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## The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury - NCT ID: NCT06343259 - Study ID: 2534 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-14 - Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital ### Study Description In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial. ### Conditions - Myocardial Injury After Non-cardiac Surgery - Hypotension During Surgery - Anesthesia, General - Anesthesia, Spinal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - General Anesthesia - Spinal Anesthesia ### Outcomes Primary Outcomes - Myocardial Injury After Non-Cardiac Surgery (MINS) Secondary Outcomes - The duration of intensive care unit (ICU) stay - The duration of hospital stay ### Location - Facility: Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, N/A, 34396, Turkey @@
## Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension - NCT ID: NCT06343246 - Study ID: MustafaKemalU - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-03-30 - Lead Sponsor: Mustafa Kemal University ### Study Description This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength. ### Conditions - Hypertension,Essential ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inspiratory muscle training with device ### Outcomes Primary Outcomes - Change of the exercise capacity from baseline to 8 week - Change of the peripheral muscle strenght from baseline to 8 week - change of the upper extremity exercise capacity from baseline to 8 week Secondary Outcomes - change of the postural balance from baseline to 8 week - change of the physical activity from baseline to 8 week - change of the quality of life from baseline to 8 week - change of the Fev1/Fvc ### Location - Facility: Hatay Mustafa Kemal University, Hatay, Antakya, N/A, Turkey @@
## FAiling HearT in the Elderly (FATE) Study - NCT ID: NCT06343233 - Study ID: FATE - Status: RECRUITING - Start Date: 2019-11-19 - Completion Date: 2024-12 - Lead Sponsor: IRCCS Multimedica ### Study Description In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure. ### Conditions - Heart Failure - Frailty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - usual care ### Outcomes Primary Outcomes - Hospitalization or death at 12 months Secondary Outcomes - Hospitalization or death at 6-12-18 months - hospitalizations and/or death from cardiovascular causes - association between events and patient characteristics ### Location - Facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT), Montescano, Italy/Pavia, 27040, Italy @@
## Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research - NCT ID: NCT06343220 - Study ID: AWARE 2.0 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-09 - Lead Sponsor: Huntington Study Group ### Study Description The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. ### Conditions - Huntington Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Examine awareness - Provide the HD research community with the insight. Secondary Outcomes ### Location - Facility: Huntington Study Group, Rochester, New York, 14618, United States @@
## Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability - NCT ID: NCT06343207 - Study ID: 249637 - Status: COMPLETED - Start Date: 2022-11-22 - Completion Date: 2023-02-02 - Lead Sponsor: Charles University, Czech Republic ### Study Description To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI). ### Conditions - Ankle Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Percussive massage gun therapy ### Outcomes Primary Outcomes - Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability. Secondary Outcomes ### Location - Facility: Faculty of physical education and sport, Charles University, Praha, N/A, 16252, Czechia @@
## Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism - NCT ID: NCT06343194 - Study ID: 6162 - Status: RECRUITING - Start Date: 2023-02-09 - Completion Date: 2024-12-22 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients. ### Conditions - Sleep Bruxism - Masseter Muscle Hypertrophy - Grinding Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bruxoff ® ### Outcomes Primary Outcomes - Change in potentials recorded by Bruxoff ® in bruxism patients. Secondary Outcomes - Change of signs and symptoms of bruxism ### Location - Facility: UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore, Rome, Lazio, 00168, Italy @@
## A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer - NCT ID: NCT06343181 - Study ID: IEO 1824 - Status: RECRUITING - Start Date: 2022-10-03 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project." ### Conditions - Metastatic Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of factors influencing patients' adherence to medical therapy Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients - NCT ID: NCT06343168 - Study ID: frailty - Status: COMPLETED - Start Date: 2021-02-18 - Completion Date: 2022-02-18 - Lead Sponsor: Uşak University ### Study Description This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.The main question it aims to answer are:What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients ### Conditions - Frailty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - prevalence of frailty ### Outcomes Primary Outcomes - Prevalence of frailty Secondary Outcomes - Activities of Daily Living - Nutritional Assessment - Comorbidity - Cognitive Assessment ### Location - Facility: Usak University, Usak, Center, 64200, Turkey @@
## Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder" - NCT ID: NCT06343155 - Study ID: E-10840098-202.3.02-235 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-06-03 - Lead Sponsor: Medipol University ### Study Description According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated. ### Conditions - Temporomandibular Disorder - Chronic Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Therapeutic Group - Rocabado's Group ### Outcomes Primary Outcomes - Temporomandibular Joint Range of Motion Measurement (ROM) Secondary Outcomes - The Jaw Functional Limitation Scale 20 (JFLS-20) - Oral Health Impact Profile - 14 (OHIP-14) ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## Effects of Time of Day and Nut Intake on Cognitive Performance - NCT ID: NCT06343142 - Study ID: 42038 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-06-30 - Lead Sponsor: Monash University ### Study Description This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance. ### Conditions - Cognitive Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Nuts - Nut-free meal ### Outcomes Primary Outcomes - N-back task - accuracy - N-back task - matched responses - N-back task - false alarm - N-back task - reaction time - Stroop test - congruent - Stroop test - incongruent - Stroop test - interference Secondary Outcomes - Multitasking - pure blocks - Multitasking - mixed blocks - Multitasking - mixing cost - Satiety - hunger - Satiety - fullness - Satiety - satisfaction - Satiety - eating capacity - Satiety index ### Location - Facility: Department of Nutrition, Dietetics and Food - Monash University, Notting Hill, Victoria, 3168, Australia @@
## Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD - NCT ID: NCT06343129 - Study ID: 3817 - Status: COMPLETED - Start Date: 2020-10-26 - Completion Date: 2022-12-12 - Lead Sponsor: University of Rochester ### Study Description The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dietary education program ### Outcomes Primary Outcomes - Mean change in systolic blood pressure - Mean change in diastolic blood pressure - Mean change in potassium levels - Proportion of participants developing hyperkalemia Secondary Outcomes - Mean Change in energy/day - Mean change in energy/kg of body mass - Mean change in total fat - Mean change in % calories from fat - Mean change in % calories from carbohydrates - Mean change in % calories from protein - Mean change in Animal protein - Mean change in Vegetable protein - Mean change in cholesterol - Mean change in Total dietary fiber - Mean change in Total fiber per 1000 kcal - Mean change in calcium - Mean change in phosphorous - Mean change in magnesium - Mean change in sodium - Mean change in potassium - Mean change in body mass - Mean change in body mass index - Mean change in sodium measured in blood - Mean change in chloride measured in blood - Mean change in bicarbonate measured in blood - Mean change in blood urea nitrogen (BUN) measured - Mean change in creatinine measured in blood - Mean change in glucose measured in blood - Mean change in calcium measured in blood - Mean change in phosphorous measured in blood - Mean change in parathyroid hormome (PTH) measured in blood - Mean change in albumin measured in blood - Mean change in magnesium measured in blood - Mean change in erythrocyte sedimentation rate (ESR) measured in blood - Mean change in fibroblast growth factor (FGF)-23 measured in blood - Mean change in total cholesterol measured in blood - Mean change in low density lipoprotein (LDL) measured in blood - Mean change in high density lipoprotein (HDL) measured in blood - Mean change in triglycerides measured in blood - Mean change in 8-isoprostane measured in urine - Mean change in symptoms - Mean change in effects of kidney disease - Mean change in burden of kidney disease - Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite - Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite ### Location - Facility: Clinical Research Center of the University of Rochester Medical Center, Rochester, New York, 14642, United States @@
## Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer - NCT ID: NCT06343116 - Study ID: BPL-Nim-CRC-3001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Biotech Pharmaceutical Co., Ltd. ### Study Description This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS). ### Conditions - Refractory Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nimotuzumab injection - Placebo - Trifluridine/tipiracil ### Outcomes Primary Outcomes - overall survival (OS) - dose-limiting toxicity (DLT) Secondary Outcomes - Progression free survival (PFS) - time to progress (TTP) - overall response rate (ORR) - disease control rate (DCR) - duration of response (DoR) - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) - Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Evaluating Occupational Exposure to Antineoplastic Drugs - NCT ID: NCT06343103 - Study ID: IEO 1735 - Status: RECRUITING - Start Date: 2022-08-02 - Completion Date: 2025-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics. ### Conditions - Cytotoxicity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Workers exposed - Workers not exposed ### Outcomes Primary Outcomes - Evaluation of the difference in micronuclei frequency Secondary Outcomes ### Location - Facility: IRCCS Ospedale Policlinico San Martino, Genova, N/A, N/A, Italy @@
## Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients - NCT ID: NCT06343090 - Study ID: BJGBYY-IIT-LCYJ-2023-003 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2043-09-30 - Lead Sponsor: Beijing GoBroad Hospital ### Study Description This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled. ### Conditions - B-cell Acute Lymphoblastic Leukemia - Acute Lymphoblastic Leukemia, in Relapse - Refractory Acute Lymphoid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CD19 CAR T-cell - CD22 CAR T cells - hematopoietic stem-cell transplantation ### Outcomes Primary Outcomes - EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) Secondary Outcomes - ORR in Sequential CAR group and CAR+HSCT group - DOR in Sequential CAR group and CAR+HSCT group - OS in Sequential CAR group and CAR+HSCT group - Adverse events (AEs) in Sequential CAR group and CAR+HSCT group - Levels of CD19 and CD22 CAR-T cells in Sequential CAR group - Levels of CD19 CAR-T cells in CAR+HSCT group - Levels of CD19 and CD22 CAR transgene in Sequential CAR group - Levels of CD19 CAR transgene in CAR+HSCT group - Quantification of B cells in Sequential CAR group and CAR+HSCT group ### Location - Facility: Beijing GoBroad Hospital, Beijing, Beijing, 102206, China @@
## Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance - NCT ID: NCT06343077 - Study ID: STUDY-22-00106 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2026-12-31 - Lead Sponsor: Ashutosh Kumar Tewari ### Study Description This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance. ### Conditions - Prostate Cancer Patients on Active Surveillance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Poly-ICLC intramuscular (IM) injection - Poly-ICLC, Intertumoral (IT) injection ### Outcomes Primary Outcomes - Proportion of subjects without Gleason group upgrade after treatment - Proportion of subjects without Gleason group upgrade after treatment - Proportion of subjects without Gleason group downgrade after treatment - Proportion of subjects without Gleason group downgrade after treatment Secondary Outcomes - Number of subjects who experience adverse events per NCI-CTCAE 5.0 - Number of subjects who experience adverse events per NCI-CTCAE 5.0 - Number of subjects who receive prostate cancer treatment - Number of subjects who receive prostate cancer treatment ### Location - Facility: Icahn School of Medicine at Mount Sinai (ISMMS), New York, New York, 10029, United States @@
## Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI - NCT ID: NCT06343064 - Study ID: PLB1001/PLB1004-NSCLC-Ib/II-01 - Status: RECRUITING - Start Date: 2023-06-13 - Completion Date: 2025-06-30 - Lead Sponsor: Avistone Biotechnology Co., Ltd. ### Study Description Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC ### Conditions - Non-Small-Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Vebreltinib - PLB1004 ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). - Incidence of dose-limiting toxicities (DLT) as defined in the protocol. - Overall Response Rate (ORR） Secondary Outcomes - Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) - Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) - Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) - Incidence of Treatment-Emergent Adverse Events ### Location - Facility: Shanghai Pulmonary Hospital, Shanghai, Shanghai, 200433, China @@
## USCOM in Newly Diagnosed FGR Cases - NCT ID: NCT06343051 - Study ID: STUDY-23-01681 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy. ### Conditions - Fetal Growth Restriction - USCOM ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - USCOM ### Outcomes Primary Outcomes - Systemic vascular resistance obtained from USCOM Secondary Outcomes ### Location - Facility: Mount Sinai Hospital, New York, New York, 10029, United States @@
## Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study - NCT ID: NCT06343038 - Study ID: 2023-01868; th23Nicolas - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.The performance of different prostate cancer diagnostic methods is also in scope of the study. ### Conditions - Castration-resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Injection, 161Tb-SibuDAB,1GBq - Injection, 177Lu-PSMA-I&T, 1GBq - Injection, 161Tb-SibuDAB, Dose Escalation ### Outcomes Primary Outcomes - Phase Ia: Tumour absorbed dose - Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT Secondary Outcomes - Phase Ia: Estimation of critical organ median absorbed doses - Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios - Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT - Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT. ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## The Effects of Tai Chi and Pilates for Individuals With Prediabetes - NCT ID: NCT06343025 - Study ID: Hasan Kalyoncu University - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-09 - Lead Sponsor: Nigde Omer Halisdemir University ### Study Description The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. ### Conditions - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pilates Exercises Group - Tai Chi Exercises Group ### Outcomes Primary Outcomes - Glisemic Control - Body Composition - Balance - Physical Activity Level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Caring Leadership Intervention Program for First-Line Nurse Managers - NCT ID: NCT06343012 - Study ID: 0305900 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2022-12-31 - Lead Sponsor: Matrouh University ### Study Description Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations. ### Conditions - Intervention - Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Caring leadership Intervention program ### Outcomes Primary Outcomes - Questionnaire to measure first-line nurse managers' knowledge - Questionnaire to measure the managerial actions of first-line nurse managers - Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior - questionnaire to measure nurse outcomes Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Marsa Matruh, N/A, 002, Egypt @@
## Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome - NCT ID: NCT06342999 - Study ID: 22-012399 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2035-07 - Lead Sponsor: Mauro H. Schenone ### Study Description The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS). ### Conditions - Hypoplastic Left Heart Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fetal Aortic Valvuloplasty Procedure - Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter - Trek RX and Mini Trek RX Coronary Dilatation Catheter ### Outcomes Primary Outcomes - Number of cases in which the procedure was successful - Number of cases in which a biventricular repair was achieved - Number cases with pulmonary hypertension Secondary Outcomes - Number of cases delivered prematurely - Number of cases with perinatal death - Number of maternal complications ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer - NCT ID: NCT06342986 - Study ID: 2023LS185 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2029-06-30 - Lead Sponsor: Masonic Cancer Center, University of Minnesota ### Study Description This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer. ### Conditions - Gynecologic Cancer - Ovarian Cancer - Fallopian Tube Cancer - Primary Peritoneal Cavity Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - FT536 - Fludarabine - CY ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Progression free survival (PFS) - Overall survival (OS) - Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Case Series - NCT ID: NCT06342973 - Study ID: 5591 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-05-30 - Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans ### Study Description The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane. ### Conditions - Alveolar Ridge Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Xenograft and allograft ### Outcomes Primary Outcomes - Horizontal bone gain - Vital bone percentage - Bone shrinkage Secondary Outcomes - Surgical complications ### Location - Facility: LSUHSC School of Dentistry, New Orleans, Louisiana, 70119, United States @@
## A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3) - NCT ID: NCT06342960 - Study ID: KYV101-003 - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2029-01 - Lead Sponsor: Kyverna Therapeutics ### Study Description A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis ### Conditions - Lupus Nephritis - Lupus Nephritis - WHO Class III - Lupus Nephritis - WHO Class IV ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - KYV-101 anti-CD19 CAR-T cell therapy - Standard lymphodepletion regimen ### Outcomes Primary Outcomes - Incidence adverse events (AEs) and laboratory abnormalities - Frequency of dose limiting toxicities Secondary Outcomes - To characterize the pharmacokinetics (PK) - To characterize the pharmacodynamics (PD) - To characterize the pharmacodynamics (PD) - To evaluate disease related biomarkers - To evaluate disease related biomarkers - To evaluate efficacy - To evaluate efficacy - To evaluate efficacy - To evaluate the immunogenicity (humoral response) of KYV-101 ### Location - Facility: University Hospital Carl Gustav Carus Dresden, Dresden, N/A, N/A, Germany @@
## ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) - NCT ID: NCT06342947 - Study ID: ALG-055009-303 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-23 - Lead Sponsor: Aligos Therapeutics ### Study Description This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks. ### Conditions - NASH - MASH - Metabolic Dysfunction-Associated Steatohepatitis - Nonalcoholic Steatohepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ALG-055009 - Placebo ### Outcomes Primary Outcomes - Percent relative change from baseline in liver fat content Secondary Outcomes - Absolute change from baseline in liver fat content - Proportion of subjects with ≥30% relative reduction in liver fat content - Proportion of subjects with ≥50% relative reduction in liver fat content - Proportion of subjects with ≥70% relative reduction in liver fat content - Proportion of subjects with normalization (<5%) in liver fat content ### Location - Facility: Aligos Clinical Study Site 18, Chandler, Arizona, 85224, United States @@
## Radiomics and Machine Learning in the Diagnosis of Ovarian Masses - NCT ID: NCT06342934 - Study ID: INT157/20 - Status: COMPLETED - Start Date: 2020-07-22 - Completion Date: 2023-12-31 - Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano ### Study Description The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive).Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass.Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way.Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience.Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors.The application of radiomics to preoperative ultrasound images could identify BRCA mutated tumors before surgical planning (radiogenomic analysis) and allow a personalized treatment.The aim of the study is to validate a predictive model to define the risk of malignancy of adnexal masses that the investigators developed at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.The model, based on the integration of radiomics and artificial intelligence, uses complex software capable of 'reading' the ultrasound images in a completely automatic way and is able to estimate the risk of malignancy of the mass.If the patient decide to participate in the clinical study, the patient will undergo transvaginal ultrasound (eventually supplemented by transabdominal ultrasound in case of large adnexal masses, if the patients are virgo or if the patients will refuse transvaginal approach for any reason). This exam is part of the routine preoperative evaluation for adnexal pathology and therefore the patients don't have to undergo any additional clinical, biochemical or imaging examination, according to national and international guidelines.Thereafter, the images stored during the preoperative ultrasound will be exported in anonymous format from the ultrasound system, and sent to the coordinating center (Fondazione IRCCS Istituto Nazionale dei Tumori di Milano). There, images will be submet to radiomic analysis through the application of a dedicated software; that will allow to evaluate the intrinsic characteristics of the tissue according to different parameters (shape, intensity, grade of heterogeneity and many others) of the 'pixels' (gray dots) that constitute the ultrasound image.This analysis, once validated, will provide clinicians an additional tool to identify malignant adnexal masses prior to surgery.If the final histological diagnosis is of serous epithelial ovarian cancer, through the use of the same radiomics software described above the investigators will try to identify the intrinsic characteristics of the tissue associated with the presence or absence of the BRCA 1 or 2 mutation ### Conditions - Ovarian Cysts - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound ### Outcomes Primary Outcomes - Diagnosis of malignant ovarian tumor Secondary Outcomes ### Location - Facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, Lombardia, 20133, Italy @@
## ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection - NCT ID: NCT06342921 - Study ID: ADC189-2022-01 - Status: RECRUITING - Start Date: 2022-12-07 - Completion Date: 2024-06-30 - Lead Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd ### Study Description The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.The main aim to answer:* Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study.* Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza.Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days.Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo. ### Conditions - Safety Issues - Effect of Drug ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 15 mg ADC189 - 45 mg ADC189 - Placebo ### Outcomes Primary Outcomes - the severity of influenza - the safety of study drug Secondary Outcomes ### Location - Facility: Rui Jin Hospital, Shanghai, Shanghai, N/A, China @@
## A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma - NCT ID: NCT06342908 - Study ID: 23-001700 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2028-01-09 - Lead Sponsor: Jonsson Comprehensive Cancer Center ### Study Description This phase I trial tests the safety and side effects, and best dose of a vaccine (neoantigen-target ppDC) in treating patients with H3 G34-mutant diffuse hemispheric glioma. Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Giving neoantigen-targeted ppDC may be safe, tolerable and/or effective in treating patients with diffuse hemispheric glioma with a H3 G34 mutation. ### Conditions - Diffuse Hemispheric Glioma, H3 G34-Mutant ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Dendritic Cell Therapy - Leukapheresis - Magnetic Resonance Imaging - Poly ICLC ### Outcomes Primary Outcomes - Incidence of regimen-limiting toxicities Secondary Outcomes - Significant increase in gamma-interferon (IFN) gene expression signature - Significant clonal T cell expansion - Targets of clonal cytotoxic T cell expansion - Pro-inflammatory phenotypic changes in immune cell populations - Changes in immune cell subset expansion and contraction in T cell and myeloid-derived cell populations - Changes of immune cell markers profile in T cell and myeloid-derived cell populations ### Location - Facility: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States @@
## Interpretation and Optimization of Nutrition in the Intensive Care Units - NCT ID: NCT06342895 - Study ID: 2020_1113 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-09 - Lead Sponsor: Dim3 ### Study Description Despite recommendations, inadequate nutritional intake in intensive care unit (ICU) patients remains frequent and can lead to complications such as infections, increased length of stay, prolonged weaning from ventilation, increased long-term mortality, and decreased quality of life after intensive care. Studies have shown that patients only receive up to 50-60% of prescribed calories and proteins due to many factors leading to nutritional support interruptions such as ICU procedures, physical therapy, transport for imaging or invasive procedures outside the ICU, and nutrition intolerance.Furthermore, this discrepancy between prescribed and delivered nutrition may go largely unnoticed, due to issues concerning inadequate manual or automated monitoring of delivered nutrition. A joint "Call to Action" by ASPEN, the Academy of Nutrition and Dietetics, and the American Society of Health-System Pharmacists stated that parenteral nutrition errors and their contributing factors could be prevented by improving the functionality of in-house Clinical Decision Support Systems and the interfaces between electronic health records (EHRs), automated preparation devices and pharmacy systems.Nutrow® is a software package designed to support nutritional management based on the calculation of recommended calorie and protein requirements, real-time calculation and monitoring of calorie and protein prescriptions, real-time calculation and monitoring of calories and protein truly delivered to patients, and information feedback to prescribers. Feedim® is a Medical Device Data System (MDDS), designed by Dim3, which transmits information from enteral feeding pumps to third-party software, such as Nutrow®.The aim of the study is to assess whether the joint use of Nutrow-Feedim improves the achievement of nutritional objectives in ICU patients prior to oral intake by reducing the discrepancy between prescribed and delivered calories and protein. ### Conditions - Nutritional Support ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Nutritional support prescription and delivery monitoring feedback - Usual care ### Outcomes Primary Outcomes - Mean total daily calories delivered/prescribed ratio (percent) Secondary Outcomes - Mean total daily protein delivered/prescribed ratio (%) - Mean total daily calories delivered/recommended ratio (percent) - Mean total daily protein delivered/recommended ratio (percent) - Nutritional support duration (days) - Time to initiation of nutritional support (days) - Weight (Kg) - Day 28 mortality rate - ICU length-of-stay (days) - Days on ventilator (days) ### Location - Facility: University Hospital Lille, Lille, N/A, 59037, France @@
## Dysphagia Severity and Functional Independence Level - NCT ID: NCT06342882 - Study ID: GO 19/833- A - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2024-02-01 - Lead Sponsor: Atılım University ### Study Description Functional independence is the ability of a person to perform daily life activities safely without any restriction, as much as possible. The functional independence depends on physical, social, cognitive and psychological abilities of the person. Therefore, full functional independence requires the harmony of all these parameters.Dysphagia can be seen in more than 50% of neurological patients, and it is called neurogenic dysphagia. Muscle weakness, tonus changes, sensory loss and coordination problems occur in these patients. Pain and fatigue are also frequently observe. These patients have problems with fine and gross motor movements, and thereby mobility and transfer activities become difficult. Life-threatening complications such as pulmonary problems, malnutrition and dehydration accompany when patients have dysphagia. Both neurological and dysphagia-related problems negatively affect the physical, psychological, emotional and cognitive functions of patients. Neurological patients with dysphagia may have more serious clinical situations due to more affected vital functions such as pulmonary functions and feeding.Dysphagia-induced malnutrition adversely affects many systems, including the musculoskeletal system. In a study conducted in the elderly with dysphagia, atrophy in the total muscle mass and swallowing muscles, and increase in intramuscular adipose tissue were reported as a result of malnutrition. Decreases in the muscle mass may negatively affect the functional independence of patients with dysphagia. Other studies in geriatric population have shown that swallowing function is associated with hand grip strength and quadriceps muscle strength, which are indicators of functional independence in activities of daily living (ADL). These studies also suggest that dysphagia may be associated with functional independence in geriatric group. Therefore, functional independence may also reduce in patients with neurogenic dysphagia. However, there is no study investigating the relationship between dysphagia severity and the functional independence levels in patients with neurological diseases. Therefore, the investigators aimed to investigate the relationship between dysphagia severity and functional independence level in patients with neurological diseases. ### Conditions - Dysphagia - Neurologic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dysphagia assessment - functional independence level ### Outcomes Primary Outcomes - dysphagia severity - functional independence Secondary Outcomes ### Location - Facility: Atılım Uiveristy, Ankara, Incek, 06830, Turkey @@
## Comparison of the Effects of Lidocaine and Articaine Used for Buccal Infiltration and Supplemental Palatinal Infiltration Anesthesia in Teeth With Irreversible Pulpitis - NCT ID: NCT06342869 - Study ID: 690 - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2022-12-01 - Lead Sponsor: Akdeniz University ### Study Description Objective: The aim of this study was to compare the effects of articaine or lidocaine in buccal infiltration or palatal infiltration in addition to buccal infiltration in maxillary first or second molars with irreversible pulpitis.Method: Among the patients who applied to Akdeniz University Faculty of Dentistry Endodontic Clinic for the treatment of maxillary molars with irreversible pulpitis, 80 volunteers who met the criteria were included in the study. Eighty patients were divided into 4 groups (n = 20). 1. group buccal infiltration with 4% articaine containing 1:100,000 epinephrine, 2. group buccal infiltration with 2% lidocaine containing 80,000 epinephrine, 3. group buccal and palatinal infiltration with 4% articaine containing 1:100,000 epinephrine, 4.group buccal and palatinal infiltration with 2% lidocaine containing 80.000 epinephrine. Pain during the endodontic procedure was determined and recorded according to the Heft Parker visual analog scale. ### Conditions - Fist and Second Molars With ırreversible Pulpitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Anesthesia ### Outcomes Primary Outcomes - Assessment of complementary palatinal anesthesia with VAS Secondary Outcomes ### Location - Facility: Akdeniz University, Antalya, N/A, 07070, Turkey @@
## Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia - NCT ID: NCT06342856 - Study ID: idiopathic infertility - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2024-07-01 - Lead Sponsor: Ain Shams University ### Study Description Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia ### Conditions - Infertility Unexplained - Oligospermia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - co enzyme Q10 , L- Carnitine ### Outcomes Primary Outcomes - Changes in Semen analysis parameters compared to baseline Secondary Outcomes - Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis ### Location - Facility: Ain Shams University, Cairo, N/A, 002, Egypt @@
## Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH) - NCT ID: NCT06342843 - Study ID: SPLAsH - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2026-11-30 - Lead Sponsor: Isala ### Study Description This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique. ### Conditions - Osteoarthritis, Hip ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Total Hip Arthroplasty ### Outcomes Primary Outcomes - Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form Secondary Outcomes - Numeric Rating Scale (NRS) - Short Form-12 (SF-12) - Hip disability and Osteoarthritis Outcome Score (HOOS) - Euro Quality of Life (EQ-5D) - Global Rating of Change scale - Timed Up and Go test (TUG test) - 40 meter self-paced walk test for hip osteoarthritis - Stair climb test - Step count application on iPhone - Muscle atrophy by using Computer Tomography (CT) scanner - Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR) - Postoperative cup position on Computer Tomography (CT) image - Comparing definite cup position with preoperative planned cup position - Comparing definite component position with surgeon's perioperative estimation of component position - overall image quality - image diagnostic confidence - metal artifacts on images - Incontinence Severity Index (ISI) - Urinary Distress Inventory, Short Form (UDI-6) - Patient Global Impression of Severity (PGIS) - Incontinence Impact Questionnaire Short Form (IIQ-7) - Incontinence after Total Hip Arthroplasty ### Location - Facility: Amphia, Breda, Brabant, 4818CK, Netherlands @@
## Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing - NCT ID: NCT06342830 - Study ID: End 20-05 P - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:* nanocurcumin gel* curcumin gel* ciprofloxacin +ibuprofen gel* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 6 months follow up periods ### Conditions - Periapical Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - nanocurcumin gel - Curcumin Gel - Ciprofloxacin 500 mg +ibuprofen 400mg - Metapaste [calcium hydroxide paste (control group)] ### Outcomes Primary Outcomes - healing of periapical lesion Secondary Outcomes - antibacterial effect (CFU) - Interappointment Pain ### Location - Facility: faculty of dentistry, Ain shams university, Cairo, N/A, 11512, Egypt @@
## Effects of Meditation on Sleep Quality of Medical Students - NCT ID: NCT06342817 - Study ID: UFFS - Status: RECRUITING - Start Date: 2023-10-18 - Completion Date: 2024-06-30 - Lead Sponsor: Universidade Federal da Fronteira Sul ### Study Description The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed ### Conditions - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - online mindfulness based meditation program ### Outcomes Primary Outcomes - Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE Secondary Outcomes - Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS - Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21 - Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S ### Location - Facility: Universidade Federal Da Fronteira Sul, Passo Fundo, RS, 99010200, Brazil @@
## Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg - NCT ID: NCT06342804 - Study ID: GIB-01-02-2023 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2024-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets). ### Conditions - Cholecystitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - 4-MUST, 2 tablets, fasted - 4-MUST, 2 tablets, after meals ### Outcomes Primary Outcomes - Pharmacokinetics - Cmax - Pharmacokinetics - tmax - Pharmacokinetics - AUC0-t - Pharmacokinetics - AUC0-inf - Pharmacokinetics - AUC ratio - Pharmacokinetics - t1/2 - Pharmacokinetics - kel - Pharmacokinetics - MRT - Pharmacokinetics - Vd - Pharmacokinetics - Cmax/AUC0-t - Pharmacokinetics - f' - Pharmacokinetics - f'' - Bioavailability - ratio of Cmax - Bioavailability - ratio of AUC0-t - Bioavailability - ratio of AUC0-inf Secondary Outcomes - Adverse event type - Adverse event frequency - Adverse event severety - Drop-outs associated with adverse events ### Location - Facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health", Saint Petersburg, N/A, 191036, Russian Federation @@
## Effect of Laser Acupuncture on Menstrual Back Pain - NCT ID: NCT06342791 - Study ID: 004349 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-06-20 - Lead Sponsor: Cairo University ### Study Description effect of laser acupuncture on menstrual back pain ### Conditions - Laser Acupuncture - Low Back Pain - Menstruation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - laser acupuncture ### Outcomes Primary Outcomes - back Pain intensity during menstruation - pain threshold - Ability to perform daily activities Secondary Outcomes - back Pain intensity during menstruation - pain threshold - Ability to perform daily activities ### Location - Facility: Faculty of physical therapy cairo university, Cairo, N/A, 37617692, Egypt @@
## Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin - NCT ID: NCT06342778 - Study ID: DIP-05-02-2023 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-12-31 - Lead Sponsor: Valenta Pharm JSC ### Study Description Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals ### Conditions - Nausea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Doxylamine + Pyridoxine - Diclectin ### Outcomes Primary Outcomes - Pharmacokinetics - Cmax - Pharmacokinetics - tmax - Pharmacokinetics - AUC0-t - Pharmacokinetics - AUC0-inf - Pharmacokinetics - AUCextr - Pharmacokinetics - t1/2 - Pharmacokinetics - kel - Pharmacokinetics - MRT - Bioequivalence - ratio of Cmax - Bioequivalence - ratio of AUC0-t - Bioequivalence - ratio of AUC0-inf Secondary Outcomes - Adverse event type - Adverse event frequency - Adverse event severety ### Location - Facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation, Yaroslavl, N/A, 150000, Russian Federation @@
## Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment - NCT ID: NCT06342765 - Study ID: SV009 - Status: RECRUITING - Start Date: 2022-09-22 - Completion Date: 2028-05-30 - Lead Sponsor: SpineVision ### Study Description The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery. ### Conditions - Intervertebral Disc Degeneration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pedicle fixation surgery ### Outcomes Primary Outcomes - Incidence of serious and non-serious device- and/or procedure-related adverse events - Change of the Oswestry Disability Index (ODI) Secondary Outcomes - Fusion success - Change of the Oswestry Disability Index (ODI) - Change of the back and leg Visual Analogue Score (VAS) - Incidence of revision surgery at implant site ### Location - Facility: DOSCEA Pôle Rachis, Bayonne, N/A, 64100, France @@
## The Role of VOCs, Airway Mucins and Airway Microbiome in Bronchopulmonary Dysplasia - NCT ID: NCT06342752 - Study ID: 6007 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-09 - Lead Sponsor: University Hospital, Antwerp ### Study Description Bronchopulmonary dysplasia (BPD), the most common respiratory complication of extremely preterm birth, significantly impacts healthcare with high morbidity and mortality rates.Despite the well-established primordial role of inflammation and oxidative stress in the development of BPD, clinical practice does not incorporate the testing for biomarkers associated with the development of BPD. The diagnosis of BPD based on required respiratory support at 36 weeks PML, stresses the need for an early prediction tool which could identify patients with high levels of these biomarkers. This on its turn, could also improve treatment approaches in clinical practice which are currently mostly supportive or non-specific and do not target underlying pathophysiologic pathways.Secondly, mucin expression aim to play a rol in other respiratory diseases, whereas in BPD only the potential role of MUC1 was explored.Thirdly, the composition of the airway microbial composition of an infant is assumed to be influenced by different factors. From early on in pregnancy the airway microbiome of the infant is formed, offering a protective role against pathologies. On the other hand, the role of the airway microbiome in the development of BPD remains unclear and needs to be elucidated.The threefold aim of this study is as follows:I. The development of a non-invasive breath test that allows early detection of bronchopulmonary dysplasia, using the potential of VOCs in exhaled breath as biomarkers for inflammation and oxidative stress.II. The exploration of the composition and diversity of the airway microbiome in infants with BPD, their association with exhaled VOCs and the exploration of the placental and vaginal microbiome.III. The detection of potential alterations in airway mucin expression in BPD patients.Through this comprehensive approach, we seek to gain a deeper understanding of how these mutual associations may contribute to the later development of BPD.In total 140 preterm infants, including 70 BPD patients and 70 preterm controls, born below 30 weeks' gestation at the Antwerp University Hospital will be included. ### Conditions - Bronchopulmonary Dysplasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breath test - Throat swabs - Placental samples - Vaginal swab - Endotracheal aspirates ### Outcomes Primary Outcomes - Exhaled breath Volatile Organic Compounds (VOCs) - Airway mucin profiles - Airway microbial profiles Secondary Outcomes - Placental headspace VOCs - Placental microbiome - Vaginal microbiome - Follow-up structural lung imaging - Hypercapnia ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations - NCT ID: NCT06342739 - Study ID: IEO 1595 - Status: RECRUITING - Start Date: 2022-03-23 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules. ### Conditions - Thyroid Nodule ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia - NCT ID: NCT06342726 - Study ID: 2024/714469 - Status: RECRUITING - Start Date: 2024-05-28 - Completion Date: 2024-06-02 - Lead Sponsor: Haukeland University Hospital ### Study Description In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine. ### Conditions - Accidental Hypothermia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - PAX Warming Blanket - Passive insulation ### Outcomes Primary Outcomes - Core body temperature Secondary Outcomes ### Location - Facility: Haukeland University Hospital, Bergen, N/A, 5021, Norway @@
## A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 - NCT ID: NCT06342713 - Study ID: BGB-45035-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-28 - Completion Date: 2025-04-30 - Lead Sponsor: BeiGene ### Study Description This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.Study details include:* The study duration will be up to 16 months.* The treatment duration will be up to 14 days.* Safety follow-up 30 days after last dose of study drug. ### Conditions - Healthy Participants - Healthy Subjects - Healthy Volunteers - Autoimmune Diseases - Healthy Adult Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BGB-45035 - Placebo ### Outcomes Primary Outcomes - Number of Participants Experiencing Adverse Events (AEs) - Number of participants with clinically significant changes from baseline in clinical laboratory values - Number of participants with clinically significant changes from baseline in vital signs - Number of participants with clinically significant changes from baseline in cardiac conduction intervals Secondary Outcomes - Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast) - Area under the plasma concentration time curve from time zero to infinite time (AUCinf) - Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau) - Maximum observed plasma concentration (Cmax) - Time to maximum plasma concentration (Tmax) - Trough plasma concentration (Ctrough) - Half life (t½) - Apparent systemic clearance (CL/F) - Apparent volume of distribution (Vz/F) - Accumulation Ratios ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants - NCT ID: NCT06342700 - Study ID: PKM18138 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-04-29 - Lead Sponsor: Sanofi ### Study Description This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.The total study duration per participant is expected to be up to 36 days, including:* Screening: up to 4 weeks* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study. ### Conditions - Autoimmune Disorder - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Rilzabrutinib crystalline form - Rilzabrutinib amorphous form ### Outcomes Primary Outcomes - Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state - Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state - Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state Secondary Outcomes - Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state - Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state - Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state - Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state - Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state - Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state - Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest ### Location - Facility: Nucleus Network Site Number : 8400001, Saint Paul, Minnesota, 55114, United States @@
## Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment - NCT ID: NCT06342687 - Study ID: JagiellonianU 1 - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Jagiellonian University ### Study Description The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection. ### Conditions - Colorectal Cancer - ERAS ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High compliance with ERAS protocol ### Outcomes Primary Outcomes - Post operative 5 year survival rate Secondary Outcomes ### Location - Facility: Jagiellonian University Medical College, Kraków, Małopolskie, 31-008, Poland @@
