSU-DRYNEEDLE-SHOULDER - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-06-25 - Lead Sponsor: Kutahya Health Sciences University ### Study Description Myofascial pain can be diagnosed by the presence of one or more myofascial trigger points (MTrPs), defined as hyperirritable spots in taut bands of skeletal muscle fibers palpable by hand. The treatment of myofascial pain primarily relies on the inactivation of MTrPs, often through manual pressure techniques or dry needling. In manual pressure techniques, the physiotherapist applies increasing pressure directly to the MTrP. In dry needling, acupuncture-like filiform needles are applied to the same point. There are two types of dry needling: superficial dry needling, which penetrates only the skin and superficial muscle, and deep dry needling, which involves inserting a needle directly into the MTrP. The sole or adjunct effectiveness of dry needling treatment targeting the trapezius and infraspinatus muscles has been investigated, particularly in patients with shoulder myofascial pain syndrome. In the study we are planning, a double-blinded efficacy trial will be conducted in patients with shoulder myofascial pain syndrome, where real and sham dry needling applications will be performed under ultrasound guidance, with both the patient and the evaluator blinded. This study design has the potential to make a significant contribution to the literature in this field. ### Conditions - Shoulder Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Real dry needling - Sham dry needling ### Outcomes Primary Outcomes - Visual Analog Scale - Patient-Specific Functional Scale - Pressure Pain Threshold Measurement Secondary Outcomes - The Shoulder Pain and Disability Index (SPADI) - The Quick DASH Outcome Measure - The 12-item Short-Form Health Survey version 2 (SF-12v2) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Biobehavioral Intervention for Latino/Hispanic Young Adults With Cancer - NCT ID: NCT06338475 - Study ID: 20205703 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06 - Lead Sponsor: University of California, Irvine ### Study Description Building upon the results of a single-arm trial designed to investigate the feasibility and acceptability of a novel intervention, Goal-focused Emotion-Regulation Therapy (GET), this trial is a randomized-controlled biobehavioral pilot trial of GET versus a time-and attention matched control (Instrumental Supportive Listening; ISL) in Latino/Hispanic young adult cancer survivors. Outcomes include improved distress symptoms, emotion regulation, goal navigation skills, and changes in stress-sensitive biomarkers.Participants will be randomized to receive six sessions of GET or ISL delivered over eight weeks. In addition to indicators of intervention feasibility, the investigators will measure primary and secondary psychological outcomes prior to (T0), immediately after (T1), and twelve weeks after intervention (T2). Additionally, identified biomarkers will be measured at baseline and at T1, and T2. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Goal-Focused Emotion-Regulation Therapy (GET) - Individual Supportive Listening (ISL) ### Outcomes Primary Outcomes - Change in Hospital Anxiety and Depression Scale (HADS) - Change in Systemic Pro-inflammatory Cytokine Levels (IL-6, IL-1ra, C-reactive Protein (CRP), sTNFαRII) - Change in Salivary Diurnal Cortisol Slope and Daily Output Secondary Outcomes - Change in Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) Subscale Score - Change in Career Thoughts Inventory (CTI) Global Score - Change in Emotion Regulation Questionnaire (ERQ) Scale Scores - Change in Cancer Assessment for Young Adults (CAYA-T) - Goal Navigation Score - Change in Emotional Approach Coping Questionnaire (EAC) Scale Scores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cali Sin Tos Aim 2 - NCT ID: NCT06338462 - Study ID: 2000034128 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Yale University ### Study Description The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique). ### Conditions - Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Chatbot - Oral testing ### Outcomes Primary Outcomes - Implementation of the mHealth strategy to assess feasibility. - Oral specimen collection to assess feasibility. Secondary Outcomes ### Location - Facility: Centro Internacional de Entrenamiento e Investigaciones Medicas (CIDIEM), Cali, N/A, N/A, Colombia @@
## The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease - NCT ID: NCT06338449 - Study ID: XZMU-2022-ZK068 - Status: COMPLETED - Start Date: 2022-10-13 - Completion Date: 2022-12-31 - Lead Sponsor: Xuzhou Medical University ### Study Description The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?Participants will:Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen. ### Conditions - Non-alcoholic Fatty Liver Disease NAFLD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic training (AT) - Resistance training (RT) - Combined aerobic and resistance training (AT + RT) ### Outcomes Primary Outcomes - Changes in body weight compared to baseline at 8 weeks - Changes in Body Mass Index compared to baseline at 8 weeks - Changes in total cholesterol compared to baseline at 8 weeks - Changes in triglycerides compared to baseline at 8 weeks - Changes in high-density lipoprotein compared to baseline