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## Disability of People With Fibromyalgia in Poland - NCT ID: NCT06296446 - Study ID: disability fibromyalgia - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-11-01 - Lead Sponsor: University of Rzeszow ### Study Description Fibromyalgia is a syndrome characterized by chronic, generalized pain in muscles and joints with the presence of characteristic, symmetrically occurring so-called "tender points" - areas of the body that are excessively sensitive to pressure. The condition is associated with a feeling of chronic fatigue, mood and sleep disturbances and a sensation of body stiffness. These complaints are bothersome and significantly impair patients' functioning in every aspect of their lives. There are few studies evaluating the functioning and disability of people with fibromyalgia. No such study has been conducted in Poland to date. Therefore, the purpose of this study is to evaluate the functioning and disability of fibromyalgia patients and the relationship of the level of disability with selected factors, such as pain intensity, emotional state, sleep quality, etc. ### Conditions - Fibromyalgia - Disabilities Multiple ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - disability Secondary Outcomes - functioning - depression - Sociodemographic data ### Location - Facility: University of Rzeszow, Rzeszów, Podkarpacie, 35-310, Poland @@
## Extended Reality-Assisted Therapy for Chronic Pain Management - NCT ID: NCT06296433 - Study ID: HCB_2023_1196 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer ### Study Description The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are:Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement. ### Conditions - Chronic Pain - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VR rehabilitation - VR video application ### Outcomes Primary Outcomes - Brief Pain Inventory Secondary Outcomes - Roland-Morris Disability Questionnaire - Short-Form 12 - Patient Global Impression of Change - Pain Catastrophization Scale ### Location - Facility: IDIBAPS, Barcelona, N/A, 08036, Spain @@
## Dysphagia After Thyroidectomy - NCT ID: NCT06296420 - Study ID: 24C304 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2026-11-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of this observational study is to develop a questionnaire for measuring swallowing and throat discomfort symptoms in patients with goiter or thyroidectomy, which complies with the model of Rasch and which satisfies the fundamental measurement axioms (e.g., unidimensionality, linearity, generalizability). Developing a scale with such characteristics would provide clinicians and researchers with a reliable tool for assessing the impact of goiter and for measuring the outcomes after surgery.Also, the study will assess the psychological impact of goiter and thyroidectomy, as well as the characteristics of the surgical scar after thyroidectomy.The questionnaire will be developed in the first phase of the study. Items and response categories will be identified through interviews performed with patients affected by goiter or after thyroidectomy.In the following phases of the study, the questionnaire will be administered to patients before and after thyroidectomy. ### Conditions - Goiter - Thyroid Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The primary outcome measure will be the questionnaire which will be developed in the first phase of the study itself. Secondary Outcomes - Patient and Observer Scar Assessment Scale (POSAS) 2.0. - Depression Anxiety Stress Scales-21 (DASS-21). ### Location - Facility: IRCCS Istituto Auxologico Italiano, Milan, MI, 20122, Italy @@
## Psychophysical Analysis of Adolescent Patients With Obesity and Efficacy of the Respiratory Approach (PSICOFISADOLOB). - NCT ID: NCT06296407 - Study ID: 01C319 - Status: RECRUITING - Start Date: 2023-08-08 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Specifically, the project aims to pursue the following objectives:1. To evaluate in male and female adolescents with obesity the interaction between different psycho-body aspects such as respiration - posture - self-perception and affectivity and tolerance to physical exercise;2. To evaluate in a subgroup of male and female adolescents the effectiveness of exercises aimed at respiratory muscles and of respiratory consciousness on the parameters above indicated and on their interaction.The final objective of this project is to define and propose "take home" specific respiratory exercises to promote greater body awareness and a condition of psychophysical well-being stable over time, creating a condition that can favor further interventions on obesity. Finally, the project aims to build solid scientific bases to insert respiratory exercise among the intervention guidelines to prevent and reduce obesity, particularly youth obesity. ### Conditions - Obesity, Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Standard metabolic integrated rehabilitation protocol - duration 3 weeks - Standard metabolic integrated rehabilitation protocol + respiratory exercises - duration 3 weeks ### Outcomes Primary Outcomes - Fat mass - Fat-free mass - Maximal Inspiratory Pressure - Maximal Expiratory Pressure - Interoceptive awareness Secondary Outcomes ### Location - Facility: Istituto Auxologico Italiano, Site Piancavallo, Oggebbio, Verbania, 28824, Italy @@
## Health Outcomes of Parents With Cystic Fibrosis-Aim 2 - NCT ID: NCT06296394 - Study ID: STUDY23080161 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-02-01 - Lead Sponsor: University of Pittsburgh ### Study Description The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stressH3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulatorsParticipants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link. ### Conditions - Cystic Fibrosis - Parenthood Status ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Parenthood ### Outcomes Primary Outcomes - Forced Expiratory Volume (FEV1) Secondary Outcomes - Pulmonary Function Tests (PFTs) - Forced Vital Capacity (FVC) - Pulmonary Function Tests (PFTs) - Forced Expiratory Volume (FEV1) - Pulmonary Function Tests (PFTs) - Forced Expiratory Flow at 25 and 75 percent (FEF25-75) - History of CF Diagnosis - History of CF Genotype Information - History of CF Mutation - Number of Hospitalizations - Length of Hospitalizations - Number of Pulmonary Exacerbations - Severity of Pulmonary Exacerbations - Treatment of Pulmonary Exacerbations - Rate of Hospitalizations Due to Pulmonary Exacerbations - Clinic Visit Attendance - Microbiologic Profile - Medication use - History of CF-Related Diabetes Status - CF-Related Diabetes Control - Hemoglobin A1C - CF-Related Diabetes Control - Glucose Tolerance - CF-Related Diabetes Control - Insulin Prescription Usage - Liver Disease Status - Transplantation Status - Transplantation Type - BMI - Sleep Quality - Parental Stress - Life Stressors - Cystic Fibrosis Questionnaire to evaluate quality of life domains - Parental Responsibility - Daily Care Check-In - Social Support - Anxiety - Depression - Self-Reported Adherence ### Location - Facility: University of Alabama-Birmingham, Birmingham, Alabama, 35294, United States @@
## Normative Values for Peripheral Muscle Strenght in Critical Patients and Healthy Individuals - NCT ID: NCT06296381 - Study ID: 6.131.540 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-30 - Lead Sponsor: University of Pernambuco ### Study Description Muscle strength is an important indicator of overall health and is a factor that has been associated with increased mortality in critical patients. Its measurement must be reliable and reproducible to ensure a quality outcome for clinical applicability. Recently, the use of digital handheld dynamometers in intensive care has gained support; however, analysis becomes challenging due to the absence of standardized reference equations for the Brazilian population. The aim of this study is to develop reference equations for the Brazilian population and define specific cutoff points for men, women, healthy individuals, and critical patients. ### Conditions - Intensive Care Unit - Muscle Strength ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Peripheral muscle strength measured by hand held dynamometer - Peripheral muscle strength measured by Medical Research Council score Secondary Outcomes - Peripheral muscle strength measured by hand grip dynamometer - Mobility in ICU measured by Perme Intensive Care Unit Mobility Score - Level of frailty in older adults by the Multidimensional Assessment of Older People (AMPI-AB) - Level of physical activity in young adults by the International Physical Activity Questionnaire - Short Form ### Location - Facility: Federal University of Pernambuco (UFPE), Recife, PE, 50740-600, Brazil @@
## DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics - NCT ID: NCT06296368 - Study ID: LCCC2305 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-04 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care. ### Conditions - Hematologic Malignancies - Lymphoma - Multiple Myeloma - Leukemia - Blood Cancers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Preference Reporting to Improve Management and Experience (PRIME) ### Outcomes Primary Outcomes - Difference in COLLABORATE scores between arms Secondary Outcomes - Difference in COLLABORATE scores between arms in a subgroup of patients ### Location - Facility: Lineberger Comphrehensive Cancer Center at University of North Carolina, Chapel Hill, North Carolina, 27516, United States @@
## Impacts of Warning Labels on Ultra-Processed Foods - NCT ID: NCT06296355 - Study ID: 24-0300d - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2024-06-20 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description Purpose: The overall purpose of this study is to identify the impacts of an ultra-processed (UPF) health warning label and UPF identify warning label compared to a control label (i.e., a barcode).Participants: \~4,000 US Latino adults of parental age (18-55 years), approximately 50% of whom will have limited English proficiency, recruited from a Latino-focused panel company.Procedures: Participants will be randomly assigned to view food products with one of three label types: health warning labels, identity labels, or barcode control labels. Participants will be asked a series of questions about the products and the label they were assigned. ### Conditions - Health Behavior - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Health Warning Label - Identity Warning Label - Barcode Label ### Outcomes Primary Outcomes - Identification of a product as ultra-processed Secondary Outcomes - Perceived product healthfulness of ultra-processed products - Intentions to purchase ultra-processed products - Perceived message effectiveness ### Location - Facility: UNC Carolina Population Center, Chapel Hill, North Carolina, 27516, United States @@
## Message Framing and Policy Support for Front-of-package Labeling - NCT ID: NCT06296342 - Study ID: 24-0300c - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-03-31 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description This study aims to assess whether different message framing about front-of-package labeling policies elicits more policy support than the control (no framing) among Latino and limited English proficiency populations. The study also seeks to identify which message framing elicits the most policy support. ### Conditions - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exposure to information framing message - Exposure to healthier choices framing message - Exposure to industry framing message ### Outcomes Primary Outcomes - Support for the front-of-package labeling policy, proportion Secondary Outcomes ### Location - Facility: The University of North Carolina at Chapel Hill's Gillings School of Global Public Health, Chapel Hill, North Carolina, 27599, United States @@
## Rubber Hand Illusion in Anorexia Nervosa - NCT ID: NCT06296329 - Study ID: 21C309 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The present research project aims to verify a possible difference in the recalibration of the real hand position (i.e. proprioceptive drift) in relation to the dimensions of the plastic hand in the Rubber Hand Illusion, among a group of female participants with anorexia nervosa compared with a normal weight control group. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rubber Hand Illusion ### Outcomes Primary Outcomes - Proprioceptive drift in centimeters Secondary Outcomes - Score at the Embodiment questionnaires ### Location - Facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, Piancavallo, VCO, 28824, Italy @@
## Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair - NCT ID: NCT06296316 - Study ID: IU022 - Status: RECRUITING - Start Date: 2023-11-21 - Completion Date: 2031-12 - Lead Sponsor: Coloplast A/S ### Study Description The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care. It will help to describe the safety profile and to confirm the clinical benefits of Restorelle mesh for at least 5 to 8 years post-surgery. ### Conditions - Genital Prolapse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Restorelle Polypropylene Mesh ### Outcomes Primary Outcomes - The incidence rate of a surgical reintervention related to Restorelle mesh use over at least the 5 first years of post-index procedure follow-up Secondary Outcomes - Incidence rate of surgical reintervention related to Restorelle mesh use in patients - Number of patients who have only had surgical reintervention not related to Restorelle mesh use - Percentage of patients who have only had surgical reintervention not related to Restorelle mesh use - Number of patients who have had more than 1 surgical reintervention (unrelated to mesh use) - Percentage of patients who have had more than 1 surgical reintervention (unrelated to mesh use) - Description of patients who have had more than 1 surgical reintervention (unrelated to mesh use) - Patient impression of improvement of surgical reintervention assessed by the PGI-I-Reintervention - Number of Adverse Device Effect - Percentage of Adverse Device Effect - Number of Restorelle mesh Device Deficiencies - Percentage of Restorelle mesh Device Deficiencies - Description of Restorelle mesh Device Deficiencies - Monitoring of postoperative pain related to Restorelle mesh use using the modified TOMUS/PREM questionnaire - Changes of prolapse symptoms - Prolapse symptoms - number - Prolapse symptoms - percentage - Assessment of health related quality of life using the EQ-5D-5L questionnaire - Assessment of health related quality of life using the PFIQ-7 questionnaire - Assessment of the sexual functioning by the PISQ-IR questionnaire - Assessment of the sexual functioning by the changes in dyspareunia status of patients who are sexually active. - Number of patients defining success via patient global impression of improvement (PGI-I) scale - Percentage of patients defining success via patient global impression of improvement (PGI-I) scale - Number of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8). - Percentage of patients satisfied after the index procedure as assessed by the Surgical Satisfaction Questionnaire (SSQ-8) ### Location - Facility: Polyclinique de la Baie, Avranches, Choisir Une Région, 50300, France @@
## Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients - NCT ID: NCT06296303 - Study ID: MBH24 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2024-06-30 - Lead Sponsor: Cairo University ### Study Description Purposes of the studyTo investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients ### Conditions - Lumbar Radiculopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pulsed electromagnetic therapy - Ultrasound phonophoresis - Conventional physical therapy ### Outcomes Primary Outcomes - Pain - Disability - Sciatic nerve cross sectional area Secondary Outcomes - H-reflex amplitude - H-reflex side-to-side amplitude (H/H) ratio ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Prolonged Cold-water Swimming on Heart Rate and Cardiac Function - NCT ID: NCT06296290 - Study ID: CARDIOCOLD - Status: COMPLETED - Start Date: 2022-06-04 - Completion Date: 2022-08-15 - Lead Sponsor: University Hospital, Caen ### Study Description A significant medical risk associated with hypothermia during exercise in a cold environment cardiac arrhythmia due to a possible autonomic conflict. However, little is known about the changes in heart rate and cardiac function after prolonged cold water swimming.The investigators propose to measure the changes in core temperarure during and after a cold water swim at at a water temperature below 15.5°C qualifying for English Channel swim and to test the association with changes in heart rate variability, resting electrocardiogram and left ventricle function. ### Conditions - Hypothermia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Heart rate from a resting ECG recording - Heart rate from a 5-minute ECG recording - Transthoracic echocardiography (TTE) analysis - Change in Body Core Temperature Secondary Outcomes - Body composition, body fat mass - Body composition, fat-free mass - Duration - Individual characteristics, gender - Individual characteristics, age - Individual characteristics, training in cold environment ### Location - Facility: CHU Caen Normandie, Caen, N/A, 14000, France @@
## Mechanical Ventilation in Surgical Patients - NCT ID: NCT06296277 - Study ID: UPO#1! - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-03-31 - Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita ### Study Description This is an investigator-initiated, international, multicenter, prospective, cross-sectional study that aims to 1) describe the incidence and types of postoperative pulmonary complications (PPCs), 2) describe patient demographics, baseline characteristics, and intraoperative ventilation management, 3) describe the occurrence of intraoperative adverse events (IAEs), and 4) their associations with PPCs, 5) assess the practice of intraoperative mechanical ventilation.Patients will be eligible for participation if: 1) adult and 2) receiving intraoperative ventilation during general anesthesia for surgery. Patients receiving ventilation outside of an operating room as well as patients receiving intraoperative ventilation during extracorporeal life support will be excluded ### Conditions - Surgery - Ventilator Lung - Postoperative Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intraoperative mechanical ventilation for surgery ### Outcomes Primary Outcomes - Postoperative pulmonary complications (PPCs) Secondary Outcomes - Intraoperative adverse events (IAEs) - Intraoperative mechanical ventilation practice - Postoperative clinical outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultra-portable Ultrasound vs. Standard Ultrasound to Help Place a Peripheral Catheter in Patients at Risk of Difficult Puncture - NCT ID: NCT06296264 - Study ID: ULTRACATHLON - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon ### Study Description The placement of an intravenous (IV) line is a common procedure when treating adult patients in critical care, in the emergency room or in the operating room. This simple and minimally invasive procedure can sometimes be made difficult depending on the patient's morphology or their clinical condition. The procedure then becomes time-consuming, anxiety-provoking, painful and its success is uncertain.The placement of intravenous (IV) lines under ultrasound by nurses is a rapidly developing alternative in intensive care, emergencies and the operating room. ### Conditions - IV Line Placement With Ultrasound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Standard ultrasound - Ultra-portable ultrasound ### Outcomes Primary Outcomes - Intravenous (IV) line placement time Secondary Outcomes - Placement of the IV line successfully obtained from the first puncture - Number of skin perforations - Overall success rate after 3 punctures - Use an alternative solution (central catheter) - Patient satisfaction with IV line placement - Nurse satisfaction with IV line placement - Immediate complications related to intravenous access - Delayed complications related to intravenous access - Date of IV line placement and removal ### Location - Facility: Saint Joseph Saint Luc Hospital, Lyon, Rhone-alpes, 69007, France @@
## Dietary Supplementation on Body Fat Composition - NCT ID: NCT06296251 - Study ID: BIO-2313 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-02-27 - Lead Sponsor: Brightseed ### Study Description The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo. ### Conditions - Dyslipidemias - Pre-diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo treatment - Plant derived phenolics ### Outcomes Primary Outcomes - Body fat mass Secondary Outcomes - Body composition - Android fat mass - Gynoid fat mass - Abdominal visceral fat mass - Abdominal circumference - Hip circumference - Chest circumference - Upper thigh circumference - Upper arm circumference - Waist to hip ratio - Fasting glucose - Fasting insulin - HbA1c - FGF21 - Systolic blood pressure - Diastolic blood pressure - Total-Cholesterol - HDL-C - LDL-C - VLDL-C - non-HDL-C - Triglycerides - Body Weight - Physical functioning - Bodily pain - Role limitations due to physical health - Role limitation due to personal or emotional problems - Emotional well-being - Social functioning - Energy/Fatigue - General health perceptions - Total kcals - Total fat - Total protein - Total carbohydrates - Fiber - Healthy Eating Index (HEI) score - ALT - AST ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia - NCT ID: NCT06296238 - Study ID: 2023P000461 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-02-15 - Completion Date: 2025-02 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.The main questions it aims to answer are:1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age. ### Conditions - Prenatal Exposure Delayed Effects ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Visual Evoked Potential (VEP) P1 Latency Secondary Outcomes - EEG Functional Connectivity - Cecile Attention Task - Infant Head Circumference - Bayley III, Cognition - MAAP - Accuracy and Speed - Hammersmith Infant Neurological Exam (HINE) ### Location - Facility: Harvard Medical School, Boston, Massachusetts, 02115, United States @@
## Effect of Vibratory Tendon Stimulation on Muscle Fatigue in the Acute Post-stroke Phase - NCT ID: NCT06296225 - Study ID: CHRO-2023-07 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2025-12-01 - Lead Sponsor: Centre Hospitalier Régional d'Orléans ### Study Description It seems that prolonged vibratory stimulation of the anterior forearm in healthy subjects leads to fatigue of the muscles concerned, with a reduction in their strength. The aim of this study is to evaluate the impact of vibratory tendon stimulation on grip force fatigue during the acute post-stroke phase.The investigations will be carried out by a specialized physiotherapist from the neurology department.The experiment consists of three successive phases:* First : measurement of the maximum handgrip force before any vibratory stimulation and then after the three sessions of ten-minute vibration.* Second : Rest period* Third: control phase with measurement of the maximum grip force every ten minutes without vibration. ### Conditions - Stroke - Stroke, Acute - Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Vibration ### Outcomes Primary Outcomes - Maximum handgrip strength measured by a digital dynamometer Secondary Outcomes - Fatigue evolution - Evolution of handgrip strength during the vibration session measured by a digital dynamometer ### Location - Facility: CH de Chartres, Chartres, N/A, N/A, France @@
## Study of Intravenous TAD® 600 mg/4 mL Solution for Injection to Evaluate Efficacy and Safety in Preventing Myocardial Injury in Patients With Pneumonia. - NCT ID: NCT06296212 - Study ID: GLT-07-22 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-09-30 - Lead Sponsor: Biomedica Foscama S.p.A. Industria Chimico-Farmaceutica ### Study Description The goal of this PHASE III clinical trial is to evaluate efficacy and safety of intravenous TAD® 600 mg/4 mL solution for injection in preventing myocardial injury in patients with pneumonia.The main question it aims to answer is:• could TAD® used as an add-on treatment to the standard therapy, due to the presence of the sodium salt glutathione, be effective and safe in preventing the risk of developing myocardial injury in hospitalized patients with pneumonia?Patients diagnosed with pneumonia (in the emergency department or hospital ward) will be asked to participate in the study and sign the Informed Consent Form (ICF) to assess their eligibility for enrollment.Eligible patients who meet the study inclusion criteria and complete the required Screening \& Baseline (V0) examinations, will be randomized with a 1:1 ratio allocation to the IMP Test group (TAD® treatment) or IMP Placebo group (Placebo treatment) in a double-blind manner, PI \& Patient blinded.TAD® (600 mg/4 mL reconstituted solution in 50 mL of 0.9% sodium chloride solution) or Placebo (50 mL of 0.9% sodium chloride solution) will be administered:* intravenously (with an infusion rate of 10 mL/min)* 2 times a day (with a dosing interval of 8 hours ± 30 minutes)* for 5 consecutive days (Day 1, Day 2, Day 3, Day 4 and Day 5)* patients will then be required to undergo five Follow-up Visits. ### Conditions - Pneumonia - Myocardial Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TAD® 600 mg/4 mL powder and solvent for solution for injection - Saline solution 0.9% of sodium chloride ### Outcomes Primary Outcomes - Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups. Secondary Outcomes ### Location - Facility: Azienda Ospedaliero-Universitaria Pisana, Pisa, PI, 56126, Italy @@
## Music, Virtual Reality for Inpatients in IUGM - NCT ID: NCT06296199 - Study ID: 2024-2064 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal ### Study Description Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR.Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety. ### Conditions - Aging - Disorder, Neurologic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - VR - Music only ### Outcomes Primary Outcomes - Feasability Secondary Outcomes - Emotions variation - Affect variation - Well-Being Variation - Quality of life variation - Anxiety variation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Massed Prolonged Exposure for PTSD in Substance Use Treatment - NCT ID: NCT06296186 - Study ID: HT94252310669 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-08 - Lead Sponsor: Veterans Medical Research Foundation ### Study Description The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week. ### Conditions - Stress Disorders, Post-Traumatic - Substance Use Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prolonged Exposure Therapy ### Outcomes Primary Outcomes - Clinician Administered PTSD Scale for DSM-5 (CAPS-5) - Time Line Follow back (TLFB) - Psychotherapy Completion Rates Secondary Outcomes - Patient Health Questionnaire-9 (PHQ-9) - Brief Psychosocial Functioning Inventory (B-IPF) - Client Satisfaction Questionnaire-8 (CSQ-8) ### Location - Facility: VA San Diego Healthcare System, San Diego, California, 92161, United States @@
## Open Lung Protective Extubation Following General Anesthesia - NCT ID: NCT06296173 - Study ID: MP-02-2024-12094 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-04-01 - Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) ### Study Description Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications. ### Conditions - Intra-abdominal Surgery - Anesthesia - Lung Injury - Ventilator-Induced Lung Injury - Atelectasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Protective "open-lung" extubation - Conventional extubation ### Outcomes Primary Outcomes - Average weekly patient recruitment rate - Protocol adherence rate - Postoperative pulmonary complications outcome completion rate Secondary Outcomes - Accuracy of self-reported protocol adherence compared to directly observed protocol adherence - Postoperative pulmonary complications - Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit - Quality of recovery - Discharge disposition - Days alive and out of hospital - Health-related quality of life ### Location - Facility: The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada @@
## A Simplified Lung Ultrasound Guided Management Protocol Of Pulmonary Congestion in Hemodialysis - NCT ID: NCT06296160 - Study ID: MRC-01-23-035 - Status: RECRUITING - Start Date: 2023-05-28 - Completion Date: 2024-05-22 - Lead Sponsor: Hamad Medical Corporation ### Study Description Pulmonary