Datasets:

hackint0sh
/

md_dataset

Dataset card Viewer Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients - NCT ID: NCT06269133 - Study ID: R2810-ONC-22115 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-21 - Completion Date: 2027-06-23 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases. ### Conditions - Advanced Non-small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - REGN2810 - Platinum-doublet chemotherapy ### Outcomes Primary Outcomes - Real-world response rate (rwRR) - Any treatment-emergent immune-mediated adverse event (imAE) - Any treatment-emergent imAE resulting in hospitalization - Any treatment-emergent imAE resulting in death - Specific treatment-emergent imAEs Secondary Outcomes - Real-world duration of response (rwDOR) - Real-world progression-free survival (rwPFS) - Real-world overall survival (rwOS) - Treatment-emergent immune-mediated adverse events (imAEs) - Infusion-related reaction (IRR) - IRR resulting in hospitalization - IRR resulting in death ### Location - Facility: Regeneron Research Facility, Tarrytown, New York, 10591, United States @@
## SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary - NCT ID: NCT06269120 - Study ID: NN9924-7787 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-09-30 - Lead Sponsor: Novo Nordisk A/S ### Study Description Participant will get oral semaglutde as prescribed by the study doctor. The study will last for about 26 ± 4 weeks (5 to 7 months). Participant will be asked to complete a questionnaire about how they take oral semaglutide tablets during normal scheduled visit with doctor. Participant will also be asked questions about health and their diabetes treatment and lab tests as part of normal doctor's appointment. ### Conditions - Type 2 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Oral Semaglutide ### Outcomes Primary Outcomes - Glycated haemoglobin (HbA1c ) reduction greater than or equal to (≥) 0.5%-point and body weight reduction ≥ 5% Secondary Outcomes - Change in HbA1c - Change in fasting plasm glucose (FPG) - Absolute change in body weight (BW) - Relative change in BW - HbA1c less than (<) 7.0% - HbA1c <6.5% - Body weight reduction ≥5% - HbA1c reduction ≥1%-point and BW reduction ≥5% - HbA1c reduction ≥1%-point and BW reduction ≥3% - Change in waist circumference - Change in blood pressure (BP) (systolic and diastolic) - Change in lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides [TG]) - Change in high sensitive C-reactive protein (hsCRP) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) - NCT ID: NCT06269107 - Study ID: NN1535-4988 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-07-10 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks). ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IcoSema - Insulin glargine ### Outcomes Primary Outcomes - Change in glycated haemoglobin (HbA1c) Secondary Outcomes - Change in body weight - Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) - Time spent less than (<) 3.0 mmol/L (54 mg/dL) - Time spent greater than (>) 10.0 mmol/L (180 mg/dL) - Weekly basal insulin dose - Change in fasting plasma glucose (FPG) - Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction - Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) - Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) - Number of severe hypoglycaemic episodes (level 3) ### Location - Facility: Scripps Whittier Diabetes Inst, La Jolla, California, 92037, United States @@
## A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior - NCT ID: NCT06269094 - Study ID: MB-2312 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-05 - Lead Sponsor: Midwest Center for Metabolic and Cardiovascular Research ### Study Description The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach. ### Conditions - Weight Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - CGM ### Outcomes Primary Outcomes - Qualitative insights on consumer behavior Secondary Outcomes ### Location - Facility: Biofortis, Inc., Addison, Illinois, 60101, United States @@
## Testing Two Interventions to Improve Health Outcomes and Quality of Life Among Rural Older Adults Living With HIV - NCT ID: NCT06269081 - Study ID: R01NR020770 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2027-01-31 - Lead Sponsor: Medical College of Wisconsin ### Study Description Engagement in HIV medical care and adherence to HIV medications are both essential in improving health outcomes among people living with HIV (PLH), but PLH living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. This project will test the efficacy of two interventions to determine their impact on HIV health outcomes and quality of life among rural, older PLH living in the Southern U.S. The two interventions, adapted from evidence-based interventions and delivered remotely, are: (1) supportive-expressive peer social support groups and (2) strengths-based case management. We hypothesize that both interventions will increase viral suppression, antiretroviral therapy adherence, and health-related quality of life and decrease depressive symptoms. Results from this study will provide us with tools to improve health outcomes for rural older people living with HIV. ### Conditions - HIV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Supportive-Expressive Peer Social Support Group Intervention - Individual Strengths-Based Case Management Intervention ### Outcomes Primary Outcomes - Viral Suppression - Antiretroviral Treatment Medication Adherence - Health-Related Quality of Life - Depressive Symptoms Secondary Outcomes - Social Support - Loneliness - Internalized HIV Stigma - General Self-Efficacy - HIV Treatment Adherence Self-Efficacy - Accessing Needed Social and Medical Services - Structural Barriers ### Location - Facility: Center for AIDS Intervention Research, Medical College of Wisconsin, Milwaukee, Wisconsin, 53202, United States @@
## Investigation of the Relationship Between Central Sensitization and Neuropathic Pain in Lumbar Disc Herniation - NCT ID: NCT06269068 - Study ID: 12.01.2024.10 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2024-06-01 - Lead Sponsor: Marmara University ### Study Description Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. CS is also one of the main mechanisms proposed in the generation of neuropathic pain, and the relationship between pain sensitization and neuropathic complaints has been shown in different diseases.In this study, it was aimed to investigate the effect of central sensitization on the distribution pattern and neuropathic character of pain in patients with lumbar disc herniation who applied to the physical medicine and rehabilitation outpatient clinic. ### Conditions - Central Sensitisation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Central sensitization inventory - Short form-36 - Oswestry Low Back Pain Disability Questionnaire - Douleur Neuropathique 4 - Visual analogue scale ### Outcomes Primary Outcomes - Central Sensitization Inventory (CSI) - DN4 Secondary Outcomes - VAS pain - SF-36 - ODI ### Location - Facility: Marmara University School of Medicine, Istanbul, Fevzi Çakmak Mah, Muhsin Yazıcıoğlu Cd, Pendik, 34899, Turkey @@
## Long-term Result of DTPA (Diethylenetriamine Pentaacetate) Chelation for Gadolinium Deposition Disease - NCT ID: NCT06269055 - Study ID: 73151 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-12-31 - Lead Sponsor: Stanford University ### Study Description This study is aimed at describing the degree of benefit, if any, and the adverse effects, if any, from receiving 5 or more treatment sessions of Gadolinium Deposition Disease using two-day chelation treatment with the chelating agents Calcium Diethylenetriamine pentaacetate (Ca-DTPA) and Zinc Diethylenetriamine pentaacetate (Zn-DTPA). ### Conditions - Gadolinium Deposition Disease - Ca-DTPA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - Rating of Gadolinium Deposition Disease Symptoms at start of GDD and currently Secondary Outcomes - PROMIS Item Bank v2.0 - Cognitive Function- Short Form 8a - Sheehan Disability Scale ### Location - Facility: Stanford University Medical Center, Stanford, California, 94305, United States @@
## Influence of an Inspiratory Muscle Fatigue Protocol on Older Adults on Respiratory Muscle Strength and Heart Rate Variability - NCT ID: NCT06269042 - Study ID: 0010 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-02 - Completion Date: 2024-03-15 - Lead Sponsor: Sierra Varona SL ### Study Description Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in older adults could influence cardiorespiratory function.In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inspiratory muscle training ### Outcomes Primary Outcomes - Respiratory muscle strength - Diaphragmatic thickness and thickening fraction - Diaphragm movement curve - Heart rate variability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Chest Mobility Exercises Versus Proprioceptive Neuromuscular Facilitation in Patients With COPD - NCT ID: NCT06269029 - Study ID: P.T.Rec/012/004297 - Status: RECRUITING - Start Date: 2024-02-17 - Completion Date: 2024-06-30 - Lead Sponsor: Cairo University ### Study Description Chest mobility exercise versus proprioceptive neuromuscular facilitation in patients with chronic obstructive pulmonary disease ### Conditions - Chronic Obstructive Pulmonary Disease Moderate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chest mobility exercises - proprioceptive neuromuscular facilitation ### Outcomes Primary Outcomes - Pulmonary function test Secondary Outcomes ### Location - Facility: Cairo university- faculty of physical therapy, Cairo, Dokki, 12556, Egypt @@
## Effect of Hip Strengthening Exercises and Pelvic Floor Exercises on Stress Urinary Incontinence in Postnatal Women - NCT ID: NCT06269016 - Study ID: P.T.REC/012/003888 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-20 - Completion Date: 2024-04-20 - Lead Sponsor: Cairo University ### Study Description this study will investigate effect of hip strengthening exercises and pelvic floor exercises on stress urinary incontinence in postnatal women. Clinical practice guidelines recommend PFMT as the first-line treatment for female SUI . Also, it has been speculated that the hip muscles are involved in the continence mechanism and that their deficiency could destabilize the normal function of the system. The addition of hip muscle exercises, regardless of PFM contractions, aimed to improve muscular condition for the motor or synergic strategies in PFM contraction. Secondary effects of these techniques, such as the influence of passive lumbar rotational mobilization in improving hip flexor strength, have been of high interest in physiotherapy in general ### Conditions - Stress Urinary Incontinence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - expremental pre and post test ### Outcomes Primary Outcomes - hip muscles strengthening exercise. Secondary Outcomes ### Location - Facility: Mai Mohamed Sherif Mohamed Hassan, Cairo, N/A, N/A, Egypt @@
## Responses to Message Source and Presentation Using Psychophysiology - NCT ID: NCT06269003 - Study ID: STUDY00001223 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-08 - Completion Date: 2024-12-31 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. ### Conditions - Vaping ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Expert - Peer - 1 Sided - 2 Sided ### Outcomes Primary Outcomes - Visual attention - Orienting response - Arousal Secondary Outcomes - Attitudes - Behavioral intentions ### Location - Facility: UMass Chan Medical School Shaw Building, Worcester, Massachusetts, 01605, United States @@
## FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT - NCT ID: NCT06268990 - Study ID: FE 1159/6-1 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Wiebke Kristin Fenske ### Study Description This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects. ### Conditions - Morbid Obesity - Metabolic Syndrome - Diabetes - PreDiabetes - Insulin Resistance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fecal microbiota transplantation ### Outcomes Primary Outcomes - Insulin sensitivity Secondary Outcomes - Insulin sensitivity - Glucose homeostasis - Body weight - Blood pressure - Fasting lipid profile - Fasting blood liver enzyme levels - Dietary intake levels - Metabolic inflammation - Gut hormones - Hunger and Satiety Scores - Fecal microbiota composition - Health-related quality of life - Tolerability of repeated FMT ### Location - Facility: Department of Internal Medicine, Medical University Graz, Graz, N/A, 8010, Austria @@
## Using of SGLt2 Inhibitors in Patients With Type 2 DM - NCT ID: NCT06268977 - Study ID: SGLt2i in diabetic type 2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-30 - Lead Sponsor: Assiut University ### Study Description To detect the efficacy of SGLT2i in improving the metabolic parameters in patients with type 2 diabetes.