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## Cardioneuroablation for Bradyarrhythmia - NCT ID: NCT06288633 - Study ID: FNWMRC - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2027-02-01 - Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health ### Study Description This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation ### Conditions - Bradycardia - Syncope - Sick Sinus Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ganglionated plexi ablation - Electrophysiological study ### Outcomes Primary Outcomes - Implantation of a permanent cardiac pacemaker Secondary Outcomes - Complications of cardioneuroablation - Presence of symptomatic or asymptomatic rhythm pauses >6 seconds - The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime - Transient or permanent atrioventricular block - Orthostatic hypotension and/or bradycardia during passive orthostasis test - Sinus tachycardia after cardioneuroablation - Implantation of a pacemaker by 24 months after randomization ### Location - Facility: Almazov National Medical Research Centre, Saint Petersburg, N/A, N/A, Russian Federation @@
## Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer - NCT ID: NCT06288620 - Study ID: MA-EBC-II-024 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2025-05-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Microwave Ablation ### Outcomes Primary Outcomes - Complete ablation rate Secondary Outcomes - Safety of microwave ablation ### Location - Facility: the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, N/A, China @@
## Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study - NCT ID: NCT06288607 - Study ID: 2023-SR-708 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-16 - Completion Date: 2024-04-18 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab\* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab\* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively. ### Conditions - Solar Lentigo ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) ### Outcomes Primary Outcomes - Lab* values - Physician Global Aesthetic Improvement Scale - Subjective Global Aesthetic Improvement Scale Secondary Outcomes ### Location - Facility: Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, N/A, China @@
## TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability - NCT ID: NCT06288594 - Study ID: DEU-PSI-HA-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: Dokuz Eylul University ### Study Description The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial. ### Conditions - Post-Traumatic Stress Disorder (PTSD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Application Plus Online Therapist Support Group - Application Only Group ### Outcomes Primary Outcomes - PTSD Symptom Severity Secondary Outcomes - Depression Anxiety and Stress Symptom Severity - Quality of Life Improvement - Feasibility: Attrition Rate - Feasibility: Recruitment Rate - Feasibility: Retention Rate - Feasibility: Adherence Rate to the Mobile Application - Feasibility: Consent Rate - Feasibility: Fidelity of Intervention Delivery - Acceptability: System Usability Scale (SUS) Score for Acceptability - Acceptability: Preferred and Least Preferred Module Components - Acceptability: Application Utilization Frequency - Acceptability: Likelihood to Recommend the Application ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## U Shaped Toothbrush in Removing Plaque in Children - NCT ID: NCT06288581 - Study ID: UDDS-Pedo-02-2024 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-08-01 - Lead Sponsor: Damascus University ### Study Description The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.Children accepted in the study will be randomly divided into two groups:The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH) ### Conditions - Dental Plaque ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Traditional toothbrush group - U shaped toothbrush group ### Outcomes Primary Outcomes - Changing in plaque index Secondary Outcomes ### Location - Facility: Damascus University, Damascus, N/A, 20872, Syrian Arab Republic @@
## Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers - NCT ID: NCT06288568 - Study ID: Shift2Health - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-05-31 - Lead Sponsor: University of Vienna ### Study Description Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health.The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe.The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift. ### Conditions - Obesity - Shift-work Disorder - Circadian Rhythm Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - high-sensitive C-Reactive Protein (hs-CRP) Secondary Outcomes - The investigators will consider levels of hormones in plasma - The investigators will consider levels of hormones in plasma - The investigators will consider levels of parameters linked to gut health in serum and in feces - The investigators will consider levels of parameters linked to gut health in serum and in feces - The investigators will consider levels of parameters linked to gut health in serum and in feces - The investigators will consider levels of parameters linked to gut health in serum and in feces - The investigators will consider parameters of cellular immunity and inflammation in plasma - The investigators will consider parameters of cellular immunity and inflammation in plasma - The investigators will consider parameters of cellular immunity and inflammation in plasma - The investigators will consider parameters of metabolism of fat and sugar in plasma - The investigators will consider parameters of metabolism of fat and sugar in plasma - The investigators will consider parameters of metabolism of fat and sugar in plasma - The investigators will consider parameters of metabolism of fat and sugar in plasma - The investigators will consider parameters of metabolism of fat and sugar in plasma - The investigators will consider levels of appetite markers in plasma - The investigators will consider levels of appetite markers in plasma - The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine - The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine - The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine - The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine - The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine - The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS) - The investigators will consider microbiome analysis of feces samples and tongue swabs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care - NCT ID: NCT06288555 - Study ID: 020/2566 - Status: COMPLETED - Start Date: 2023-12-21 - Completion Date: 2024-01-23 - Lead Sponsor: Ponlawat Hanchana, MD ### Study Description The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.The main question it aims to answer is:How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?Participants underwent both the Ipswich touch test and the 10-g monofilament test. ### Conditions - Diabetic Foot ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ipswich touch test ### Outcomes Primary Outcomes - The accuracy of the Ipswich touch test Secondary Outcomes ### Location - Facility: Ponlawat Hanchana, MD, Saraburi, N/A, 18120, Thailand @@
## Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting - NCT ID: NCT06288542 - Study ID: MD-250-2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: Cairo University ### Study Description This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures ### Conditions - Effect of Dextrose on Postoperative Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - group d - group R ### Outcomes Primary Outcomes - frequency of post-opertive nausea and vomiting in 24 hour Secondary Outcomes - TOTAL AMOUNT OF ANTIEMETIC REQUIRED ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY - NCT ID: NCT06288529 - Study ID: 1 - Status: COMPLETED - Start Date: 2023-07-15 - Completion Date: 2024-01-31 - Lead Sponsor: University of Health Sciences Balikesir Hospital Eduation and Research ### Study Description Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI. ### Conditions - Chronic Kidney Diseases - Type2diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Development of post-contrast acute kidney injury Secondary Outcomes ### Location - Facility: University of Health Sciences Balikesir Education and Research Hospital, Balıkesir, N/A, 10100, Turkey @@
## BenRalizumab Effect on Airway Remodeling in Severe asTHma - NCT ID: NCT06288516 - Study ID: 7484 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-06-01 - Lead Sponsor: Aristotle University Of Thessaloniki ### Study Description Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients? ### Conditions - Asthma; Eosinophilic - Airway Remodeling ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Benralizumab 30 mg/ml ### Outcomes Primary Outcomes - Change in sub-basement membrane thickness - Change in airway smooth muscle area - Change in airway smooth muscle layer thickness - Change in submucosal eosinophil number - Change in epithelial integrity - Change in collagen thickness Secondary Outcomes - Change of cytokine and protein levels - Change in exacerbation rate - Change in blood eosinophil levels - dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) ### Location - Facility: Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital, Thessaloniki, N/A, 57010, Greece @@
## Hydrolysed Rice Formula Study - NCT ID: NCT06288503 - Study ID: HRF2023 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-07 - Lead Sponsor: Nutricia UK Ltd ### Study Description This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety. ### Conditions - Cow's Milk Protein Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hydrolysed Rice Protein Formula - Cow's Milk Based Extensively Hydrolysed Formula ### Outcomes Primary Outcomes - Growth Secondary Outcomes - Gastrointestinal Tolerance - Stool frequency and consistency - Study Product Intake - Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD) - Patient Reported Atopic Symptoms - Cow's Milk Related Symptom Score - Food Allergy Quality of Life-Parental Burden (FAQL-PB) - Acceptability of the Study Formula - Nutrient Intake (Energy, Protein, Micronutrients) - Dietetic Goal - Overall Safety ### Location - Facility: Gloucestershire Royal NHS Trust, Gloucester, Gloucestershire, GL1 3NN, United Kingdom @@
## A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism - NCT ID: NCT06288490 - Study ID: AMCS-009 - Status: TERMINATED - Start Date: 2013-04 - Completion Date: 2014-06-25 - Lead Sponsor: Amorphical Ltd. ### Study Description Primary objective:Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).Secondary objectives:Phase I* ACC dose selection - to confirm the conversion factor of ACC from CCS* To determine the effect of food on ACC absorptionPhase II* To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism* To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption.Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced.Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis.The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care. ### Conditions - Hypoparathyroidism ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - amorphous calcium carbonate ### Outcomes Primary Outcomes - Calcium (albumin-corrected) serum level - composite value based on multiple measurements Secondary Outcomes - Urine calcium level - 24h urine collection - Phosphorous serum level - composite value based on multiple measurements - Urine calcium level - 24h urine collection - Urine calcium level - 24h urine collection - Assessment of symptoms and signs related with hypocalcemia - composite value based on multiple measurements - Urine creatinine level - 24h urine collection - Urine creatinine level - 24h urine collection - Urine creatinine level - 24h urine collection - Urine phosphorus level - 24h urine collection - Urine phosphorus level - 24h urine collection - Urine phosphorus level - 24h urine collection ### Location - Facility: Rambam Health Care Campus, Haifa, N/A, 31096, Israel @@
## Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol - NCT ID: NCT06288477 - Study ID: 2023-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-02-01 - Lead Sponsor: October University for Modern Sciences and Arts ### Study Description Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth ### Conditions - Vital - Pulpotomy - Techniques ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - A cotton pellet moistened with full-strength FC - Neo-Putty ### Outcomes Primary Outcomes - Clinical success Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Enteral Feeding of Fibre to Improve Microbiota - NCT ID: NCT06288464 - Study ID: 315656 - Status: RECRUITING - Start Date: 2023-01-09 - Completion Date: 2025-12-01 - Lead Sponsor: Lancashire Teaching Hospitals NHS Foundation Trust ### Study Description Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery. ### Conditions - Bowel Dysfunction - Colon Disease - Ileum--Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Soluble Fibre ### Outcomes Primary Outcomes - Concentration of Microbiota - Concentration of Immune Cell Populations Secondary Outcomes - Length of Stay - Rate of clinical complications ### Location - Facility: Lancashire Teaching Hospitals NHS, Preston, Lancashire, PR2 9HT, United Kingdom @@
## DePTH: De-emphasize PTH - NCT ID: NCT06288451 - Study ID: STUDY00018021 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2027-02-28 - Lead Sponsor: University of Washington ### Study Description The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care). ### Conditions - Kidney Failure, Chronic - Chronic Kidney Disease-Mineral and Bone Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oral calcitriol with cinacalcet rescue - IV activated vitamin D ### Outcomes Primary Outcomes - Change in fibroblast growth factor-23 Secondary Outcomes - Change in serum calcium - Change in serum phosphate - Change in serum bone-specific alkaline phosphatase - Change in serum parathyroid hormone - Change in T50 test of serum calcification propensity ### Location - Facility: University of Washington, Seattle, Washington, 98104, United States @@
## Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions - NCT ID: NCT06288438 - Study ID: E5012-R - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-03-31 - Lead Sponsor: VA Office of Research and Development ### Study Description Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions. ### Conditions - Multimorbidity - Physical Deconditioning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Motivational Interviewing Techniques - Physical Therapy Interventions - Education - Health Status Updates - Physical Therapy Consult ### Outcomes Primary Outcomes - 2 Minute Step Test Secondary Outcomes - Arm Curl Test - 30 Second Sit To Stand - Physical Activity - Exercise readiness to change - Self-efficacy for Exercise Scale - Self-efficacy of Managing Chronic Conditions - The Patient-Specific Functional Scale - Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form - Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey - Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a - Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a - Physical Activity and Social Support Scale - Geriatric Pain Measure - Pain Coping Inventory ### Location - Facility: Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, 80045, United States @@
## Spatial Transcriptomics in Kidney Transplantation - NCT ID: NCT06288425 - Study ID: SPACE-KIT - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-03 - Completion Date: 2035-01-01 - Lead Sponsor: Western Sydney Local Health District ### Study Description The study is an investigator-led, prospective, longitudinal, observational cohort study.The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology.By utilising new spatial technologies, the investigators aim to:* Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes* Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney* Develop refinements to histological kidney rejection diagnostic and scoring classification* Correlate of spatial and refined biopsy scoring features to clinically important outcomes ### Conditions - Transplant Complication - Kidney Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non interventional ### Outcomes Primary Outcomes - Kidney biopsy features - Kidney biopsy transcriptomic signature - Kidney cell type composition Secondary Outcomes - All cause graft loss - Death censored graft loss (DCGL) - Treatment resistant rejection - Delayed graft function (DGF) - Biopsy evidence of borderline rejection - Biopsy proven acute rejection - Chronic rejection - Interstitial fibrosis scores (IFTA) - BK virus associated nephropathy - Kidney function - Albuminuria - Surrogate end-points - Donor to recipient mismatches - Proteinomic signature ### Location - Facility: Westmead Hospital, Westmead, New South Wales, 2145, Australia @@
## A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting - NCT ID: NCT06288412 - Study ID: NN1436-7615 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-11-04 - Lead Sponsor: Novo Nordisk A/S ### Study Description The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Insulin icodec - Insulin degludec ### Outcomes Primary Outcomes - Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe) Secondary Outcomes - Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe) - Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe) - Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe) - Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe) - Amount of carbohydrate intake during exercise (CHOexe) - Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe) - Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe) - Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe) - Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref) - Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast) - Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast) - Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast) - Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast) - Number of clinically significant hypoglycaemic episodes during fasting (Hypofast) - Amount of carbohydrate administered intravenously during fasting (CHOfast) - Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast) - Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref) ### Location - Facility: Medical University of Graz, Graz, N/A, 8010, Austria @@
## Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study - NCT ID: NCT06288399 - Study ID: DAS-7688 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-21 - Completion Date: 2024-06-30 - Lead Sponsor: Novo Nordisk A/S ### Study Description The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No treatment given ### Outcomes Primary Outcomes - Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics Secondary Outcomes ### Location - Facility: Farwaniya Hospital, Farwaniya, N/A, 85000, Kuwait @@
## Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing - NCT ID: NCT06288386 - Study ID: 2024-ATTACHMENTS - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-04 - Completion Date: 2025-02 - Lead Sponsor: University of Pavia ### Study Description The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:* group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)* group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)Digital impressions with iTero intraoral scanner will be performed; digital impressions will be performed after 3 months (T1) and 6 months (T2) from the baseline.Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.After attachments placement, the clinicians will be asked to answer, on a scale from 1 to 10, to this questionnaire's questions about the two different flowable composites; each question is repeated for each composite resin.Type of brushing (with manual or electric toothbrush) and hand of brushing will be recorded. ### Conditions - Malocclusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - GrandioSO Heavy Flow - Filtek Z350XT Flowable ### Outcomes Primary Outcomes - Changes in the volume of attachments - Attachments failure rate - Type of brushing - Change in questionnaire's answers - Hand of brushing Secondary Outcomes ### Location - Facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, Pavia, Lombardy, 27100, Italy @@
## Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC - NCT ID: NCT06288373 - Study ID: NACI-CERV-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2031-03-01 - Lead Sponsor: Tongji Hospital ### Study Description It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group. ### Conditions - Cervical Cancer - Locally Advanced Cervical Cancer - Concurrent Chemoradiotherapy - Neoadjuvant Chemoimmunotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Camrelizumab - Cisplatin - Nab paclitaxel - Radical surgery - external beam radiation therapy (EBRT) + brachytherapy - Cisplatin ### Outcomes Primary Outcomes - Progression-free survival, PFS - Objective Response Rate, ORR Secondary Outcomes - Overall survival, OS - Proportion of patients undergoing radical surgery - Pathologic Complete Response - The surgical complication rate - Safety and toleraty - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score - Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Neoadjuvant Immunochemotherapy in PD-L1-negative LACC - NCT ID: NCT06288360 - Study ID: NACI-CERV-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-12-12 - Lead Sponsor: Tongji Hospital ### Study Description This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer. ### Conditions - Cervical Cancer - Locally Advanced Cervical Cancer - PD-L1 Negative - Neoadjuvant Chemoimmunotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Camrelizumab - Paclitaxel-albumin - Cisplatin - radical surgery ### Outcomes Primary Outcomes - Pathologic complete response Secondary Outcomes - Surgical Complications - Objective response rate - Positive surgical margin rate - event-free survival - overall survival - adverse event ### Location - Facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China @@
## Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa. - NCT ID: NCT06288347 - Study ID: 216099 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-06-17 - Lead Sponsor: University of Valencia ### Study Description The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group. ### Conditions - Orthorexia Nervosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - GGON mobile app. ### Outcomes Primary Outcomes - Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa Secondary Outcomes - Change in Orthorexia symptomatology - Change in eating symptomatology - Change in self-esteem. - Change in emotional symptomatology - Change in obsessive beliefs ### Location - Facility: University of Valencia, Valencia, N/A, 46010, Spain @@
## Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children - NCT ID: NCT06288334 - Study ID: PUTH PD_V 1.2 - Status: RECRUITING - Start Date: 2020-08-06 - Completion Date: 2024-05-31 - Lead Sponsor: Peking University Third Hospital ### Study Description To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease. ### Conditions - Allergic Disease - Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - 1-3 Cetirizine Pharmacokinetic samples ### Outcomes Primary Outcomes - Plasma concentration Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity. - NCT ID: NCT06288321 - Study ID: UW22221 - Status: COMPLETED - Start Date: 2022-08-10 - Completion Date: 2023-03-22 - Lead Sponsor: The University of Hong Kong ### Study Description A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops. ### Conditions - Retinopathy of Prematurity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Microdrop Mydrin-P - Standard Mydrin-P ### Outcomes Primary Outcomes - Successfulness of a ROP exam Secondary Outcomes - Pupil diameters - Heart rate - Blood pressure - Oxygen saturation - Oxygen requirement - Episodes of vomiting - Volume of gastric residuals - Episodes of apnoea - Episodes of periorbital blanching ### Location - Facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN) - NCT ID: NCT06288308 - Study ID: FAR in lupus nephritis (LN) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12 - Lead Sponsor: Assiut University ### Study Description Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) ### Conditions - Lupus Nephritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - fibronigin to albumin ratio ### Outcomes Primary Outcomes - Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrospective Study on Data Aiming to Establish a Prediction Score for Return Home at the Time of Admission to a Multidisciplinary Medical Department (SCORDOM - NCT ID: NCT06288295 - Study ID: Etude SCORDOM - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-02-28 - Lead Sponsor: Elsan ### Study Description The goal of this observational study is to define clinical, biological and socio-cultural criteria, from the very first days of hospitalization on the multidisciplinary medicine department, to guide the patient's discharge from hospital (return to home when discharged from hospital).The data collected will be those contained in the medical records of patients over 60 years of age who were admitted to the multidisciplinary medical department between October 2021 and February 2022 and between October 2022 and February 2023.This study also aims at developing and validating a predictive score of orientation at the end of hospitalisation.Participants are patients previously hospitalized. They will be informed about the study by post and will be able to object to the use of his or her data. ### Conditions - Continuity of Patient Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters Secondary Outcomes - Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters ### Location - Facility: Hôpital Privé Nancy Lorraine, Nancy, N/A, 54000, France @@
## Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain - NCT ID: NCT06288282 - Study ID: STUDY-23-01287 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2024-12-20 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants. ### Conditions - Chronic Back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Screener and Opioid Assessment for patients with pain revised (SOAPPR) - Current Opioid misuse measure (COMM) surveys Secondary Outcomes - Pain Intensity with Brief Pain inventory (BPI) ### Location - Facility: Mount Sinai Pain management centers, New York, New York, 10029, United States @@
## Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat - NCT ID: NCT06288269 - Study ID: PhrapokklaoHospital - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-01-15 - Lead Sponsor: Phrapokklao Hospital,Thailand ### Study Description The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled. ### Conditions - Stroke - Hypertension - Type2diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Severity of Stroke and 1 year survival ### Outcomes Primary Outcomes - Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42) - 1 year survival death Secondary Outcomes ### Location - Facility: Trat Provincial Public Health Office, Trat, N/A, 23000, Thailand @@
## Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery - NCT ID: NCT06288256 - Study ID: STUDY-22-01390 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2024-06 - Lead Sponsor: Icahn School of Medicine at Mount Sinai ### Study Description Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts. ### Conditions - Lumbar Spine Pathology - Elective Spine Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Current Opioid Misuse Measure (COMM) Score Secondary Outcomes - Numerical Rating Scale (NRS) Score ### Location - Facility: Mount Sinai Spine Center, New York, New York, 10029, United States @@
## Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE - NCT ID: NCT06288243 - Study ID: Samatya - Status: COMPLETED - Start Date: 2018-12-01 - Completion Date: 2019-05-29 - Lead Sponsor: Medipol University ### Study Description Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality.Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively. ### Conditions - Stroke, Acute - Swallowing Disorder - Cognitive Impairment - Stroke - Movement Disorders - Dysphagia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinician-observed assessment tests ### Outcomes Primary Outcomes - The Correlation Between Swallowing Skills and Cognitive Status - The Correlation Between Swallowing Skills and Functionality Secondary Outcomes - The relationship between stroke risk factors and swallowing skills - The relationship between demographic informations and swallowing skills ### Location - Facility: Medipol University, Istanbul, N/A, N/A, Turkey @@
## An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients - NCT ID: NCT06288230 - Study ID: LT01-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Lantu Biopharma ### Study Description This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients. ### Conditions - Spinal Muscular Atrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - vesemnogene lantuparvovec ### Outcomes Primary Outcomes - Numbers of participants with adverse events (AEs), serious adverse events (SAEs) Secondary Outcomes - Change from baseline in hours of daily ventilation support and motor function - Change from baseline in ambulatory function - Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits - NCT ID: NCT06288217 - Study ID: NS-CIP-001 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-12 - Lead Sponsor: NeuraStasis, Inc ### Study Description This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study. ### Conditions - Stroke, Ischemic - Upper Extremity Paresis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) - Upper Limb Rehabilitation - Sham Stimulation ### Outcomes Primary Outcomes - Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change Secondary Outcomes - Action Research Arm Test (ARAT) Average Change - Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response % - Proportion of subjects completing all pre-specified treatment doses - Subject Questionnaire on Device Usage - Therapist Questionnaire on Device Usage - Serious adverse device effects (SADE) rate at 24 hours post-therapy session - Stroke impact scale (SIS) Summative Score Average Change - Analysis of the number of stimulations per therapy session ### Location - Facility: The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States @@
## Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease - NCT ID: NCT06288204 - Study ID: Denise Mafra16 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-07-31 - Lead Sponsor: Universidade Federal Fluminense ### Study Description This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months. ### Conditions - Chronic Kidney Diseases - Hypertension - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Propolis + Royal Jelly - Royal Jelly - Placebo ### Outcomes Primary Outcomes - Change in inflammation, oxidative stress - Change in intestinal microbiota Secondary Outcomes - Change in senescence biomarkers - Change in uremic toxins ### Location - Facility: Denise Mafra, Rio de Janeiro, RJ, 22260050, Brazil @@
## Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma - NCT ID: NCT06288191 - Study ID: MIA2023/490 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2036-04 - Lead Sponsor: Melanoma Institute Australia ### Study Description The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival. ### Conditions - Cutaneous Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination ### Outcomes Primary Outcomes - Pathological complete response rate Secondary Outcomes - Pathological near pathological response (near pCR), partial response (pPR) and pathological non-response (pNR) rate - Toxicity and tolerability of neoadjuvant immunotherapy and surgery - Objective response rate to neoadjuvant therapy - Metabolic response rate to neoadjuvant immunotherapy - Recurrence-free survival - Disease progression rate - Event-free survival rate - Overall survival - Patient reported quality of life (QLQ-C30) - Patient reported quality of life (EQ-5L-5D) - Study treatment completion rate and the causes of any missed treatments - De-escalation of adjuvant radiotherapy. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations - NCT ID: NCT06288178 - Study ID: 2022/18 - Status: COMPLETED - Start Date: 2022-12-19 - Completion Date: 2023-02-20 - Lead Sponsor: Ege University ### Study Description The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels. ### Conditions - Obesity - Glycemic Index - Blood Glucose - Bread ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Bread consumption ### Outcomes Primary Outcomes - One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption. Secondary Outcomes - This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week. ### Location - Facility: Avrasya University, Trabzon, N/A, 61000, Turkey @@