at 8 weeks - Changes in low-density lipoprotein compared to baseline at 8 weeks - Changes in alanine aminotransferase compared to baseline at 8 weeks - Changes in aspartate aminotransferase compared to baseline at 8 weeks - Changes in alkaline phosphatase compared to baseline at 8 weeks - Changes in gamma-glutamyl transferase compared to baseline at 8 weeks - Changes in direct bilirubin compared to baseline at 8 weeks - Changes in total bile acids compared to baseline at 8 weeks - Changes in adenosine deaminase compared to baseline at 8 weeks Secondary Outcomes - Changes in percentage of body fat compared to baseline at 8 weeks - Changes in waist-to-hip ratio compared to baseline at 8 weeks - Changes in blood glucose compared to baseline at 8 weeks - Changes in the level of insulin compared to baseline at 8 weeks - Changes in albumin compared to baseline at 8 weeks - Changes in C-reactive protein compared to baseline at 8 weeks ### Location - Facility: Outdoor track and field facility of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China @@
## Varian ProBeam Proton Therapy System China Clinical Trial (Guangzhou) - NCT ID: NCT06338436 - Study ID: VAR-2022-05 - Status: COMPLETED - Start Date: 2022-12-21 - Completion Date: 2023-11-13 - Lead Sponsor: Varian, a Siemens Healthineers Company ### Study Description This study is prospective, single-center, single-arm objective performance criteria.This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. ### Conditions - Tumor, Solid ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Proton Radiation Therapy System (ProBeam) ### Outcomes Primary Outcomes - Effectiveness evaluation: Local tumor control rate 90 days after the proton radiation treatment completion - Safety evaluation: Incidence of Acute radiation injury - Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria Secondary Outcomes ### Location - Facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, N/A, China @@
## Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure - NCT ID: NCT06338423 - Study ID: JagiellonianU-08 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2022-12-31 - Lead Sponsor: Jagiellonian University ### Study Description This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.Method PatientsA prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:* January 2015 - December 2016 - only standard mattresses were used* January 2017 - December 2019 - both types of mattresses were used* January 2020 - December 2022 - only vacuum mattresses were usedParticipants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol \< 85%.Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center\[\]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day ### Conditions - Rhabdomyolysis - Acute Kidney Injury - Bariatric Surgery Candidate ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - vacuum mattress - Standard Mattress ### Outcomes Primary Outcomes - Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI) Secondary Outcomes - Concentration of myoglobin marker - Concentration of creatine kinase marker - Concentration of creatinine marker ### Location - Facility: Jagiellonian University Mecical Collage, Kraków, Malopolskie, 31-501, Poland @@
## Effect of Kangaroo Mother Care on Oxidative Stress and Bonding - NCT ID: NCT06338410 - Study ID: UHS/Education/126-24/131 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2024-03-20 - Lead Sponsor: University of Health Sciences Lahore ### Study Description The goal of this clinical trial is to learn if Kangaroo Mother care can have effect on oxidative stress in premature neonates. It will also learn about the bonding between mother and her premature infant. The main questions it aims to answer are:* Does Kangaroo mother care lower the biomarker of oxidative stress in premature neonates?* Is Kangaroo mother care associated with mother-infant bonding? Researchers will compare Kangaroo mother care to Conventional incubator care to see if Kangaroo mother care works to have effect on oxidative stress.Participants will be:* given Kangaroo mother care on third day of life or standard incubator care for one hour* Urine sample for oxidative stress biomarker will be collected via noninvasive method before and after Kangaroo mother care or conventional incubator care from premature neonates.* Mother-infant bonding scale will be filled by mothers of enrolled premature infants before and after kangaroo mother care and conventional incubator care ### Conditions - Kangaroo Mother Care - Oxidative Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kangaroo Mother Care ### Outcomes Primary Outcomes - biomarker of Oxidative Stress (Allantoin) in urine sample of premature infants - Mother- Infant Bonding Secondary Outcomes ### Location - Facility: Services Hospital, Lahore, Lahore, Punjab, 54000, Pakistan @@
## Social & Affective Cognition in Alzheimer's Disease & Associated Disorders - NCT ID: NCT06338397 - Study ID: 2023_0455 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2027-05-02 - Lead Sponsor: University Hospital, Lille ### Study Description Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains. ### Conditions - Alzheimer's Disease - Frontotemporal Degeneration (Semantic & Behavioral Variants) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - SCANN ### Outcomes Primary Outcomes - Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants. Secondary Outcomes - Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants. - Correlation coefficient between the SBOC score with MRI markers in all participants - Correlation coefficient between mini-SEA sub scores & MRI markers in all participants. - Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. - Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examining Engagement Trends Among Participants in Peripheral Neuropathy Clinical Research - NCT ID: NCT06338384 - Study ID: 44735129 - Status: NOT_YET_RECRUITING - Start Date: 2025-04 - Completion Date: 2027-04 - Lead Sponsor: Power Life Sciences Inc. ### Study Description This trial aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in peripheral neuropathy clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.Ultimately, this trial endeavors to deepen our understanding of the factors impacting peripheral neuropathy clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition. ### Conditions - Peripheral Neuropathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of peripheral neuropathy patients who decide to enroll in a clinical research - Rate of peripheral neuropathy patients who remain in clinical trial to trial completion Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Effect of Pelvic Floor Muscle Exercise on Sexual Function - NCT ID: NCT06338371 - Study ID: IZTU-TEKBAŞ-001 - Status: COMPLETED - Start Date: 2021-11-01 - Completion Date: 2022-05-06 - Lead Sponsor: Serap Tekbas ### Study Description The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months ### Conditions - Pelvic Floor Muscle Weakness - Sexuality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Pelvic Floor exercise training ### Outcomes Primary Outcomes - Determining Number of Participants - Initial scale application - Distribution of participants into groups Secondary Outcomes - Providing pelvic floor exercise for training group - Female Sexual Function Index - Female Sexual Function Index - Female Sexual Function Index ### Location - Facility: Izmir Tinaztepe University, İzmir, Buca, 35400, Turkey @@
## Understanding Participation Habits Among Plaque Psoriasis Patients - NCT ID: NCT06338358 - Study ID: 44519568 - Status: NOT_YET_RECRUITING - Start Date: 2025-04 - Completion Date: 2027-04 - Lead Sponsor: Power Life Sciences Inc. ### Study Description The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.The data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups. ### Conditions - Plaque Psoriasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of patients who decide to enroll in a plaque psoriasis clinical research. - Number of plaque psoriasis study participants who remain in clinical study until completion. Secondary Outcomes ### Location - Facility: Power Life Sciences, San Francisco, California, 94107, United States @@
## Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients - NCT ID: NCT06338345 - Study ID: 38RC23.0222 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2028-09-01 - Lead Sponsor: University Hospital, Grenoble ### Study Description The use of antibiotic therapy is common in intensive care units and primarily involves beta-lactams. Its optimal implementation is made difficult by the pharmacokinetic changes inherent in critically ill patients.Despite the current recommendations from the French Society of Anesthesiology and Intensive Care (SFAR) and the French Society of Pharmacology and Therapeutics (SFPT), there are no recommendations on prescription modalities for patients under veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The use of antibiotic therapy is common in VA-ECMO patients and their pharmacokinetic variability factors are then exacerbated.We aim to conduct a prospective, multicenter, interventional study designed to identify predictive factors for failure to achieve therapeutic target circulating concentrations of beta-lactams in patients under VA-ECMO treated with one of the studied beta-lactams ### Conditions - Cardiogenic Shock - Post-cardiac Surgery - Cardiac Arrest - Extracorporeal Membrane Oxygenation Complication - Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Therapeutic drug monitoring of beta-lactam ### Outcomes Primary Outcomes - Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. - Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. - Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. - Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. - Predictive factors for failure to achieve target plasma concentrations in patients under VA-ECMO treated with Piperacillin-Tazobactam, Cefepime, or Meropenem. Secondary Outcomes ### Location - Facility: CHU de Clermont Ferrand - Hôpital Gabriel Montpied, Clermont-Ferrand, N/A, 63003, France @@