- To detect the side-effects of SGLT2i ### Conditions - Type 2 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - SGLT2 inhibitor ### Outcomes Primary Outcomes - Effect of adding SGLTi on BP - Effect of adding SGLTi on BMI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics - NCT ID: NCT06268964 - Study ID: 2023-5 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-30 - Lead Sponsor: Universidad de Colima ### Study Description The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children. ### Conditions - Functional Abdominal Pain Syndrome - Functional Gastrointestinal Disorders - Irritable Bowel Syndrome Variant of Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trimebutine - Lactobacillus rhamnosus - Placebo ### Outcomes Primary Outcomes - Average Score on Visual Analog Scale for Abdominal Pain Secondary Outcomes - Improvement in Quality of Life with PedsQL 3.0 - Improvement in Quality of Life with PedsQL 3.0 - Average Score on Visual Analog Scale for Abdominal Pain ### Location - Facility: School of Medicine, University of Colima, Colima, N/A, 28040, Mexico @@
## Recovery and Symptom Relief Following Percutaneous Ablation of Abdominal Wall Endometriosis - NCT ID: NCT06268951 - Study ID: 23-005485 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04 - Completion Date: 2027-12 - Lead Sponsor: Mayo Clinic ### Study Description To determine the characteristics of recovery and symptom relief following ablation of abdominal wall endometriosis. ### Conditions - Endometriosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Symptom severity due to abdominal wall endometriosis following ablation. Secondary Outcomes ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery - NCT ID: NCT06268938 - Study ID: mastoid obliteration - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-04 - Completion Date: 2028-12-01 - Lead Sponsor: Assiut University ### Study Description Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery ### Conditions - Cholesteatoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Canal wall down tympanomastoidectomy ### Outcomes Primary Outcomes - Size of mastoid cavity in mm Secondary Outcomes ### Location - Facility: Assiut university hospital, Assiut, N/A, N/A, Egypt @@
## The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka - NCT ID: NCT06268925 - Study ID: UAHS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-22 - Completion Date: 2024-05-03 - Lead Sponsor: University of Peradeniya ### Study Description it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exercises ### Outcomes Primary Outcomes - Efficacy of telerehabilitation program - Feasibility and acceptability Secondary Outcomes - lower extremity muscle strength and dynamic balance - pain, - pain stiffness and physical activity ### Location - Facility: M.S.F.Sarjana, Puttalam, North Western, 61300, Sri Lanka @@
## Cryoanalgesia for Irreversible Pulpitis - NCT ID: NCT06268912 - Study ID: END-ECL-2022-01 - Status: COMPLETED - Start Date: 2022-09-07 - Completion Date: 2024-01-07 - Lead Sponsor: Universitat Internacional de Catalunya ### Study Description The aim of the present study was to evaluate the effectiveness of pulpal anesthesia in pain control during endodontic treatment by lowering the temperature of the injected plain 3% cold Mepivacaine (5ºC) compared to 3% Mepivacaine at room temperature in teeth with irreversible pulpitis. ### Conditions - Pulpitis - Irreversible ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cold Mepivacaine - Mepivacaine at room temperature ### Outcomes Primary Outcomes - Assessment of Pain and Anxiety Secondary Outcomes ### Location - Facility: Gonzalo Gomez, Barcelona, N/A, 08, Spain @@
## First Mobilization Protocol for Total Knee Arthroplasty Patients - NCT ID: NCT06268899 - Study ID: E-77082166-302.08.01-285977 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-08 - Completion Date: 2024-03-30 - Lead Sponsor: Gazi University ### Study Description This single blinded randomized controlled study evaluates the effect of developed First Mobilization Protocol applied to knee arthroplasty patients on state anxiety, kinesiophobia, initial mobilization related symptoms. ### Conditions - Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - First mobilization protocol ### Outcomes Primary Outcomes - Anxiety evaluated using the Trait Anxiety Inventory (Trait Anxiety Inventory, TAI) - Kinesiophobia evaluated using the Tampa Kinesiophobia Scale - Anxiety evaluated using the State Anxiety Inventory (State Anxiety Inventory, SAI) - Symptoms evaluated using the Numerical Rating Scale for Symptoms Related to First Mobilization Secondary Outcomes ### Location - Facility: Gazi University Health Research and Application Center, Ankara, N/A, 06560, Turkey @@
## Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease - NCT ID: NCT06268886 - Study ID: CN008-0003 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-11-16 - Lead Sponsor: Bristol-Myers Squibb ### Study Description The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease. ### Conditions - Alzheimer Disease, Early Onset ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BMS-986446 - Placebo ### Outcomes Primary Outcomes - Mean change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score Secondary Outcomes - Mean change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) - Mean change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score - Mean change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score - Mean change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score - Mean change from baseline in Mini Mental State Examination (MMSE) score ### Location - Facility: MD First Research - Chandler, Chandler, Arizona, 85226-3732, United States @@
## A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. - NCT ID: NCT06268873 - Study ID: D6972C00003 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2027-12-10 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued. ### Conditions - Chronic Kidney Disease and Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baxdrostat/dapagliflozin - Dapagliflozin in combination with placebo ### Outcomes Primary Outcomes - To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. Secondary Outcomes - To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). - To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. - To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). - To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). ### Location - Facility: Research Site, Fairhope, Alabama, 36532, United States @@
## A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants - NCT ID: NCT06268860 - Study ID: 20220015 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-08-29 - Lead Sponsor: Amgen ### Study Description The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rocatinlimab vial injection - Rocatinlimab prefilled syringe ### Outcomes Primary Outcomes - Maximum Observed Serum Concentration (Cmax) of Rocatinlimab - Area Under the Serum Concentration-time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rocatinlimab - AUC From Time Zero to Infinity (AUCinf) of Rocatinlimab Secondary Outcomes - Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE) - Number of Participants Experiencing Serious Adverse Events (SAE) - Number of Participants Positive to Anti-rocatinlimab Antibody ### Location - Facility: Fortrea Clinical Research Unit - Daytona Beach, Daytona Beach, Florida, 32117-5116, United States @@
## Efficacy of Marine By-product Hydrolysate on the Reduction of Atopic Dermatitis Symptoms - NCT ID: NCT06268847 - Study ID: DERMATIDYSS - Status: RECRUITING - Start Date: 2024-01-09 - Completion Date: 2024-06-18 - Lead Sponsor: Abyss Ingredients ### Study Description This interventional, double-blind, randomized, placebo-controlled study aims to evaluate the effect of a marine by-product hydrolysate supplementation on the reduction of atopic dermatitis symptoms. ### Conditions - Atopic Dermatitis - Eczema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Placebo - ACT01 - ACT02 ### Outcomes Primary Outcomes - SCORAD (SCORing Atopic Dermatitis) Secondary Outcomes - EASI (Eczema Area and Severity Index) - Investigator Global Assessment scale - Corneometer - Tewameter - Quality of Life Index - Perceived Stress - Participant's Satisfaction ### Location - Facility: Eurofins, Barcelona, N/A, 08013, Spain @@
## Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome - NCT ID: NCT06268834 - Study ID: ZonulinPPI - Status: COMPLETED - Start Date: 2023-10-04 - Completion Date: 2023-12-31 - Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital ### Study Description Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels. ### Conditions - Proton Pump Inhibitor Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Blood for zonulin level was drawn from the group. ### Outcomes Primary Outcomes - Zonulin levels in long-term proton pump inhibitor users Secondary Outcomes ### Location - Facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, N/A, N/A, Turkey @@
## Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland - NCT ID: NCT06268821 - Study ID: ADC-UK-PMS-23059 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-01 - Lead Sponsor: Abbott Diabetes Care ### Study Description The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. ### Conditions - Type 2 Diabetes Treated With Insulin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - FreeStyle Libre 2 Flash Glucose Monitoring System ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - Time in range (TIR) - Time above range (TAR) - Time below range (TBR) - Frequency of hypoglycaemia events ### Location - Facility: Pihlajalinna Jämsä, Välikatu 1,, Jämsä, N/A, 42100, Finland @@
## Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy - NCT ID: NCT06268808 - Study ID: ADC-UK-PMS-23058 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: Abbott Diabetes Care ### Study Description The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen. ### Conditions - Type 2 Diabetes Treated With Insulin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - FreeStyle Libre 2 Flash Glucose Monitoring System ### Outcomes Primary Outcomes - HbA1c Secondary Outcomes - Time in range (TIR) - Time above range (TAR) - Time below range (TBR) - Frequency of hypoglycaemia events ### Location - Facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari, N/A, N/A, Italy @@
## A Diagnostic Test Accuracy Study Comparing Biopsy to Aspiration in Shoulder and Elbow Arthroplasty Revision Surgery (BASE Study) - NCT ID: NCT06268795 - Study ID: BASE - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2028-09-01 - Lead Sponsor: Wrightington, Wigan and Leigh NHS Foundation Trust ### Study Description The aim of this study is to compare the diagnostic accuracy of percutaneous aspiration against open biopsy, using microbiological and histological methods, for the detection of shoulder and elbow periprosthetic joint infection (PJI). This is to establish the utility of pre-operative joint aspiration in the treatment pathway for shoulder and elbow PJI. ### Conditions - Periprosthetic Joint Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of diagnostic accuracy Secondary Outcomes - Culture analysis ### Location - Facility: Wrightington Wigan & Leigh Teaching Hospitals NHS Foundation Trust, Wigan, Lancashire, WN6 9EP, United Kingdom @@
## The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women - NCT ID: NCT06268782 - Study ID: 1204202118 - Status: COMPLETED - Start Date: 2021-09-21 - Completion Date: 2023-09-19 - Lead Sponsor: University of Turku ### Study Description The aim of this quasi-experimental study was to assess the effectiveness of a 6-week online exercise program on self-assessed quality of life (QoL), physical activity (PA), and dysfunctions of pelvic floor muscles of postpartum women immediately and 6 months after the online intervention. The data were collected with e-questionnaires. The data collection started in September 2021 and ended in September 2023. ### Conditions - Quality of Life - Physical Activity - Urinary Incontinence - Pelvic Organ Prolapse ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Rehabilitate your core ### Outcomes Primary Outcomes - Quality of Life Secondary Outcomes - Physical activity - Urinary incontinence - Pelvic organ prolapse ### Location - Facility: Department of Nursing Science, Faculty of Medicine, University of Turku, Turku, N/A, 20014, Finland @@
## Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs - NCT ID: NCT06268769 - Study ID: TaC:Drop - Status: RECRUITING - Start Date: 2024-03-09 - Completion Date: 2029-09 - Lead Sponsor: Edward Geissler ### Study Description The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit. ### Conditions - Immunosuppression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tacrolimus Pill - Tacrolimus capsule ### Outcomes Primary Outcomes - Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) Secondary Outcomes - Time to reach the first trough level in target range - Proportion of patients with trough levels lower, within, or higher than the target range - Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels - Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose - Tacrolimus concentration/dose (C/D) ratio - Intra-patient variability of C/D ratio and daily dose - Treatment failure rate - Time to treatment failure after transplantation - Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection - Incidence rate of graft failure - Mortality rate - Graft function measured by eGFR (estimated glomerular filtration rate) - Incidence rate of for-cause biopsies - Incidence rate of acute rejection episodes requiring treatment - Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection - Incidence rate of delayed graft function - Incidence rate of primary non-function of the renal allograft - Incidence of hepatotoxicity - Incidence of CMV and BKV infection (including organ manifestation, if relevant) - Incidence, type, severity and seriousness of adverse reactions (ARs) - Blood pressure - Incidence of de novo tremor - Incidence of gastrointestinal disorders requiring diagnostic investigation - Incidence of new onset diabetes mellitus after transplantation (NODAT) - Recurrence of primary kidney disease - Incidence of de novo DSA - Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34) - Doses and duration of glucocorticosteroid treatment - Dose of mycophenolate - Incidence and time to study treatment discontinuation - Incidence, time to and reason for patient withdrawal from study ### Location - Facility: Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care, Berlin, N/A, 10117, Germany @@