congestion secondary to volume overload or interstitial tissue inflammation is common in chronic hemodialysis patients. This pulmonary congestion occurs mainly during the period between dialysis sessions and is an independent risk factor for cardiovascular event morbidity and mortality in this population. The evaluation of this pulmonary congestion and the estimation of the dry weight of hemodialysis patients according to conventional methods represent a real challenge for clinical nephrologists. Lung ultrasound is a new diagnostic approach validated in the assessment of pulmonary congestion. It would allow a better assessment of dry weight in chronic hemodialysis patients based on the results of preliminary studies, including our latest pilot study. However, there is little evidence comparing this novel approach to traditional approaches. ### Conditions - End Stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Intervention Group ### Outcomes Primary Outcomes - Assess the effectiveness of adding B-line score evaluation through lung ultrasound to the standard of care to improve pulmonary congestion (measured by B lines score) in hemodialysis patients Secondary Outcomes - The impact of utilizing B lines score based additional fluid removal on interdialytic ambulatory blood pressure. - The impact of utilizing B lines score based additional fluid removal on intradialytic ambulatory blood pressure ### Location - Facility: Kaysi Saleh, Bruxelles, Van Gehuchten, 1020, Belgium @@
## Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy - NCT ID: NCT06296147 - Study ID: STUDY23080006 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-11-01 - Lead Sponsor: University of Pittsburgh ### Study Description The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality Headset - Aromatherapy Patch - Standard of Care ### Outcomes Primary Outcomes - Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure. - Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure. - Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure. Secondary Outcomes - Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. - Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations. ### Location - Facility: University of Pittsburgh Medical Center Shadyside Hospital, Pittsburgh, Pennsylvania, 15232, United States @@
## Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation - NCT ID: NCT06296134 - Study ID: 17501 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-12-31 - Lead Sponsor: Azienda Sanitaria Universitaria Friuli Centrale ### Study Description The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation. ### Conditions - Pelvic Floor Disorders - Levator Ani Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - perineal massage ### Outcomes Primary Outcomes - Comparison of the percentages of women without levator ani muscle co-activation after treatment or after standard care, evaluated at 37-38 weeks of gestation, using chi square test. Secondary Outcomes - Evaluation of significant differences in spontaneous or iatrogenic vaginal tears between the groups - percentage of women who completely adhere to perineal massage, i.e. who perform the perineal massage once a day, at least 5 days a week, from 34 gestational weeks until delivery. ### Location - Facility: Serena Xodo, Udine, N/A, 33100, Italy @@
## A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma - NCT ID: NCT06296121 - Study ID: BCD-264-2 - Status: RECRUITING - Start Date: 2023-12-21 - Completion Date: 2026-07 - Lead Sponsor: Biocad ### Study Description The aim of this study is to confirm the comparability of the efficacy and safety profiles of BCD-264 and Darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BCD-264 - Darzalex ### Outcomes Primary Outcomes - Overall response rate according to IMWG (International Myeloma Working Group) criteria Secondary Outcomes - Stringent complete response rate according to IMWG criteria - Complete response (CR) rate according to IMWG criteria - Very good partial response (VGPR) rate according to IMWG criteria - Duration of response - Progression-free survival - Time to progression - Time to response - Overall survival ### Location - Facility: Chelyabinsk Regional Clinical Hospital, Chelyabinsk, N/A, N/A, Russian Federation @@
## Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty - NCT ID: NCT06296108 - Study ID: I05-310-22 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-12-31 - Lead Sponsor: Ankara University ### Study Description The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty. ### Conditions - Postoperative Acute Kidney Injury - Arthroplasty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - acute kidney injury ### Outcomes Primary Outcomes - Acute kidney injury in patients undergoing arthroplasty surgery Secondary Outcomes - Risk factors causing acute kidney injury in patients undergoing arthroplasty surgery ### Location - Facility: Ankara University Medical School Anesthesiology and ICU Department, Ankara, N/A, N/A, Turkey @@
## To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis - NCT ID: NCT06296095 - Study ID: KDS-CUD-1 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-08-09 - Completion Date: 2024-12-31 - Lead Sponsor: Anhui Provincial Hospital ### Study Description The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis ### Conditions - Cirrhosis, Liver ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Cell therapy ### Outcomes Primary Outcomes - DLT,MTD Secondary Outcomes - fibrosis staging and inflammatory grading - All-cause mortality - TE（Transient elastography） ### Location - Facility: Anhui province hospital, Hefei, Anhui, 230000, China @@
## Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial - NCT ID: NCT06296082 - Study ID: 49317 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-06-30 - Lead Sponsor: Universiteit Antwerpen ### Study Description Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeksTrial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \~30° flexion; 7) being able to walk independently with or without aids.Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities. ### Conditions - Stroke - Spasticity as Sequela of Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Botulinum toxin type A - Dry Needling ### Outcomes Primary Outcomes - tonic stretch reflex threshold Secondary Outcomes - Passive Resistance - Ultrasound Imaging: Morphometric Analysis - Ultrasound Imaging: Eco-textural Analysis of Muscle: - Dynamometry - Gait Analysis - 10 Meter Walk Test (10MWT) - Timed up and Go Assessment (TUG) - Quality of Life EuroQoL 5D - EQ visual analogue scale (EQ VAS) - Cost-effectiveness - Patient Acceptance ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exergames on an Unstable Surface in Stroke Inpatients - NCT ID: NCT06296069 - Study ID: SwingIT-stroke - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-07-31 - Lead Sponsor: Eleftheria Giannouli ### Study Description Aim of this study is to assess the feasibility and effects of exergame-based cognitive-motor training on a labile platform on physical and cognitive functioning in stroke inpatients.This is two-armed pilot randomized controlled trial taking place in an inpatient neurologic rehabilitation clinic. A total of 30 persons that are undergoing inpatient rehabilitation due to a stroke will be randomly assigned to either the intervention group (IG) or the control group (CG). Participants of the IG will receive exergame-based motor-cognitive training on a labile surface, whereas participants of the CG will train on a stable surface. Primary outcome is feasibility comprising measures of adherence, attrition, safety and usability. Secondary outcomes will be measures of cognitive (psychomotor speed, inhibition, selective attention, cognitive flexibility, brain activity) and motor (functional mobility, gait speed, balance, proprioception) functioning. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - exergame-based cognitive-motor training on an unstable surface - exergame-based cognitive-motor training on an stable surface ### Outcomes Primary Outcomes - Security incidents - Attrition rate - Adherence rate - Usability - Training Load - Enjoyment - User experience - Training Goals Secondary Outcomes - Changes in cognitive flexibility - Changes in psychomotor speed - Changes in selective attention - Changes in inhibition and brain activity - Changes in functional mobility - Changes in coordination - Changes in dynamic balance - Changes in static balance - Changes in gait - Changes in leg proprioception - Changes in balance confidence - Changes in gait confidence ### Location - Facility: Rehaklinik Zihlschlacht, Zihlschlacht-Sitterdorf, Thurgau, 8588, Switzerland @@
## Phase I Study of Combined Immune Cell Therapy in Patients With Stage 4 Colorectal Cancer With Metastatic Lesion Who Failed Prior Standard of Care - NCT ID: NCT06296056 - Study ID: SDH-combi - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Nyamdavaa Tuul ### Study Description To evaluate the safety, immune response, and potential efficacy of combined immune cell therapy in patients with stage 4 colorectal cancer who have failed standard treatment and have unresectable lesions or metastatic lesions. ### Conditions - Colorectal Cancer Stage IV - Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Combi ### Outcomes Primary Outcomes - Number of Patients with grade 1-5 adverse events and list of adverse event frequency - immune response - potential efficacy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome - NCT ID: NCT06296043 - Study ID: SBU-FUT-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-08-15 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome. ### Conditions - Premenstrual Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Progressive Muscle Relaxation Exercise Group - Su-Jok Intervention ### Outcomes Primary Outcomes - PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10) - FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10) - SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10) - NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10) - Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined). Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Culturally Tailored ACT for Black Trauma - NCT ID: NCT06296030 - Study ID: 22-0010 - Status: WITHDRAWN - Start Date: 2021-09-01 - Completion Date: 2023-08-31 - Lead Sponsor: Azusa Pacific University ### Study Description Blacks in America more frequently meet the criteria for posttraumatic stress disorder (PTSD) than any other US race or ethnicity. Yet, blacks are among the groups least likely to use mental health services for trauma. Thus, a large number of traumatized blacks suffer silently and remain untreated.Acceptance and Commitment Therapy (ACT) is an empirically-based psychological intervention that uses acceptance and mindfulness strategies, with commitment and behavior change strategies, to increase psychological flexibility and decrease anxiety outcomes. While culturally tailored mental health interventions have been shown useful for racial and ethnic minorities, there have been few efforts to tailor ACT for blacks. This NIH R21 would compare an ACT model specifically culturally tailored for blacks (POOF) to the classic ACT model in a randomized trial, where clinicians will conduct 12-session telehealth synchronous virtual groups. Eighty black participants who self-identify as suffering from stress or anxiety will be confidentially recruited. Two specific aims are proposed:Aim 1) It is expected that POOF participants will report higher levels of acceptability of treatment than classic ACT participants and that POOF participants will have better adherence to treatment regimens than traditional ACT participants.Aim 2) Given that race-based stress may mediate anxiety symptoms in U.S. based blacks, it is expected that POOF will decrease race-based stress, thereby mattering the most for improving anxiety outcomes for blacks.The proposed R21 pilot study will be the first randomized controlled trial to evaluate an ACT intervention tailored explicitly for black racial trauma. This study will provide critical data needed to plan and design a future R01 controlled longitudinal effectiveness study. The long-term objective is to significantly reduce the prevalence of stress and anxiety-related symptoms due to traumatic events for Blacks by increasing treatment acceptability for this population. Since blacks have the highest rates of trauma prevalence and chronicity, yet they are still underrepresented in mental health treatment, this tailored intervention can have a significant public health impact. ### Conditions - Stress Disorders, Traumatic - Anxiety - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - POOF ACT program - Classic ACT program ### Outcomes Primary Outcomes - Race-Based Traumatic Stress Secondary Outcomes ### Location - Facility: Azusa Pacific University, Azusa, California, 91702, United States @@
## Effectiveness of Conservative Interventions in the Treatment of Trigger Finger - NCT ID: NCT06296017 - Study ID: AEŞH- EK1- 2023-115 - Status: RECRUITING - Start Date: 2023-10-02 - Completion Date: 2024-12 - Lead Sponsor: Hacettepe University ### Study Description There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF. ### Conditions - Trigger Finger - Stenosing Tenosynovitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Extracorporeal Shock Wave Therapy - Trigger Finger Splint - Extracorporeal Shock Wave Therapy+ Trigger Finger Splint ### Outcomes Primary Outcomes - Visual analog scale Secondary Outcomes - Grip and pinch strength - Number of trigger - Functional assessment - Treatment satisfaction - Functional assessment ### Location - Facility: Feray Karademir, Ankara, N/A, 06100, Turkey @@
## Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease Relation Between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease - NCT ID: NCT06296004 - Study ID: CAPILLAROSCOPY behcet disease - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description Relation between Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness in Behçet's Disease ### Conditions - Behçet's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nail Fold Capillaroscopy, Optical Coherence Tomography Angiography, and Femoral Vein Wall Thickness by U.S ### Outcomes Primary Outcomes - measuring parameter of Nail Fold Capillaroscopy in behcet disease - measuring