## Obstructive Colon Cancer, a Bridge to Surgery in Right Sided Obstructive Colon Cancer - NCT ID: NCT06338332 - Study ID: AW23.050, W19.249 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-01 - Lead Sponsor: Amphia Hospital ### Study Description Rationale: Approximately 13% (range 10-28%) of all colorectal cancer patients (CRC) present with an acute obstruction. Postoperative mortality after an emergency resection is known for its high risk of morbidity and mortality. Different options can be considered in the management of obstructing right sided CRC: 1) primary resection, simultaneous treatment of obstruction and tumour resection, or 2) staged treatment of the obstruction with secondary resection of the tumour. Currently, in the Netherlands, an emergency resection has been judged to be inferior to postponing surgery. Patients who present with right sided obstructive colon cancer at one of the participating hospitals are subjected to a bridge to surgery (BTS) protocol.Objective: The primary objective of this study is to determine the feasibility of BTS protocols in right sided obstructive colon cancer and reduce mortality- and morbidity (stoma rates, major- and minor complications) rates in potentially curable patients presenting with acute obstructing colon cancer.Study design: This is a multicentre, prospective registration study Study population: All patients presenting with high clinical suspicion or histologically proven right sided colon cancer and signs of obstruction of the large bowel.Intervention: Prospective registration of the implementation of bridge to surgery protocols in patients with (acute) malignant right sided obstruction of the colon, without suspicion of perforation (tumour perforation or blow out) in order to optimize patients preoperatively. The BTS approach encompasses the utilization of either ileostomy creation, stent placement or nasogastric tube for decompression, which is subsequently followed by definitive surgical treatment at a later stage. BTS also involves pre-optimization, prior to the surgical procedure, with the following approach: optimizing the nutritional health status improving the physical health status of the patient.Main study parameters/endpoints: The primary endpoint is complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification ≥3). With a total follow up of three years. Secondary endpoints: overall mortality, morbidity (stoma rates, minor complications), in hospital stay, oncologic quality of resection and other occurring adverse events. ### Conditions - Colonic Neoplasms Malignant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Complication-free survival Secondary Outcomes - Complications overall - Type of surgical intervention - Time till surgery - Resection - TNM - Hospital stay - One year stoma rate - One year survival rates - Disease free survival rates one year - Disease free survival rates three years - Three year survival rates - Tumour type (obstructing, not obstructing), - Metastasis preoperative - Pre-operative diagnostics - Type of bridge-to-surgery - Nutrition (TPN/extra nutrition) - Consultation of other specialist ### Location - Facility: Amphia Hospital, Breda, Noord-Brabant, 4818CK, Netherlands @@
## Book Sharing for Toddlers With Clefts - NCT ID: NCT06338319 - Study ID: 23-048-E - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-08 - Lead Sponsor: Seattle Children's Hospital ### Study Description Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups. ### Conditions - Cleft Palate - Cleft Lip and Palate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Book-Sharing for Toddlers with Clefts (BOOST) ### Outcomes Primary Outcomes - Expressive One Word Picture Vocabulary Test-Fourth Edition - Receptive One Word Picture Vocabulary Test-Fourth Edition - Child Language Sample - MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test Secondary Outcomes - Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes - NCT ID: NCT06338306 - Study ID: 08073421 - Status: RECRUITING - Start Date: 2022-01-07 - Completion Date: 2025-06-30 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description Heart transplant is the only effective treatment for people with advanced heart failure.Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors.To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant.Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes.Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent.The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them.This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors.The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC".The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC).The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy. ### Conditions - Heart Transplant Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tacrolimus（FK506） ### Outcomes Primary Outcomes - Tacrolimus quantification in an unconventional matrix - Tacrolimus quantification in PBMCs - Tacrolimus quantification in whole blood Secondary Outcomes - Genetic profile in heart transplant recipients ### Location - Facility: Fondazione IRCCS Policlinico San Matteo, Pavia, N/A, 27100, Italy @@
## Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques - NCT ID: NCT06338293 - Study ID: KY20240123-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inclisiran sodium - Rosuvastatin ### Outcomes Primary Outcomes - The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) Secondary Outcomes - The change rate of TAV and plaque load of the target vascular lesion; - The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc. - The change rates of other components of plaque (fiber, calcification, crystal, macrophage) - The change rates of lesion OFR and target vessel OFR - The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Remotely Observed Methadone Evaluation II - NCT ID: NCT06338280 - Study ID: VDW002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Sonara