## Fear of Other's Judgment, Self-esteem and Use of Social Networks Among Students - NCT ID: NCT06268756 - Study ID: 2023_RIPH_020_RESANXIEST - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-06-07 - Lead Sponsor: Université de Reims Champagne-Ardenne ### Study Description Fear of being judged negatively by others can lead to avoidance of social situations or even social isolation. If the intensity of this fear is excessive and results in significant impairment of functioning or significant suffering, the subject may suffer from social anxiety.The considerable growth of social networks in a decade has led to the emergence of new behaviors among young people. Individuals spend on average 2 hours and 27 minutes per day with differences in usage: time spent, social network used, function sought. The use of these networks may be reasonable and moderate but may also be excessive and abusive (Amnon, 2014). Some authors even talk about addiction or dependence on social networks (Perales and Billieux, 2020) even if the existence of this disorder is not consensus.People who fear being judged negatively by others may be more at risk of misuse of social networks. Indeed, the use of social networks would compensate for their existing problems (Kardefelt-Winther, 2014) and would thus be a new emotional management strategy. It would also reduce dreaded social situations such as face-to-face exchanges (Weidman and Rodebaugh, 2012; Yen and Ko, 2012). Self-esteem is defined as a subjective judgment of oneself in relation to one's values and vision of the real and ideal self (Rosenberg. 1979). The greater the gap between the vision of the real self and the ideal self, the lower the self-esteem. ### Conditions - Self-esteem ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection ### Outcomes Primary Outcomes - Rosenberg Self-esteem Scale Secondary Outcomes ### Location - Facility: Ufr Medecine Urca, Reims, N/A, 51100, France @@
## Effects of a Combined Exercise Intervention on the Gut Microbiome of People With Type 2 Diabetes - NCT ID: NCT06268743 - Study ID: 2023-114 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-08 - Lead Sponsor: University of New Brunswick ### Study Description The goal of this experimental trial is to learn about the changes in bacterial diversity in individuals with type 2 diabetes who perform endurance and strength training at different intensities.Participants with type 2 diabetes will be randomly assigned to 16 weeks of either moderate-intensity endurance and strength training or high-intensity endurance and strength training.Researchers will compare the moderate-intensity and high-intensity exercise groups for differences in glycemia and bacterial diversity. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - High intensity - Moderate intensity ### Outcomes Primary Outcomes - Glycemic control through glycated hemoglobin - Gut microbiome diversity through 16S ribosomal RNA genes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of SinuSonic on Psychological and Physical Well-Being - NCT ID: NCT06268730 - Study ID: 23-2437 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-07 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The goal of this clinical trial is to evaluate the effects of using the SinuSonic on psychological and physical well-being in adults who have nasal/sinus congestion.The study aims are:* Aim #1: to evaluate the effect of the SinuSonic on physical and psychological well-being in individuals with chronic nasal congestion;* Aim #2: to evaluate the relationship between autonomic reactivity and psychological well-being (i.e., anxiety and depression) in individuals with chronic nasal congestion;* Exploratory Aim: to evaluate the impact of adverse experiences on physical and psychological well-being in individuals who experience chronic nasal congestion.Participants will be asked to complete self-report measures of physical health, mental health and autonomic regulation before using SinuSonic (i.e., baseline research session) and after 5 weeks of directed use (post-intervention). Demographic information and adverse experiences will be documented during the baseline research session. Participants will be asked to document (weekly) current nasal symptoms and SinuSonic usage. ### Conditions - Nasal Congestion and Inflammations - Sinus Congestion Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - SinuSonic ### Outcomes Primary Outcomes - Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale - Change in the Depression Subscale of the Hospital Anxiety and Depression Scale Secondary Outcomes - Change in the Body Perception Questionnaire - Change in the Total Nasal Symptom Score - Change in the Patient Global Impression of Change - Adverse Traumatic Experiences Survey at Baseline - Short Form Health Survey (SF-20) at Baseline ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599-7160, United States @@
## GI Alpha-Gal Study - NCT ID: NCT06268717 - Study ID: 23-0316 - Status: RECRUITING - Start Date: 2023-10-17 - Completion Date: 2025-10-17 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description This is a double-blind, crossover food challenge study using pork with and without α-gal in patients with a clinical diagnosis of gastrointestinal (GI)- α-gal allergy, and to investigate the pathophysiology underlying their symptoms. ### Conditions - Alpha-Gal Syndrome - Irritable Bowel Syndrome - Diarrhea - Abdominal Pain - Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Ground pork containing alpha-gal - Pork meat not containing alpha-gal ### Outcomes Primary Outcomes - Allergic reaction (food challenge positive) - No allergic reaction (food challenge negative) - Lactulose excretion - C13 mannitol excretion - Basophil activation threshold response at timepoint 0 - Basophil activation threshold response at 2 hours - Basophil activation threshold response at 4 hours - Basophil activation threshold response at 6 hours - Serum tryptase at timepoint 0 - Serum tryptase at 2 hours - Serum tryptase at 4 hours - Serum tryptase at 6 hours - Mast cell count on stomach biopsies (per high powered field (hpf)) - Mast cell count on small bowel biopsies (per high powered field (hpf)) - Eosinophil cell count on stomach biopsies (per high powered field (hpf)) - Eosinophil cell count on small bowel biopsies (per high powered field (hpf)) Secondary Outcomes ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States @@
## Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection - NCT ID: NCT06268704 - Study ID: UNM HRRC #23-503 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-05-01 - Lead Sponsor: University of New Mexico ### Study Description This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain. ### Conditions - Sacroiliac Joint Dysfunction - Sacro-Iliac Spondylosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexamethasone - Methylprednisolone - 2% Lidocaine HCl Injection ### Outcomes Primary Outcomes - Pain using Numeric Pain Rating Score Secondary Outcomes ### Location - Facility: University of New Mexico Hospital, Albuquerque, New Mexico, 87131, United States @@
## Sustainable Reduction of Dengue in Colombia: Vector Breeding Site Intervention With an Insecticidal Coating - NCT ID: NCT06268691 - Study ID: ProjectCOLOMBIA-ZMG.U-Freiburg - Status: COMPLETED - Start Date: 2019-02-04 - Completion Date: 2023-07-31 - Lead Sponsor: Rocio Cardenas Sanchez ### Study Description Effective control of Aedes aegypti mosquitoes in breeding sites with high reproductive rates could have a major impact on reducing arbovirosis in endemic communities. The application of a safe, effective, low cost and sustained insecticide coating (IC) could be an affordable response to dengue for local health services. Therefore, a cluster randomised trial for the application of a new vector control tool (insecticidal coating of water containers) was conducted in the metropolitan area of Cúcuta, Colombia. The IC is an aqueous solution containing polymeric microcapsules of insecticides and insect growth regulators (pyriproxyfen-PPF (0.063%) and alphacypermertrin-ACM (0.07%) in suspension, without interaction between them, development by INESFLY®, Spain.The main questions it aims to answer are:Whether the control of the main breeding sites of Aedes mosquitoes, through the application of insecticide coating, in clusters of dwellings, could reduce dengue transmission in a sustainable way, compared to untreated clusters, in Cúcuta, Colombia.Whether the control of the main breeding sites of Aedes mosquitoes through the application of insecticide coating, in clusters of dwellings, could reduce the Aedes Indices in a sustainable way, compared to untreated clusters. The initial preparation phases: i) socialization ii) A safety evaluation to determine the health risks of IC in domestic water containers; iii) The determination of the effects and efficacy of IC on Aedes aegypti.The Baseline study to characterise the study clusters from entomological, epidemiological and socio-economic approaches was carried out in 2019-2020. The IC application phase in the intervention arm was carried out between Nov-2021 and Jan-2022, with the respective monitoring of the safety of IC use. This was followed by entomological monitoring. Finally, the 9-month post-intervention evaluation. Epidemiological data were obtained from the National Public Health Surveillance System - SIVIGILA.The study was conducted in 20 clusters of 2000 dwellings each, where 10 clusters were randomly assigned to the control arm and 10 clusters to the intervention arm.In order to determine the effect of IC application in household tanks, the dengue incidence and entomological indices are compared in the study clusters. The data are analysed under the difference in difference approach. Additionally, the acceptance of IC in the intervened communities and local health services is determined. ### Conditions - Dengue - Vector Borne Diseases - Arbovirus Infections - Zika - Chikungunya Fever ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Insecticide Coating INESFLY ### Outcomes Primary Outcomes - Change of dengue incidence for 12 months Secondary Outcomes - Change of vector densities estimated through larval and pupal indices. ### Location - Facility: Instituto Departamental de Salud de Norte de Santander, Cúcuta, Norte De Santander, 540001, Colombia @@
## The Effect of Menstrual Cycle Phase on Muscle Protein Synthesis - NCT ID: NCT06268678 - Study ID: 4539513 - Status: RECRUITING - Start Date: 2023-12-08 - Completion Date: 2025-01-30 - Lead Sponsor: University of Exeter ### Study Description The combination of dietary protein ingestion and resistance exercise are essential to increase muscle protein synthesis. The vast majority of studies assessing protein intake following resistance exercise in young adults has been conducted exclusively in men or in studies where both men and women are assessed. The increase in muscle mass is thought to be impacted by sex hormones that fluctuate across different phases of the menstrual cycle. However, the effect of menstrual cycle phase on muscle protein synthesis following exercise is not known. ### Conditions - Menstrual Cycle Phase - Muscle Protein Synthesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Phase of the menstrual cycle ### Outcomes Primary Outcomes - Muscle protein synthesis Secondary Outcomes - Plasma amino acid kinetics - Serum insulin concentrations - Sex hormone concentrations - Energy expenditure ### Location - Facility: University of Exeter, Exeter, Devon, EX1 2LT, United Kingdom @@
## Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy - NCT ID: NCT06268665 - Study ID: UCDCC307 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2027-06 - Lead Sponsor: Eve Rodler ### Study Description This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2). ### Conditions - Breast Cancer - Breast Cancer Stage I - Breast Cancer Stage II - Breast Cancer Stage III - Breast Cancer Stage IV - Invasive Breast Cancer - Ovarian Cancer - Ovarian Cancer Stage 1 - Ovarian Cancer Stage II - Ovarian Cancer Stage III - Ovarian Cancer Stage IV - Ovarian Cancer Stage IA - Ovarian Cancer Stage IB - Ovarian Cancer Stage IC - Ovarian Cancer Stage 2 - Ovarian Cancer Stage 3 - Ovarian Cancer Stage IIIb - Ovarian Cancer Stage IIIC - Breast Cancer Stage IIIA - Breast Cancer Invasive - Breast Cancer, Stage IA - Breast Cancer, Stage IB - Breast Cancer Stage IIA - Breast Cancer Stage IIB - Breast Cancer Stage IIIB - Breast Cancer Stage IIIc - Cancer, Breast - Tumors, Breast - Mammary Cancer - Mammary Carcinoma - Breast Carcinoma - Breast Neoplasm - Malignant Breast Neoplasm - Malignant Tumor of Breast - Cancer of Ovary - Ovary Cancer - Ovary Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tart Cherry Juice ### Outcomes Primary Outcomes - Efficacy of tart cherry juice supplementation in the prevention of paclitaxel-induced peripheral neuropathy (PIPN) in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. Secondary Outcomes - Compare the effectiveness of high- dose and low-dose tart cherry juice supplement in reducing the severity of PIPN in breast and ovarian cancer patients undergoing treatment with paclitaxel-based chemotherapy. - Assess the impact of tart cherry juice on dose delivery of taxane chemotherapy. - Tolerability of daily intake of high-dose and low-dose tart cherry juice. - Safety profile of daily intake of high-dose and low-dose tart cherry juice. ### Location - Facility: University of California Davis Comprehensive Cancer Center, Sacramento, California, 95827, United States @@
## Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer - NCT ID: NCT06268652 - Study ID: B2023-686-01 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2028-01-15 - Lead Sponsor: Sun Yat-sen University ### Study Description This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer. ### Conditions - Breast Cancer - Refractory Breast Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Organoid-guided personalized treatment - Gemcitabine - Capecitabine - Vinorelbine - Eribulin ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall Survival (OS) - Objective Response Rate (ORR) - Duration of Response (DOR) - Disease Control Rate (DCR) - Incidence of Treatment-related Adverse Events ### Location - Facility: Yanxia Shi, Guangzhou, None Selected, 510060, China @@
## Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique - NCT ID: NCT06268639 - Study ID: ECM#2024-216 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-06-30 - Lead Sponsor: King Khalid University ### Study Description The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration. ### Conditions - Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Osseodensification ### Outcomes Primary Outcomes - Increase in Bone Density at Implant Sites Using Osseodensification Technique Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Detection of Endometrial Cancer Through Risk Modelling - NCT ID: NCT06268626 - Study ID: H22-02426 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-01 - Lead Sponsor: University of British Columbia ### Study Description The goal of this study is to combine information on risk factors from health questionnaires with minimally invasive biological tests (vaginal DNA and microbiome swabs, pH, hormones) to predict the risk of endometrial cancer (EC), better understand progression of the disease, and identify opportunities for intervention.This study will recruit patients who are already scheduled to undergo diagnostic evaluation for abnormal uterine bleeding via endometrial biopsy. In Part A, consented participants will be asked to fill out an online risk factor questionnaire. Samples will be collected by the gynecologist at the biopsy appointment. After biopsy results are obtained, all samples from participants diagnosed with EC or precursors, plus a random subset with benign results, will be selected to be sequenced and analyzed.In Part B, that subset of selected non-malignant participants, based on biopsy, will be invited to take part in lifestyle tracking using a Fitbit, questionnaires, and to provide another round of at-home vaginal samples to identify any persistent genetic mutations or microbiome alterations 6-8 months later. ### Conditions - Endometrial Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association Between Risk Factor Data and Endometrial Cancer and It's Precursors. - Change in Risk Prediction of Endometrial Cancer When Mutation and Microbiome Data Is Combined With Traditional Risk Factors, Compared to Traditional Risk Factors Alone. - Persistence of Mutations and Microbiome Alterations in Participants With Endometrial Hyperplasia. Secondary Outcomes ### Location - Facility: VGH Research Pavilion, Vancouver, British Columbia, V5Z 1M9, Canada @@
## A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy - NCT ID: NCT06268613 - Study ID: SB27-1005 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2025-12 - Lead Sponsor: Samsung Bioepis Co., Ltd. ### Study Description The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:• What the body does to the study drug, which is called "pharmacokinetic"Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda. ### Conditions - Non-small Cell Lung Cancer Stage II - Non-small Cell Lung Cancer Stage IIIA ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SB27 - EU sourced Keytruda - US sourced Keytruda ### Outcomes Primary Outcomes - Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 - Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6 Secondary Outcomes - Disease-free Survival - Overall Survival ### Location - Facility: SB Investigative Site, Busan, N/A, N/A, Korea, Republic of @@
## The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma - NCT ID: NCT06268600 - Study ID: NPC-Thyroid function - Status: RECRUITING - Start Date: 2019-01-01 - Completion Date: 2025-11-30 - Lead Sponsor: Jiangxi Provincial Cancer Hospital ### Study Description This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area. ### Conditions - Nasopharyngeal Carcinoma - Nasopharyngeal Cancer - Hypothyroidism ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Modified neck target volume delineation ### Outcomes Primary Outcomes - Regional Recurrence-free Survival Secondary Outcomes - Radiation-induced hypothyroidism - Overall Survival - Progression-free Survival ### Location - Facility: Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital, Nanchang, None Selected, 330029, China @@
## A Before and After Study Studying the Impact of an Analgesia Protocol After Discharge From Outpatient Surgery - NCT ID: NCT06268587 - Study ID: 2023/80 - Status: COMPLETED - Start Date: 2019-09-01 - Completion Date: 2022-02-28 - Lead Sponsor: Centre Hospitalier Universitaire de Liege ### Study Description The goal of this before and after study is to measure the effectiveness of a home analgesia protocol after outpatient surgery in a tertiary hospital. The main question it aims to answer is:- Measure the impact of the protocol on the proportion of patients with a VAS greater than 3/10 on day one and who did not take the analgesics.The participants are divided into two groups. The control group leaves the hospital with instructions and prescriptions. The experimental group leaves the hospital with instructions, analgesics for a maximum of two days with detailed dosages and an explanatory booklet on postoperative pain. ### Conditions - Postoperative Pain - Outpatient Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measure the impact of the home analgesia protocol on the proportion of patients with a VAS &gt; 3/10 on day one and who did not take analgesics. ### Outcomes Primary Outcomes - Measure the impact of the protocol on the proportion of patients with a pain greater than 3/10 on a Visual Analogue Scale at day one and who did not take the analgesics. Secondary Outcomes - Measure the adequacy of post-op analgesics by measuring the proportion of patients with a Visual Analogue Scale < or = 3/10 on day one for each group - Measure the impact of the protocol on the occurrence of nausea and vomiting on day one - Measure the impact of the protocol on general satisfaction of stay in outpatient surgery on day 7 with a Visual Analogue Scale Satisfaction ### Location - Facility: CHU de Liège, Liège, Wallonie, 4000, Belgium @@
## Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML - NCT ID: NCT06268574 - Study ID: RIVER-52 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2026-09 - Lead Sponsor: Ryvu Therapeutics SA ### Study Description The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients. ### Conditions - Acute Myeloid Leukemia (AML) - High-risk Myelodysplastic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - RVU120 ### Outcomes Primary Outcomes - Complete Remission (CR), with and without measurable residual disease (MRD) Secondary Outcomes - Overall response rate - Duration of response - Progression-free survival - Overall survival - Incidence of Adverse Events (Safety and Tolerability) - Percentage of participants bridged to hematopoietic stem cell transplantation - Maximum Plasma Concentration (Cmax) - Maximum Plasma Concentration (Tmax) - Area Under the Concentration Time-Curve (AUC) - Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO) - Impact of treatment on health-related quality of life (QOL-E) ### Location - Facility: MTZ Clinical Research, Warszawa, Mazowieckie Województwo, 02-172, Poland @@
## Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months - NCT ID: NCT06268561 - Study ID: IRBN852023/CHUSTE - Status: RECRUITING - Start Date: 2023-06-05 - Completion Date: 2024-06 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient. ### Conditions - Endophthalmitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Visual acuity analysis - Intraocular pressure analysis - Analysis of optical coherence tomography (OCT) images - Analysis of retinograms ### Outcomes Primary Outcomes - Visual acuity Secondary Outcomes - IOP measured in mmHg by tonometer and confirmed with Goldman Applanation - Tomography - Resumption of intravitreal therapy ### Location - Facility: CHU Saint Etienne, Saint-Étienne, N/A, 42000, France @@
## Effect of Manual Diaphragmatic Activation on Diaphragm Function in Patients With Gastroesophageal Reflux Disease - NCT ID: NCT06268548 - Study ID: P.T.REC/012/004790 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2024-02-27 - Lead Sponsor: Cairo University ### Study Description This study was conducted to investigate Effect of manual diaphragmatic activation on diaphragm function in patients with gastroesophageal reflux disease ### Conditions - Diaphragm Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Manual diaphragmatic activation ### Outcomes Primary Outcomes - Diaphragm Excursion Secondary Outcomes ### Location - Facility: Faculty of physical therapy, Giza, N/A, 12613, Egypt @@
## Identification of Anticancer Drugs Associated With Heart Failure: a WHO Pharmacovigilance Database Analysis - NCT ID: NCT06268535 - Study ID: CaenUH_DL_1 - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2022-05-31 - Lead Sponsor: University Hospital, Caen ### Study Description Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy.Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death.Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions.The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction.Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs. ### Conditions - Heart Failure - Cancer, Therapy-Related ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cancer therapy with FDA and/or EMA approval on the 31st March 2022 ### Outcomes Primary Outcomes - Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies Secondary Outcomes - Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies - Description of the pathologies (cancer) for which the incriminated drugs have been prescribed - Description of the drug-drug interactions associated with adverse events ### Location - Facility: Caen University Hospital, Caen, N/A, N/A, France @@
## Adjunctive Mindfulness During Opioid Tapering for patientS With Chronic Pain (The AMOS Study) - NCT ID: NCT06268522 - Study ID: 2023P001582 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-06 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mindfulness-Oriented Recovery Enhancement: (MORE) group - Psychoeducation ### Outcomes Primary Outcomes - Pain Interference - Opioid Dose Secondary Outcomes - Pain Intensity - Opioid Misuse - Opioid Withdrawal - Opioid Craving ### Location - Facility: Brigham and Women's Hospital, Chestnut Hill, Massachusetts, 02467, United States @@
## Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta - NCT ID: NCT06268509 - Study ID: MONAS - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-08 - Lead Sponsor: Dr Cipto Mangunkusumo General Hospital ### Study Description The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?Participants in the intervention group will receive:* Fetomaternal ultrasound examination each trimester* Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination* Supplements: multivitamin, minerals, vitamin D, fatty acid* Intervention regarding any abnormal results of nutritional panel* All standard maternal health services according to Indonesian Ministry of Health protocolParticipants in the control group will receive:- All standard maternal health services according to Indonesian Ministry of Health protocol ### Conditions - Pregnancy Complications - Maternal Death - Preeclampsia - Intrauterine Infection - Pregnancy Hemorrhage - Preterm Birth - Neonatal Death - Low; Birthweight, Extremely (999 Grams or Less) - Asphyxia Neonatorum - IUGR ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nutritional panel laboratory examination - Pregnancy supplements (other than provided by Ministry of Health) - Fetomaternal ultrasound ### Outcomes Primary Outcomes - Composite of poor maternal outcomes - Composite of poor neonatal outcomes Secondary Outcomes ### Location - Facility: Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office, Jakarta, N/A, N/A, Indonesia @@
## Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins - NCT ID: NCT06268496 - Study ID: LRP23021-A serum - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Cosmetique Active International ### Study Description The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo. ### Conditions - Hyperpigmentation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - serum formula 2039125 03 ### Outcomes Primary Outcomes - IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP) - modified Melasma Area and Severity Index (mMASI) for patients with melasma - Post-Acne Hyperpigmentation Index (PAHPI) - solar lentigo pigmentation scale Secondary Outcomes - colorimetry measurements ### Location - Facility: Medcin Instituto da Pele Ltda, Osasco, N/A, N/A, Brazil @@