## Lower Silesia Sinus Reducer Registry - NCT ID: NCT06288165 - Study ID: CopperHealthCentre2 - Status: RECRUITING - Start Date: 2022-05-11 - Completion Date: 2027-05-11 - Lead Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ), ### Study Description Lower Silesia Sinus Reducer Registry is a , single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation . ### Conditions - Safety Issues - Efficacy, Self ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Coronary Sinus Reducer Implantation ### Outcomes Primary Outcomes - The Clinical success - reduction of angina symptoms Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events - Change in potential aerobic capacity and endurance - The six minute walking test (6MWT) - Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire. ### Location - Facility: Department of Cardiology, The Copper Health Centre (MCZ), Lubin, Lower Silesia, 59-300, Poland @@
## Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation - NCT ID: NCT06288152 - Study ID: STS-Transplant - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Alp Sener ### Study Description End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function. ### Conditions - Renal Transplant - Kidney Transplant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Sodium Thiosulfate ### Outcomes Primary Outcomes - Effects of STS will be measured by: Delayed graft function Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Management of Open Fracture Tibia in Teenagers - NCT ID: NCT06288139 - Study ID: open fracture tibia - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes ### Conditions - Open tíbia Fracture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number Secondary Outcomes - To evaluate treatment outcomes - Soft tissue healing - Complication ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Maternal and Fetal Metabolic Changes - NCT ID: NCT06288126 - Study ID: MoMM-FET - Status: COMPLETED - Start Date: 2019-08-01 - Completion Date: 2021-01-18 - Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana ### Study Description The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.Primary objectives:* measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM* ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.* Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.Secondary objectives:* Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.* Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).The participants will be recruited during first trimester ultrasound after signing the informed consent. ### Conditions - Pregnancy Related - Maternal-Fetal Relations - Metabolism Disorder, Glucose ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Blood adipokine levels - Abdominal Fat Thickness - Fetal Adipose Tissue Deposits Secondary Outcomes - Gestational diabetes prevalence - Obstetric complications and mode of delivery ### Location - Facility: Azienda Ospedaliera Universitaria Pisana, Pisa, N/A, 56126, Italy @@
## Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial - NCT ID: NCT06288113 - Study ID: 23-001509 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-01-27 - Lead Sponsor: Jonsson Comprehensive Cancer Center ### Study Description This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer. ### Conditions - Castration-Resistant Prostate Carcinoma - Stage IVB Prostate Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Computed Tomography - Gallium Ga 68 Gozetotide - Lutetium Lu 177 Vipivotide Tetraxetan - Positron Emission Tomography - Questionnaire Administration - Single Photon Emission Computed Tomography ### Outcomes Primary Outcomes - 12-month overall survival Secondary Outcomes - Incidence of adverse events (AEs) - Rate of prostate specific antigen (PSA) response - Biochemical progression-free survival (PFS) - Overall Survival from start of first regimen - Overall survival from the end of the first regimen - Radiographic progression-free survival (rPFS) - Bone Pain - Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT). - Changes in health-related quality of life_Brief Pain Inventory Short form - Changes in health-related quality of life_ Eastern Cooperative Oncology Group score ### Location - Facility: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States @@
## The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient - NCT ID: NCT06288100 - Study ID: OWHTOPTS - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Al-Azhar University ### Study Description High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle , and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy . ### Conditions - Genu Varum ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observation ### Outcomes Primary Outcomes - The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient Secondary Outcomes ### Location - Facility: Mohamed Abdelfattah Abbas, Assiut, N/A, N/A, Egypt @@
## Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse - NCT ID: NCT06288087 - Study ID: 2023-20/672 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-04-11 - Lead Sponsor: Acibadem University ### Study Description The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment. ### Conditions - Advanced Cardiac Life Support - Virtual Reality - Serious Game ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - VR Based Training with Machine Guidance (MG Group) - VR Based Training with Educator Guidance in Metaverse (EG Group) ### Outcomes Primary Outcomes - Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study Secondary Outcomes ### Location - Facility: Acibadem University CASE (Center of Advanced Simulation and Education), Istanbul, Non-US/Canada, 34752, Turkey @@
## Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration - NCT ID: NCT06288074 - Study ID: SF-2022-1-1061 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-12-31 - Lead Sponsor: Capital Medical University ### Study Description Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia. ### Conditions - Severe Community-acquired Pneumonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Multi-omics tests ### Outcomes Primary Outcomes - Hospital mortality Secondary Outcomes - Cause of death - Length of stay - Length of ICU stay - Expense during hospitalization ### Location - Facility: Beijing Institute of Respiratory Medicine, Beijing, Beijing, 100027, China @@
## Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain. - NCT ID: NCT06288061 - Study ID: Phrenic Nerve Neuromodulation - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-07-04 - Lead Sponsor: University of Seville ### Study Description Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.Hypothesis:Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility. ### Conditions - Inflammatory Bowel Diseases - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-invasive Neuromodulation - Cervico-dorsal Massage ### Outcomes Primary Outcomes - The Visual Analogue Scale (VAS) - Cervical mobility - The Neck Disability Index (NDI) - The Pressure Pain Threshold (PPT) Secondary Outcomes - The Inflammatory Bowel Disease Questionnaire (IBDQ-32) - The World Health Organization Quality of Life (WHOQOL-BREF) - The Central Sensitization Inventory (CSI) ### Location - Facility: Hospital Universitario Puerto Real, Puerto Real, Cádiz, 11510, Spain @@
## Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain - NCT ID: NCT06288048 - Study ID: 23/107-EC X TFM 07/03/2023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-06-30 - Lead Sponsor: Universidad Europea de Canarias ### Study Description The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are:* Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity?* Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold?* Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght?Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength.Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy.Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold. ### Conditions - Lateral Elbow Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT - Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching ### Outcomes Primary Outcomes - Pain Intensity - Pain pressure threshold - Two-point discrimination threshold - Maximum hand grip strength Secondary Outcomes ### Location - Facility: Universidad Europea de Canarias, La Orotava, Santa Cruz De Tenerife, 38300, Spain @@
## Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy - NCT ID: NCT06288035 - Study ID: R.21.02.1191 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2025-03 - Lead Sponsor: Mansoura University ### Study Description Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy. ### Conditions - Postoperative Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dexamethasone Oral - Dexamethasone ### Outcomes Primary Outcomes - Postoperative nausea or vomiting (PONV) Secondary Outcomes - Rescue antiemetic - Early PONV - Late PONV - Visual Analogue Scale (VAS) at the time of discharge from PACU - VAS at the time of discharge from hospital - Postoperative fatigue - Postoperative quality of recovery - Post-Discharge Nausea and Vomiting (PDNV) ### Location - Facility: Mansoura University Faculty of Medicine, Mansoura, Aldakahlia, 35516, Egypt @@
## Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL - NCT ID: NCT06288022 - Study ID: COA. MURA2023/947 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: Mahidol University ### Study Description Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL. ### Conditions - Surgery-Complications - Nephrolithiasis Staghorn Calculus - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - total tubeless mini-PCNL - tubeless mini-PCNL ### Outcomes Primary Outcomes - incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL Secondary Outcomes - The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL ### Location - Facility: Ramathibodi Hospital, Mahidol University, Bangkok, Ratchathewi, 10400, Thailand @@
## Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds - NCT ID: NCT06288009 - Study ID: 2135389 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-01 - Lead Sponsor: University of California, Davis ### Study Description When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring. ### Conditions - Scarring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Running locking suture - Standard running suture ### Outcomes Primary Outcomes - Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) Secondary Outcomes - Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) - Width of Scar as measured using Trace-to-Tape Method - Complications or Adverse Events from Treatment ### Location - Facility: University of California, Davis - Dermatology Department, Sacramento, California, 95816, United States @@
