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## Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section - NCT ID: NCT06318546 - Study ID: FMASU MS59/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-11 - Lead Sponsor: Ain Shams University ### Study Description The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section ### Conditions - Post Spinal Shivering ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Dexmedetomidine Injection [Precedex],,, - Fentanyl ### Outcomes Primary Outcomes - Post spinal shivering Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of CD19 CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases - NCT ID: NCT06318533 - Study ID: 2023-11-01 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-03-13 - Lead Sponsor: YANRU WANG ### Study Description A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10\^9 cells, 9×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases. ### Conditions - Autoimmune Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anti-CD19 CAR NK cells ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicity (DLTs) - Treatment Emergent Adverse Events（TEAEs） Secondary Outcomes - Disease control rate of subjects - Remission rate of subjects ### Location - Facility: Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China @@
## Clinical Success of Stainless Steel Crowns Applied Using Different Cements - NCT ID: NCT06318520 - Study ID: AFSU-DHF-TOPAL-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Afyonkarahisar Health Sciences University ### Study Description The main question of the study was to evaluate the one-year clinical success of SSc bonded with two different cement types in MIH teeth with excessive material loss. The researchears will compare the survival rate, effect on gingival health and radiographic success of calcium silicate-based resin-containing cement and resin-modified glass ionomer cement. ### Conditions - Dental Enamel Hypomineralization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Use of Calcium silicate based resin cement and resin modified glass ionomer cement ### Outcomes Primary Outcomes - Anatomical Integrity - Marginal Compliance - Proximal Contact - Crown Marginal Location - Restoration success - Green and Vermillion's Oral Hygiene Index Secondary Outcomes - Marginal Fit of the Crown (RADIOLOGICAL) ### Location - Facility: Afyonkarahisar Health Sciences University, Afyonkarahisar, N/A, 03030, Turkey @@
## The Intestinal Microbiome in Triple Negative Breast Cancer Treated With Immunotherapy - NCT ID: NCT06318507 - Study ID: PBRC 2023-014 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-12-31 - Lead Sponsor: Pennington Biomedical Research Center ### Study Description This study will determine how the intestinal microbiome differs between patients with obesity and early triple-negative breast cancer who achieve a pathologic complete response from preoperative anti-PD-1 immunotherapy (pembrolizumab) versus patients who do not. ### Conditions - Breast Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fecal microbial diversity ### Outcomes Primary Outcomes - Pathologic Complete Response (pCR) Secondary Outcomes ### Location - Facility: Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States @@
## Analysis of Jumping in Patients With Ankle Instability (Ankle-optogait) - NCT ID: NCT06318494 - Study ID: Ankle-optogait - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-04-28 - Completion Date: 2025-07 - Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio ### Study Description The study is, in accordance with current legislation, definable as a single-center interventional study with evaluations carried out at a single timeframe.The objective of the study is to compare jumping performance between subjects with ankle instability and healthy volunteer subjects.In particular, the primary objective is to verify the difference in the monopodalic CMJ value of the diseased limb of subjects with ankle instability compared to the control group at time 0.The population is made up of patients suffering from ankle instability and a control group of healthy volunteers, divided as follows:25 subjects GROUP A: Study group: patients suffering from ankle instability25 subjects GROUP B: control group: healthy voluntary subjects not affected by ankle pathology ### Conditions - Ankle Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - jumping performance ### Outcomes Primary Outcomes - verify the difference in the monopodalic CMJ (countermovement jump test) of the diseased limb of subjects with ankle instability compared to the control group Secondary Outcomes ### Location - Facility: Istituto Clinico San Siro, Milan, N/A, N/A, Italy @@
## TADCLOT- a Double Blind Randomized Controlled Trial - NCT ID: NCT06318481 - Study ID: IRB-80/2023 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-12-15 - Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan ### Study Description Compare the safety and efficacy of a twice-daily Clopidogrel regimen vs. Ticagrelor in reducing major adverse events in patients undergoing primary PCI in a double-blind randomized controlled