## Effect of Hyaluronic Acid Oral Supplementation on Sexual and Urinary Symptoms of Women With Recurrent Urinary Tract Infections - NCT ID: NCT06268483 - Study ID: JalUrol - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-03-28 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Uncomplicated urinary tract infections (UTI) are one of the most common bacterial infections globally, causing a significant proportion of medical consultations in primary and outpatient settings. Recurrent UTI (rUTI) have a detrimental impact on the patient's quality of life, causing a negative effect on women's social relationships, self-esteem, as well as irritability and tiredness. Moreover, several real-life studies have shown that reproductive-aged women with rUTI more frequently experience sexual dysfunction as compared to controls without infections. The glycosaminoglycan layer of the bladder urothelium, mainly composed by chondroitin sulfate (CS) and hyaluronic acid (HA), provides a protective barrier against the penetration of bacteria. A deficiency of this layer facilitates bacterial adherence, leading to recurrent infection. Treatment to restore this layer with intravesical instillation of HA has been proven to reduce the incidence of rUTI episodes. Furthermore, intravesical instillation with HA has been associates with sexual function improvement in women with rUTI and painful bladder . Therefore, in conditions where the glycosaminoglycan layer of the bladder is impaired, such as rUTIs, treatment with HA to restore it appears to have a beneficial effect on urinary and sexual symptoms.Recently, a randomized control trial has demonstrated that an oral formulation of HA, CS, quercetin and curcumin was effective in improving urinary symptoms in women undergoing intravesical chemotherapy for bladder cancer. However, there are no studies investigating the impact of the oral administration of HA and CS on the sexual and urinary symptoms of women with rUTI. Since rUTI are highly prevalent in sexually active women and exert a detrimental impact on women's quality of life, sexual and urinary symptoms, the identification of oral treatments that could alleviate these bothersome consequences is of primary clinical importance.Therefore we will conduct this randomized, cross-over trial to evaluate the efficacy of an oral preparation of HA, CS, N-Acetylglucosamine and vitamin C in improving sexual and urinary symptoms in a cohort of reproductive-aged women with rUTI.Methods:Pre-menopausal, sexually active women referred to our center for symptomatic rUTIs. At the time of enrollment, participants were randomized with a 1:1 allocation ratio by means of a computer-generated random list in two groups: intervention (I) and control (C) (Figure 1).Inclusion and exclusion criteria We included sexually active, reproductive-aged women with symptomatic rUTIs. Exclusion criteria: younger than 18, if they had used combined hormonal contraception during the previous 6 months; pregnant, breastfeeding or trying to conceive, if they had symptoms of upper UTI, a history of urinary tract anomalies/vesicoureteral reflux, stress urinary incontinence, interstitial cystitis, diabetes, urinary tract stones, neurologic conditions, clinical depression or depressive symptoms.All women will be assessed with a thorough medical and sexual history. To psychometrically quantify sexual function impairment all participants completed The Female Sexual Function Index (FSFI) questionnaire at baseline and at each follow up assessment.Treatment Protocol Group I: an oral preparation (capsule) of HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg once a day in the morning plus an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.Group C: an oral preparation of cranberry, D-mannose, propolis extract, tumeric and Boswellia twice a day for three months.After three months of treatment (follow up 1) all women were evaluated with medical and sexual history. Participants also completed the FSFI and IPSS questionnaires. At this point the treatment was reversed (crossover scheme) for additional three months.At 6 months follow up (follow up 2) participants were again investigated with medical and sexual history and the IPSS and FSFI were completed. Figure 2 report the complete study design. Monthly phone calls were performed to check for adherence to treatment.Statistics: The sample size consisted of 25 participants in each group, calculated by using the two-sample t-test analysis. Baseline clinical and psychometric scores will be compared between I and C groups. Second, potential differences in FSFI values at 3-6 months follow-up assessment will be evaluated between and within groups. Potential predictors of FSFI improvement will be evaluated. ### Conditions - Urinary Tract Infections, Recurrent ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HA 100 mg, CS 400 mg, N-Acetylglucosamine 200 mg and vitamin C 80 mg + cranberry, D-mannose, propolis extract, tumeric and Boswellia - cranberry, D-mannose, propolis extract, tumeric and Boswellia ### Outcomes Primary Outcomes - Improvement in sexual symptoms Secondary Outcomes - Improvement in urinary symptoms ### Location - Facility: IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan, MI, 20122, Italy @@
## Antiplatelet Therapy in Chronic Urticaria - NCT ID: NCT06268470 - Study ID: Chula-ARC 001/18 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-06-01 - Completion Date: 2024-05-01 - Lead Sponsor: Chulalongkorn University ### Study Description This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria ### Conditions - Chronic Urticaria ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Desloratadine plus cilostazol and dipyridamole - Desloratadine ### Outcomes Primary Outcomes - Weekly urticaria activity score Secondary Outcomes - D-dimer levels ### Location - Facility: Faculty of Medicine, Chulalongkorn University, Bangkok, N/A, 10330, Thailand @@
## Arterial Chemoembolization for the Treatment of Desmoid Fibromatosis - NCT ID: NCT06268457 - Study ID: CE-AVEC 789/2023/Oss/IOR - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2028-02-01 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description Desmoid fibromatoses are rare (1-2 cases/million per year) and locally aggressive mesenchymal tumors. For asymptomatic disease, current guidelines suggest an initial period of active surveillance.The current scientific evidence regarding the efficacy and safety of the treatment of desmoid fibromatosis by arterial embolization is constituted by several retrospective and prospective studies. Embolization of desmoid tumors alone, without chemotherapy, on the contrary, has been shown to be inefficient. Using Doxorubicin in desmoid fibromatosis is effective but associated with systemic toxicity. Consequently, this drug is reserved for symptomatic, nonresponsive, rapidly growing or life-threatening tumors. The intrinsic hypervascularity of desmoid tissue can be exploited as a conduit to achieve local distribution of Doxorubicin by navigation of a catheter endovascular. ### Conditions - Desmoid ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Chemoembolization with Doxorubicin ### Outcomes Primary Outcomes - Volume reduction in cm - Reduction of pain (VAS score) - Reduction of antalgic therapy (mg) Secondary Outcomes - Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire) - Improvement in quality of life (EORTC QLQ - BM22) ### Location - Facility: Istituto Ortopedico Rizzoli, Bologna, Emilia Romagna, 40136, Italy @@
## Infant Sleep and Exposure to Mixture of Chemical Environmental Pollutants - NCT ID: NCT06268444 - Study ID: PI2023_843_0077 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2026-02 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description During their first year of life, children spend more than half their time sleeping, a function essential to their neurodevelopment. This period of maturation and development of the future adult is considered extremely vulnerable to environmental exposure. During this period, the child\'s diet is mainly provided by breastfeeding, where persistent chemical substances have been found. A cocktail of 19 mostly persistent substances (POPs) present in breast milk has recently been identified as the main contributor to neurodevelopmental risk. However, the reality of their impact on neurophysiological development, in particular on infant sleep, has yet to be assessed.In this project, the sleep of children under 6 months of age will be studied using an actimetry watch worn for 7 days by the child, accompanied by a sleep diary. Exposure to environmental pollutants will be assessed by measuring their presence in the infant\'s milk (breastfeeding) and wearing a silicone bracelet to collect air pollutants. A questionnaire on exposure will complement this evaluation. ### Conditions - Newborn - Chemical Pollutants Exposure - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - 7-day actimetry sleep recording - Determination of environmental pollutants in breast milk - Measurements of environmental pollutants in indoor air deposited on the bracelet worn by the child - Continuous recording of the child's temperature for 7 days - Use of a sleep diary for 7 days - Parental questionnaire of environmental exposure ### Outcomes Primary Outcomes - total sleep time per day in infants using actimetry Secondary Outcomes - Concentration of various substances in breast milk - concentration of chemical polluants on newborn bracelets - Child Temperature level (°C) ### Location - Facility: CHRU Amiens, Amiens, N/A, 80054, France @@
## Oxytocin Rest to Reduce Cesarean Delivery - NCT ID: NCT06268431 - Study ID: 43084 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2026-03-15 - Lead Sponsor: Christiana Care Health Services ### Study Description Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery. ### Conditions - Prolonged Labor - Failed Induction - Labor Dystocia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oxytocin rest ### Outcomes Primary Outcomes - Cesarean rate Secondary Outcomes - Time to delivery (hours) - Time to vaginal delivery (hours) - Time to active labor (hours) - Duration of active labor (hours) - Composite maternal adverse outcome - Composite neonatal adverse outcome - Labor Agentry Scale score - Rate of intraamniotic infection (IAI) - Rate of postpartum endometritis - Rate of postpartum hemorrhage ### Location - Facility: ChristianaCare Health System, Newark, Delaware, 19718, United States @@
## Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy - NCT ID: NCT06268418 - Study ID: 2024PI020 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2024-08-30 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice.An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging ### Conditions - Radionucleide Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Artificial intelligence ### Outcomes Primary Outcomes - Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images Secondary Outcomes - Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings - NCT ID: NCT06268405 - Study ID: 22-5806 - Status: RECRUITING - Start Date: 2023-09-21 - Completion Date: 2024-09-21 - Lead Sponsor: University Health Network, Toronto ### Study Description The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM.Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Liquid Biopsy - Positron Emission Mammography (PEM) ### Outcomes Primary Outcomes - Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images Secondary Outcomes ### Location - Facility: University Health Network, Toronto, Ontario, M5G 2M9, Canada @@
## A Comparative Study of AI Methods for Fetal Diagnostic Accuracy in Ultrasound - NCT ID: NCT06268392 - Study ID: CT-2023-11-20-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-08-01 - Lead Sponsor: Copenhagen Academy for Medical Education and Simulation ### Study Description This study serves as a supplemental investigation to the randomized controlled SCAN-AID study (NCT0632187). This study will evaluate and compare the fetal growth estimation outcomes of AI-supported groups, expert sonographers, and control groups using a secondary AI predictive model. ### Conditions - Fetal Growth Retardation - Fetal Macrosomia - Fetal Growth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Fetal weight - Ultrasound fetal weight estimation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BMA and Dynamic Nomogram for Survival Prediction in Patients With CRC - NCT ID: NCT06268379 - Study ID: #08-01-03-23 - Status: COMPLETED - Start Date: 2010-02-15 - Completion Date: 2021-12-15 - Lead Sponsor: Cabrini Health ### Study Description This project will examine the outstanding statistical techniques for predicting the survival of patients with colorectal cancer (CRC) (colorectal neoplasia database). The motivating clinical question that led to proposing this project is based on the general assumption that: "Right-sided colorectal cancer (CRC) has worse survival than left-sided CRC." The question is, which aspects of the patient's characteristics are responsible for this difference? This led us to BMA model selection and provide a clinician-friendly online nomogram. ### Conditions - Colon Cancer - Model Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surgery ### Outcomes Primary Outcomes - OS - RFS Secondary Outcomes ### Location - Facility: Cabrini Health, Melbourne, Victoria, 3144, Australia @@
## Effects of Exercise-Based Interventions on Symmio Self-Movement Screen - NCT ID: NCT06268366 - Study ID: UEvansville - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: University of Evansville ### Study Description Musculoskeletal screening for physical risk factors requires equipment and a trained healthcare or fitness professional to perform and interpret the scoring so that appropriate exercise interventions can be prescribed. However, barriers such as healthcare costs and accessibility, low perceived need to seek medical care, and previous unfavorable evaluation of seeking medical care are associated with healthcare avoidant behaviors. This research aims to explore the effectiveness of the Symmio Self-Screen application to generate specific exercise interventions to address an individual's associated physical risk factors. The ability of the Symmio application to prescribe a targeted exercise program which can reduce asymmetries, improve movement quality, and enhance overall function is unknown. Therefore, the purpose of this study is to determine the effectiveness of the Symmio application in designing individualized exercise interventions which target the unique movement limitations and asymmetries in adults. ### Conditions - Movement Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - Symmio Self-Movement Screen Secondary Outcomes - Global Rating of Change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study - NCT ID: NCT06268353 - Study ID: 109324-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-03-15 - Lead Sponsor: University of Copenhagen ### Study Description Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing.Purpose:The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment. ### Conditions - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - blood sampling ### Outcomes Primary Outcomes - CAPGDF15 levels in plasma Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hearing and Structure Preservation Via ECochG - NCT ID: NCT06268340 - Study ID: ABIntl-23-25 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2026-06-30 - Lead Sponsor: Advanced Bionics AG ### Study Description The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance. ### Conditions - Hearing Loss, Sensorineural - Severe-to-profound Hearing Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ECochG monitored CI surgery incl. corrective action guide - Routine CI surgery without ECochG monitoring ### Outcomes Primary Outcomes - Hearing Preservation Secondary Outcomes - Structure Preservation - Speech perception ### Location - Facility: Universitair Ziekenhuis Gent, Gent, N/A, 9000, Belgium @@
## Adding Adjuvant Cisplatin and Gemicitabine Versus Capecitabine in Triple-negative Breast Cancer Patients in Non pCR After Neoadjuvant Standard Chemotherapy - NCT ID: NCT06268327 - Study ID: Adjuvant treatment in BC - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-10-30 - Lead Sponsor: Assiut University ### Study Description In our study; investigator aim To show efficacy and toxicity of Adjuvant cisplatin and gemcitabine in triple-negative breast cancer patients with non pathologically complete response after neoadjuvant chemotherapy To compare outcome of adjuvant cisplatin and gemcitabine versus capecitabine ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cisplatin injection and gemcitabine - Capecitabine tablets ### Outcomes Primary Outcomes - Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathologically complete response after neoadjuvant standard chemotherapy Secondary Outcomes - Comparison of patients who receive cisplatin and gemcitabine versus capecitabine in Triple negative breast cancer ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. - NCT ID: NCT06268314 - Study ID: hypoalbuminemia in pediatrics. - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-06-01 - Lead Sponsor: Assiut University ### Study Description To determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Feeding Pattern and Hypoalbuminemia in Pediatrics With Chronic Kidney Disease. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults - NCT ID: NCT06268301 - Study ID: TAK-721-1003 - Status: COMPLETED - Start Date: 2023-02-06 - Completion Date: 2023-02-20 - Lead Sponsor: Takeda ### Study Description The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Budesonide ### Outcomes Primary Outcomes - Maximum Observed Concentration (Cmax) - Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) - Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) Secondary Outcomes - Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death - Number of Participants With Clinically Significant Abnormal Vital Sign Values - Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values - Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) - Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) - Time to First Occurrence of Cmax (tmax) - Lag Time to First Quantifiable Concentration (tlag) - Terminal Disposition Phase Half-life (t1/2z) - Terminal Disposition Phase Rate Constant (λz). - Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration - Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration ### Location - Facility: Celerion, Lincoln, Nebraska, 68502, United States @@
## Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS) - NCT ID: NCT06268288 - Study ID: 22-011492 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-12-22 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management. ### Conditions - Postural Tachycardia Syndrome - Autonomic Dysfunction - Postural Orthostatic Tachycardia Syndrome - POTS - Postural Orthostatic Tachycardia Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GammaCore intervention - STEPS management protocol ### Outcomes Primary Outcomes - The change in COMPASS-31 scores between individuals in both arms of the study - The change in Child Functional Disability Inventory scores between individuals in both arms of the study - The change in heart rate increase in head up tilt table tests in individuals in both arms of the study Secondary Outcomes - Does nVNS influence headache frequency in adolescent patients with POTS - Does nVNS influence ability to increase exercise duration in adolescent patients with POTS - Does use of nVNS influence degree of depression in adolescent patients with POTS ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy - NCT ID: NCT06268275 - Study ID: HE651314 - Status: COMPLETED - Start Date: 2022-09-19 - Completion Date: 2024-02-13 - Lead Sponsor: Khon Kaen University ### Study Description The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia. ### Conditions - Hemodynamic Instability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Scalp block - Esmolol ### Outcomes Primary Outcomes - MAP - SBP - DBP - HR Secondary Outcomes - BIS - Cumulative postoperative opioids consumption - Postoperative adverse events ### Location - Facility: Khon Kaen University, Khon Kaen, Naimuang, Muang, 40002, Thailand @@
## Surgical-imaging Research on Obesity (SIRO) - NCT ID: NCT06268262 - Study ID: XYFY2023-KL045-01 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2028-12 - Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University ### Study Description The global obesity epidemic is well established, and is an important public health issue. The previous researches had applied the clues that obesity is a kind of systemic disease. The investigators hypothesized that a serious alteration of the body systems will occur after bariatric surgery, which may shed light on the mechanisms of obesity. Thus, the research aims to combine the imaging and surgery to investigate the alterations of the body that induced by obese and alterations after surgery. ### Conditions - Overweight and Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Imaging parameters of obesity - Imaging parameters of obesity - Imaging parameters of obesity Secondary Outcomes - Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample - Neurotransmitter, inflammatory factors and hormones relating to obesity in blood sample - Neurotransmitter, inflammatory factors and hormones related to obesity in blood sample - Genetic information from venous blood sample, biopsied liver tissue, biopsied fat tissue, and gastric tissue ### Location - Facility: Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China @@
## Ulinastatin Improves Post-Cardiac Surgery Cognitive Dysfunction - NCT ID: NCT06268249 - Study ID: TJ-IRB20231224 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2023-12-30 - Lead Sponsor: Qin Zhang ### Study Description This study is a retrospective, observational study that aims to include patients undergoing cardiac surgery. 1. Evaluate the preventive effect of ursodeoxycholic acid on post-cardiac surgery cognitive dysfunction over the past eight years. 2. Utilize the pre-existing preoperative and postoperative 24-hour plasma samples from previous studies to measure the levels of glycocalyx and its related regulatory factors. 3. Assess the clinical correlation between the measured parameters and patient outcomes. ### Conditions - Cardiac Complication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ulinastatin ### Outcomes Primary Outcomes - POCD - Postoperative Cognitive Dysfunction Secondary Outcomes - Survival time ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Electro-acupuncture to Treat Disorder of Consciousness - NCT ID: NCT06268236 - Study ID: BF2023-252 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-31 - Lead Sponsor: The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine ### Study Description With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments. ### Conditions - Disorder of Consciousness - Electroacupuncture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electroacupuncture - Sham electroacupuncture ### Outcomes Primary Outcomes - Coma Recovery Scale - Revised score Secondary Outcomes - phase locking value - amplitude of low-frequency fluctuation - Amide proton transfer-weighted signal - f value - neurite density index - latency value of N20 - latency between III and V potentials - Glasgow Outcome Scale-Extended score - Glasgow Outcome Scale-Extended score - brain-computer interface accuracy ### Location - Facility: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, 510120, China @@
## Home-Based Action Observation Training for Chewing and Swallowing Function - NCT ID: NCT06268223 - Study ID: 2023/315 - Status: RECRUITING - Start Date: 2023-10-13 - Completion Date: 2024-07-01 - Lead Sponsor: Ondokuz Mayıs University ### Study Description The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study. ### Conditions - Cerebral Palsy - Chewing Disease - Action Obervation Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chewing Exercise Training ### Outcomes Primary Outcomes - Karaduman Chewing Performance Scale - Turkish version of the Mastication Observation and Evaluation Instrument - Test of Masticating and Swallowing Solids in Children - Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative - The Pediatric version of the Eating Assessment Tool - Dysphagia Disorder Survey - Behavioral Pediatrics Feeding Assessment Scale Secondary Outcomes ### Location - Facility: Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer, Samsun, Atakum, 55200, Turkey @@
## Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer - NCT ID: NCT06268210 - Study ID: 4-2023-1546 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-06 - Lead Sponsor: Yonsei University ### Study Description In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with resectable, treatment-naive EGFR-mutant (exon 19 deletion or exon 21 L858R) non-small cell lung cancer, ranging from clinical stage IB to IIIB. The study is designed to assess the impact on pathological response, as well as effectiveness and safety considerations. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lazertinib+Pemetrexed+Carboplatin - Lazertinib ### Outcomes Primary Outcomes - Primary pathological response Secondary Outcomes - Surgical Resection Methods (Segmentectomy or Lobectomy) - Pathologic Complete Response - Objective Response Rate - Event-Free Survival - Disease-Free Survival - Overall Survival - Number of patients with Adverse events according to CTCAE v5.0 ### Location - Facility: Severance hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Interoception-Based Yoga for Chronic Pain - NCT ID: NCT06268197 - Study ID: IRB23-0329 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-12-30 - Lead Sponsor: University of Illinois at Urbana-Champaign ### Study Description The purpose of this research is to examine the feasibility and acceptability of an interoception-based yoga program for chronic pain. Interoception involves your ability to feel sensations in your body (such as your heartbeat or muscle tension) as well as how you think about and interpret those sensations. Interoception may be an important component of chronic pain and the research team is studying whether yoga can change how you feel, think about, and interpret sensations in your body. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Yoga Intervention ### Outcomes Primary Outcomes - Feasibility - Acceptability Secondary Outcomes - Interoceptive Sensibility - PROMIS Pain Interference ### Location - Facility: University of Illinois Urbana-Champaign, Urbana, Illinois, 61801, United States @@
## Effect of Omega 3 on Oxidative Stress and Nutritional Status of Children on Regular Dialysis - NCT ID: NCT06268184 - Study ID: omega3 in oxidative stress - Status: RECRUITING - Start Date: 2021-10-04 - Completion Date: 2024-04-01 - Lead Sponsor: Tanta University ### Study Description evaluaion the effects of oral omega-3 supplementation on nutritional status and oxidative stress in pediatric patients with end stage renal disease on regular hemodialysis ### Conditions - Oxidative Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - D3 LAB SYRUP - placebo capsule ### Outcomes Primary Outcomes - decrease oxidative stress - increase antioxidant activity - improvement of nutritional status assessed by anthropometric measurements. - mid upper arm circumference in centimeters - triceps skin fold thickness in millimeter's - improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) - improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) - improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) - improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) - improvement of nutritional status assessed by Bioelectrical Inbody Analysis(BIA) - improvement of nutritional status assessed by laboratory investigations. - s. ionized calcium level - s.phosphorus level - alkaline phosphatase level - parathormone hormone level - 25(oh)vitamin D level Secondary Outcomes ### Location - Facility: Faculty of Medicine, Tanta, Gharbia, N/A, Egypt @@
## Ultrasound Assessment of Rectus Femoris Cross-sectionnal Area Following Lung Transplantation - NCT ID: NCT06268171 - Study ID: 2023_0214 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-11-05 - Lead Sponsor: Hopital Foch ### Study Description In France, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. This progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or COPD, and an increase in the average age of patients. In these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality.After transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. There is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. The combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the ICU.Muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. This study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. Objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity.In summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies. ### Conditions - Lung Transplant - Physiotherapy - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound measurement of the cross-sectional area of the rectus femoris ### Outcomes Primary Outcomes - Evaluation of the change at D7 in the cross-sectional area of the rectus femoris following lung transplantation Secondary Outcomes - Measure change in CSA-RF at D7 according to LT pattern - Evaluate the relationship between length of stay in intensive care unit and variation in CSA-RF at D7 - Determine the relationship between CSA-RF at D-1 and Body Mass Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit - NCT ID: NCT06268158 - Study ID: 2023/45 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: TC Erciyes University ### Study Description After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study will be conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, will be used. ### Conditions - Abdominal Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Eye patch ### Outcomes Primary Outcomes - Richard-Campbell Sleep Scale - Nursing Delirium Screening Scale Secondary