## Effects of Warm Water Footbath Intervention on Sleep Quality , Fatigue and Heart Rate Variability in Patients With Heart Failure - NCT ID: NCT06287996 - Study ID: 23MMHIS503e NA - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-23 - Completion Date: 2024-08-01 - Lead Sponsor: Mackay Memorial Hospital ### Study Description This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index. ### Conditions - Footbath - Heart Failure - Sleep Quality - Fatigue - Heart Rate Variability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - footbath and actigraphy - actigraphy ### Outcomes Primary Outcomes - sleep quality Secondary Outcomes - fatigue ### Location - Facility: Mackay Memorial Hospital, Taipei, Zhongshan, 104, Taiwan @@
## Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity - NCT ID: NCT06287983 - Study ID: KayseriCHIMT001 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-05-15 - Lead Sponsor: Kayseri City Hospital ### Study Description In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life. ### Conditions - Ankylosing Spondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic) - The Sample Spondylitis Exercise Program ### Outcomes Primary Outcomes - Respiratory function test (Spirometry) Secondary Outcomes - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): - Bath Ankylosing Spondylitis Functional Index (BASFI) - Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) - Modified Borg Scale - Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS) - 6-minute walk test (6MWT) - Chest expansion measurement ### Location - Facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, Kayseri, N/A, 38080, Turkey @@
## TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS - NCT ID: NCT06287970 - Study ID: 2023-250-KY - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-02-18 - Lead Sponsor: Jiani Wu ### Study Description This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly. ### Conditions - Chronic Prostatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Auricular Vagus Nerve Stimulation - Sham Transcutaneous Auricular Vagus Nerve Stimulation ### Outcomes Primary Outcomes - Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4 Secondary Outcomes - Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12 - The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12 - Proportion of responders at week 4, 8 and 12 - The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12 - The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12 - The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12 - The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12 ### Location - Facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences, Beijing, Beijing, 100053, China @@
## Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical - NCT ID: NCT06287957 - Study ID: IU-DHF-AG-01 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-15 - Lead Sponsor: Istanbul University ### Study Description Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept. ### Conditions - Peri-implant Mucositis - Peri-Implantitis - Bleeding on Probing - Periodontal Pocket ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Labrida BioClean - EMS Handy 3.0 Perio Premium ### Outcomes Primary Outcomes - Probing Depth Secondary Outcomes - Bleeding on Probing ### Location - Facility: Istanbul University, Istanbul, Fatih, 34080, Turkey @@
## 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome - NCT ID: NCT06287944 - Study ID: 23694 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-18 - Completion Date: 2027-02-24 - Lead Sponsor: City of Hope Medical Center ### Study Description This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS. ### Conditions - Acute Lymphoblastic Leukemia - Acute Myeloid Leukemia - Myelodysplastic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Actinium Ac 225-DOTA-Daratumumab - Biospecimen Collection - Bone Marrow Aspiration - Bone Marrow Biopsy - Computed Tomography - Daratumumab - Echocardiography - Fludarabine - Hematopoietic Cell Transplantation - Indium In 111-DOTA-Daratumumab - Melphalan - Multigated Acquisition Scan - Radionuclide Imaging - Single Photon Emission Computed Tomography - Sirolimus - Tacrolimus - Total Marrow and Lymphoid Irradiation ### Outcomes Primary Outcomes - Incidence of adverse events (CTCAE) - Incidence of adverse events (Bearman) - Dose limiting toxicity (DLT) - Maximum tolerated dose/recommended phase II dose (MTD/RP2D) Secondary Outcomes - Overall survival (OS) - Event-free survival (EFS) - Cumulative incidence of relapse/progression (CIR) - Graft versus host disease and relapse free survival (GRFS) - Complete remission (CR) proportion - Non-relapse mortality (NRM) - Incidence of infection - Neutrophil recovery rate - Incidence of grade 2-4 and 3-4 acute graft-versus-host disease (GVHD) - Incidence of chronic GVHD (cGVHD) ### Location - Facility: City of Hope Medical Center, Duarte, California, 91010, United States @@
## Probiotics for Gallstones in Post-bariatric Surgery Patients - NCT ID: NCT06287931 - Study ID: sdllycyy001 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: Shandong Linglong Yingcheng Hospital ### Study Description Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery. ### Conditions - Bariatric Surgery Candidate - Gallstone - Gallstone Attack - Gastrointestinal Quality of Life Index - Probiotics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ursodoxycholic acid group - Bifidobacterium group ### Outcomes Primary Outcomes - The incidence of gallstones in bariatric surgery patients Secondary Outcomes ### Location - Facility: Shandong Linglong Yingcheng Hospital, Yantai, Shandong, 264000, China @@
## A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations - NCT ID: NCT06287918 - Study ID: 3HP-2827-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd. ### Study Description The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II). ### Conditions - Solid Tumors With FGFR2 Alterations, Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 3HP-2827 ### Outcomes Primary Outcomes - Dose Escalation Stage- incidence of adverse events (AEs) - Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results - Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters - Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 - Expansion stage -Objective response rate（ORR） Secondary Outcomes - Plasma Concentration of 3HP-2827 and/or its major metabolites - Duration of Response (DOR) as assessed by RECIST v1.1 - Progression-free survival (PFS) as assessed by RECIST v1.1 - Overall survival - Dose escalation stage - Objective Response Rate (ORR) - Expansion Stage- incidence of adverse events (AEs) - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results - Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters ### Location - Facility: Mayo Clinic, Phoenix, Arizona, 85054, United States @@
## A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin - NCT ID: NCT06287905 - Study ID: Soh-Med-23-02-24 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2024-07-01 - Lead Sponsor: Sohag University ### Study Description Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment ### Conditions - Morality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Prazosin Oral Tablet ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - Morbidity ### Location - Facility: Meray Medhat Shokry Zaghary, Sohag, N/A, 82515, Egypt @@
## Diagnosis of HCM With AI-ECG - NCT ID: NCT06287892 - Study ID: AI-ECG-HCM - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram. ### Conditions - Hypertrophic Cardiomyopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnosis of HCM with AI-ECG Secondary Outcomes ### Location - Facility: 180 Fenglin Road, Shanghai, N/A, 200032, China @@
## Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia - NCT ID: NCT06287879 - Study ID: 20231121 - Status: RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-12-30 - Lead Sponsor: Zhongnan Hospital ### Study Description Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia ### Conditions - Dry Eye - MGD-Meibomian Gland Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Dry eye examination ### Outcomes Primary Outcomes - Lacrimal river height - tear break-up time - tear-film lipid layer thickness - meibomian glands two-dimensional digital infrared images Secondary Outcomes ### Location - Facility: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China @@
## Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp - NCT ID: NCT06287866 - Study ID: 2099470 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-01 - Lead Sponsor: University of California, Davis ### Study Description Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. We are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, we numb and then shave off a thin piece of skin (usually from the groin area) and place it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method. ### Conditions - Scarring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pinch Graft ### Outcomes Primary Outcomes - Time to re-epithelialization Secondary Outcomes - Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) - Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS) ### Location - Facility: University of California, Davis - Dermatology Department, Sacramento, California, 95816, United States @@