parameter of Optical Coherence Tomography Angiography in behcet disease - measuring parameter of Femoral Vein Wall Thickness in behcet disease Secondary Outcomes - relation between Nail Fold Capillaroscopy and activity of behcet disease - relation between Optical Coherence Tomography Angiography and activity of behcet disease - relation between Femoral Vein Wall Thickness and activity of behcet disease ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis - NCT ID: NCT06295991 - Study ID: 2023/005 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-07-30 - Lead Sponsor: Hacettepe University ### Study Description The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals. ### Conditions - Balanced; Rearrangement - Respiratory Function Test ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Lycra garment ### Outcomes Primary Outcomes - Balance parameters - Respiratory functions - Respiratory muscle strength measurement Secondary Outcomes - Gross motor function measurement - Functional independence assessment - Assessment of activity restriction - Quality of life assessment - Assessment of posture ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multimarker Approach in Acute Chest Pain - NCT ID: NCT06295978 - Study ID: 4896 - Status: RECRUITING - Start Date: 2021-02-01 - Completion Date: 2024-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Chest pain is one of the most common causes of access in the Emergency Room, and it can be a clinical manifestation of a broad spectrum of diseases including those 'time dependent' conditions such as acute coronary syndrome (ACS). Diagnosis or exclusion of acute myocardial infarction (AMI) is a daily challenge in the emergency department (ED), especially when classic clinical criteria and ECG alone are unable to make the diagnosis. The ED physician has the extremely delicate task of managing patients with chest pain and being able to frame them correctly; therefore, he needs to make differential diagnosis since chest pain can be caused by non-cardiac vascular events but also extra-cardiovascular events, such as pulmonary, neurological, osteoarticular, gastrointestinal and psychological. Recently, the importance of inflammatory processes and endothelial damage in cardiovascular disease has been highlighted, and consequently the focus has been on new markers, in a "multimarker" approach in which the strengths of each are combined together to provide an optimal solution to a clinical problem.The data suggest how a future integration of these biomarkers in the routine approach to the patient with acute chest pain in the ED might allow a better patient stratification and proper management, allowing the clinician to make an early safe discharge or a timely admission for those who deserve in-depth diagnostic-therapeutic investigation. ### Conditions - Cardiovascular Disease Other ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Biochemical marker assays ### Outcomes Primary Outcomes - The predictive value of markers for the risk of cardiovascular events in chest pain Secondary Outcomes - Multimarker approach to improve cardiovascular risk stratification ### Location - Facility: Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Roma, N/A, 00168, Italy @@
## Clonal Hematopoiesis in Ovarian Cancer Survivors and Risk of Secondary Blood Cancers - NCT ID: NCT06295965 - Study ID: RG1123813 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2031-12-31 - Lead Sponsor: University of Washington ### Study Description This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer. ### Conditions - Recurrent Fallopian Tube Carcinoma - Recurrent Ovarian Carcinoma - Recurrent Primary Peritoneal Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients - Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors - Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN Secondary Outcomes ### Location - Facility: Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States @@
## A Study of Pasireotide in People With Prolactinoma - NCT ID: NCT06295952 - Study ID: 23-371 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2027-02 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description The researchers are doing this study to find out whether pasireotide is an effective treatment for people with prolactinoma who cannot receive dopamine agonist therapy. Another purpose of this study is to find out whether pasireotide is a safe treatment for people with prolactinoma. ### Conditions - Prolactin-Producing Pituitary Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pasireotide ### Outcomes Primary Outcomes - biochemical response rate Secondary Outcomes - radiographic response ### Location - Facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital - NCT ID: NCT06295939 - Study ID: CA code 016/2565, 012/2566 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-04-29 - Completion Date: 2024-05-31 - Lead Sponsor: Sanpasitthiprasong Hospital ### Study Description Research Question:Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.Primary Objectives:To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.Secondary Objectives:1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications. ### Conditions - Pregnancy Loss - Grief - Social Support ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - social support program - Routine nursing care ### Outcomes Primary Outcomes - The Perinatal Grief Assessment Questionnaire. Secondary Outcomes ### Location - Facility: Sanpasitthiprasong Hospital, Ubon Ratchathani, N/A, 34000, Thailand @@
## Serplulimab Combined With CCRT for LS-SCLC. - NCT ID: NCT06295926 - Study ID: K5236 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2027-12-31 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis. ### Conditions - Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Serplulimab ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes - Overall survival - Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 - objective response rate (ORR) ### Location - Facility: Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Hydroxytyrosol Dietary Supplement and Prevention of Age-Related Diseases - NCT ID: NCT06295913 - Study ID: HYTOLIVE15 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: National Research Council, Spain ### Study Description The primary objective of this study is to ascertain the effects of chronic consumption of a hydroxytyrosol-rich extract from olive (Hytolive®) in a population at high risk of developing age-related pathologies such as type 2 diabetes and cardiovascular diseases. The markers measured will be associated with oxidative stress, inflammation, and homeostasis glucose and lipid profiles. Improvements in these parameters could potentially prevent the onset of pathologies associated with aging. ### Conditions - Overweight - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Group 1, hydroxytyrosol-rich extract capsule (Hytolive®) - Group 2, capsule of placebo ### Outcomes Primary Outcomes - LDL-ox as marker of oxidative status Secondary Outcomes - Emotional well-being determined by Warwick-Edinburgh Mental Well-being Scale - Sleep quality determined by Pittsburgh Sleep Quality Index - Fatigue test determined by Borg Rating Of Perceived Exertion - Fasting glucose - Fasting insulin - Glycated hemoglobin (HbA1c) - Glucagon-like peptide-1 (GLP-1) - Total cholesterol - High density lipoproteins (HDL) - Low density lipoproteins (LDL) triglicéridos, apoliporpotein A1 and B) - Triglycerides - Apoliporpotein A1 - Apoliporpotein B - Total antioxidant status (TAS) - Total oxidative status (TOS) - Oxides of nitrogen (NOx) - Thiobarbituric acid reactive substances (TBARS) - C reactive protein - Interleukine 6 (IL-6) - Tumor necrosis factor alpha (TNF-α) - Interleukine 10 (IL-10) - Alanine aminotransfesare (transaminases ALT) - Aspartate aminotransferase (transaminase AST) ### Location - Facility: Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC), Madrid, Comunidad Autónoma De Madrid, 28040, Spain @@
## The Effect of Aromatherapy Massage on Sleep Quality - NCT ID: NCT06295900 - Study ID: 19.10.2023/63 - Status: RECRUITING - Start Date: 2024-01-05 - Completion Date: 2024-12 - Lead Sponsor: Nilgün Erdoğan ### Study Description Sleep disturbance is one of the most common complaints of patients admitted to ICU. Insufficient sleep in intensive care units may be associated with environmental reasons such as excessive light at night, loud warning sounds and mechanical ventilation alarms, as well as non-environmental factors, including the situation at the time of admission. Sleep assessment is subjective in nature, so it is difficult to perform in the ICU. Since communication with the patient is prevented, clear information about perceived rest and disturbing factors cannot be provided. For this reason, night rest is an issue that is often forgotten and ignored. This study applied a mixture of lavender, medicinal chamomile and neroli oil (in 20 ml of sweet almond oil; lavender oil 2 drops, medicinal chamomile 4 drops, neroli oil 6 drops) to patients who were monitored in intensive care on high-flow and oxygen, once a day for three days. This study will be conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on sleep quality. ### Conditions - Diabetes Mellitus - Respiratory Failure - Pneumonia - Respiratory Disease - Stroke, Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intervention 1 Group - Intervention 2 Group - Placebo Control Group ### Outcomes Primary Outcomes - Patient Introduction Form Secondary Outcomes - Patient Follow-up Form ### Location - Facility: Ömer Halisdemir University Training and Research Hospital, Nigde, N/A, 51100, Turkey @@
## Educational Efficacy of VR vs. Simulator in Emergency Medical Training - NCT ID: NCT06295887 - Study ID: E-2402 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-13 - Completion Date: 2025-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description It has not been revealed which is more effective: an education program using virtual reality technology or a simulation education program using Sim-man.In this study, the participants are new doctors who graduated from medical school and started working as interns at hospitals. The participants were divided into two groups. One group received a training program using virtual reality technology, and the other group received simulation training using Sim-man. The investigators would like to compare the increase in confidence and satisfaction before and after training.After the classes and surveys are completed for each group, the participants will be able to receive other educational methods if they wish. ### Conditions - Simulation Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Educational Program using VR or simulator designed to improve medical intern's performance managing emergency situation ### Outcomes Primary Outcomes - self-rated confidence for managing emergency situation - self-rated confidence for managing emergency situation - performance in managing emergency situation Secondary Outcomes - usability of Virtual Reality simulation program using User Experience Questionnaire Short - usability of Virtual Reality simulation program using Simulator Sickness Questionnaire - usability of Virtual Reality simulation program using System Usability Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Aromatherapy Massage on Pain, Anxiety and Comfort - NCT ID: NCT06295874 - Study ID: 12.10.2022/50 - Status: RECRUITING - Start Date: 2023-01-05 - Completion Date: 2024-08-30 - Lead Sponsor: Nilgün Erdoğan ### Study Description Patients in the intensive care unit (ICU) experience physical and psychological discomfort, including pain. Anxiety is a condition frequently encountered in the ICU. The hospital environment, especially the ICU, is reported as a significant cause of anxiety for patients. Comfort is a holistic, subjective and multidimensional concept that is affected by physical, environmental, social and psycho-spiritual contexts and changes over time and space. Comfort in intensive care is often associated with pain relief and end-of-life care. Assessment tools have been developed to measure patient comfort in the ICU, including levels of pain, delirium, and sedation. This work; Patients who are monitored in intensive care under high-flow and oxygen are treated with a mixture of lavender, thyme and eucalyptus oil (20 ml; lavender oil 5 drops, thyme oil 4 drops, eucalyptus oil 3 drops and 20 ml almond oil) twice a day for three days. This study was conducted to determine the effect of aromatherapy massage applied for a total of 30 minutes on some physiological parameters, pain, anxiety and intensive care comfort of the patients. ### Conditions - Respiratory Insufficiency - Pulmonary Disease, Chronic Obstructive - Diabetes Mellitus, Type 2 - High Blood Pressure - Stroke, Ischemic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Effect of aromatherapy massage on vital signs, pain, anxiety and comfort level ### Outcomes Primary Outcomes - Patient Introduction Form Secondary Outcomes - Patient Follow-up Form ### Location - Facility: Ömer Halisdemir University Training and Research Hospital, Nigde, N/A, 51100, Turkey @@
## Prospective Cohort Study of Panvascular Disease - NCT ID: NCT06295861 - Study ID: 2023-1194 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-21 - Completion Date: 2028-12-31 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description To construct a comprehensive big data platform for Chinese people with panvascular disease, and establish a Chinese panvascular disease oriented to guide treatment decisions Cohort and imaging, biological database; According to the clinical features, morphological structure, pathological characteristics of panvascularization, vascular age As the core of the evaluation, a standard evaluation system and a risk prediction model of intervention technology suitable for the diagnosis and treatment of patients with panvascular disease in China were established. Into the Further optimize the treatment strategies, protocols and clinical pathways for panvascular disease to improve patient prognosis and promote its application. ### Conditions - ASCVD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no different intervention between the two cohort. ### Outcomes Primary Outcomes - Cardiovascular adverse events - Cardiovascular mortality Secondary Outcomes - Rate of receiving vascular