Outcomes - Richmond Agitation-Sedation Scale ### Location - Facility: Erciyes University, Kayseri, Talas, 38080, Turkey @@
## ECC5004 RBA FE Study in Healthy Participants - NCT ID: NCT06268145 - Study ID: EC0006 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2024-03-30 - Lead Sponsor: Eccogene ### Study Description This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - ECC5004 ### Outcomes Primary Outcomes - ECC5004 PK parameters: AUC0-tlast - ECC5004 PK parameters: AUC0-inf - ECC5004 PK parameters: Cmax - ECC5004 PK parameters: tmax Secondary Outcomes - Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations - ECC5004 PK parameters: AUC0-tau - ECC5004 PK parameters: AUC 0-24 - ECC5004 PK parameters: tlag - ECC5004 PK parameters: t1/2 - ECC5004 PK parameters: CL/F - ECC5004 PK parameters: AUC(extr) ### Location - Facility: Eccogene Investigational Site, Anaheim, California, 92801, United States @@
## Longevity in Russia - NCT ID: NCT06268132 - Study ID: MLS90 - Status: RECRUITING - Start Date: 2019-12-25 - Completion Date: 2025-12-31 - Lead Sponsor: Center for Strategic Planning, of the Federal Medical and Biological Agency ### Study Description This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity.The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration. ### Conditions - LONGEVITY 1 - Frailty - Aging - Age-related Cognitive Decline - Aging Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality among long-living adults - Morbidity among long-living adults Secondary Outcomes - Aging phenotypes - Social, economic, and medical- history-related determinants - Genetic determinants - Epigenetic determinants - Metagenomic determinants ### Location - Facility: RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation, Moscow, N/A, 129226, Russian Federation @@
## Effectiveness of Delirium Care Protocol After Cardiac Surgery - NCT ID: NCT06268119 - Study ID: MustafaKU-SBF-GKS-01 - Status: COMPLETED - Start Date: 2023-03-06 - Completion Date: 2023-05-22 - Lead Sponsor: Gonul Kara Soylemez ### Study Description This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. ### Conditions - Delirium, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. ### Outcomes Primary Outcomes - Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU) Secondary Outcomes - Glasgow Coma Scale (GCS) - Richmond Agitation-Sedation Scale (RASS) - Information Assessment Form for Postoperative Delirium (Pretest-Posttest) ### Location - Facility: Antalya Training and Research Hospital, Antalya, Center, 07000, Turkey @@
## Graphic Novel for Patients Undergoing EUS-FNB - NCT ID: NCT06268106 - Study ID: IRB N/A - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-01 - Lead Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies ### Study Description Endoscopy with endoscopic ultrasound (EUS) is a primary technique for diagnosing and treating severe pancreatic disorders. However, the procedure can cause fear and anxiety in patients, especially when a biopsy is involved. Graphic medicine, a form of visual storytelling that explores narratives of healthcare, is being used to alleviate this anxiety.This is a prospective single-center interventional pilot study with the aim to evaluate the impact of a novel graphic on the stress and behaviors of patients with pancreatic lesions undergoing EUS-FNB. The study will run for six months with the aim to enroll patients to llok for differences in the anxiety and stress levels.Enrolled patients will be randomly allocated to the test or control group, with the test group receiving a graphic novel to read while waiting for the procedure. Post-procedure, patients will complete the Beck Anxiety Inventory (BAI) and a modified version of the Depression Anxiety Stress Scales-21 (mDASS-21), now named mASS-14 (modified Anxiety Stress Scales-14), to assess anxiety and stress levels.This study is conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent will be obtained from all participants before enrollment. ### Conditions - Anxiety - Pancreatic Cancer - Pancreatic Cystic Lesions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Graphic novel visualization ### Outcomes Primary Outcomes - Anxiety and stress level according to BAI - Anxiety and stress level according to mASS-14 Secondary Outcomes ### Location - Facility: Irccs - Ismett, Palermo, PA, 90127, Italy @@
## The Therapeutic Effect of Thalidomide in Syringomyelia - NCT ID: NCT06268093 - Study ID: XWTETS - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2028-02 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage. ### Conditions - Syringomyelia - Thalidomide ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Thalidomide ### Outcomes Primary Outcomes - ASIA Score Secondary Outcomes - syringomyelia remission - The evoked electromyographic signal (eEMG) potential - Visual Analog Scale (VAS) - Klekamp and Sammi syringomyelia scale - modified Japanese Orthopaedic Association Scores (mJOA) - xuanwu syringomyelia scale - Incidence of complications ### Location - Facility: Fengzeng Jian, Beijing, Beijing City, 100032, China @@
## Depth of Anesthesia on Postoperative Delirium and Cognitive After Surgery - NCT ID: NCT06268080 - Study ID: A+9317 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2028-12-31 - Lead Sponsor: Auckland City Hospital ### Study Description The goal of this clinical trial (Balanced-2 study) is to compare light to deep general anesthesia using widely available brain monitors, to see if 'light' anesthesia could reduce rates of delirium, cognitive decline, and disability in older adults undergoing major surgery.Delirium is the most common serious surgical complication, occurring in an estimated one in four older adults undergoing major surgery. Delirium causes significant distress to patients and family, and is associated with prolonged hospital stay, physical disability, progression to dementia-like illnesses, and discharge to long-term care. Between 10 - 30% of adults aged 70 years and above have surgery every year, and preserving brain health and wellbeing is an important priority during this time.Older adults (aged ≥65 years, or Indigenous, Pasific patients aged ≥55 years) undergoing major surgery with general anesthesia (excluding heart and brain surgery) and able to provide consent will be able to participate. Participants will be randomized to two groups - a lighter general anesthesia group and a deeper general anesthesia group using processed electroencephalography (a brain monitor that provides information on depth of anesthesia using brain waves). The anesthesiologist will titrate anesthetic drugs according to the brain monitor. Participants will be followed up to determine if they experience delirium after surgery, and longer term impact of delirium such as cognitive and physical decline will also be measured.If found to be effect, this simple, cheap, and widely available treatment could reduce disability, preserve brain health and wellbeing of many older adults undergoing surgery worldwide, and save millions in healthcare dollars. ### Conditions - Delirium, Postoperative - Anesthesia - Surgery-Complications - Cognition Disorder - Delirium - Cognitive Decline ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Depth of anesthesia titration using pEEG ### Outcomes Primary Outcomes - Incidence of postoperative delirium (POD) Secondary Outcomes - Incidence of severe delirium - Incidence of new mild and major postoperative neurocognitive disorders - Postoperative cognitive decline - Functional decline - All-cause mortality - Duration of delirium ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Kidney Uptake at F-18 FDG PET/CT Studies and Renal Function Status - NCT ID: NCT06268067 - Study ID: Renal uptake at F18 FDG PET/CT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description Searching for a possible correlation between renal uptake at F-18-FDG PET/CT and renal functional parameters in both normal subjects and patients with CKD. ### Conditions - Renal Uptake at F-18-FDG PET/CT ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PET/CT ### Outcomes Primary Outcomes - significance of renal uptake at F18-FDG PET CT studies Secondary Outcomes - Early detection of patients with CKD ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea - NCT ID: NCT06268054 - Study ID: DEH113-III-0123 - Status: NOT_YET_RECRUITING - Start Date: 2025-02 - Completion Date: 2027-09 - Lead Sponsor: EMS ### Study Description The purpose of this study if to evaluate the efficacy and safety of DEH113 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea. ### Conditions - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - DEH113 - Placebo Comparator ### Outcomes Primary Outcomes - Sum of Total Pain Relief (TOTPAR) over 0-6 hours post-dose Secondary Outcomes - Sum of Total Pain Relief (TOTPAR) over 0-4 and 0-8 hours post-dose - Sum of Pain Intensity Difference (SPID) over 4, 6 and 8 hours post-dose. - Use of rescue medication - Number of additional drug intake - Patients' Global Impression of Change (PGIC) - Incidence of Adverse Events Associated with DEH113 in the Treatment of Primary Dysmenorrhea ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HIT-Stroke Trial 2 - NCT ID: NCT06268041 - Study ID: 427659 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2028-04 - Lead Sponsor: University of Cincinnati ### Study Description People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Moderate-Intensity Aerobic Training - High-Intensity Interval Training ### Outcomes Primary Outcomes - 6-Minute Walk Test Distance Secondary Outcomes - 6-Minute Walk Test Distance - Self-Selected Gait Speed - Fastest Gait Speed - PROMIS-Fatigue Scale version 8a - Aerobic Capacity - EuroQol-5D-5L ### Location - Facility: University of Delaware, Newark, Delaware, 19713, United States @@
## Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery - NCT ID: NCT06268028 - Study ID: BELMA TA - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-10 - Completion Date: 2024-11-10 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.The research is a pre-test-post-test, randomized controlled experimental study. ### Conditions - Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Training ### Outcomes Primary Outcomes - A pre-test will be applied to 70 women who constitute the sample of the research. Secondary Outcomes - Apost-test will be applied to 70 women who constitute the sample of the research. ### Location - Facility: Aydın Maternity and Child Health Hospital, Aydın, N/A, 09010, Turkey @@
## Botensilimab and Balstilimab Optimization in Colorectal Cancer - NCT ID: NCT06268015 - Study ID: Pro00115311 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2028-07 - Lead Sponsor: Nicholas DeVito, MD ### Study Description This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years. ### Conditions - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Botensilimab - Balstilimab - Oxaliplatin - Leucovorin - Fluorouracil - Bevacizumab - Panitumumab ### Outcomes Primary Outcomes - Disease control rate based on iRECIST at second restaging scan - Proportion of subjects with a best overall response of complete response or partial response according to iRECIST Secondary Outcomes - Disease control rate based on RECIST v1.1 at second restaging scan - Proportion of subjects with a best overall response of complete response or partial response according to RECIST v1.1 - Months of overall survival - Months of progression-free survival ### Location - Facility: Duke University, Durham, North Carolina, 27710, United States @@
## Effect of Vernonia Cinerea Lozenges as a Smoking Cessation Aid in Patients With Non-communicable Diseases - NCT ID: NCT06268002 - Study ID: 5876557033 - Status: COMPLETED - Start Date: 2017-09-01 - Completion Date: 2021-12-31 - Lead Sponsor: Chulalongkorn University ### Study Description Vernonia cinerea is an herbal which has been recorded in many Thai herbal formulation and Thai traditional medicine has used this herbal for treating various diseases included hypertension, asthma, fever, hepatitis, kidney stone and smoking cessation. Now aday there are more interest for using Vernonia cinerea as a medication to aid smoker to quit smoking because it is cheaper than other current therapeutic medications. The objective of this study is to evaluate efficacy and safety of Vernonia cinerea lozenge for smoking cessation when compared to placebo. ### Conditions - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vernonia cinerea - Placebo ### Outcomes Primary Outcomes - continuous abstinence rate Secondary Outcomes - continuous abstinence rate (CAR) and point prevalence rate ### Location - Facility: Krittin Bunditanukul, Bangkok, N/A, 10600, Thailand @@
## The Effectiveness of Early Intervention to Correct the Position of PDC:s - NCT ID: NCT06267989 - Study ID: Gothenburg University - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2027-12-30 - Lead Sponsor: Region Örebro County ### Study Description Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008).It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews.Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided. ### Conditions - Ectopic Tooth Eruption - Palatal Expansion Technique - Randomized Clinical Trial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Extraction of the primary canine teeth - Expansion ### Outcomes Primary Outcomes - Succeful eruption of the palatally displaced canines into the dental arch Secondary Outcomes - Cost effectiveness of the interventions - Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention. ### Location - Facility: Gothenbrug University, Gothenburg, N/A, N/A, Sweden @@
## Validation of the ProSomnus® RPMO2 Device - NCT ID: NCT06267976 - Study ID: REB23-1003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-30 - Lead Sponsor: ProSomnus Sleep Technologies ### Study Description The purpose of the study is to:1. Evaluate the SpO2 accuracy of the oximeter component of the ProSomnus RPMO2 Device during non-motion conditions over the range of 70-100% SaO2 by comparison to SaO2 values determined by arterial blood sample specimen analyzed by a CO-oximeter.2. Evaluate the pulse rate performance simultaneously collected over the SpO2 range. ### Conditions - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ProSomnus RPMO2 ### Outcomes Primary Outcomes - SpO2 accuracy - Pulse rate accuracy Secondary Outcomes ### Location - Facility: University of Calgary, Calgary, Alberta, T2N4N1, Canada @@
## A Study to Understand What the Body Does to the Study Medicine Called PF-07220060 When Taken by Healthy Adults - NCT ID: NCT06267963 - Study ID: C4391010 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-31 - Completion Date: 2024-04-18 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.The study is seeking for participants who:* are males aged 18 to 65 years and are healthy.