trial. ### Conditions - Stent Thrombosis - Myocardial Infarction, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ticagrelor 90 MG - Clopidogrel ### Outcomes Primary Outcomes - Evaluation of efficacy and safety Secondary Outcomes - Secondary endpoint ### Location - Facility: National Institute of Cardiovascular Diseases, Karachi, SIndh, 755000, Pakistan @@
## The Effectiveness of Various Teaching Methods to Enhance the Comprehensive Nursing Assessment Skills of New Nurses - NCT ID: NCT06318468 - Study ID: N202306106 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10-31 - Lead Sponsor: Taipei Medical University WanFang Hospital ### Study Description This study is going to compare different teaching strategies for improving newly recruited nurses' comprehensive nursing assessment skills. ### Conditions - Competence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Nursing health assessment teaching and discussion using humanoid diagrams - Nursing health assessment teaching and discussion using case study ### Outcomes Primary Outcomes - Comprehensive health assessment questionnaire - Comprehensive health assessment questionnaire - Comprehensive health assessment questionnaire - Confidence scale (C-scale) - Confidence scale (C-scale) - Confidence scale (C-scale) Secondary Outcomes - Course satisfaction questionnaire ### Location - Facility: Taipei Medical University WanFang Hospital, Taipei, N/A, N/A, Taiwan @@
## The Effect of Breathing Exercise on Sleep and Stress Levels in Women With Breast Cancer Receiving Chemotherapy Treatment - NCT ID: NCT06318455 - Study ID: İstanbul University-Cerrahpaşa - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-04-30 - Lead Sponsor: University of Yalova ### Study Description Women receiving chemotherapy have poor sleep quality and high stress levels. With a method such as breathing exercise, which can be applied at any time without side effects, positive improvements in women's sleep and stress levels can be recorded. ### Conditions - Women Receiving Chemotherapy - 18 Years of Age and Above - Women With High Stress Levels - Women With Poor Sleep Quality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breathing exercise ### Outcomes Primary Outcomes - anxiety state scale Secondary Outcomes ### Location - Facility: University of İstanbul-cerrahpaşa (IUC), Istanbul, N/A, N/A, Turkey @@
## The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes - NCT ID: NCT06318442 - Study ID: 22HH8018 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-06 - Completion Date: 2027-06-01 - Lead Sponsor: Imperial College London ### Study Description TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)DESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.AIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.OUTCOME MEASURES:* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.ELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetesSTUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.ANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes. ### Conditions - Steroid-Induced Diabetes - Steroid Induced Hyperglycemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Semaglutide Oral Product - Metformin Oral Tablet - Placebo ### Outcomes Primary Outcomes - Difference in Glucose tolerance Secondary Outcomes - Difference in insulin secretion - Difference in insulin sensitivity - Difference in insulin sensitivity - Difference in insulin sensitivity ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, N/A, United Kingdom @@
## Evaluation of the Effect of Stretching Exercises Applied to Diabetes Patients on Physiological Parameters and Compliance to Treatment: A Randomized Controlled Study - NCT ID: NCT06318429 - Study ID: diabet - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-06-30 - Lead Sponsor: University of Yalova ### Study Description This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes. ### Conditions - Individuals With Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - stretching exercise group ### Outcomes Primary Outcomes - blood sugar Secondary Outcomes ### Location - Facility: University of İstanbul-cerrahpaşa (IUC), Istanbul, N/A, N/A, Turkey @@
## Precision Rifampin Trial for Personalized Dosing - NCT ID: NCT06318416 - Study ID: HSR230382 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-01-30 - Lead Sponsor: University of Virginia ### Study Description Individual pharmacokinetic variability is an important driver of tuberculosis (TB) treatment failure particularly among undernourished populations, and that suboptimal serum drug concentrations are associated with delayed response to treatment, death, and acquired bacterial drug resistance. Serum drug exposures can be approximated by urine excretion as measured by spectrophotometry, replacing the need for specialized equipment for serum testing. Anti-TB pharmacokinetic variability has also been associated with enteric pathogen burden. The overall hypothesis is that urine spectrophotometry will identify people with below-target rifampin serum concentrations, which can be corrected to target levels after dose adjustment as confirmed by serum