revascularization - Readmission rate for vascular reasons ### Location - Facility: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310000, China @@
## The Effects of Cardiac Rehabilitation Programme in Hypertensive Rheumatoid Arthritis Patients - NCT ID: NCT06295848 - Study ID: KayseriCH005 - Status: RECRUITING - Start Date: 2022-12-15 - Completion Date: 2024-06-15 - Lead Sponsor: Kayseri City Hospital ### Study Description The aim of this study is to investigate the beneficial impacts of the 6-week standardized CR program applied to hypertensive RA patients whose disease activity is under control with regular pharmacological treatment.Subjects will be randomly assigned to one of two groups: 1.) standard of care (SOC) treatment or 2.) SOC plus a 6 week CR program. ### Conditions - Cardiac Rehabilitation - Rheumatoid Arthritis - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Framingham Risk Score(FRS) - QRISK-3 Risk Score - 24-Hour Ambulatory Blood Pressure - DAS28 - Maximal oxygen consumption (VO2max) Secondary Outcomes - The Six-Minute Walk Test (6MWT) - The 36-Item Short Form Survey (SF-36) - International Physical Activity Questionnaire (IPAQ) - Short Form - Beck Depression Inventory (BDI) ### Location - Facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri, Kocasinan, 38080, Turkey @@
## Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood - NCT ID: NCT06295835 - Study ID: CS-2024-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Abbott Point of Care ### Study Description Method comparison study for Potassium (K) and ionized calcium (iCa). ### Conditions - Potassium (K) and Ionized Calcium (iCa) in Capillary Whole Blood ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Fingerstick blood draw ### Outcomes Primary Outcomes - Performance comparison - Performance comparison Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effectiveness of Chinese Medicine Nuan-gong-ye on Primary Dysmenorrhea - NCT ID: NCT06295822 - Study ID: CMUH112-REC2-063 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-02-28 - Lead Sponsor: China Medical University Hospital ### Study Description Primary dysmenorrhea is a common under-diagnosed complaint, with a prevalence of about 45-95% in women of childbearing age and about 10-25% in severe cases. Menstrual pain can be classified as primary or secondary. Primary menstrual pain is a crampy pain in the lower abdomen without any pelvic pathology, which usually occurs 6 to 12 months after the first menstruation. Primary menstrual pain is usually most severe on the first day of the menstrual cycle and lasts for 8 to 72 hours. The cause is still unknown, but studies suggest that it may be related to increased prostaglandins, which cause painful contractions of the uterus. The pain is often accompanied by other menstrual discomfort symptoms, including headache, breast tenderness, drowsiness, nausea, vomiting, constipation or diarrhea, and psychological anxiety, depression or irritability. In the case of secondary menstrual pain, there are clear pelvic pathologies, such as endometriosis, uterine fibroids, and pelvic inflammatory disease. ### Conditions - Chinese Medicine - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nuan-gong-ye - Placebo ### Outcomes Primary Outcomes - Visual Analogue Scale (VAS) Secondary Outcomes - Short Form McGill Pain Questionnaire (MPQ-SF) ### Location - Facility: China Medical University Hospital, Taichung, N/A, 404, Taiwan @@
## A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007) - NCT ID: NCT06295809 - Study ID: V940-007 - Status: RECRUITING - Start Date: 2024-05-06 - Completion Date: 2029-04-30 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints. ### Conditions - Carcinoma, Squamous Cell - Skin Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab - V940 - Surgery ### Outcomes Primary Outcomes - Event Free Survival (EFS) Secondary Outcomes - Overall response rate (ORR) - Freedom from surgery (FFS) rate - Pathological complete response (pCR) rate - Major pathological response (mPR) rate - Disease-free survival (DFS) - Disease-specific survival (DSS) - Overall Survival (OS) - Percentage of participants who experience and adverse event (AE) - Percentage of participants who discontinue study intervention due to AEs - Change from baseline in Global health status/QoL score (QLQ-C30 Items 29 and 30) - Change from baseline in physical functioning score of QLQ (C30 Items 1-5) - Change from baseline in Role functioning score of QLQ-C30 Items 6-7 ### Location - Facility: One Clinical Research ( Site 3211), Nedlands, Western Australia, 6009, Australia @@
## A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008) - NCT ID: NCT06295796 - Study ID: 8527-008 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-17 - Completion Date: 2025-04-14 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study. ### Conditions - Renal Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MK-8527 ### Outcomes Primary Outcomes - Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma - Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma - Maximum concentration (Cmax) of MK-8527 in plasma - Time to Maximum concentration (Tmax) of MK-8527 in plasma - Apparent terminal half-life (t1/2) of MK-8527 in plasma - Apparent Clearance (CL/F) of MK-8527 in plasma - Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma Secondary Outcomes - Number of participants who experience one or more adverse events (AEs) - Number of participants who discontinue study due to an AE - AUC0-last of MK-8527-triphosphate (TP) in peripheral blood mononuclear cells (PBMCs) - AUC0-inf of MK-8527-TP in PBMCs - Cmax of MK-8527-TP in PBMCs - Concentration at 168 hours (C168) of MK-8527-TP in PBMCs - Concentration at 672 hours (C672) of MK-8527-TP in PBMCs - Tmax of MK-8527-TP in PBMCs - t1/2 of MK-8527-TP in PBMCs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Evaluation of the Relation Between Different Questionnaires Measuring Radiation-induced Side-effect - NCT ID: NCT06295783 - Study ID: 2023-1059 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2027-02-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn more about how you would rate the intensity or severity of your symptoms during or after radiation therapy using questionnaires with different rating scales. ### Conditions - Radiation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MDASI-HN - EORTC QLQ-C30 - EORTC HN35 ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Obinutuzumab in Treatment of Fibrillary Glomerulonephritis - NCT ID: NCT06295770 - Study ID: 23-006712 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this research is to learn if Obinutuzumab is effective and safe in treating patients with fibrillary glomerulonephritis (FGN). ### Conditions - Fibrillary Glomerulonephritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Obinutuzumab ### Outcomes Primary Outcomes - Change in proteinuria from baseline to 12 months post treatment with Obinutuzumab Secondary Outcomes - Change in proteinuria from baseline to 6 months post treatment with Obinutuzumab - Rate of complete or partial remission - Improvement in serum albumin - Stabilization of kidney function - Serious Adverse Events (SAEs) ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures - NCT ID: NCT06295757 - Study ID: 2023LS102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-01-01 - Lead Sponsor: Masonic Cancer Center, University of Minnesota ### Study Description Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes. ### Conditions - Tobacco Use - Cigarette Smoking - Nicotine Dependence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Cigarettes ### Outcomes Primary Outcomes - Average Nicotine Level Secondary Outcomes - Average Puff Volume ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Outcomes and Cosmesis With Whole Breast Irradiation and Boost - NCT ID: NCT06295744 - Study ID: 2023-1724 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2032-02 - Lead Sponsor: University of Wisconsin, Madison ### Study Description This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months. ### Conditions - Early-stage Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiation Therapy ### Outcomes Primary Outcomes - Harvard Breast Cosmesis Scale Score Secondary Outcomes - Change in BREAST-Q Score - Incidence of Acute Toxicities - Incidence of Late Toxicities - Ipsilateral Breast Tumor Recurrence-Free Survival - Overall Survival (OS) ### Location - Facility: UW Carbone Cancer Center, Madison, Wisconsin, 53792, United States @@
## INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC - NCT ID: NCT06295731 - Study ID: INBRX106-01-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Inhibrx, Inc. ### Study Description This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20. ### Conditions - Head and Neck Squamous Cell Carcinoma (HNSCC) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - INBRX-106 - Pembrolizumab ### Outcomes Primary Outcomes - Phase 2: Objective Response Rate (ORR) - Phase 3: Progression-Free Survival (PFS) - Phase 3: Overall Survival (OS) Secondary Outcomes - Phase 3: Objective Response Rate (ORR) - Duration of Response (DOR) - Clinical Benefit Rate (CBR) - Phase 3: Time to Chemotherapy (TTCtx) - Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference - TTCD in physical functioning (PF) - TTCD in role functioning (RF) - TTCD in Global Health Status/quality of life (GHS/QoL) - Incidence and severity of Adverse Events (AEs) - Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tele-assessment of Functional Performance and Quality of Life in Patients With Duchenne Muscular Dystrophy: Validity and Reliability Study - NCT ID: NCT06295718 - Study ID: 2023/51 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-07-01 - Completion Date: 2024-05-10 - Lead Sponsor: Sahra Şirvan ### Study Description Thanks to tele-assessment methods, it may be possible to evaluate DMD patients without traveling to clinical centers. In recent years, the applicability of remote assessment methods in DMD patients, as in many populations, is being investigated. However, studies have generally focused on a single evaluation parameter such as physical function, a special evaluation method or a special evaluation tool. The aim of this study is to investigate whether remote assessment of functional performance and quality of life in DMD patients is valid and reliable. If a valid and reliable tele-evaluation method that includes functional performance and quality of life parameters is found to be valid and reliable, the travel burden on patients and caregivers can be eased, patients\' stress and anxiety related to travel can be reduced, caregivers can save time and energy and provide patients with the best possible treatment. ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Timed Performance Tests - Brooke Upper Extremity Functional Classification (BUEFS) - Vignos Lower Extremity Functional Classification (VAEFS) - PedsQL-3.0 Neuromuscular Module by PedsQL Multidimensional Fatigue Scale Secondary Outcomes ### Location - Facility: İstanbul University - Cerrahpaşa, Istanbul, N/A, 34758, Turkey @@
## Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD) - NCT ID: NCT06295705 - Study ID: 5230588 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-04 - Lead Sponsor: Loma Linda University ### Study Description This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Hip-Hop Dance ### Outcomes Primary Outcomes - Child Description of Impact on Social-Emotional Health Secondary Outcomes - Parent Perspective of Impact on Social-Emotional Health - Change in Social-Emotional Behavior ### Location - Facility: Loma Linda University Health, Loma Linda, California, 92350, United States @@
## A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis - NCT ID: NCT06295692 - Study ID: 77242113PSO3005 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2027-12-23 - Lead Sponsor: Janssen Pharmaceutical K.K. ### Study Description The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP). ### Conditions - Generalized Pustular Psoriasis - Erythrodermic Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - JNJ-77242113 ### Outcomes Primary Outcomes - Percentage of Participants With Generalized Pustular Psoriasis (GPP) who Experience Treatment Success Based on Clinical Global Impression (CGI) Scale According to Japanese Dermatological Association (JDA) Total Score at Week 16 - Percentage of Participants With Erythrodermic Psoriasis (EP) who Experience Treatment Success Based on CGI Scale at Week 16 Secondary Outcomes - Percentage of Participants With GPP who Experience Treatment Success Based on CGI Scale According to JDA Total Score Over Time - Percentage of Participants With EP who Experience Treatment Success Based on CGI Scale Over Time - Change From Baseline in Total Score of JDA Severity Index for GPP - Change From Baseline in Severity Classification of JDA Severity Index for GPP - Change From Baseline in Body Surface Area (BSA) for EP - Percentage of Participants who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) - Percentage of Participants who Achieve an IGA Score of Cleared (0) - Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) - Change From Baseline in Dermatology Life Quality Index (DLQI) Score - Percentage of Participants who Achieve a DLQI Score of 0 or 1 - Change From Baseline in EuroQol-5 Dimension 5-Level (EQ-5D-5L) - Percentage of Participants With Adverse Events (AEs) and Serious AEs ### Location - Facility: JR Sapporo Hospital, Hokkaido, N/A, 060-0033, Japan @@
## A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease - NCT ID: NCT06295679 - Study ID: 20180442 - Status: RECRUITING - Start Date: 2022-12-19 - Completion Date: 2028-12-19 - Lead Sponsor: Amgen ### Study Description The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice. ### Conditions - Major Cardiovascular Event - Established Atherosclerotic Cardiovascular Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First Secondary Outcomes - Time to CV Death, MI, or Stroke, Whichever Occurs First - Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline - Percent Change in LDL-C From Baseline - Number of Participants Who Experienced Adverse Events - Number of Participants Who Experienced Adverse Drug Reactions ### Location - Facility: China Japan Friendship Hospital, Beijing, Beijing, 100029, China @@
## Gingival Crevicular Fluid (GCF) Bactericidal Permeability Protein (BPI) and Interleukin (IL)-1 Beta - NCT ID: NCT06295666 - Study ID: 26.12.2018/901 - Status: COMPLETED - Start Date: 2019-02-19 - Completion Date: 2020-01-20 - Lead Sponsor: Akdeniz University ### Study Description Objective: The aim of this study is to determine the amounts of BPI (Bactericidal permeability protein) and interleukin-1beta (IL-1β) in gingival fluid samples obtained from individuals with periodontally healthy and periodontal disease, to compare these amounts between study groups, and to evaluate their relationship with clinical parameters. In cases where clinical parameters increase, IL-1β amounts also increase significantly. The amount of IL-1β in individuals with periodontal disease is significantly higher compared to healthy individuals. There is positive correlation between BPI and clinical parameters. The amount of BPI in individuals with periodontal disease is significantly higher than in healthy individuals. More studies are needed to better understand the importance and therapeutic effect of BPI in periodontitis ### Conditions - Periodontitis - Gingival Crevicular Fluid - Interleukin 1-beta - Bactericidal Permeability Protein ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Gingival Crevicular Fluid Bactericidal Permeability Increasing Protein levels in periodonitis Secondary Outcomes ### Location - Facility: Akdeniz Üniversitesi Diş Hekimliği Fakültesi, Antalya, N/A, N/A, Turkey @@
## Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement - NCT ID: NCT06295653 - Study ID: 7-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-30 - Lead Sponsor: Tanta University ### Study Description The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement. ### Conditions - Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - implant placement and soft tissue augmentation with Autogenous Subepithelial Connective Tissue Graft or Amniotic Chorion Membrane ### Outcomes Primary Outcomes - measure changes in periimplant mucosal thickness Secondary Outcomes - mid-buccal keratinized mucosal width ### Location - Facility: Faculity of Dentistry Tanta University, Tanta, Elgarbia, 6620012, Egypt @@