## Effect of Breast Milk Circadian Properties on Infant's Growth Parameters and Absorption of Nutrients - NCT ID: NCT06342674 - Study ID: Nejla CANBULAT ŞAHİNER - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-31 - Lead Sponsor: Sakarya University ### Study Description The most ideal method for providing breast milk is breastfeeding. However, it may be necessary to express breast milk for reasons such as the newborn being in an intensive care unit, the mother being hospitalized for any reason, or the mother starting to work. The content of breast milk varies according to gestational age and stages of lactation. However, it varies from day to day depending on the infant's needs. In recent literature, it is emphasized that the content of breast milk (carbohydrates, fats, proteins, vitamins, trace elements, etc.) varies according to circadian variation. In the literature review, no national or international study was found indicating whether the circadian properties of breast milk have an effect on the infant's growth parameters. This study was designed as a randomized controlled experimental study to determine the effect of the circadian properties of breast milk on the growth parameters of the infant and the absorption levels of nutrients by the baby in preterm newborns.no effect on the infant's growth parameters and nutrient absorption levels by the infant.Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk. ### Conditions - Breast Feeding - Breast Milk Collection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Giving breast milk to the newborn according to the circadian rhythm - Usual care ### Outcomes Primary Outcomes - Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups - Evaluation of the baby's height measurements in the study and control groups - Evaluation of the baby's head circumference in the study and control groups Secondary Outcomes - Evaluation of nutritional absorption of infants in the study and control groups ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment - NCT ID: NCT06342661 - Study ID: 2022IIT205 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2028-11 - Lead Sponsor: First Affiliated Hospital of Harbin Medical University ### Study Description 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years. ### Conditions - Cerebrovascular Disease Small Vessel ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological testing ### Outcomes Primary Outcomes - Patient characteristics - VISTA expression in PBMCs in the VCI and control groups Secondary Outcomes ### Location - Facility: First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150010, China @@
## Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic - NCT ID: NCT06342648 - Study ID: Cutaneous water in renal colic - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: Suez Canal University ### Study Description Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared. ### Conditions - Renal Colic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sterile Water Injection - Diclofenac Sodium injection ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hydra Single-centre Experience - Copenhagen, Denmark - NCT ID: NCT06342635 - Study ID: HYD/DENMARK-001/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-10-31 - Lead Sponsor: Sahajanand Medical Technologies Limited ### Study Description The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series. ### Conditions - Aortic Valve Stenosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hydra Transcatheter Aortic Valve (THV) Series ### Outcomes Primary Outcomes - Primary safety endpoint - Primary performance endpoint Secondary Outcomes - Technical success - Cardiovascular mortality - All-cause mortality - All stroke - Disabling stroke - Myocardial infarction - Major vascular complication - Acute kidney injury - New permanent pacemaker implantation due to procedure related conduction abnormalities - New-onset atrial fibrillation - Coronary artery obstruction requiring intervention - Re-hospitalization for procedure- or valve-related causes - Mean aortic valve gradient - Effective Orifice Area (EOA) - Paravalvular leak - New York Heart Association (NYHA) functional class - Quality-of-life evaluation - Bioprosthetic Valve Failure (BVF) - Bioprosthetic valve dysfunction (BVD) - Stroke or peripheral embolism - VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns - Rates of Hypoattenuated Leaflet Thickening (HALT) - Rates of Reduced leaflet motion (RLM) - Commissural alignment ### Location - Facility: Copenhagen University Hospital, Rigshospitalet, Copenhagen, N/A, N/A, Denmark @@
## Young-onset Colorectal Cancer Screening Based on Artificial Intelligence - NCT ID: NCT06342622 - Study ID: Weiguo Dong - Status: COMPLETED - Start Date: 2023-12-01 - Completion Date: 2024-01-25 - Lead Sponsor: Renmin Hospital of Wuhan University ### Study Description In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data. ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Using routine clinical data and machine learning models. ### Outcomes Primary Outcomes - The performance of machine learning screening models Secondary Outcomes ### Location - Facility: Renmin Hospital of Wuhan University, Wuhan, Hubei, 430060, China @@
## Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease - NCT ID: NCT06342609 - Study ID: 32857-01-EKSTROM - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-15 - Completion Date: 2024-09-07 - Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ### Study Description This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Colchicine 0.5 MG ### Outcomes Primary Outcomes - Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography Secondary Outcomes - Effect of Colchicine on markers of inflammation using laboratory tests - Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA - Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA - Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD) ### Location - Facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Torrance, California, 90502, United States @@
## A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants - NCT ID: NCT06342596 - Study ID: 18597 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-04 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - [14C]-LY3473329 - [14C]-LY3473329 - LY3473329 ### Outcomes Primary Outcomes - Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered - Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered - Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 Secondary Outcomes - Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 - Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity - Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 - Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity - Part 1: PK: Maximum Concentration (Cmax) of LY3473329 - Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity - Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) - Part 1: Total Number of Metabolites of LY3473329 - Part 2: PK: AUC (0-∞) of LY3473329 - Part 2: PK: AUC (0-∞) of [14C]-LY3473329 - Part 2: PK: AUC (0-∞) of Total Radioactivity - Part 2: PK: Cmax of LY3473329 - Part 2: PK: Cmax of [14C]-LY3473329 - Part 2: PK: Cmax of Total Radioactivity - Part 2: Total Radioactivity Recovered in Urine and Feces ### Location - Facility: Fortrea Clinical Research Unit, Holbeck, Leeds, LS11 9EH, United Kingdom @@
## Advanced Social Relations Training - NCT ID: NCT06342583 - Study ID: CNR-IRIB-PRO-2024-004 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-02-10 - Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica ### Study Description Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them. ### Conditions - Autism - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Advanced social relations training with technical device - Advanced social relations training without technical device ### Outcomes Primary Outcomes - Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) - Eye contact - Smile in relation to group members' expressions - Greeting - Asking a question - Proposing an idea or activity to be carried out - Answering a question - Taking verbal initiative - Approval/sharing gestures Secondary Outcomes ### Location - Facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), Messina, N/A, 98164, Italy @@
## Quantitative Analysis of EEG Changes in Response to Nociception - NCT ID: NCT06342570 - Study ID: 3-2023-0462 - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2026-12-30 - Lead Sponsor: Gangnam Severance Hospital ### Study Description This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception. ### Conditions - Patients Undergoing Laparoscopic Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There is no Intervention name to describe. ### Outcomes Primary Outcomes - Correlation between changes in ANI and EEG band power in response to surgical stimulation. Secondary Outcomes - Correlation between changes in ANI and EEG band power in response to tracheal intubation - Correlation between changes in ANI and EEG connectivity in response to surgical stimulation - Correlation between changes in ANI and EEG connectivity in response to tracheal intubation - Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration - Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration - Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI - Differences in EEG connectivity during surgery between groups with large and small changes in ANI - Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI - Differences in EEG connectivity during recovery between groups with large and small changes in ANI - Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic - Differences in EEG connectivity depending on the type of inhaled anesthetic - Differences in ANI depending on the type of inhaled anesthetic ### Location - Facility: GangnamSeverance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Transitional ePRO Diary Liver - NCT ID: NCT06342557 - Study ID: FROM - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2034-02-21 - Lead Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS ### Study Description The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients. ### Conditions - Liver Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - four-item Morisky Medication Adherence Scale (MGLS) Secondary Outcomes ### Location - Facility: ASST-Papa Giovanni XXIII, Bergamo, Milano, 24127, Italy @@
## Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. - NCT ID: NCT06342544 - Study ID: AGN_2023_14 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-06 - Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild ### Study Description Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off. ### Conditions - Ocular Myasthenia Gravis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - immediate treatment with corticosteroids - addition of rituximab if recurrence ### Outcomes Primary Outcomes - proportion of patients who progressed to generalized myasthenia within 2 years of follow-up Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## More Effective Violence Risk Management - eDASA+APP FI - NCT ID: NCT06342531 - Study ID: 210324 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: University of Turku ### Study Description The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care. ### Conditions - Violence ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - eDASA+APP FI ### Outcomes Primary Outcomes - Workplace violence Secondary Outcomes - Coercive measures - Job satisfaction ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation - NCT ID: NCT06342518 - Study ID: MU ESWT - Status: COMPLETED - Start Date: 2020-12-01 - Completion Date: 2021-12-01 - Lead Sponsor: Istanbul Medeniyet University ### Study Description This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound. ### Conditions - Lateral Epicondylitis - Tennis Elbow ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal Shock Wave Therapy (ESWT) - Sham ESWT - Resting Splint , Exercises and ice ### Outcomes Primary Outcomes - Hand Grip Strength - Pain severity - Functionality - Quality of life score - deep muscular tissue sensitivity - thickness of the common extensor tendon (CET) Secondary Outcomes ### Location - Facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department, Istanbul, N/A, 34732, Turkey @@