Health ### Study Description Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Sonara ### Outcomes Primary Outcomes - Retention - Take homes received over time Secondary Outcomes - Opioid cravings - Urine toxicology - Opioid withdrawal severity - Health-related quality of life - Drug Abuse Treatment Costs Analysis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validation of Innovative Biosensors for Rett Autonomic Symptom Tracking - NCT ID: NCT06338267 - Study ID: SENS-102-RSRT - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Rett Syndrome Research Trust ### Study Description The VIBRANT study aims to validate biosensors to objectively and directly measure symptoms in Rett syndrome and create confidence in the use of these devices in clinical trials. VIBRANT will use several FDA-cleared wearable biosensors and a non-wearable device to collect symptom data from patients with Rett syndrome for up to 9 weeks. Symptoms of interest include heart rate, breathing, sleep, blood oxygen levels, and movement. Participants will use the biosensors intermittently at home, document device use and symptom status, and will come to the clinic for 1 overnight sleep study. A cohort of up to 10 participants receiving an intervention in a separate clinical trial may also enroll and participate on a custom device schedule for up to 1 year.The study will provide information on the feasibility and ease of use for families at home, biosensor data will be compared to data collected at the same time from the overnight sleep study to demonstrate how well they work in individuals with Rett syndrome, and Emerald will be developed to include movement as a measurable symptom. ### Conditions - Rett Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assess breathing rate and apnea (breath holds) with RespiraSense - Assess heart rate variability with Vivalink VV330 ECG patch - Assess blood oxygen levels with Viatom Kids O2 pulse oximeter ring - Validate FDA-cleared Vivalink VV330 ECG patch for heart rate variability metrics in Rett syndrome compared to in-lab PSG - Validate ECG-derived breathing compared to in-lab PSG - Validate FDA-cleared RespiraSense breathing sensor in Rett syndrome compared to in-lab PSG - Validate FDA-cleared Viatom Kids O2 pediatric pulse oximeter ring in Rett syndrome compared to in-lab PSG and/or Nonin wristOx pulse oximeter - Validate Emerald ability to reliably measure breathing and sleep compared to in-lab PSG - Validate Emerald ability to reliably measure breathing and sleep at home compared to FDA-cleared comparator - Develop Emerald ability to measure daytime movement Secondary Outcomes ### Location - Facility: Rush University, Chicago, Illinois, 60612, United States @@
## Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women - NCT ID: NCT06338254 - Study ID: E-10840098-772.02-5416 - Status: COMPLETED - Start Date: 2022-09-04 - Completion Date: 2023-06-10 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women. ### Conditions - Pregnancy Complications - Edema Leg - Physiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - percussion massage therapy ### Outcomes Primary Outcomes - The Visual Analog Scale (VAS) - Evaluation of edema - Fatigue Severity Scale (FSS) - Short Form-36 (SF-36) Secondary Outcomes ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model - NCT ID: NCT06338241 - Study ID: CPP2021-008391 - Status: RECRUITING - Start Date: 2024-03-02 - Completion Date: 2025-09-02 - Lead Sponsor: Mario Pérez Sayáns ### Study Description The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars. ### Conditions - Bone Loss - Regenerative Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin - Bovine Hydroxyapatite ### Outcomes Primary Outcomes - Bone Regeneration_Reduction in radiolucent volume - Bone Regeneration_bone volume - Bone Regeneration_bone density - Bone Regeneration_Fractal dimension Secondary Outcomes - Pain levels through visual analog scale - Clinical Inflammation evaluating by presence/absence - Healing measured by healing index - Post-surgical complications evaluated by presence or absense - Oral Health-related Quality of Life measured by OHIP-14 test ### Location - Facility: Faculty of Dentistry of Universidade de Santiago de Compostela, Santiago De Compostela, A Coruña, 15705, Spain @@
## A New Decisional Tree for the Management of Acetabular Fractures : Monocentric Observational Study - NCT ID: NCT06338228 - Study ID: 2023-A02458-37 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: University Hospital, Grenoble ### Study Description Acetabular fractures are challenging fractures to treat. Many fracture patterns occur, in a deep anatomical area surrounded by numerous vascular and nervous elements, generally in a polytraumatic context . A reduction with less than 2 mm of incongruence is generally considered acceptable, limiting post-operative osteoarthritis that could rapidly require total hip arthroplasty. Due to the long learning curve, this surgery is limited to large reference centers. In the last twenty years, the main series published in the literature are small series due to the rarity of the fractures and their trauma context (loss of follow-up, polytrauma patients...). The large variety of fracture patterns according to the Letournel classification creates a spread in patient distribution and decreases the power