## Relative Contribution of Brain Insulin Action for Postprandial Metabolism - NCT ID: NCT06295640 - Study ID: 300/2022 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-01 - Lead Sponsor: University of Ulm ### Study Description The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. ### Conditions - Glucose Metabolism Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Oral glucose tolerance test with double-tracer dilution and intranasal insulin spray - Oral glucose tolerance test with double-tracer dilution and intranasal placebo spray ### Outcomes Primary Outcomes - Endogenous glucose production - Rate of glucose disappearance Secondary Outcomes - Proglucagon cleavage products - Glucose tolerance - Whole-body insulin sensitivity - Insulin secretion - Post-absorptive energy expenditure - Sex differences - Menstrual cycle effects - Autonomic nervous system activity ### Location - Facility: Universityhospital Ulm, Ulm, N/A, 89081, Germany @@
## The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies - NCT ID: NCT06295627 - Study ID: SYSKY-2024-115-01 - Status: COMPLETED - Start Date: 2023-01-30 - Completion Date: 2024-01-15 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed. ### Conditions - Catheter-associated Urinary Tract Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There were no interventions in retrospective analysis ### Outcomes Primary Outcomes - How many patients in the infected group and how many patients in the non-infected group had bladder irrigation - How many patients in the infected group and how many patients in the non-infected group were given enema - How many times the indwelling catheter was changed in patients in the infected group and patients in the non-infected group respectively - How many patients in the infected group and the non-infected group had co-diabetes Secondary Outcomes ### Location - Facility: Sun Yat-Sen Memorial Hospital, Canton, Guangdong, 510030, China @@
## Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease - NCT ID: NCT06295614 - Study ID: SPARKL - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-04-01 - Lead Sponsor: Ecole Polytechnique Fédérale de Lausanne ### Study Description The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ARC-IM System implantation ### Outcomes Primary Outcomes - Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. Secondary Outcomes - 10-meter walk test - 6-minute walk test - Timed up and Go and its cognitive version - Freezing of gait circuit - Kinematic analysis - Muscle analysis - Mini Balance Evaluation Systems Test (mini-BESTest) - Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - King's Parkinson's disease Pain Scale (KPPS) - The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV. - Parkinson's Disease Questionnaire-39 (PDQ-39) - Activities specific Balance Confidence Questionnaire (ABC-Q) - The Freezing of Gait Questionnaire (FOG-Q) - Home-use kinematic monitoring - Daily falls tracking - Satisfaction questionnaire - User Evaluation of Satisfaction with technology (QUEST 2.0) - System Usability Scale (SUS) ### Location - Facility: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Vaud, 1011, Switzerland @@
## Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis - NCT ID: NCT06295601 - Study ID: 2024/5591 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-08-15 - Lead Sponsor: Inonu University ### Study Description This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional rehabilitation - Action observation therapy and motor imagery ### Outcomes Primary Outcomes - Berg Balance Scale - Berg Balance Scale - Muscle strength and functional mobility - Muscle strength and functional mobility Secondary Outcomes - Fatigue Severity Scale - Fatigue Severity Scale - Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire - Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer - NCT ID: NCT06295588 - Study ID: STUDY00009135 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: University of Rochester ### Study Description To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation. ### Conditions - Fatigue - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fucoidan extracted from F. Vesiculosus - Fucoidan extracted from U. Pinnatifida ### Outcomes Primary Outcomes - percentage of participants who are randomized to the study out of all participants approached - percentage of participants who start the intervention who go on to complete the 8-week or 16-week intervention - percentage of participants who take at least 80% of the fucoidan pills during the study Secondary Outcomes - mean change in Brief Fatigue Inventory - mean change in plasma viscosity in blood - mean change in erythrocyte sedimentation rate in blood - mean change in thyroid stimulating hormone in blood - mean change in C-reactive protein in blood - mean change in leptin in blood - mean change in D Dimer in blood - mean change in TNF alpha in blood - mean change in neopterin in blood - mean change in lactase dehydrogenase in blood - mean change in procalcitonin in blood - mean change in frailty using a modified Fried's Frailty questionnaire ### Location - Facility: University of Rochester Medical Center, Rochester, New York, 14642, United States @@
## Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass - NCT ID: NCT06295575 - Study ID: ZZhang - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2022-07-01 - Lead Sponsor: Nanjing Children's Hospital ### Study Description A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora. ### Conditions - Congenital Heart Disease - Intestinal Disease - Dysbiosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - probiotics containing Bifidobacterium infantis and Lactobacillus - placebos containing lactose ### Outcomes Primary Outcomes - incidence of morbidity - gastrointestinal functional recovery indicators - biomarkers - microbiome Secondary Outcomes ### Location - Facility: Children's Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210093, China @@
## Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea - NCT ID: NCT06295562 - Study ID: CMUH112-REC3-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-31 - Lead Sponsor: China Medical University Hospital ### Study Description This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters. ### Conditions - Obstructive Sleep Apnea of Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Atomoxetine 80mg combined with oxybutynin 5mg - Venlafaxine 37.5mg - Atomoxetine 80mg combined with trazodone 100mg - Placebo ### Outcomes Primary Outcomes - Physiological parameter Secondary Outcomes - Endotypic traits ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma - NCT ID: NCT06295549 - Study ID: LB2304-0001 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2028-06-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma ### Conditions - Relapsed and Refractory B-cell Non-Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - LUCAR-G39P cells product ### Outcomes Primary Outcomes - Incidence, severity and type of TEAEs - Pharmacokinetics in peripheral blood - Pharmacokinetics in bone marrow - The recommended Phase II dose (RP2D) for this cell therapy Secondary Outcomes - Overall Response Rate (ORR) - Progression-free survival (PFS) - Overall Survival (OS) - Time to Response (TTR) - Duration of Response (DoR) - Immunogenicity assessment of LUCAR-G39P cells ### Location - Facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, 210029, China @@
## Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children - NCT ID: NCT06295536 - Study ID: WS10363 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-08 - Lead Sponsor: Essilor International ### Study Description The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia. ### Conditions - Ametropia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Comparator device, Closed-field autorefractometer ### Outcomes Primary Outcomes - Objective refractive error Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Heat Waves and the Elderly With COPD - NCT ID: NCT06295523 - Study ID: STU_2019_1759_COPD - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD. ### Conditions - COPD - Aging - Hyperthermia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Water Spray - Control ### Outcomes Primary Outcomes - Core body temperature - Forced expiratory volume (FEV1) - Forced vital capacity (FVC) - FEV1/FVC ratio Secondary Outcomes ### Location - Facility: Texas Health Presbyterian Hospital Dallas, Dallas, Texas, 75231, United States @@
## Observational Study of the Association Between Food Intake and Endometrial Polyps - NCT ID: NCT06295510 - Study ID: CDUTCM20240223 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: qinxiu zhang ### Study Description There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps. ### Conditions - Diet Habit - Endometrial Polyp - Women ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No interventions. ### Outcomes Primary Outcomes - Hormonal dietary intake - Comparison of daily living habits Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lung Cancer Screening by Artificial Intelligence Device - NCT ID: NCT06295497 - Study ID: LC-SHIELD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Lung-SIGHT ### Outcomes Primary Outcomes - The prevalence of early-staged lung cancer detected by first-round LDCT thorax (T0) in a high-risk non-smoker population Secondary Outcomes - Sensitivity of AI-assisted programme in lung nodule detection and monitoring compared to radiologist assessment - Rate of invasive workup and incidence of associated complications. - Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT - Diagnostic accuracy and discrimination ability of plasma-based fragmentomic assay in detection of lung cancer via assessment of sensitivity, specificity, positive predictive value and negative predictive value - To determine the quality adjusted life years (QALYs) gained through screening ### Location - Facility: Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants - NCT ID: NCT06295484 - Study ID: 5136 - Status: RECRUITING - Start Date: 2021-08-21 - Completion Date: 2026-12-31 - Lead Sponsor: Sunnybrook Health Sciences Centre ### Study Description Background:In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (\>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding. ### Conditions - Preterm Birth - Premature Lungs - Respiratory Distress Syndrome in Premature Infant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Alternating traditional CPAP, NIPPV, and high CPAP ### Outcomes Primary Outcomes - The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O). Secondary Outcomes - 1. Neural respiratory rate per minute - 2. Edi peak measured in MicroVoltage - 3. The difference in transcutaneous pCO2 in mmHg - 4. The difference in oxygen requirements in percent (i.e, 21%) ### Location - Facility: Sunnybrook Health Sciences Center, Toronto, Ontario, M4N 3M5, Canada @@
## A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a DFG Laser and CO2 Laser - NCT ID: NCT06295471 - Study ID: 2024P000112 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-08 - Lead Sponsor: Massachusetts General Hospital ### Study Description This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - DFG Laser - CO2 Laser - Optical coherence tomography (OCT) ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) pain score - Wound healing time Secondary Outcomes - Vessel density via OCT imaging - Vessel length via OCT imaging - Vessel thickness via OCT imaging ### Location - Facility: MGH Clinical Unit for Research Trials & Outcomes in Skin, Boston, Massachusetts, 02114, United States @@
## Gamma Sensory Flicker for Parkinson's Disease Patients With Freezing of Gait - NCT ID: NCT06295458 - Study ID: STUDY00006945 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Emory University ### Study Description The purpose of the study is to examine the safety of special eyewear and earphones that emit a visual and auditory stimulus in the gamma range (gamma flicker) in patients with Parkinson's disease for 1 hour per day and to assess the effects this stimulus has on reducing a walking problem referred to as freezing of gait (FOG) as well as on a specific spinal fluid chemical marker, amyloid.Based on previous animal studies this gamma stimulus has the potential as