mass spectrometry. Therefore, this protocol includes a clinical trial to assess efficacy and safety of rifampin dose adjustment based on urinary excretion levels among adults and children who are being treated for drug-sensitive pulmonary TB at our longstanding collaborative research site in Haydom Lutheran Hospital, Tanzania. ### Conditions - Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - urine spectrophotometry for rifampin absorbance ### Outcomes Primary Outcomes - Rifampin serum area under the concentration time curve for the 24 hour dosing interval - Adverse events Secondary Outcomes - Time to sputum culture conversion to negative - Weight change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Estradiol Supplementation and Rotator Cuff Repair - NCT ID: NCT06318403 - Study ID: 177012 - Status: NOT_YET_RECRUITING - Start Date: 2025-04 - Completion Date: 2028-05 - Lead Sponsor: University of Utah ### Study Description Rotator cuff tears in the shoulder are common, often cause pain and disability, often fail to heal with surgery, and both tears and failure of healing are associated with estradiol deficiency. In this study, women who have gone through menopause will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, and function when given with rotator cuff repair. ### Conditions - Rotator Cuff Tears - Rotator Cuff Injuries - Rotator Cuff Syndrome - Menopause Related Conditions - Menopause ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transdermal estrogen - Rotator Cuff Repair Surgery ### Outcomes Primary Outcomes - American Shoulder and Elbow Surgeons (ASES) Score Secondary Outcomes - Simple Shoulder Test (SST) Score - Visual Analogue Score (VAS) for pain - Magnetic Resonance Imaging (MRI) tendon healing - Strength Assessment - Range of motion ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health - NCT ID: NCT06318390 - Study ID: 2023-0271 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-08-31 - Lead Sponsor: The University of Texas at Arlington ### Study Description The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI). ### Conditions - Cardiovascular Diseases - Hypertension - Cognitive Decline - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - XO Genius ### Outcomes Primary Outcomes - Endothelial Function - Neurocognitive Function - Peripheral blood pressure (systolic, diastolic, mean) - Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) - Arterial stiffness Secondary Outcomes ### Location - Facility: UT Arlington - Science and Engineering Innovation and Research Building, Arlington, Texas, 76019, United States @@
## Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals - NCT ID: NCT06318377 - Study ID: 2022-0541 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2025-08-31 - Lead Sponsor: The University of Texas at Arlington ### Study Description The overall research objective of this proposal is to determine the impact of increased daily peanut consumption on indices of neurocognitive and physiological health in BL individuals ### Conditions - Cardiovascular Diseases - Hypertension - Cognitive Decline - Diet, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Peanut group ### Outcomes Primary Outcomes - Endothelial Function - Neurocognitive Function - Peripheral blood pressure (systolic, diastolic, mean) - Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG) - Arterial stiffness Secondary Outcomes ### Location - Facility: UT Arlington - Science and Engineering Innovation and Research Building, Arlington, Texas, 76019, United States @@
## Postoperative Delirium in the Post-anesthesia Care Unit - NCT ID: NCT06318364 - Study ID: TJ-IRB202402016 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2024-12-30 - Lead Sponsor: Qin Zhang ### Study Description This study aims to investigate the incidence of postoperative delirium (POD) in the PACU and analyze its influencing factors, in order to provide theoretical basis for early screening and intervention for high-risk POD population. Blood samples of some study subjects will be collected and analyzed using molecular detection methods to provide a basis and insights into the pathophysiological mechanisms of POD. ### Conditions - Delirium, Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NO Intervention ### Outcomes Primary Outcomes - Postoperative delirium Secondary Outcomes ### Location - Facility: The First Hospital of Harbin Medical University, Harbin, Heilongjiang, 150000, China @@
## Transcutaneous Acupoint Electrical Stimulation and Postoperative Delirium Delirium - NCT ID: NCT06318351 - Study ID: TJ-IRB202402015 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-08-30 - Lead Sponsor: Qin Zhang ### Study Description Investigating postoperative delirium in patients undergoing thoracoscopic lung resection surgery who have received or not received relevant transcutaneous acupoint electrical stimulation treatment preoperatively, observing postoperative recovery quality indicators, evaluating the necessity of treatment, and clarifying the potential mechanisms by which transcutaneous acupoint electrical stimulation may improve postoperative delirium. ### Conditions - Delirium, Postoperative ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - transcutaneous acupoint electrical stimulation ### Outcomes Primary Outcomes - Delirium Secondary Outcomes - Recovery ### Location - Facility: Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, 510000, China @@
## Virtual Reality to Promote Relaxation Prior to Simulation - NCT ID: NCT06318338 - Study ID: UPCC 14523 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Abramson Cancer Center at Penn Medicine ### Study Description The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT). ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality Program ### Outcomes Primary Outcomes - Feasibility of a pre-simulation VR platform prior to radiation Secondary Outcomes - Patient feedback on pre-simulation VR program - Patient situational anxiety prior to and after use of VR program ### Location - Facility: Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, 19104, United States @@
## Growth Process and Development of the Musculoskeletal System in Young Gymnasts - NCT ID: NCT06318325 - Study ID: ADINEGEV-2021_102 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-03-15 - Lead Sponsor: University of Haifa ### Study Description assessment of the musculoskeletal system will be performed twice a year, for three years of young gymnasts. ### Conditions - Development, Adolescent ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - examination ### Outcomes Primary Outcomes - ultrasound tissue characterized - muscle strength test - range of motion - bone strength - Bone Age Secondary Outcomes ### Location - Facility: The Academic college Levinsky-Wingate at the Wingate Institute, Netanya, N/A, N/A, Israel @@
## Effects of Hypoxia on Cognitive Performance - NCT ID: NCT06318312 - Study ID: HYP_MR_2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-27 - Completion Date: 2024-05-03 - Lead Sponsor: University of Castilla-La Mancha ### Study Description The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?* Which hypoxia exposure causes the greatest detriments in cognitive function? ### Conditions - Hypoxia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypoxia ### Outcomes Primary Outcomes - Memory - Attention - Anticipation - Reaction time Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Exogenous Ketone Ester Supplementation on 3-hydroxybutyrate Concentrations in Human Cerebrospinal Fluid - NCT ID: NCT06318299 - Study ID: 109227 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: University of Aarhus ### Study Description It is well established that the brain is capable of consuming ketone bodies, especially during low glucose availability, e.g. fasting. Cerebral metabolism of ketone bodies depends on passage of the blood brain barrier and especially the global blood concentration of ketone bodies.Ketone bodies can be administered exogenously, and the most commonly used in clinical trials is 3-hydroxybutyrate (3-OHB). 3-OHB is carried by simple diffusion and facilitated diffusion through several monocarboxylic acid transporters (MCTs) across the blood-brain barrier.To our knowledge, no studies in human adults exist that concurrently measure 3-OHB concentrations in blood and cerebrospinal fluid (CSF) after ingestion or infusion of exogenous ketone supplementation, necessitating further study.Aims:* The 3-OHB CSF/blood ratio after oral ingestion of 30 g ketone ester - primary endpoint* The window of effect: Ketone supplementation 1 h or 2 h before CSF sampling* If concentration measurements by point-of-care testing are non-inferior to mass spectrometry* If acute 3-OHB ingestion increases plasma brain-derived neurotrophic factor (BDNF) levels ### Conditions - Ketosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Ketone Ester - Placebo ### Outcomes Primary Outcomes - 3-OHB CSF/blood ratio Secondary Outcomes - CSF 3-OHB concentrations, POCT - CSF 3-OHB concentrations, Mass Spectrometry - CSF glucose concentrations - Blood 3-OHB concentrations - Plasma 3-OHB concentrations - Blood glucose concentrations - Plasma BDNF concentrations - Blood 3-OHB concentrations - Plasma 3-OHB concentrations - Blood glucose concentrations - Plasma BDNF concentrations ### Location - Facility: Aarhus University Hospital, Aarhus, N/A, 8200, Denmark @@
## Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma - NCT ID: NCT06318286 - Study ID: MK3475-IIT-60977 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-13 - Completion Date: 2026-10-30 - Lead Sponsor: Hyogo Medical University ### Study Description In this Phase-II study, the investigators will investigate the efficacy and safety of lenvatinib in combination with pembrolizumab and chemotherapy in patients with malignant pleural mesothelioma. ### Conditions - Malignant Pleural Mesothelioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lenvatinib - Pemetrexed - Cisplatin/Carboplatin - Pembrolizumab ### Outcomes Primary Outcomes - Tumor shrinkage (response rate) (Physician Judgment by Medical Institution, Modified RECIST [Response Evaluation Criteria in Solid Tumors] criteria) Secondary Outcomes - Progression-Free survival (PFS) (Physician Judgment by Medical Institution, Modified RECIST criteria) - Overall survival time (OS) - Tumor shrinkage (disease control rate) (Physician Judgment by Medical Institution, Modified RECIST criteria) - Duration of response (Physician Judgment by Medical Institution, Modified RECIST criteria) - Best overall response (Physician Judgment by Medical Institution, Modified RECIST criteria) - Incidence of adverse events ### Location - Facility: Hyogo Medical University Hospital, Nishinomiya, Hyogo, 6638501, Japan @@