of statistical analysis. That is the reason why big series are rare and only a few of them allow significant conclusions . The other studies are meta-analyses with their limitationsThe lack of consensus makes it difficult to interpret the results between series, so the investigators developed a decision tree to address this knowledge gap.The aim of this study is to assess and compare the results of a decisional tree for acetabular fracture in a large cohort of patients from a well-known experimental trauma center. ### Conditions - Management of Acetabular Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The main objective of the study is to evaluate and compare the results of a decision tree for the management of acetabulum fractures (also called acetabulum) in a large cohort of patients from the trauma center at Grenoble University Hospital Secondary Outcomes - Define the prognostic factors associated with poor clinical outcomes and total hip replacement surgery - Compare clinical and radiological findings with the literature - Compare clinical and radiological findings with the literature - Compare clinical and radiological findings with the literature - Compare clinical and radiological findings with the literature - Compare clinical and radiological findings with the literature - Propose a new assessment of the traumatic hip joint based on PROMs (Patient Reported Outcomes Measures) via a dedicated digital application (Orthense by Digikare) - Evaluation of Outcomes and Complications of Early Weight Bearing in Older Adults ### Location - Facility: Grenoble Alpes University Hospital,La tronche, Grenoble, N/A, 38700, France @@
## Advice of Moderate Drinking Pattern Versus Advice on Abstention on Major Disease and Mortality - NCT ID: NCT06338215 - Study ID: UNATI_2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-06-30 - Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra ### Study Description The goal of this clinical trial is to test two advices on alcohol drinking in more than 10.000 Spanish adult drinkers (men of 50 or more years and women of 55 or more years).The main question it aims to answer is to test the non-inferiority advice of a moderate alcohol drinking pattern on all-cause mortality and other chronic disease like cardiovascular disease, cancer or type 2 diabetes.Participants will receive during 4 years an advice to drink alcohol following a Mediterranean Alcohol Drinking Pattern (MADP): consuming alcohol in moderation, avoidance of binge drinking and preference for red wine.Researchers will compare those who will receive a MADP advice with those who will receive an advice on abstention to see if the advice on MADP is not inferior than the abstention advice to prevent all-cause mortality and other chronic diseases. ### Conditions - All Cause Mortality - Cardiovascular Diseases - Invasive Cancer - Liver Cirrhosis - Type 2 Diabetes - Depression - Dementia - Injury Traumatic - Tuberculosis - Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Moderate Alcohol Drinking Pattern - Abstention ### Outcomes Primary Outcomes - Comparison between groups of the incidence of a global Index of all-cause mortality and other alcohol-related diseases Secondary Outcomes - Comparison between groups of the incidence of the most severe outcomes ### Location - Facility: University of Navarra, Pamplona, Navarra, 31008, Spain @@
## Real-World Effectiveness of Mavacamten in Canada - NCT ID: NCT06338202 - Study ID: CV027-1137 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-31 - Lead Sponsor: Bristol-Myers Squibb ### Study Description The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada. ### Conditions - Obstructive Hypertrophic Cardiomyopathy (oHCM) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Mavacamten ### Outcomes Primary Outcomes - Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation Secondary Outcomes - Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation - Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation - Age - Sex at birth - Ethnicity - Employment status - Body mass index (BMI) - Obstructive hypertrophic cardiomyopathy (oHCM) disease duration - Proportion of patients in each New York Heart Association (NYHA) functional class II and III - Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient - Left ventricular ejection fraction by 2D echocardiogram (LVEFb) - Mavacamten dose regimen - Proportion of patients who discontinued mavacamten - Duration of treatment prior to mavacamten discontinuation - Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation - Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation - Reason for discontinuing mavacamten treatment - Functional assessment schedule ### Location - Facility: London Health Science Centre (LHSC), London, Ontario, N6A 5A5, Canada @@
## The 5Ad Diet for Functional Bowel Disorders - NCT ID: NCT06338189 - Study ID: USuffolk - Status: RECRUITING - Start Date: 2022-05-08 - Completion Date: 2026-04-01 - Lead Sponsor: University of Suffolk ### Study Description The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances.The primary aims of this RCT are to determine:* Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances.* Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue.To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days.Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation. ### Conditions - Functional Bowel Disorder - Irritable Bowel Syndrome - Food Intolerance - Food Intolerance Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - The 5Ad Diet - The Low FODMAP Diet ### Outcomes Primary Outcomes - Abdominal Pain - Abdominal Bloating - Flatulence - Bowel Urgency - Straining - Incomplete Defecation - Stool Form - Frequency of defecation Secondary Outcomes - Fatigue - Mental Fatigue - Physical Fatigue ### Location - Facility: University of Suffolk, Ipswich, Suffolk, IP4 1QJ, United Kingdom @@
## Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB) - NCT ID: NCT06338176 - Study ID: Pro00128904 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-04-30 - Lead Sponsor: University of Alberta ### Study Description Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system. ### Conditions - Staph Aureus Bacteremia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - OPTIMUS-SAB clinical care pathway ### Outcomes Primary Outcomes - Adherence to quality-of-care indicators Secondary Outcomes - Length of stay - Hospital re-admission rates - All-cause mortality - In hospital mortality - Costing evaluation - Implementation evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery - NCT ID: NCT06338163 - Study ID: POSSIBLE 1.6 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-09-30 - Lead Sponsor: Marco Catarci ### Study Description This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, \& lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center. ### Conditions - Surgical Site Infection - Surgical Procedures, Operative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Polihexanide-based bundle - Standard bundle ### Outcomes Primary Outcomes - Surgical Site Infections rate - Incisional (superficial and deep) Surgical Site Infections rate - Infectious morbidity rates Secondary Outcomes - Anastomotic leakage rates - Overall morbidity rates - Major morbidity rates - Comprehensive complication index - Overall length of postoperative hospital stay - Readmission rates ### Location - Facility: OSpedale Santa Maria Annunziata, Firenze, FI, 50012, Italy @@
## Precision Medicine Study - NCT ID: NCT06338150 - Study ID: STUDY-23-00503 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description This will be a 2 year study to evaluate and improve cancer sequencing as applied to the characterization of tumor molecular make-up and the identification of novel therapeutics (n=100). Participants who will undergo tumor biopsy for management of multiple myeloma (MM) will self-refer to the study or be referred by their treating physician. Participants will initially meet with a clinician to review study consents and provide medical, medication, and family history information. After informed consent, biospecimen samples from peripheral blood, cheek swab, and tumor samples from bone marrow (aspirate and biopsy), peripheral blood, or any mass/fluid containing tumor cells will be obtained (from procedures indicated as part of their standard oncology care) for cancer sequencing (CS) (whole exome sequencing of germline and tumor genomes, RNA sequencing of tumor transcriptome, single cell, and CyTOF analysis). CS data will be interpreted via somatic variation identification, network modeling, and cancer transcriptome profiling to facilitate mapping activity levels of genes to networks and for identifying genes activated or dysregulated in cancer cells. Sequencing and analysis will be performed at the Genomics Core Facility at the Icahn School of Medicine at Mount Sinai. In instances where internal sequencing capabilities do not allow for certain types of analysis, de-identified samples or data may be sent out to third parties for additional analysis. The study will be using GenPath, a division of BioReference® Health, LLC for this project which is a CLIA certified lab. All genetic tests will be performed in a CLIA certified lab and all tests will be FDA or NYS approved. The RNA Sequencing test will receive NYS Department of Health (Wadsworth Center) approval before results are provided to physicians and patients. Samples will be de-identified and processed by the Mount Sinai Human Immune Monitoring Core (HIMC) before being sent to an external CLIA-certified lab for sequencing and analysis. Interpretation will be performed by a multidisciplinary team that includes genomicists, pathologists, and clinicians familiar with the particular cancer diagnosed in the participant. Once results are available, they will be shared with the participant and treating physician during a follow-up results session and any findings obtained explained. This study is not intended to implement findings, only to report them. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Total number of somatic Single-nucleotide variants (SNVs) per patient Secondary Outcomes - Total number of somatic insertions (INS) per patient - Total number of somatic deletions (DEL) per patient - Number of SNVs per megabase of the MM genome - Number of INS per megabase of the MM genome - Number of DEL per megabase of the MM genome - Number of mutations per megabase among MM subgroups - Number of mutations per megabase among genomic regions for all MM and mutational subgroups - Gene mutations identified - Chromosomal abnormalities identified - Molecular signatures identified - Established Prognostic markers identified - Somatic variants identified as targets of FDA-approved drugs (pharmacogenomics variant data) - Network-informed key driver variants identified - Transcriptome variations identified - Germline mutations identified in cancer predisposition genes - FDA approved drugs available that block enzymes produced in those pathways identified - Treatment recommended by computational pipeline based on patient's clinical and genetic - Germline whole exome sequencing profile - Tumor genome whole exome sequencing profile - Tumor transcriptome profile - Single-cell sequencing profile - Cytometric profile - Signaling Pathways associated - Enzymes associated with each signaling pathway identified - Improvement of cancer sequencing-guided treatment recommendations by machine learning ### Location - Facility: Mount Sinai Health System, New York, New York, 10029, United States @@
## Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment - NCT ID: NCT06338137 - Study ID: 4-2024urol - Status: COMPLETED - Start Date: 2022-08-25 - Completion Date: 2024-01-01 - Lead Sponsor: Menoufia University ### Study Description Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy. ### Conditions - Renal Stone ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Holmium Yag laser ### Outcomes Primary Outcomes - Stone free rates Secondary Outcomes - Preoperative complications ### Location - Facility: Hossam Kandeel, Shibīn Al Kawm, State Or Province, 32511, Egypt @@
## Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients - NCT ID: NCT06338124 - Study ID: David Ibrahim - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Egymedicalpedia ### Study Description Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels . ### Conditions - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Triglyceride glucose index ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: Assuit University Hospital, Assiut, N/A, N/A, Egypt @@
## Interventions Meant to Improve the Outcome of Critical Care Patients in the ED - NCT ID: NCT06338111 - Study ID: 2461 - Status: COMPLETED - Start Date: 2020-11-09 - Completion Date: 2023-04-30 - Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy ### Study Description This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department. ### Conditions - Sepsis Syndrome - Emergency Department - Biomarker ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ELISA Sepsis Biomarkers dosage ### Outcomes Primary Outcomes - Can we better predict mortality in septic patients from the Emergency Department? Secondary Outcomes ### Location - Facility: Cluj County Hospital Emergency Department, Cluj-Napoca, Cluj, 400006, Romania @@
## Effect of an 8-week Heartfulness Meditation Program on Burnout and Stress at Veterinary Specialty Hospital - NCT ID: NCT06338098 - Study ID: HFNVSH.001 - Status: COMPLETED - Start Date: 2023-02-28 - Completion Date: 2023-10-02 - Lead Sponsor: Heartfulness Institute ### Study Description This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout. ### Conditions - Stress - Burnout, Professional ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - 8-week wellness and relaxation meditation program ### Outcomes Primary Outcomes - Assess the current level of Anxiety - Changes level of Stress - Assess the current level of Burnout - Changes level of Burnout Secondary Outcomes ### Location - Facility: Angell Animal Medical Center,, Boston, Massachusetts, 02130, United States @@
## The Effect of Emotional Freedom Technique (EFT) on Depression in Postmenopausal Women - NCT ID: NCT06338085 - Study ID: meryemvrlshn00000000002 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-05-20 - Lead Sponsor: Meryem Vural Şahin ### Study Description The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care. ### Conditions - Menopause ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - emotional liberation technique ### Outcomes Primary Outcomes - Beck Depression Scale Secondary Outcomes - Menopause Rating Scale (MRS) ### Location - Facility: family health center no. 1 in Çayyolu, Ankara, Çankaya, N/A, Turkey @@
## Impact of the Menstrual Cycle in Reproductive Aged Women With Type 1 Diabetes Using a Closed Loop System (DIABETEXX/1). - NCT ID: NCT06338072 - Study ID: DIABETEXX/1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2025-08-01 - Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal ### Study Description The aim of this observational study is to assess the effectiveness of automatic insulin infusion in responding to changes in insulin sensitivity throughout various phases of the menstrual cycle in a cohort of reproductive-aged women with type 1 diabetes, using an advanced closed-loop system. By gaining insights into both the limitations and effectiveness of this adaptation, we aim to inform the enhancement of control algorithms and learning strategies within closed-loop systems. This research is especially vital for addressing the distinct challenges that women commonly encounter in maintaining glycemic control. ### Conditions - Type 1 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time in range Secondary Outcomes - Time below range - Time above range - Caloric intake - Temperature - Photoplethysmography - Accelerometry ### Location - Facility: Lía Nattero-Chávez, Madrid, N/A, 28034, Spain @@

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