a novel, non-invasive, non-pharmacological approach, to remove amyloid from the brain. The investigators have found in a prior study, that amyloid levels are high in the spinal fluid of Parkinson's patients with FOG.Parkinson's disease (PD) patients often experience a complex gait disorder known as Freezing of Gait (FOG). FOG is characterized by brief arrests of stepping when initiating gait, turning, and walking straight and patients describe it as their feet being "glued" to the floor. FOG in Parkinson's disease (PD) is a considerable public health burden worldwide. It is a poorly understood gait symptom that has potentially grave consequences as FOG is intermittent and unpredictable in nature, a leading cause of falls with injury, and results in loss of independence.FOG is generally found to be associated with cognitive decline, particularly executive dysfunction which, in turn, has been associated with higher spinal fluid amyloid (Aβ42) levels in PD. ### Conditions - Gait Disorders, Neurologic - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GammaSense Stimulation System - Control Group ### Outcomes Primary Outcomes - Number of participants with Adverse events - Number of participants compliant with the study procedures Secondary Outcomes - Change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale in participants with PD - Change in the freezing of gait severity in participants with PD. - Change in subjective changes in FOG. ### Location - Facility: Emory Movement Disorders Center, Atlanta, Georgia, 30329, United States @@
## Impact of Integrated Cardiopulmonary Ultrasound on Clinical Outcome of Shocked Patients in Intensive Care Unit - NCT ID: NCT06295445 - Study ID: Cardiopulmonary Ultrasound - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-09-15 - Lead Sponsor: Egymedicalpedia ### Study Description Shock is one of the most common conditions in the intensive care unit (ICU) affecting one-third of critically ill patients. It reduces oxygen and nutrition's perfusion to the solid organs and is closely associated with increased mortality. Most literature has described how hemodynamic monitoring could provide an effective way to identify underlying pathophysiological processes and guide appropriate therapy in shock patients. ### Conditions - Shock ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - care cardio-pulmonary ultrasound - treatment without any use of point of care cardio-pulmonary ultrasound scans for guidance of the management ### Outcomes Primary Outcomes - Mortality rate - Number of mortalities Secondary Outcomes ### Location - Facility: Al-Azhar University hospitals, Cairo, N/A, N/A, Egypt @@
## A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) - NCT ID: NCT06295432 - Study ID: DZ2022E0001 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-06 - Lead Sponsor: Dizal Pharmaceuticals ### Study Description DZD9008 in combination with AZD4205 for the treatment of patients with advanced NSCLC with EGFR mutations who have progressed after standard treatment. The purpose of this study is to assess the safety and efficacy of this combination therapy. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DZD9008+AZD4205 ### Outcomes Primary Outcomes - Part A: incidence of DLT , ≥grade 3 TEAEs and SAEs; Part B: incidence of ≥grade 3 TEAEs as assessed by CTCAE, incidence of SAEs. Secondary Outcomes ### Location - Facility: Guangdong Provincial People'S Hospital, Guangzhou, Guangdong, 510000, China @@
## The Effect of Dual Task on Manual Ability Performance in Children With Cerebral Palsy - NCT ID: NCT06295419 - Study ID: Igdir182 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-01 - Lead Sponsor: Igdir University ### Study Description The aim of the study is to investigate the effect of dual task conditions on manual dexterity performance in young people and children with CP between the ages of 7-18 and to compare it with their peers.Evaluations to be made in the study (children with CP) and control (typically developing peers) groups:* Demographic information, Gross Motor Function Level (GMFCS), Manual Skills Classification System (MACS) and dominant extremity will be noted and the evaluation will begin by applying the Abilhand Kids questionnaire.* Firstly, the child's performance on a single cognitive task will be evaluated in a supported sitting position on a chair. The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or young person.* Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10.* In order to evaluate the single motor performance of manual skills, the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph.* Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the 9-Hole Test and writing a paragraph.* In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds.* The Body Control Measurement Scale will be applied for body evaluation purposes.As a result of this study, the changes in manual dexterity and cognitive performance in dual-task conditions in children and adolescents with CP will be revealed. Additionally, changes in this performance in dual-task situations will be compared with a control group of typically developing children. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - dual task - single task ### Outcomes Primary Outcomes - Abilhand Kids - cognitive task (single task) - motor performance of manual skills (writing a paragraph) (single task) - motor performance of manual skills (single task) - motor performance of manual skills (dual task) - motor performance of manual skills (writing a paragraph) (dual task) - The Body Control Measurement Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reading Ability in Childhood Obesity - NCT ID: NCT06295406 - Study ID: 21C310 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-11-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory. ### Conditions - Obesity, Childhood - Obesity, Adolescent ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological assessment ### Outcomes Primary Outcomes - Raw score at the neuropsychological assessment Secondary Outcomes ### Location - Facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, Piancavallo, VCO, 28824, Italy @@
## Renin Angiotensin Aldosterone System In Septic Kids - NCT ID: NCT06295393 - Study ID: 20-0229-CCMC - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2025-06-01 - Lead Sponsor: Northwell Health ### Study Description Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups. ### Conditions - Sepsis - Acute Kidney Injury Due to Sepsis - Acute Kidney Injury (Nontraumatic) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Difference in serum renin in sepsis Secondary Outcomes - Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury - Septic induced kidney injury will be associated with alterations in renal blood flow - Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients - Changes in the components of the RAAS over the first three days in sepsis - Changes in renal blood flow on Ultrasound in Sepsis - Renal blood flow and RAAS in sepsis ### Location - Facility: Cohen Children's Medical Center, New Hyde Park, New York, 11004, United States @@
## Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees - NCT ID: NCT06295380 - Study ID: CarenAmp - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase). ### Conditions - Lower Limb Amputation Knee - Injuries - Biomechanical Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Virtual environment practiced on the Caren - Conventional physiotherapy ### Outcomes Primary Outcomes - Kinematic data - Kinetic data - Electromyography Secondary Outcomes ### Location - Facility: IRCCS Centro Neurolesi, Messina, Sicily, 98124, Italy @@
## Cost Communication and Financial Navigation in Cancer Patients (COSTCOM) - NCT ID: NCT06295367 - Study ID: EAQ222CD - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2029-08-01 - Lead Sponsor: ECOG-ACRIN Cancer Research Group ### Study Description This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer. ### Conditions - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Best Practice - Financial Navigation - Interview - Survey Administration ### Outcomes Primary Outcomes - Cost-related cancer care non-adherence Secondary Outcomes - Rate of Material Financial Hardship - Patient-reported financial worry - Patient-reported Quality of life - mental and physical health - Patient-reported satisfaction with care at 12 months ### Location - Facility: Mercy Hospital Fort Smith, Fort Smith, Arkansas, 72903, United States @@
## Early Variations in Immune Aging - NCT ID: NCT06295354 - Study ID: 2024-17062 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-12 - Lead Sponsor: Radboud University Medical Center ### Study Description Background:Despite an increase in lifespan over the last decades, our healthspan lags behind. In our aging population, it is pressing that we prevent age-related morbidities and associated burden on the health care system. Instead of investigating aging in already aged populations, the currently proposed study aims to elucidate the process of immune aging in relation to biological aging, demographic and lifestyle factors in young and midlife adults, and to identify early biomarkers and pathways associated with fast versus slow immune aging and aging endotypes.Study design:A single-center, observational prospective cohort study in the Netherlands. Participants from priorly established cohorts will be invited to join the EVIA-study. We will obtain demographic and basic clinical data and biological samples (blood and stool) at baseline and after three years, with a short, yearly online questionnaire in between. ### Conditions - Aging - Aging Well - Immuno Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention, we just study 'aging' ### Outcomes Primary Outcomes - Immunological function - Immunological Aging Score - Biological Aging Score - Metagenomics - Genetics and epigenetics - Clinical events Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Short Stature and Psychological Well-being - NCT ID: NCT06295341 - Study ID: 01C312 - Status: RECRUITING - Start Date: 2023-05-10 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The first aim of the present study is to evaluate the psychological impact of the condition of short stature (family) in a sample of Italian children, comparing them with subjects of normal stature, measuring their levels of psychological well-being, psychological distress, quality of health-related life and any behavioral issues. The secondary objective is to study the psychological impact evaluated with the tests described below (see methods section) in children with GH deficiency and the effects of replacement therapy (6 months) with GH from recombinant DNA. ### Conditions - Short Stature - Short; Stature, Psychosocial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Recombinant human growth hormone (only for children with growth hormone deficiency) ### Outcomes Primary Outcomes - Psychological well-being through the Psychological Well-Being Scales (PWB) - Psychological distress through the Depression Anxiety Stress Scale (DASS-21) - Quality of life through the Quality of Life in Short Stature Youth (QoLISSY), - Skills and problems through the Strengths and Difficulties Questionnaire (SDQ) Secondary Outcomes - Behavioral problems through the Child Behaviour Checklist for Children (CBCL) ### Location - Facility: Istituto Auxologico Italiano, Milano, N/A, 20145, Italy @@
## From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients - NCT ID: NCT06295328 - Study ID: NL 72439.018.19 - Status: RECRUITING - Start Date: 2022-04-13 - Completion Date: 2024-04-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description Rationale: Currently, there is no curative therapy available for patients that are chronically infected with the hepatitis B virus (HBV). Especially the presence of a viral reservoir of stable episomal, covalently closed circular DNA (cccDNA) in the nucleus of infected hepatocytes poses a great challenge for the development of curative therapies. HBV cccDNA acts as the template for production of viral proteins and HBV genomes. In a preclinical study, terbinafine (an antifungal agent) was identified as a potent and specific suppressor of HBx-mediated cccDNA transcription. HBx is an accessory viral protein of HBV which has been proven to be essential for HBV replication and enhances replication at the transcriptional level in vivo. The suppression of cccDNA transcription results in a strong reduction of the production of viral genomes (RNA and DNA) as well as viral proteins. This will allow recovery of the immune system, increase viral clearance and prevent replenishment of the cccDNA pool in the hepatocyte, all contributing to cure chronic hepatitis B (CHB).Objective: to provide proof of concept for the inhibition of HBx mediated cccDNA transcription by terbinafine, both as monotherapy and add-on therapy next to tenofovir. Secondary outcomes will be the safety and tolerability of terbinafine in this specific group.Study design: This pilot study is a stratified, single center, randomized, double-blinded, placebo-controlled, dose-ascending proof of concept clinical trial.Study population: patients chronically infected with the hepatitis B virus with a normal liver function and no signs of liver damage, who do not use any antiviral medication (group A, n=16) or are treated with tenofovir \> 6 months (group B, n=16).Intervention: Patients will be randomly allocated to daily oral treatment with terbinafine or a matched placebo, either as monotherapy (group A) or as add-on therapy to tenofovir (group B).Main study parameters/endpoints: Primary outcomes: decline in level of serum HBsAg \>0.32log10 IU/mL in both groups A and B and decline in serum HBV DNA \>0.86log10 in group A at the end of study treatment (week 10 vs baseline). Secondary outcomes: 1) Safety and tolerability of terbinafine as mono- or combination therapy; 2) level of serum HBsAg and HBV DNA at 3 months follow-up; 3) decline of HBsAg levels over time (all visits); 4) HBV RNA, large HBsAg (LHBs) HBcrAg levels, and HBeAg status at baseline and end of study 4).Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will undergo physical examinations and blood sample collections (13 samples and in total 467.5 mL). They will also be asked to fill in the HBQOL and EQ5D5L quality of life questionnaires and a medicine diary. In total there will be 13 visits in the hospital of which 7 will be for blood collection only. Terbinafine can induce liver damage 1 of 50,000 to 120,000 prescriptions (LiverTox), a weekly safety laboratory control is implemented in the visits to detect possible liver toxicity in an early stage and prevent liver damage. ### Conditions - Chronic Hepatitis b ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Terbinafine - Placebo - Tenofovir ### Outcomes Primary Outcomes - Change in level of serum HBsAG - Change in serum HBV DNA Secondary Outcomes - Safety of terbinafine - Tolerability of terbinafine - Serum levels of HBsAG - Serum levels of HBV DNA - Serum levels of HBV RNA - Serum levels of HBcrAg ### Location - Facility: Amsterdam UMC, Amsterdam, Noord-Holland, 1105AZ, Netherlands @@
## Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome - NCT ID: NCT06295315 - Study ID: 01C310 - Status: RECRUITING - Start Date: 2023-04-21 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated. ### Conditions - Prader-Willi Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Psychological well-being through the Psychological General Well-Being Index (PGWBI) - Perception of life quality through the 36-Item Short Form Survey (SF-36) - Mental distress through the Symptom Checklist-90-R (SCL-90-R) Secondary Outcomes - Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21) - Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). - Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ) ### Location - Facility: Istituto Auxologico Italiano IRCCS, site Piancavallo, Oggebbio, Verbania, 28824, Italy @@