## A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer - NCT ID: NCT06318273 - Study ID: M24-742 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2027-06-17 - Lead Sponsor: AbbVie ### Study Description Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 120 adult participants will be enrolled in the study across sites worldwide.In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans. ### Conditions - Metastatic Castration-Resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ABBV-969 ### Outcomes Primary Outcomes - Percentage of Participants With Adverse Events (AEs) - Percentage of Participants Achieving Prostate Specific Antigen (PSA) response Secondary Outcomes - Maximum Observed Plasma Concentration (Cmax) of ABBV-969 - Time to Maximum Observed Concentration (Tmax) of ABBV-969 - Terminal Phase Elimination Half-Life (t1/2) of ABBV-969 - Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969 - Antidrug Antibody (ADA) - Neutralizing Antibodies (nAbs) - Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase) ### Location - Facility: City of Hope /ID# 262059, Duarte, California, 91010, United States @@
## Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt) - NCT ID: NCT06318260 - Study ID: 2023-508298-10-00 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2026-03 - Lead Sponsor: Steen Hvitfeldt Poulsen ### Study Description The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid Cardiomyopathy (ATTRwt). The main questions it aims to answer are:* What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt.* Safety of dobutamine infusion in this patient population.Participants will be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously. ### Conditions - ATTR Amyloidosis Wild Type ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dobutrex ### Outcomes Primary Outcomes - Cardiac output Secondary Outcomes - Increase in invasively measured SVI by ≥ 20%. - Reduction in mean PAWP and/or mPAP by 10 %. - Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %. - Correlation between echo- and invasive measured SVI, and CO. - Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects. ### Location - Facility: Department of Cardiology, Aarhus University Hospital, Aarhus, N/A, 8200, Denmark @@
## Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets - NCT ID: NCT06318247 - Study ID: 2022-134(R) - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-30 - Lead Sponsor: The Dental Hospital of Zhejiang University School of Medicine ### Study Description To evaluate the clinical effect of site preservation after third molars extraction by using tooth extraction of third molars with site preservation using bio-oss and bio-guide in preventing the formation of deep periodontal pockets in the distal of second molars. ### Conditions - Periodontal Pocket - Periodontal Bone Loss - Impacted Third Molar Tooth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - site preservation ### Outcomes Primary Outcomes - Probing pocket depths (PPD) - Distal bone wall defect (DBWD) - Clinical attachment lose (CAL) - Bleeding on probing (BOP) Secondary Outcomes - Pain score - Patient satisfaction - Gingival index (GI) ### Location - Facility: Stomatology Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310000, China @@
## PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer - NCT ID: NCT06318234 - Study ID: 202435 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Xiao Chen ### Study Description This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed. ### Conditions - Rectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 18F-FAPI，18F-FDG ### Outcomes Primary Outcomes - Evaluation efficacy of tumor regression level Secondary Outcomes - expression of FAP - expression of GLUT1 - SUV ### Location - Facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, Chongqing, N/A, N/A, China @@
## Effects of Perioperative Immunonutrition in Patients With Head and Neck Cancer - NCT ID: NCT06318221 - Study ID: 06156930 - Status: COMPLETED - Start Date: 2019-05-01 - Completion Date: 2021-02-01 - Lead Sponsor: TC Erciyes University ### Study Description A prospective randomized controlled study compared the effects of perioperative immunonutrition and standard enteral nutrition (EN) on postoperative short-term outcomes of patients with head and neck (HNC).Five days before surgery and the postoperative day 10, immunonutrition support was given to the intervention group (n=17), and standard EN support was given to the control group (n=17). Body analyses were made, food consumption records were taken, NRS-2002 and quality of life scales were applied, and