## Tapestry Rotator Cuff Repair PMCF - NCT ID: NCT06287853 - Study ID: EMBODY-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2029-06-30 - Lead Sponsor: Zimmer Biomet ### Study Description The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor. ### Conditions - Rotator Cuff Tears - Rotator Cuff Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tapestry Biointegrative Implant ### Outcomes Primary Outcomes - Re-tear rate after arthroscopic rotator cuff repair Secondary Outcomes - The American Shoulder and Elbow Surgeons (ASES) Score - Constant-Murley Score (CMS) - The Single Assessment Numeric Evaluation (SANE) Score - EQ-5D-5L (EuroQol) - Return to Work/Activity - Patient Satisfaction - Adverse Event - MRI Sugaya Classification - MRI Goutallier Classification ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Canadian Bone Strength Development Study - NCT ID: NCT06287840 - Study ID: 17-301 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: University of Saskatchewan ### Study Description The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are:1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years. ### Conditions - Type-1 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Trabecular Thickness (μm) - Bone Strength (Failure load) Secondary Outcomes - Total, Cortical and Trabecular Bone Area (mm^2) - Total, Cortical and Trabecular Bone Density (mg HA/cm^3) - Cortical Thickness (μm) - Cortical Porosity - Trabecular Bone Volume Fraction (%) - Trabecular Bone Number (1/mm) - Trabecular Bone Separation (μm) - Total Body and Hip Bone Mineral Content (g) - Total Body and Hip Areal Bone Mineral Density (g/cm^2) - Age from Peak Height Velocity (years) - Pubertal Development - Long Jump (m) - Hand Grip (N) - Bone Impacts - Physical Activity (minutes/day) - Food Frequency Questionnaire - Health - Osteocalcin - Procollagen type I N-propeptide (P1NP-N) - C-terminal telopepide (CTx) - Sclerostin - Insulin growth factor-1 - Alkaline phosphatase ### Location - Facility: University of Saskatchewan, Saskatoon, Saskatchewan, S7N5B2, Canada @@
## Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research - NCT ID: NCT06287827 - Study ID: 190224 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-06-01 - Lead Sponsor: UNICEF - Venezuela ### Study Description The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela.The main question it aims to answer is:What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ \<-2 or mid-upper-arm circumference (MUAC) \<125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery.Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context.The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered. ### Conditions - Acute Malnutrition in Childhood - Wasting - Child Malnutrition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Simplified protocol - Standard protocol ### Outcomes Primary Outcomes - Recovery rate - Weight gain - Mid-Upper Arm Circumference (MUAC) gain - Duration of the treatment - Prevalence of child morbidity - Number of RUTF delivered per child - Cost per child Secondary Outcomes - Prevalence of child stunting ### Location - Facility: Bolivar State Centers, Puerto Ordaz, Bolivar, 8050, Venezuela @@
## French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC) - NCT ID: NCT06287814 - Study ID: RECHMPL23_0299 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-10-31 - Lead Sponsor: University Hospital, Montpellier ### Study Description Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project. ### Conditions - Colorectal Cancer - Stage III Colon Cancer - Minimal Residual Disease - Liquid Biopsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample/lliquid biopsy ### Outcomes Primary Outcomes - 3-year disease-free survival (DFS) Secondary Outcomes - Sensitivity (Se) of the ctDNA diagnostics - Specificity (Sp) of the ctDNA diagnostics - Positive predictive value of the ctDNA diagnostics - Negative predictive value of the ctDNA diagnostics - Area under the curve of the ctDNA diagnostics - Time to clinical recurrence - Overall survival - Time to molecular recurrence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1 - NCT ID: NCT06287801 - Study ID: 2024P000271 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention. ### Conditions - Healthy Aging - Health Care Utilization - Health-Related Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Annual Wellness Visit - Geriatric Resources and Assessment for the Care of Elders ### Outcomes Primary Outcomes - Hospitalizations - Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS) - Net Promotor Score Secondary Outcomes - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH) - Caregiver Strain - Patient's out-of-pocket costs for up to 180 days after enrollment - Caregiver's hours spent caregiving. - Pilot ACOs Staffing costs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis - NCT ID: NCT06287788 - Study ID: NFEC-2024-068 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC. ### Conditions - Radiation-induced Oropharyngeal Mucositis - Swallowing-induced Breakthrough Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The AUC of the predictive model Secondary Outcomes - The accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model - The important predictors of severe oropharyngeal mucositis in the predictive model ### Location - Facility: Southern Medical University, Guangzhou, Guangdong, 510515, China @@
## Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer - NCT ID: NCT06287775 - Study ID: NCI-2024-01398 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-24 - Completion Date: 2026-01-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer. ### Conditions - Extensive Stage Lung Small Cell Carcinoma - Stage IV Lung Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Atezolizumab - Biopsy - Biospecimen Collection - Computed Tomography - Durvalumab - Echocardiography - Iadademstat - Magnetic Resonance Imaging - Multigated Acquisition Scan ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes - Objective response rate - Overall survival - Incidence of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Natural History Study of RYR1-Related Disorders - NCT ID: NCT06287762 - Study ID: 10001737 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-12-30 - Lead Sponsor: National Institute of Nursing Research (NINR) ### Study Description Background:Congenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults.Objective:To learn more about the signs, symptoms, and course of RYR1-related disorders.Eligibility:People aged 7 years and older with an RYR1-related disorder.Design:Ambulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth.Visits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days.All participants will undergo tests including:Photos and videos. These will be taken to document the participant s condition.Blood and urine tests.Activity Tracker. Participants will wear a device to record their activity.Questionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics.Participants who visit the Clinical Center will also undergo:Tests of heart and lung function.Motor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip.Imaging scans.Skin biopsy. Adult participants may opt to have a sample of skin taken (one time only).Eye exam ### Conditions - Ryanodine Receptor 1-Related Myopathy - Ryanodine Receptor 1 Related Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Adverse and disease-related events - Medical data review - Ophthalmology - Patient-reported outcomes - Pulmonary function - Motor function and performance Secondary Outcomes - Characterize phenotype and disease course over an extended (2-year) period (total 5 years).Collect exploratory biomarker data. ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## French Assessment of MRD by Liquid Biopsies in PDAC Patients (FRENCH.MRD.PDAC) - NCT ID: NCT06287749 - Study ID: RECHMPL23_0298 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-10-31 - Lead Sponsor: University Hospital, Montpellier ### Study Description The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after1. curative-intended surgery and2. adjuvant chemotherapy.FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project ### Conditions - Pancreatic Cancer Resectable - Pancreatic Ductal Adenocarcinoma - Minimal Residual Disease - Liquid Biopsy - ctDNA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample/Liquid Biopsy ### Outcomes Primary Outcomes - 3-year Disease-free survival (DFS) Secondary Outcomes - Sensitivity (Se) of the ctDNA diagnostics - Specificity (Sp) of the ctDNA diagnostics - Positive predictive value of the ctDNA diagnostics - Negative predictive value of the ctDNA diagnostics - Are Under the Curve of the ctDNA diagnostics - Time to clinical recurrence - Overall survival - Time to molecular recurrence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy - NCT ID: NCT06287736 - Study ID: 2023H0386 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Ohio State University ### Study Description This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers. ### Conditions - Diabetic Peripheral Neuropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Spinal Cord Stimulator Implantation (SCS) ### Outcomes Primary Outcomes - Change in Pain level - Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) - Change in PROMIS quality of life in relation to pain level Secondary Outcomes - change in neuropathic symptoms using Michigan Neuropathy Screening instrument ### Location - Facility: The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States @@
## French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM) - NCT ID: NCT06287723 - Study ID: RECHMPL23_0297 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-10-31 - Lead Sponsor: University Hospital, Montpellier ### Study Description Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.FRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project. ### Conditions - Colorectal Cancer - Liver Metastases - Stage IV Colorectal Cancer - Minimal Residual Disease - Liquid Biopsy - ctDNA ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample/Liquid biopsy ### Outcomes Primary Outcomes - 3-year disease free survival Secondary Outcomes - Sensitivity (Se) of the ctDNA diagnostics - Specificity (Sp) of the ctDNA diagnostics - Positive predictive value of the ctDNA diagnostics - Negative predictive value of the ctDNA diagnostics - Area under the curve of the ctDNA diagnostics - Time to clinical recurrence - Overall survival - Time to molecular recurrence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA - NCT ID: NCT06287710 - Study ID: CHUBX 2023/32 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2025-04-17 - Lead Sponsor: University Hospital, Bordeaux ### Study Description In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion). ### Conditions - Premature Baby 26 to 32 Weeks - Premature Baby 33 to 36 Weeks ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). ### Outcomes Primary Outcomes - Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, Secondary Outcomes - Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness ### Location - Facility: Bordeaux Hospital University, Bordeaux, N/A, 33076, France @@
## Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia - NCT ID: NCT06287697 - Study ID: LOA/RAP/2019/20 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-01-21 - Completion Date: 2024-11-30 - Lead Sponsor: Mahidol University ### Study Description This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design. ### Conditions - Energy Expenditure - Body Composition - Infants and Young Children - Infant and Young Child Feeding ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Total Energy Expenditure - Body composition Secondary Outcomes - Weight - Length - Head circumference - Mid-upper arm circumference - Triceps skinfold thickness - Subscapular skinfold thickness - Infant and Young Child Feeding (IYCF) - Dietary intake ### Location - Facility: Institute of Nutrition, Mahidol University, Salaya, Nakhon Pathom, 73170, Thailand @@
## Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis - NCT ID: NCT06287684 - Study ID: ESICM-22 - Status: RECRUITING - Start Date: 2023-09-13 - Completion Date: 2025-12-30 - Lead Sponsor: Mater Dei Hospital, Malta ### Study Description Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection. ### Conditions - Sepsis - Septic Shock - Pneumonia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood transcriptomics and BAL protein profiling ### Outcomes Primary Outcomes - Patient stratification as transcriptomic endotypes - Lung endothelial barrier integrity Secondary Outcomes - Survival ### Location - Facility: Mater Dei hospital, Intensive Care Unit, Imsida, N/A, MSD2080, Malta @@
## Colorectal Omics and ofCS Proteoglycans - NCT ID: NCT06287671 - Study ID: COCO - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2032-12 - Lead Sponsor: Claus Anders Bertelsen, PhD, MD ### Study Description This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.The main questions to answer are:* can these biomarkers predict anastomotic leakages* can these biomarkers predict recurrence after colorectal cancer* can these biomarkers be used as diagnostic tests for colorectal cancer* can these biomarkers be identified in the tumorParticipants will undergo elective colorectal resection or stoma closure. ### Conditions - Colorectal Cancer - Diverticulitis, Colonic - Inflammatory Bowel Diseases - Stoma Colostomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Colorectal resection or stoma closure ### Outcomes Primary Outcomes - Rate of anastomotic leakage diagnosed by CT-scan or reoperation - Rate of major postoperative complications - Short-term mortality - Recurrence after colorectal cancer - Diagnostic value of omics and other biomarkers detecting colorectal cancer - Correlation between biomarker in plasma and tissue Secondary Outcomes ### Location - Facility: Nordsjaellands Hospital, Hillerød, N/A, 3400, Denmark @@
## The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence - NCT ID: NCT06287658 - Study ID: E-57428665-050.04-240046 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Ondokuz Mayıs University ### Study Description This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement. ### Conditions - Urinary Incontinence - Menopause - Wolman Disease - Quality of Life - Psychological Well-Being ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Training on Kegel exercise and Ba Duan Jin applications online - training on Kegel exercises and Ba Duan Jin applications after the research is completed ### Outcomes Primary Outcomes - Psychological Well-Being Scale - Incontinence Quality of Life Scale Secondary Outcomes ### Location - Facility: Tuba Yilmaz Bulut, Kocaeli, N/A, N/A, Turkey @@
## Color Fundus Photograph With Experts Labelling - NCT ID: NCT06287645 - Study ID: Retinal Images Dataset - Status: RECRUITING - Start Date: 2022-05-12 - Completion Date: 2026-06-30 - Lead Sponsor: Pakistan Council of Scientific and Industrial Research ### Study Description This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care. ### Conditions - Retinal Disease - Diabetic Retinopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Color Fundus Photography/Non-Mydriatic Opthalmic Cameras ### Outcomes Primary Outcomes - Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale - Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale - Finding inter-rater agreement among the graders Secondary Outcomes ### Location - Facility: Al Ibrahim Eye Hospital, Karachi, N/A, N/A, Pakistan @@
## CPAP in Patients With Severe Obesity After Anesthesia - NCT ID: NCT06287632 - Study ID: 2024P000451 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure* Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present). ### Conditions - Obesity, Abdominal - Anesthesia Morbidity - Apnea, Obstructive Sleep - Atelectases, Postoperative Pulmonary - Ventilator Lung ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Recruitment/ITP-CPAP (Intervention A) - Standard CPAP (Intervention B) - Atmospheric Pressure ### Outcomes Primary Outcomes - End expiratory lung impedance Secondary Outcomes - Regional lung ventilation - Right ventricular function - Mean pulmonary artery pressure - Inspiratory effort - Abdominal muscle thickness - Respiratory rate - Oxygen saturation - Systemic blood pressure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery - NCT ID: NCT06287619 - Study ID: 22-5685 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: University Health Network, Toronto ### Study Description POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo. ### Conditions - Chronic Iron Deficiency Anaemia - Cardiac Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Monoferric Injectable Product - 0.9% sodium chloride solution ### Outcomes Primary Outcomes - Feasibility Outcome 1: Percentage of major protocol deviations - Feasibility Outcome 2: Adequate patient enrollment - Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days Secondary Outcomes ### Location - Facility: Kingston Health Sciences Centre, Kingston, Ontario, K7L 3N6, Canada @@
## A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy - NCT ID: NCT06287606 - Study ID: CTP0302 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-08-29 - Completion Date: 2024-05-14 - Lead Sponsor: Taejoon Pharmaceutical Co., Ltd. ### Study Description A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy ### Conditions - Bowel Preparation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CTP0302-A - CTP0302-B - Conventional OST ### Outcomes Primary Outcomes - Ratio of subjects With successful Bowel Cleansing Secondary Outcomes - Each segments ratio of subject with successful Bowel Cleansing ### Location - Facility: Taejoon Pharmaceutical Co., Ltd., Seoul, N/A, N/A, Korea, Republic of @@
## The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC - NCT ID: NCT06287593 - Study ID: NeoLiq - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-12-31 - Lead Sponsor: Zhejiang University ### Study Description This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients. ### Conditions - EGF-R Positive Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ctDNA monitoring ### Outcomes Primary Outcomes - the rate of major pathological response (MPR) Secondary Outcomes - the rate of pathological complete response (pCR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension. - NCT ID: NCT06287580 - Study ID: STU-2024-0140 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2027-01-01 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health. ### Conditions - Essential Hypertension - Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - chlorthalidone 25 mg - Placebo ### Outcomes Primary Outcomes - Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention - Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test - Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery - Change in Cerebral blood flow from baseline at 2 weeks post intervention Secondary Outcomes ### Location - Facility: Institute for Exercise and Environmental Medicine, Dallas, Texas, 75231, United States @@
## Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP) - NCT ID: NCT06287567 - Study ID: IIT2023078-EC-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-11-30 - Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China ### Study Description This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy ### Conditions - Idiopathic Thrombocytopenic Purpura - Immune Thrombocytopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lusutrombopag Oral Tablet ### Outcomes Primary Outcomes - Percentage of Participants with a Platelet Response after 4 Weeks (Day 29) Secondary Outcomes - Percentage of Participants with a Platelet Response after 12 Weeks (Day 85) - Percentage of Participants Who at least once Achieved a Platelet Count of ≥100x10^9/L in the Core Study - Change in Platelet Count - Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment - Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment - Time to first Achieve a Platelet Count of ≥ 50x10^9/L - Time to first Achieve a Platelet Count of ≥100x10^9 /L - Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively. - Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate - Cumulated Number of Weeks of Response（≥50x10^9/L） - Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline - The Incidence and Rating of Bleeding Events During the Study - Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study - Number of Participants With Adverse Events (AEs) - Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16 - Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16 ### Location - Facility: Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, 300020, China @@
## Effect of Early Implementation of Prone Positioning - NCT ID: NCT06287554 - Study ID: 404/2024 - Status: COMPLETED - Start Date: 2020-03-04 - Completion Date: 2022-04-20 - Lead Sponsor: Zulekha Hospitals ### Study Description Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU. ### Conditions - Severe Acute Respiratory Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PRONE POSITION ### Outcomes Primary Outcomes - Number of discharged patients Secondary Outcomes - The total length of stay - ICU length of stay - Patients who underwent tracheostomy procedures ### Location - Facility: Al-Azhar faculty of medicine, Cairo, N/A, 12546, Egypt @@
## The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection - NCT ID: NCT06287541 - Study ID: 2023-SR-486 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2027-07-01 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT. ### Conditions - Non Muscle Invasive Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Urine biomarker -Guided without reTURBT ### Outcomes Primary Outcomes - 2-year RFS rate Secondary Outcomes - RFS ### Location - Facility: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China @@
## A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL) - NCT ID: NCT06287528 - Study ID: 23-307 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2028-02-23 - Lead Sponsor: Memorial Sloan Kettering Cancer Center ### Study Description Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks. ### Conditions - Philadelphia-Negative ALL - Philadelphia-Positive ALL - Relapsed ALL, Adult - Refractory Acute Lymphoblastic Leukemia - Refractory Acute Lymphoblastic Leukemia (ALL) - Refractory Acute Lymphoid Leukemia in Relapse ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - 19-28z/IL-18 CAR T cells ### Outcomes Primary Outcomes - Toxicity as determined by CTCAE, version 5.0 Secondary Outcomes ### Location - Facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States @@
## Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain - NCT ID: NCT06287515 - Study ID: 2023-0940 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2027-07-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain. ### Conditions - Hypophysectomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Stereotactic Radiosurgery ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis - NCT ID: NCT06287502 - Study ID: KHRehab_LeungHC_2 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-09 - Completion Date: 2024-06-30 - Lead Sponsor: Kowloon Hospital, Hong Kong ### Study Description This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention. ### Conditions - Sarcopenia - Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - β-hydroxy β-methylbutyrate (HMB) - Resistance, aerobic, flexibility and balance exercise training ### Outcomes Primary Outcomes - Grip strength Secondary Outcomes - Body weight - Body mass index - Appendicular skeletal muscle mass index - 6-metre walk test - 5-time chair stand test - Short Physical Performance Battery (SPPB) ### Location - Facility: Kowloon Hospital, Kowloon, N/A, N/A, Hong Kong @@