## A Study to Explore the Efficacy and Safety of HWH486 in Adults With Chronic Spontaneous Urticaria - NCT ID: NCT06295302 - Study ID: RFCU-IIa-202308 - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2026-01 - Lead Sponsor: Hubei Biological Medicine Industrial Technology Institute Co., Ltd. ### Study Description This is a multicenter, randomized, double-bind and placebo-controlled phase IIa dose-finding study to assess the safety and efficacy of HWH486 in adults with chronic spontaneous urticaria (CSU). In addition, the pharmacokinetic characteristics will also be investigated. ### Conditions - Chronic Spontaneous Urticaria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HWH486 - Placebo ### Outcomes Primary Outcomes - Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) Secondary Outcomes - Change in Hive Severity Score (HSS) over a 7-day period (HSS7) - Change in Itch Severity Score (ISS) over a 7-day period (ISS7) ### Location - Facility: West China Hospital,Sichuan University, Chengdu, Sichuan, N/A, China @@
## Hybrid Closed-loop Insulin Delivery System in Perioperative Diabetic Patients: an Open-label, Randomized Controlled Trial - NCT ID: NCT06295289 - Study ID: ZRKY-2023-04 - Status: RECRUITING - Start Date: 2023-10-16 - Completion Date: 2024-12-04 - Lead Sponsor: Huazhong University of Science and Technology ### Study Description Perioperative management of glucose levels remains challenging. The purpose of the study is to compare the hybrid closed-loop insulin delivery system with the standard insulin therapy ( insulin pump with CGM, insulin dose controlled by physicians) in controlling glucose levels among patients in the perioperative period. ### Conditions - Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hybrid Closed-loop Insulin Delivery System - Insulin pump ### Outcomes Primary Outcomes - TIR Secondary Outcomes - TAR - TBR - MBG ### Location - Facility: Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Effect of Teletherapy-supported Training on Nursing Students - NCT ID: NCT06295276 - Study ID: HSOsnabruck - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-12-31 - Lead Sponsor: Hochschule Osnabruck ### Study Description Design: This study is a pilot randomized controlled trial (RCT) with two-arm parallel groups, the gold standard for determining treatment efficacy. The flowchart (see appendix) provides an overview of the study design. Participants are randomized and stratified by age into intervention group and waiting list group.The intervention is teletherapy-supported muscular training for 20 minutes 4 times a week.The duration of the intervention is six weeks in total. At the beginning Neck Disability Index (NDI), Oswestry Disability Index (ODI), Short-Form-36 (SF36), and the Numerical rating Scale (NRS) are collected. After six weeks, the same outcome measures and the global rating scale ### Conditions - Low Back Pain - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - teletherapy-guided exercise programme - Waiting list/control intervention ### Outcomes Primary Outcomes - Neck Disability Index (NDI) - Oswestry Disability Index (ODI) - NRS Numeric rating scale for pain Secondary Outcomes - Short-Form: SF 36-Quality of life - Global rating scale ### Location - Facility: Diakonie Pflege Schule, Osnabrück, Niedersachsen, 49078, Germany @@
## Application of AI Technology for the Diagnosis and Treatment of Geriatric Diseases - NCT ID: NCT06295263 - Study ID: KYLL-202203-028-1 - Status: RECRUITING - Start Date: 2022-03-01 - Completion Date: 2026-06-29 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description 1) Characteristics of handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with Alzheimer's disease.(2) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), imaging, EEG, and other relevant markers in patients with Parkinson's disease.(3) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers in patients with other neurological disorders.(4) Characteristics of handwriting, gait, language, eye movement, biological samples (blood, urine, stool, saliva, etc.), images, EEG and other relevant markers in elderly patients. ### Conditions - Parkinson Disease - Alzheimer Disease - Nervous System Diseases - Geriatric Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Handwriting, gait, speech, eye movements, biological samples (blood, urine, stool, saliva, etc.), images, EEG, and other relevant markers ### Outcomes Primary Outcomes - Handwriting - gait - speech - eye movements - biological samples (blood, urine, stool, saliva, etc.) - images - EEG - other relevant markers Secondary Outcomes ### Location - Facility: Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China @@
## ASHA Bangladesh--Integrated Intervention to Address Poverty and Depression - NCT ID: NCT06295250 - Study ID: STUDY00001114 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-12-30 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description The goal of this randomized controlled trial is to compare the impact of an integrated intervention combining poverty alleviation and depression treatment to depression treatment alone, in low income rural Bangladeshi women with depression. The main question\[s\] it aims to answer are: 1) whether adding poverty alleviation to depression treatment in an integrated intervention improves depression outcomes at 24 months, as assessed by depressive symptoms and by the presence or absence of relapse; and 2) whether adding poverty alleviation to depression treatment improves implementation outcomes including treatment uptake and retention. Participants in both arms will participate in interviews at 6,12,18 and 24 months. ### Conditions - Depression - Economic Vulnerability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manualized Group Based Psychotherapy - Poverty Alleviation ### Outcomes Primary Outcomes - Change in Depressive symptoms at 24 Months - Change in Depressive symptoms at intermediate timepoints - 24 Month Relapse Secondary Outcomes - Economic vulnerability - Anxiety - Function - European Quality of Life Five Dimensions Five Level scale - Tension Scale ### Location - Facility: International Centre for Diarrhoeal Disease Research, Dhaka, N/A, N/A, Bangladesh @@
## Automatic Adjustment for Asynchronies During Mechanical Ventilation - NCT ID: NCT06295237 - Study ID: i-Sync - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-07-01 - Lead Sponsor: Hospital San Carlos, Madrid ### Study Description Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software. ### Conditions - Mechanical Ventilation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Intellisync+ ### Outcomes Primary Outcomes - Duration of asyncronies Secondary Outcomes ### Location - Facility: Hospital Clinico San Carlos, Madrid, N/A, 28040, Spain @@
## Retrospective Evaluation of Effect of Anterior Iliac Block - NCT ID: NCT06295224 - Study ID: GOKAEK-2024/02.19 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-03-15 - Lead Sponsor: Kocaeli University ### Study Description In this study, the investigators aimed to evaluate the effect of ultrasound-guided anterior iliac block which was performed preoperatively. Anterior iliac bone harvesting is associated with severe postoperative pain. As several fascial plane blocks were defined to provide analgesia, their effects are debatable and requires high volumes of local anesthetic considering the regional anesthesia technique used for the main surgical procedure. ### Conditions - Regional Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Morphine consumption Secondary Outcomes - NRS score ### Location - Facility: Kocaeli Universty, Kocaeli, N/A, N/A, Turkey @@
## Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study. - NCT ID: NCT06295211 - Study ID: FEDII_HL_PR/R-Bv-Bs - Status: COMPLETED - Start Date: 2013-09-01 - Completion Date: 2024-02-22 - Lead Sponsor: Federico II University ### Study Description This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023. ### Conditions - Hodgkin Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Progression overall survival - Response to treatment - Incidence of treatment emergent adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Different Talocrural Joint Mobilization Techniques in Lateral Ankle Sprain - NCT ID: NCT06295198 - Study ID: OPMM-Ankle Instability - Status: RECRUITING - Start Date: 2023-07-30 - Completion Date: 2024-03-30 - Lead Sponsor: Bahçeşehir University ### Study Description Decreased ankle dorsiflexion range of motion (DFROM) has been identified among the factors that increase the risk of lateral ankle sprain (LAS) in basketball players. Restoring the DFROM is important in restoring reduced functional abilities and reducing the risk of re-injury. There is evidence that talocrural joint mobilization improves DFROM, but studies investigating the effectiveness of different mobilization techniques are needed. Our study aims to investigate the effects of single-session Mulligan and Maitland talocrural joint mobilization methods on dorsiflexion joint range of motion, jumping performance, and kinesiophobia in elite basketball players. ### Conditions - Ankle Sprains - Ankle Injuries - Kinesiophobia - Jumping From Height ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single lep drop jump test ### Outcomes Primary Outcomes - Single-leg drop jump test Secondary Outcomes - Weight-bearing lunge test - Tampa kinesiophobia scale - Fear Avoidance Belief Questionnaire ### Location - Facility: Bahcesehir University, Besiktas, Istanbul, 34353, Turkey @@
## Digital Therapeutic Workplace Technology as a Employee Management Tool and Employee's Mental Health Care - NCT ID: NCT06295185 - Study ID: AJOUIRB-IV-2024-097 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Ajou University School of Medicine ### Study Description The purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of Hisbeans's employees and the managerial performance of Hisbeans, which is represented as a 'social enterprise'. ### Conditions - Depression - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - application MARO - Sham application ### Outcomes Primary Outcomes - Change in network on the Standard Name Generator Approach scale - Change in depression symptoms severity on the Patient Health Questionnaire-9 Secondary Outcomes - Change in social capital on the Social Capital Scale - Change in perceived workload on the Perceived Workload Scale - Change in job self-efficacy on the Job Self-Efficacy Scale - Change in sense of meaningfulness for job on the Sense of Meaningfulness for Job Scale - Change in work orientation toward his or her job on the Work Orientation Scale - Change in sense of psychological safety on the Perception of Psychological Safety Scale of Company Employees - Change in firm performance on the Company weekly sales records - Change in amsenteeism/leaves on the absenteeism/leave scales for employees with severe mental disabilities - Change in stress regulation skill on the Emotional/Cognitive/Behavioral State Questionnaire - Change in anxiety symptoms severity on the General Anxiety Disorder-7items scale - Change in perceived stress level on the Perceived Stress Scale - Change in social functioning on Social Adaptation Self Rating Scale - Change in positive psychological capital on Korean version of Positive Psychological Capital Scale - Change in Organizational Companionship on Organizational Culture Inventory - Change in individual's social network on Lubben Social Network Scale-18 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement - NCT ID: NCT06295172 - Study ID: LF15_NLF_301 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2026-04-30 - Lead Sponsor: Samyang Biopharmaceuticals Corporation ### Study Description The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds ### Conditions - Nasolabial Folds ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lafullen15 - Lafullen ### Outcomes Primary Outcomes - Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma - NCT ID: NCT06295159 - Study ID: MCC-22574 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2027-03 - Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute ### Study Description The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. ### Conditions - Melanoma Stage III - Melanoma Stage IV - Advanced Melanoma - Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nivolumab - Nivolumab + Relatlimab - Ipilimumab ### Outcomes Primary Outcomes - Pathologic Major Response (pMR) Secondary Outcomes - Preoperative Radiologic Response Rate - Complete Pathologic Response Rate (pCR) - Partial Pathologic Response Rate (pPR) - Non-Response Pathologic Response Rate (pNR) - Progression Free Survival (PFS) - Overall Survival (OS) ### Location - Facility: Moffitt Cancer Center, Tampa, Florida, 33612, United States @@

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