## Tacrolimus in CD3+ T Lymphocytes - NCT ID: NCT06342505 - Study ID: MEC-2022-0037 - Status: COMPLETED - Start Date: 2022-05-30 - Completion Date: 2022-11-10 - Lead Sponsor: Erasmus Medical Center ### Study Description The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are:(i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug?Participants will:* Receive standard clinical care;* Undergo two extra venipunctures for the collection of blood. ### Conditions - Immunosuppression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Venipunctures ### Outcomes Primary Outcomes - The intracellular tacrolimus concentration in CD3+ T lymphocytes Secondary Outcomes - Intracellular cytokine production ### Location - Facility: Erasmus MC, Rotterdam, N/A, 3015 GD, Netherlands @@
## Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure - NCT ID: NCT06342492 - Study ID: KCHRRF_CS Lead Failure_0025 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Kansas City Heart Rhythm Research Foundation ### Study Description This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure. ### Conditions - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Coronary Sinus Lead Revision ### Outcomes Primary Outcomes - Need for lead revision Secondary Outcomes - Electrocardiography characteristics - QRS Interval ### Location - Facility: Menorah Medical Center, Overland Park, Kansas, 66209, United States @@
## Discharge Training for Patients With Intertrochanteric Fracture - NCT ID: NCT06342479 - Study ID: NM: 04.20.ND:30.03.2023 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-07-01 - Lead Sponsor: Erzurum Technical University ### Study Description This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically. ### Conditions - Surgical Wound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Discharge Education ### Outcomes Primary Outcomes - Toronto Wound Symptom Assessment System Secondary Outcomes - Discharge readiness scale ### Location - Facility: Erzurum Technical University Faculty of Health Sciences, Erzurum, N/A, 25000, Turkey @@
## Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis - NCT ID: NCT06342466 - Study ID: 2023-358-02 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Jin Lu, MD ### Study Description This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months. ### Conditions - Systemic Amyloidosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bortezomib - Pomalidomide - Dexamethasone ### Outcomes Primary Outcomes - Hematologic VGPR + CR rate at 6 months Secondary Outcomes - Overall Hematologic response rate at 6 months - At least one organ response at 6 months - TTNT at 2 years - Estimated PFS at 2 years - Estimated OS at 2 years - TRAE ### Location - Facility: Peking University People's Hospital, Beijing, Beijing, 100044, China @@
## Examining Arts as Therapy in Children With Cancer, CREATe Trial - NCT ID: NCT06342453 - Study ID: STUDY00026814 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-30 - Lead Sponsor: OHSU Knight Cancer Institute ### Study Description This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer. ### Conditions - Hematopoietic and Lymphatic System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Art Therapy - Discussion - Media Intervention - Survey Administration ### Outcomes Primary Outcomes - Number of participants that complete all interventions and data collection time points Secondary Outcomes - Number of eligible participants that enroll in the study (feasibility threshold of 60%) - Number of participants that complete all interventions and all surveys in the study. - Number of intervenor fidelity surveys that obtain at least 95% score. - Comparison of scores on the PRO-CTCAE between intervention arms - Comparison of scores on the PROMIS between intervention arms - Comparison of scores on the Faces between intervention arms ### Location - Facility: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States @@
## Early Detection of Advanced Adenomas and Colorectal Cancer - NCT ID: NCT06342440 - Study ID: 23228/AACRC - Status: RECRUITING - Start Date: 2020-03-15 - Completion Date: 2025-12-15 - Lead Sponsor: City of Hope Medical Center ### Study Description This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses. ### Conditions - Colorectal Cancer - Colorectal Neoplasms - Colorectal Polyp - Colorectal Adenocarcinoma - Colorectal Disorders - Colorectal Dysplasia - Colorectal Cancer Stage I - Colorectal Cancer Stage II - Colorectal Cancer Stage III - Colorectal Cancer Stage IV - Colorectal Neoplasms Malignant - Colorectal Serrated Adenocarcinoma - Colorectal Adenoma With Severe Dysplasia - Colorectal Adenoma With Mild Dysplasia - Colorectal Adenoma With Moderate Dysplasia - Colorectal Adenoma and Carcinoma 1 - Colorectal Adenomatous Polyp - Colorectal Adenocarcinoma Metastatic in the Liver ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DENEB ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Monrovia, California, 91016, United States @@
## Stomach Cancer Exosome-based Detection - NCT ID: NCT06342427 - Study ID: 23228/DESTINEX - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: City of Hope Medical Center ### Study Description Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer. ### Conditions - Gastric Cancer - Gastric Adenocarcinoma - Gastric Cancer Stage - Gastric Neoplasm - Gastric Lesion - Gastric Cancer in Situ - Gastric Cancer Stage IV - Gastric Cancer Stage IIIB - Gastric Cancer Stage III - Gastric Cancer Stage IB - Gastric Cancer Stage IA - Gastric Cancer, Stage 0 - Gastric Cancer Stage IIIA - Gastric Cancer Stage II - Gastric Cancer TNM Staging - Gastric Cancer Metastatic to Lung - Gastric Cancer Metastatic to Liver - Gastric Cancer Stage I - Gastric Cancer TNM Staging Primary Tumor (T) T2B ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DESTINEX ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer - NCT ID: NCT06342414 - Study ID: 23228/ELUCIDATE - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: City of Hope Medical Center ### Study Description It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery. ### Conditions - Hepatocellular Carcinoma - Intrahepatic Cholangiocarcinoma - Cholangiocarcinoma - Primary Liver Cancer - Primary Liver Carcinoma - Hepatic Cancer - Hepatic Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ELUCIDATE ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## Early Onset Colorectal Cancer Detection - NCT ID: NCT06342401 - Study ID: 23228/ENCODE - Status: RECRUITING - Start Date: 2023-04-15 - Completion Date: 2025-10-15 - Lead Sponsor: City of Hope Medical Center ### Study Description Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid) ### Conditions - Colorectal Cancer - Colorectal Neoplasms - Colorectal Adenocarcinoma - Colorectal Cancer Stage I - Colorectal Cancer Stage IV - Colorectal Cancer Stage II - Colorectal Cancer Stage III - Colorectal Neoplasms Malignant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ENCODE ### Outcomes Primary Outcomes - Sensitivity Secondary Outcomes - Specificity - Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage - NCT ID: NCT06342388 - Study ID: 2024-0427 - Status: WITHDRAWN - Start Date: 2024-07 - Completion Date: 2026-06 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? ### Conditions - No Medicaid Coverage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call Secondary Outcomes - Duration of coverage gaps - Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call - Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage - NCT ID: NCT06342375 - Study ID: 2024-0434 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-06 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? ### Conditions - No Medicaid Coverage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Outbound phone call ### Outcomes Primary Outcomes - Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call Secondary Outcomes - Duration of coverage gaps - Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call - Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Magnesium Sulfate in Neonatal HIE" - NCT ID: NCT06342362 - Study ID: SICHN/IRB-001/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-12-02 - Lead Sponsor: Sindh Institute of Child Health and Neonatology ### Study Description The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management. ### Conditions - Neonates With HIE ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Magnesium sulfate - placebo or standard treatment) ### Outcomes Primary Outcomes - Neuroprotective effects Secondary Outcomes ### Location - Facility: SICHN, Karachi, Sindh, 74201, Pakistan @@
## A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above. - NCT ID: NCT06342349 - Study ID: SIBP-V03-I - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2024-12-30 - Lead Sponsor: Shanghai Institute Of Biological Products ### Study Description To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. ### Conditions - Influenza ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Quadrivalent influenza virus split vaccine (MDCK cells) - Quadrivalent influenza virus split vaccine (Chicken embryo) - Phosphate buffer solution ### Outcomes Primary Outcomes - Solicited Adverse Events (AEs) - Unsolicited Adverse Events - Serious Adverse Events (SAE) Secondary Outcomes - Seroconversion rate - Ratio of ≥1:40 - Geometric mean increase (GMI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HS-IT101 Injection in the Treatment of Advanced Solid Tumors - NCT ID: NCT06342336 - Study ID: HS-IT101ST01-I - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2028-03-31 - Lead Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. ### Study Description Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor. ### Conditions - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HS-IT101 Injection ### Outcomes Primary Outcomes - Adverse Events (AE) - Serious Adverse Events (SAE) Secondary Outcomes - Objective Response Rate (ORR) - Time-to-response (TTR) - Duration of Response (DOR) - Disease Control Rate (DCR) - Progression-Free-Survival (PFS) - Overall Survival (OS) - Lymphocyte subpopulation - TCR repertoire ### Location - Facility: Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China @@
## The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy - NCT ID: NCT06342323 - Study ID: IRB00006761-M2023235 - Status: RECRUITING - Start Date: 2023-10-08 - Completion Date: 2025-10-07 - Lead Sponsor: Peking University Third Hospital ### Study Description This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:Study Design: Prospective, single-center, exploratory clinical study.Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy. ### Conditions - Lung Cancer - Liver Cancer - Pancreatic Cancer - Renal Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SBRT ### Outcomes Primary Outcomes - success rate Secondary Outcomes - Treatment error ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## RE104 Safety and Efficacy Study in Postpartum Depression - NCT ID: NCT06342310 - Study ID: RE104-201-PPD - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Reunion Neuroscience Inc ### Study Description The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. ### Conditions - Postpartum Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RE104 for Injection ### Outcomes Primary Outcomes - RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score Secondary Outcomes - RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score - RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline) - RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) - RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) - RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S) - RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) - RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dermatoscopy Guided Resection for Skin Cancer - NCT ID: NCT06342297 - Study ID: OLL-1003043 - Status: RECRUITING - Start Date: 2024-01-14 - Completion Date: 2026-01-14 - Lead Sponsor: Region Örebro County ### Study Description In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report. ### Conditions - Basal Cell Carcinoma - Cutaneous Squamous Cell Carcinoma - Surgical Margin ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dermatoscopy ### Outcomes Primary Outcomes - Pathology resection side margin (radical/not radical) Secondary Outcomes ### Location - Facility: Örebro University Hospital, Örebro, N/A, 70375, Sweden @@
## Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer - NCT ID: NCT06342284 - Study ID: NYPC ERC# 2021-030 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2031-03-21 - Lead Sponsor: The New York Proton Center ### Study Description This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards. ### Conditions - Thoracic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Proton Beam Radiation with or without concurrent chemotherapy ### Outcomes Primary Outcomes - Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. Secondary Outcomes - Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics. ### Location - Facility: New York Proton Center, New York, New York, 10035, United States @@
## Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease - NCT ID: NCT06342271 - Study ID: 24-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-30 - Lead Sponsor: University of Talca ### Study Description People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2). ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nordic walking training - Free Walking training ### Outcomes Primary Outcomes - Change in the amplitude of arm swing - Change in the arm swing asymmetry Secondary Outcomes - Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m]. - Change in the functional mobility will be measured through the Timed up and go (TUG). - Change in the quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## COES: Curing Order Effects on Sealants - NCT ID: NCT06342258 - Study ID: HS-23-00611 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2026-06-30 - Lead Sponsor: University of Southern California ### Study Description Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures. ### Conditions - Dental Sealant - Sealant Retention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Ultradent Ultra Seal XT Plus ### Outcomes Primary Outcomes - Sealant Longevity Secondary Outcomes - Caries - Molar hypomineralization ### Location - Facility: Herman Ostrow School of Dentistry of USC, Los Angeles, California, 90089, United States @@
## Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy - NCT ID: NCT06342245 - Study ID: 2023.568 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-11 - Completion Date: 2027-06-11 - Lead Sponsor: Chinese University of Hong Kong ### Study Description This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion. ### Conditions - Achilles Tendinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiofrequency coblation micro-tenotomy ### Outcomes Primary Outcomes - Victorian Institute of Sports Assessment Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Efficacy of Neurofeedback Mindfulness in Migraine Management - NCT ID: NCT06342232 - Study ID: BEH1986 - Status: COMPLETED - Start Date: 2021-09-09 - Completion Date: 2023-03-01 - Lead Sponsor: University of Saskatchewan ### Study Description This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention. ### Conditions - Migraine Headaches ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neurofeedback mindfulness - Simple attention controlled task ### Outcomes Primary Outcomes - Migraine Disability - Migraine Severity - Headache Management Self-efficacy Secondary Outcomes - Anxiety - Depression ### Location - Facility: University of Saskatchewan, Saskatoon, Saskatchewan, S7N5A2, Canada @@
## Chronic Migraines and Neurofdeeback Mindfulness - NCT ID: NCT06342219 - Study ID: 423629 - Status: NOT_YET_RECRUITING - Start Date: 2024-12 - Completion Date: 2026-06 - Lead Sponsor: University of Saskatchewan ### Study Description As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study. ### Conditions - Chronic Migraine, Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neurofeedback Mindfulness - Attention Task ### Outcomes Primary Outcomes - Migraine Disability - Migraine Severity - Headache management self-efficacy - Dependence on medicine Secondary Outcomes - Anxiety - Depression ### Location - Facility: University of Saskatchewan, Saskatoon, Saskatchewan, S7N5A2, Canada @@
## The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools - NCT ID: NCT06342206 - Study ID: CMUH111-REC2-144 - Status: RECRUITING - Start Date: 2022-09-08 - Completion Date: 2024-09-07 - Lead Sponsor: China Medical University Hospital ### Study Description Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). \[30\] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development. ### Conditions - Stroke, Ischemic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients Secondary Outcomes ### Location - Facility: YuanRung Hospital, Changhua, N/A, 510, Taiwan @@
## Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial - NCT ID: NCT06342193 - Study ID: virtual reality - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-06-15 - Lead Sponsor: Uşak University ### Study Description The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia. ### Conditions - Cystoscopy - Virtual Reality - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - virtual reality group ### Outcomes Primary Outcomes - anxiety Secondary Outcomes ### Location - Facility: Usak Training and Research Hospital, Uşak, Center, 64100, Turkey @@
## Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome - NCT ID: NCT06342180 - Study ID: Usakupcos1 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-07-20 - Lead Sponsor: Uşak University ### Study Description We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls. ### Conditions - Uric Acid Concentration, Serum, Quantitative Trait Locus 7 - Polycystic Ovary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Serum uric acid level ### Outcomes Primary Outcomes - Uric acid levels in PCOS subtypes Secondary Outcomes ### Location - Facility: Usak Egitim Ve Araştırma Hastanesi, Uşak, N/A, 64100, Turkey @@
## Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma - NCT ID: NCT06342167 - Study ID: NCC4409 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-12-01 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT. ### Conditions - Locally Advanced Esophageal Squamous Cell Carcinoma - Sintilimab - Radiotherapy - Concurrent Chemoradiotherapy - Immunonutrition ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiotherapy - Programmed Cell Death Protein 1 Inhibitor - Immunonutrition support ### Outcomes Primary Outcomes - 1-year Progression-free survival rate (PFS) Secondary Outcomes - Objective response rate - Progression-free survival - Overall survival rate - Overall survival - Incidence of adverse events ### Location - Facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing, 100021, China @@
## Does Endorphin Massage Reduce the Anxiety of Pregnant Women? - NCT ID: NCT06342154 - Study ID: MCBU-SBF-YC-03 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2024-12-10 - Lead Sponsor: Celal Bayar University ### Study Description Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage. ### Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Endorphin Massage ### Outcomes Primary Outcomes - visual analog scale (VAS) - State and Trait Anxiety Scales - cortisol level Secondary Outcomes ### Location - Facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, Manisa, N/A, 45060, Turkey @@
## Empagliflozin for No-reflow Phenomenon in PCI for STEMI - NCT ID: NCT06342141 - Study ID: 24-1423 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-03-15 - Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez ### Study Description Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging. ### Conditions - STEMI - No-Reflow Phenomenon ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Empagliflozin 25 milgrams (Mg) - Empagliflozin 10 Mg - Placebo 25 Mg - Placebo 10 Mg ### Outcomes Primary Outcomes - Non-Reflow Phenomenon Secondary Outcomes - Infract size - Longitudinal Strain - High-sensitivity Troponin Clearance - Creatine Kinase-myocardial band Clearance - Adverse Cardiovascular Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Molecular Landscape of Microvascular Inflammation in Kidney Allografts - NCT ID: NCT06342128 - Study ID: MVI_Kidney_001 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-12 - Lead Sponsor: Paris Translational Research Center for Organ Transplantation ### Study Description Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches. ### Conditions - Kidney Rejection Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - RNA-based molecular signatures assessed using bulk and spatial transcriptomics - Probability of graft survival based on outcome data - Probability of patient survival on outcome data Secondary Outcomes ### Location - Facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, N/A, 75010, France @@
## Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens - NCT ID: NCT06342115 - Study ID: CLEMENT TRIAL - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-04 - Lead Sponsor: Beneficência Portuguesa de São Paulo ### Study Description The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes. ### Conditions - Febrile Neutropenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ceftolozane-Tazobactam - Meropenem ### Outcomes Primary Outcomes - Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population Secondary Outcomes - Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population - Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population - Incidence of microbiologically documented infections and identification of causative organisms in culture - In-hospital mortality - Occurrence of graft versus host disease (GVHD) - Frequency of multidrug resistant-pathogen infections or colonization - Faecal microbiota analysis - Percentage of Participants Who Report 1 or More Adverse Event (AE) - Percentage of Participants With Any Serious Adverse Event (SAE) - Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE) ### Location - Facility: A Beneficência Portuguesa de São Paulo, São Paulo, N/A, N/A, Brazil @@
## PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF) - NCT ID: NCT06342102 - Study ID: ID 4286 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-04-30 - Lead Sponsor: Ospedale Edoardo Bassini ### Study Description Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study. ### Conditions - Regional Anesthesia Block - Regional Anesthesia - Total Hip Replacement Surgery - Total Hip Arthroplasty \(THA\) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PENG + LFCN block - FIC block ### Outcomes Primary Outcomes - Movement of the lower limb affected by surgery Secondary Outcomes - pain control - pain control - pain control - Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses - Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses - Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus. - NCT ID: NCT06342089 - Study ID: NCT06342089 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-05 - Lead Sponsor: Cairo University ### Study Description * Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .* Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.* Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.* The severity and treatment needs of each case with MIH will be recorded in patient's chart.* The results of the study will be regularly monitored by the supervisors who will have full access to these results. ### Conditions - Molar Incisor Hypomineralization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Type I diabetes milletus ### Outcomes Primary Outcomes - Association between molar incisor Hypomineralization and type I diabetes milletus Secondary Outcomes - Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus. - Treatment need ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery - NCT ID: NCT06342076 - Study ID: 2023-596 - Status: COMPLETED - Start Date: 2024-01-01 - Completion Date: 2024-03-01 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.The main question(s) it aims to answer are:\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods. ### Conditions - Postoperative Pain - Postoperative Complications - Analgesia - Regional Anesthesia Morbidity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block - Patients undergoing rectus sheat block and posterior transversus abdominis plane block ### Outcomes Primary Outcomes - visuel analog scale Secondary Outcomes - amount of opioid used ### Location - Facility: Başakşehir Çam and Sakura City Hospital, Istanbul, Basaksehir, N/A, Turkey @@
## The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction - NCT ID: NCT06342063 - Study ID: 20-0070-E - Status: COMPLETED - Start Date: 2021-04-01 - Completion Date: 2024-01-31 - Lead Sponsor: Women's College Hospital ### Study Description This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial. ### Conditions - ACL Injury - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blood Flow Restriction Therapy - Blood Flow Restriction Therapy Sham ### Outcomes Primary Outcomes - Biodex Strength Testing Secondary Outcomes - Short Form Health Survey 12 (SF-12) - Knee Injury and Osteoarthritis Outcome Score (KOOS) ### Location - Facility: Mount Sinai Hospital, Toronto, Ontario, M5G 1X5, Canada @@
## Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS - NCT ID: NCT06342050 - Study ID: STU-2023-0548 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.The main aims / objectives of this sub-study are:* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups. ### Conditions - Obesity - Metabolic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Gut Microbial Composition - Blood Microbial Composition - Body Weight (kg) - Body Height (meters) - Fat Mass (Kg) - Fat-free Mass (Kg) - Body water (%) - Skeletal Muscle Mass (kg) - Fasting Glucose (mg/dL) - Fasting Insulin (mIU/L) - Lipopolysaccharides (%) - Lipopolysaccharides binding protein (mIU/L) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial - NCT ID: NCT06342037 - Study ID: N22TON - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2030-04-01 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer. ### Conditions - Metastatic Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tiragolumab - Atezolizumab - Ipilimumab ### Outcomes Primary Outcomes - PFS-12 - Incidence of adverse events Secondary Outcomes - Objective response rate - Clinical benefit rate - Progression-free survival - Overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pistachio Consumption on Inflammatory Markers and Lean Body Mass - NCT ID: NCT06342024 - Study ID: 23-871 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-08-31 - Lead Sponsor: Virginia Polytechnic Institute and State University ### Study Description Pistachio nuts (Pistacia vera L.) are a nutrient- and energy-dense food, and are a significant source of 15 different micronutrients. In addition to an excellent micronutrient profile, pistachios are a good source of monounsaturated and polyunsaturated fats (linoleic acid, oleic acid, and plant sterols). Pistachios have the lowest amount of total fat, and the highest protein, fiber, and phytosterol content compared to other nuts. They possess a high antioxidant content. Specifically, pistachios have high amounts of lutein, zeaxanthin, and phenolic compounds (e.g., anthocyanins, flavonoids, and proanthocyanidins). These aforementioned compounds are known for their anti-inflammatory effects. Pistachios also have been shown to reduce the risk of cardiovascular disease, metabolic syndrome, and all-cause mortality.The purpose of this study will be to determine the effects of consuming 1.5 ounces of pistachios per day compared to consuming no pistachios per day on inflammatory markers (creatine kinase, C-reactive protein, cortisol, Interleukin-8, tumor necrosis factor-alpha, copper-zinc superoxide dismutase, and glutathione peroxidase concentrations) and lean body mass in women and men, 40 to 60 years of age, who have been recreationally active for at least six months (exercising three to five days per week). It is hypothesized that pistachio consumption will significantly lower inflammatory response and significantly increase lean body mass.This will be a randomized study where participants will first complete a two-week baseline run-in period during which they will consume their typical diet. Following this, participants will be randomized to one of two groups for six months: consuming 1.5 ounces of pistachios per day or a control group (consuming no pistachios). Those consuming pistachios will be in addition to their usual diet.The overall goal of this study is to evaluate the effects of pistachio consumption on inflammatory markers and lean body mass in women and men, 40 to 60 years of age, who exercise three to five days per week. This study could provide a simple, healthy way for recreationally active individuals to decrease inflammation and improve body composition. ### Conditions - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pistachio group ### Outcomes Primary Outcomes - C-reactive protein concentrations in the blood - Creatine kinase concentrations in the blood - Cortisol concentrations in the blood - Interleukin-8 concentrations in the blood - Tumor necrosis factor-alpha concentrations in the blood - Copper-zinc superoxide dismutase concentrations in the blood - Glutathione peroxidase concentrations in the blood - Lean body mass Secondary Outcomes - Body weight - Height - Body Mass Index - Magnesium concentrations in the blood - Iron concentrations in the blood - Zinc concentrations in the blood ### Location - Facility: Virginia Polytechnic Institute and State University, Blacksburg, Virginia, 24061, United States @@
## Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease - NCT ID: NCT06342011 - Study ID: KY-2024-039 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Anti-inflammatory diet group ### Outcomes Primary Outcomes - C-reactive protein - Erythrocyte sedimentation rate (ESR) - Leukocyte Secondary Outcomes - Self-Rating Anxiety Scale，SAS - Self-Rating depression scale，SDS - Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ) - Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES) - Body Mass Index ### Location - Facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu, Zhejiang, 322000, China @@
## Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children - NCT ID: NCT06341998 - Study ID: HERO2020 - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2024-02-01 - Lead Sponsor: Shandong First Medical University ### Study Description Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST). ### Conditions - Germ Cell Tumor - Yolk Sac Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children ### Outcomes Primary Outcomes - Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate Secondary Outcomes - Progression-free Survival ### Location - Facility: Shandong Cancer Hospital and Institute, Jinan, Shandong, 250117, China @@
## DOsimetry and Radiation Induced NAusea in Head and Neck Cancers - NCT ID: NCT06341985 - Study ID: IEO 1593 - Status: RECRUITING - Start Date: 2021-11-15 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer. ### Conditions - Head and Neck Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exclusive radiotherapy ### Outcomes Primary Outcomes - Evaluation of nausea (acute toxicity) using CTCAE V5.0 Secondary Outcomes - Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire - Identification of the organs at risk most strongly correlated with the onset of nausea - Identification of dosimetric cutoffs for the onset of nausea - Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques - Development of machine-learning predictive models for the onset of nausea ### Location - Facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ancona, N/A, N/A, Italy @@
## Improving Psychological Outcomes for Acute Respiratory Failure Survivors Using a Self-Management Intervention - NCT ID: NCT06341972 - Study ID: IRB00247005 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2027-09-01 - Lead Sponsor: Johns Hopkins University ### Study Description A growing number of patients are surviving a stay in the intensive care unit (ICU) but may experience long-lasting psychological problems, but research evaluating such treatment for ICU patients is scant.The goal of this pilot randomized controlled trial is to evaluate the feasibility, acceptability, and potential benefit of an evidence-based psychological intervention for anxiety and associated outcomes for ICU patients.The main question\[s\] it aims to answer are:* Is this intervention feasible and acceptable in ARF patients?* Is this intervention in the ICU and hospital associated with reduced anxiety symptoms?Participants will participate in a cognitive behavioral therapy informed self-management intervention aimed to reduce anxiety symptoms. Researchers will compare the intervention group to patients who receive usual care to see if the intervention reduces symptoms at the the conclusion of the intervention and at 3 months follow-up. ### Conditions - Respiratory Failure - Anxiety - Critical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive behavioral therapy based self-management for anxiety ### Outcomes Primary Outcomes - Treatment Satisfaction Questionnaire - average accrual rate of 2 patients/month across all patients - treatment feasibility as assessed by sessions completed - treatment feasibility as assessed by drop out rate Secondary Outcomes - Visual Analog Scale - Anxiety - State Anxiety Inventory - Hopkins Rehab Engagement Scale - Self Efficacy for Managing Chronic Disease Rating Scale - Hospital Anxiety and Depression Scale - Quality of Life as assessed by the European Quality of Life Scale (EQ-5D) - Post Traumatic Stress Disorder as assessed by the Impact of Events Scale - 6 - Healthcare Utilization as assessed by Healthcare Utilization interview - Montreal Cognitive Assessment - Blind ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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