## Effects of Mediterranean Diet on Subjective Cognitive Decline - NCT ID: NCT06287489 - Study ID: No.:2023-08-010ACF - Status: RECRUITING - Start Date: 2023-10-26 - Completion Date: 2025-12-31 - Lead Sponsor: Chih-Ping Chung ### Study Description Research Questions:1. Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?2. What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?Research Objective:Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms. ### Conditions - Subjective Cognitive Decline ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Mediterranean diet - Regular diet ### Outcomes Primary Outcomes - Cognitive functional change - Physical function 1 - gait speed change - Physical function 2 - handgrip strength change - Physical function 3 - stand from chair speed change - Brain MRI structural change - total and regional voxel-based brain parenchymal features change - Brain MRI functional change - total and regional voxel-based brain functional features change - Brain MRI neurovascular lesion change - small vessel disease markers - Brain MRI neurovascular structural change - microvascular density Secondary Outcomes - AD circulatory biomarkers ### Location - Facility: Taipei Veterans General Hospital, Taipei, N/A, 11217, Taiwan @@
## Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA) - NCT ID: NCT06287476 - Study ID: H-23043870 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-15 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Acute exercise bout on visit 2 and 3 ### Outcomes Primary Outcomes - Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls Secondary Outcomes - Pulmonary DTPA clearance at rest in COPD vs. controls - Pulmonary DTPA clearance after exercise in COPD vs. controls - Rest-to-exercise change in lung tissue mass in COPD vs. controls ### Location - Facility: Center For Physical Activity Research, Rigshospitalet, Copenhagen, N/A, N/A, Denmark @@
## Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway - NCT ID: NCT06287463 - Study ID: DCC-3084-01-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-08 - Lead Sponsor: Deciphera Pharmaceuticals LLC ### Study Description This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). ### Conditions - Advanced Solid Tumor - RAF Mutation - RAS Mutation - NF1 Mutation - Non-Small Cell Lung Cancer - Pancreatic Ductal Adenocarcinoma - Melanoma - BRAF Gene Mutation - CRAF Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - DCC-3084 ### Outcomes Primary Outcomes - Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1) - Objective Response Rate (ORR) (ModA Part 2) Secondary Outcomes - ORR (ModA Part 1) - Progression-Free Survival (PFS) (ModA Part 1 and 2) - Overall Survival (OS) (ModA Part 1 and 2) - Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2) ### Location - Facility: NEXT Oncology, San Antonio, Texas, 78229, United States @@
## A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults - NCT ID: NCT06287450 - Study ID: IN006001 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-10 - Lead Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd ### Study Description The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults. ### Conditions - Respiratory Syncytial Virus Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Bivalent RSV Vaccine (IN006) - Placebo ### Outcomes Primary Outcomes - Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination - Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination - Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination - Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination Secondary Outcomes - Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) - Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) - Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay) - GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) - GMFR for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) - Vaccine Response Rate for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]) - Frequency of Pre-F Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay) - Frequency of Pre-F Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay) - Percentage of Participants (Part 2, Aged 60 to 79 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination - Percentage of Participants (Part 2, Aged 60 to 79 Years) With Unsolicited AEs Through 28 Days After Revaccination - Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any MAAEs Through 6 Months After Revaccination - Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any SAEs, AESIs, and AEs Leading to Study Discontinuation Through 6 Months After Revaccination ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HRS9531 Controls Weight Regain in Obese Subjects - NCT ID: NCT06287437 - Study ID: B2023-335R - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HRS9531 - HRS9531 placebo ### Outcomes Primary Outcomes - Percent Change in Body Weight from 24 weeks Secondary Outcomes - Energy intake change from 24 weeks - Energy expenditure change from 24 weeks - Metabolic adaptation from 24 weeks - Systolic blood pressure and diastolic blood pressure change from 24 weeks - Body fat rate change from 24 weeks - Serum total cholesterol change from 24 weeks - Triglyceride change from 24 weeks - Nonestesterified fatty acid change from 24 weeks - Energy intake at baseline - Energy expenditure at baseline - Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale) - Percent Change in Body Weight at 24 weeks - Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale) - Energy expenditure at 24 weeks - Energy intake at 24 weeks ### Location - Facility: Xiaoying Li, Shanghai, N/A, N/A, China @@
## The Efficacy Of AGE On Periodontitis - NCT ID: NCT06287424 - Study ID: HMO-2O-0536 - Status: COMPLETED - Start Date: 2021-04-04 - Completion Date: 2023-01-01 - Lead Sponsor: Hadassah Medical Organization ### Study Description The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Aged Garlic Extract - Placebo ### Outcomes Primary Outcomes - Gingival Bleeding Index (GBI) - Probing Pocket Depth (PPD) Secondary Outcomes ### Location - Facility: Hebrew University, Jerusalem, N/A, 9112102, Israel @@
## Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies - NCT ID: NCT06287411 - Study ID: 202436 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: Xiao Chen ### Study Description This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards. ### Conditions - Hepatic Malignancies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FAPI PET/MR combined with gadoxetate disodium ### Outcomes Primary Outcomes - Diagnostic performance Secondary Outcomes - Quantitative parameters of PET/MR ### Location - Facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, Chongqing, Chongqing, 400010, China @@
## Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL - NCT ID: NCT06287398 - Study ID: NHL38 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2031-11 - Lead Sponsor: Australasian Leukaemia and Lymphoma Group ### Study Description The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?* Is consolidation epcoritamab after ASCT deliverable and safe?* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.Participants will undergo three phases in this trial:1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT. ### Conditions - DLBCL - Diffuse Large B Cell Lymphoma - High-grade B-cell Lymphoma - High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements - DLBCL, Nos Genetic Subtypes - High Grade B-Cell Lymphoma, Not Otherwise Specified - Follicular Large Cell Lymphoma, Relapsed - Follicular Large Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Epcoritamab ### Outcomes Primary Outcomes - Event-free survival (EFS) Secondary Outcomes - Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT - Overall response rate (ORR) - Complete response rate (CRR) - Overall Survival (OS) - Progression free survival (PFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits - NCT ID: NCT06287385 - Study ID: NELN202212A - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-12-15 - Lead Sponsor: Danone Nutricia ### Study Description This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives. ### Conditions - Healthy Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Goat-milk Based Formula ### Outcomes Primary Outcomes - Stool characteristics Secondary Outcomes - Gastrointestinal symptoms - Quality of life of subjects - Lifestyle-related immune indicators ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, N/A, China @@
## Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia - NCT ID: NCT06287372 - Study ID: 3261 - Status: COMPLETED - Start Date: 2022-07-04 - Completion Date: 2023-07-04 - Lead Sponsor: Damascus University ### Study Description The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures. ### Conditions - Myocardial Injury - Cardiac Surgery - Myocardial Protection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardioplegic solution ### Outcomes Primary Outcomes - Changes in markers of myocardial injury Secondary Outcomes - Changes in myocardial amino acid concentrations ### Location - Facility: Damascus University Cardiac Surgery Hospital, Damascus, N/A, N/A, Syrian Arab Republic @@
## Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain? - NCT ID: NCT06287359 - Study ID: Local/2024/MP-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Centre Hospitalier Universitaire de Nīmes ### Study Description Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents. ### Conditions - Low Back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - individual interviews ### Outcomes Primary Outcomes - Individual interviews Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece. - NCT ID: NCT06287346 - Study ID: 240101 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2030-01-01 - Lead Sponsor: CeraRoot SL ### Study Description The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?* What are the complications associated to the procedure and differences between the two groups. ### Conditions - Edentulism - Tooth Loss ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dental implant ### Outcomes Primary Outcomes - Survival rate Secondary Outcomes - Complications ### Location - Facility: Family Holistic Dentistry, Boulder, Colorado, 80303, United States @@

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