* have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2* have a total body weight of at least 50 kilograms.The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Oral [14C]PF-07220060 - Oral PF-07220060 - IV [14C] PF-07220060 ### Outcomes Primary Outcomes - Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered. - Amount of metabolites of [14C]PF-07220060 in plasma, urine, and feces. Secondary Outcomes - Dose normalized AUCinf of intravenous radiolabeled PF-07220060 in plasma (if data permit) - The absolute oral bioavailability (F) of PF-07220060 - The fraction of PF-07220060 dose absorbed (Fa) - Number of participants with treatment emergent clinically significant laboratory abnormalities - Number of participants with treatment emergent clinically significant abnormal ECG measurements - Number of participants with treatment emergent clinically significant abnormal vital measurements - Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) - Number of participants with treatment emergent clinically significant abnormal physical examination ### Location - Facility: PRA Health Sciences, Groningen, N/A, 9728 NZ, Netherlands @@
## Effect of Oral Feeding in Infants With Pierre Robin Syndrome - NCT ID: NCT06267950 - Study ID: PILUO-INFANT - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-10 - Lead Sponsor: Zeng Changhao ### Study Description This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding) and the PNG group (with Nasogastric Tube Feeding), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared. ### Conditions - Pierre Robin Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - systematic therapy - intermittent oro-esophageal tube feeding - gastric tube feeding ### Outcomes Primary Outcomes - Number of patients diagnosed as the pulmonary infection "Positive" Secondary Outcomes - Nutritional status-total protein - Nutritional status-hemoglobin - Nutritional status-albumin - Body weight - The Functional Oral Intake Scale for Infants ### Location - Facility: Hsinchu Rehabilitation Hospital, Xinzhu, N/A, N/A, Taiwan @@
## Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery - NCT ID: NCT06267937 - Study ID: 101 - Status: COMPLETED - Start Date: 2023-03-10 - Completion Date: 2024-01-30 - Lead Sponsor: University of Chile ### Study Description Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. ### Conditions - Hip Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Access to surgery - type of intitution ### Outcomes Primary Outcomes - survival after hip fracture Secondary Outcomes ### Location - Facility: hospital Clinico Universidad de Chile, Santiago, Region Metropolitana, 8380456, Chile @@
## SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines - NCT ID: NCT06267924 - Study ID: Olith10703 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-28 - Completion Date: 2024-09-30 - Lead Sponsor: Otolith Labs ### Study Description The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.Participants will be:* Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)* Randomized and stratified into groups based on the referring clinic to be assigned one study device* Asked to use the study device as instructed by the study coordinator* Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators* Asked to provide their vertigo diagnosis from their physician* Compensated for their participationResearchers will compare the randomized groups to determine which group responds better to which device. ### Conditions - Vestibular Migraine - Migraine Associated Vertigo ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Otoband Experimental - Otoband Sham ### Outcomes Primary Outcomes - DHI Change in Scores Secondary Outcomes - Number of related adverse events - Change in number of vestibular migraine episodes weekly - Global Impression of Change (severity of episodes) - DHI change from transition to end of study - Device responder rate ### Location - Facility: Otolith Labs, Washington, District of Columbia, 20001, United States @@
## Rehabilitation Gaming System for Intensive Care Units - NCT ID: NCT06267911 - Study ID: 202223-10 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: University of the Balearic Islands ### Study Description Admission to an Intensive Care Unit (ICU) is a potentially traumatic experience for a mentally vulnerable person. Beyond the stress and anxiety associated with the ICU environment and medical procedures, survivors of critical illness are at risk of developing cognitive and psychological sequelae related to Post-Intensive Care Syndrome (PICS). These disorders are associated with high economic, medical and personal costs.This trial aims to evaluate the efficacy of an innovative neuropsychological e-health intervention for early cognitive stimulation and psychological support of people in critical care, i.e. the Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) intervention, in improving comfort during ICU admission and cognition and mental health three and 12 months after ICU discharge. The RGS-ICU intervention, applied as an adjunct to standard ICU care, is based on non-immersive virtual reality techniques and has been specifically designed and developed to suit the needs of people in critical care and the characteristics of the ICU environment. To ensure the safety of the intervention, participants' physiological parameters will be automatically recorded by advanced continuous monitoring systems as part of standard ICU care.The investigadors hypothesize that the cognitive stimulation and psychological support protocols of the RGS-ICU intervention, applied as an adjunct to standard ICU care, in addition to being safe for people in critical care units, will improve comfort during ICU admission and cognitive and mental health outcomes after ICU discharge, compared to receiving standard ICU care alone.The findings derived from this trial may contribute to establish a novel and superior paradigm of human-centered ICU care to improve the comfort of people admitted to the ICU. This achievement could also have a relevant impact on medical and economic costs during ICU admission, and on functionality and health-related quality of life after ICU discharge associated with the reduction of cognitive and psychological sequelae linked to PICS.The RGS-ICU intervention has been designed at Corporacion Parc Taulí with the collaboration of the University of the Balearic Islands and has been developed by Eodyne Systems S.L., a company dedicated to the development of science-based technological solutions for intervention, monitoring, diagnosis, and prognosis in stroke and other brain disorders. ### Conditions - Critical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive stimulation and psychological support (RGS-ICU) ### Outcomes Primary Outcomes - Attention performance - Working memory performance - Learning/memory performance - Executive function performance - Processing speed performance - Incidence of Treatment-Emergent Adverse Events [Safety] Secondary Outcomes - Dyspnea intensity - Pain intensity - Worry intensity - Sadness intensity - Comfort experienced - Anxiety symptoms - Symptoms of depression - Symptoms of post-traumatic stress disorder ### Location - Facility: University of the Balearic Islands, Palma De Mallorca, Balearic Islands, 07122, Spain @@
## Non Interventional Study on Iron Toxicity After First Allo-transplant in MDS/CMML - NCT ID: NCT06267898 - Study ID: EBMT- 842205547 - Status: COMPLETED - Start Date: 2009-11-01 - Completion Date: 2015-05-21 - Lead Sponsor: European Society for Blood and Marrow Transplantation ### Study Description Stem cell transplantation and blood product transfusions are standard of care for Myelodysplastic Syndromes (MDS). Several studies have shown changes in serum ferritin and non-transferrin-bound iron (NTBI) in patients undergoing stem cell transplantation. A large proportion of MDS patients are at risk for organ damage from tissue siderosis, due to the development of iron overload.Toxic effects of iron may play an important role in the complications associated with HSCT. Iron chelation therapy may reduce the acute and chronic treatment-related toxicity by removing excess of iron, iron radicals and reactive oxygen species (ROS).There is little information about the efficacy and safety of iron chelation in MDS patients. This audit wants to evaluate the effect of iron toxicity on treatment-related mortality in untreated, adult MDS or CMML patients during and after treatment with myeloablative conditioning (MAC) and reduced intensity conditioning (RIC) allo-HSCT, by prospectively collecting data from 200 MDS or CMML patients from 2009 onwards. ### Conditions - MDS - CMML ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - non-relapse mortality (treatment related mortality). Secondary Outcomes - treatment-related toxic effects - relapse rate - event-free survival - overall survival ### Location - Facility: Antwerp University Hospital (UZA), Antwerp, N/A, 2650, Belgium @@
## Fixation of Fracture Neck of Femur in Children - NCT ID: NCT06267885 - Study ID: Children NOF fracture fixation - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description Find the best way for fixation of fracture neck of femur in children either by cannulated screws or wagner's technique ### Conditions - Fracture Neck of Femur ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cannulated screws vs wagner's technique ### Outcomes Primary Outcomes - The better method for fixation of fracture neck of femur Secondary Outcomes ### Location - Facility: Assiut university, Assiut, N/A, N/A, Egypt @@
## A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum - NCT ID: NCT06267872 - Study ID: HVTN 309 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2026-07-11 - Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) ### Study Description This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed. ### Conditions - HIV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - CD4BS CH505M5 Pr-NP1 - CH505TF chTrimer - 3M-052-AF (labeled as AP 60-702) - Aluminum Hydroxide Suspension (Alum) - ACU-026-001-1 (labeled as empty LNP) ### Outcomes Primary Outcomes - Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine - Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine - Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation - Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation - Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation - Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation - Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry - Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay - Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay Secondary Outcomes - Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) - Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) - Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay - Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay - Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay - Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay - Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay - Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay - Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry - Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry - Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry ### Location - Facility: Alabama CRS (Site ID: 31788), Birmingham, Alabama, 35222, United States @@
## Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children - NCT ID: NCT06267859 - Study ID: No. 2 of 2023/11/7 - Status: RECRUITING - Start Date: 2023-11-08 - Completion Date: 2034-01-30 - Lead Sponsor: Tashkent Pediatric Medical Institute ### Study Description The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.The main questions it aims to answer:* Analysis of common congenital diseases among children;* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;* Based on the results of the primary research, common diseases among children will be identified;* Analysis of existing treatment methods and their effectiveness;* Development of modern methods of treatment and rehabilitation of children. ### Conditions - Respiratory Diseases - Congenital Heart Defects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - The use of a combination of microelements and vitamins against the background of physiotherapy ### Outcomes Primary Outcomes - Working with archival documentation. - Formation of a group of patients to study immunity and the antioxidant system in venous blood. - Clinical scientific research. - Clinical trial evaluation. Secondary Outcomes ### Location - Facility: Turdieva Shokhida Tolkunovna, Tashkent, Yunus-obad District, 100140, Uzbekistan @@
## A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder - NCT ID: NCT06267846 - Study ID: NBI-1070770-MDD2029 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-12 - Lead Sponsor: Neurocrine Biosciences ### Study Description To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD). ### Conditions - Major Depressive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NBI-1070770 - Placebo ### Outcomes Primary Outcomes - Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 Secondary Outcomes - Change in Total MADRS Score from Baseline at Postbaseline Timepoints ### Location - Facility: Neurocrine Clinical Site, Little Rock, Arkansas, 72211, United States @@