biochemical parameters were recorded. ### Conditions - Head and Neck Cancer - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Experimental (Immunonutrition) Group - Active Comparator Group ( Standard enteral nutrition) ### Outcomes Primary Outcomes - Body weight - Body weight loss - Body mass index - Resting metabolic rate - Nutrition Risk Screening 2002 - The EORTC Core Quality of Life questionnaire-30 (EORTC QLQ-C30) - The EORTC Quality of life - Head and Neck Cancer Module (EORTC QLQ-H & N35) - Albumin - C-reactive protein - Prealbumin Secondary Outcomes - Length of hospital stay - Complication development status ### Location - Facility: Erciyes University, Talas, Kayseri, 38280, Turkey @@
## Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19 - NCT ID: NCT06318208 - Study ID: C-LCI - Status: COMPLETED - Start Date: 2021-04-20 - Completion Date: 2022-01-03 - Lead Sponsor: University of Rostock ### Study Description The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing. ### Conditions - SARS-CoV-2 Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lung function testing ### Outcomes Primary Outcomes - Pulmonary function Secondary Outcomes - Changes in pulmonary function - Sociodemographic factors ### Location - Facility: Kinder- und Jugendklinik Universitätsmedizin Rostock, Rostock, N/A, 18057, Germany @@
## Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care. - NCT ID: NCT06318195 - Study ID: 2023-06821-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-08 - Lead Sponsor: Karolinska Institutet ### Study Description The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment. ### Conditions - Post Traumatic Stress Disorder - Acute Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Condensed Internet delivered prolonged exposure (CIPE) ### Outcomes Primary Outcomes - Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5) Secondary Outcomes - Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) - Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress. ### Location - Facility: Karolinska Universitetssjukhuset; Tema Kvinnohälsa och Hälsoprofessioner; Medicinsk Enhet Medicinsk Psykologi; Sektion Beteendemedicin, Stockholm, N/A, N/A, Sweden @@
## Testicular Self-Examination Awareness in Young Men - NCT ID: NCT06318182 - Study ID: NCT-SBF-EK-001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-12-09 - Completion Date: 2024-07-15 - Lead Sponsor: Hitit University ### Study Description This study aims to determine the effect of education based on the health belief model on testicular self-examination awareness and health beliefs in young men.H0 Hypothesis: Education based on the health belief model has no effect on the awareness of testicular self-examination and health beliefs about testicular self-examination of young men in the experimental and control groups.H1a Hypothesis: The training based on the health belief model will increase the awareness of young men in the experimental group about testicular self-examination compared to those in the control group.H1b Hypothesis: The training based on the health belief model will increase the mean scores of the sensitivity subscale of young men in the experimental group compared to those in the control group.H1c Hypothesis: The training based on the health belief model will increase the mean scores of the benefit subscale of young men in the experimental group compared to those in the control group.H1d Hypothesis: The training based on the health belief model will increase the mean scores of the seriousness subscale of young men in the experimental group compared to those in the control group.H1e Hypothesis: The training based on the health belief model will decrease the mean scores of the barriers subscale of young men in the experimental group compared to those in the control group.H1f Hypothesis: The training based on the health belief model will increase the mean scores of the health motivation subscale of young men in the experimental group compared to those in the control group.H1g Hypothesis: The training based on the health belief model will increase the mean scores of the self-efficacy subscale of young men in the experimental group compared to those in the control group. ### Conditions - Testicular Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Education ### Outcomes Primary Outcomes - Demographic information and testicular cancer questionnaire - Testicular Cancer Knowledge Test - Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination Secondary Outcomes - For the control group, Testicular Cancer Knowledge Test - For the control group, Health Beliefs Scale for Testicular Cancer and Testicular Self-Examination ### Location - Facility: Hitit University, Corum, N/A, 19000, Turkey @@
## A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis) - NCT ID: NCT06318169 - Study ID: BIO89-100-131 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2029-02 - Lead Sponsor: 89bio, Inc. ### Study Description The study will assess the efficacy and safety of 2 dose regimens of pegozafermin for the treatment of liver fibrosis stage 2 or 3 in adult participants with MASH (previously known as nonalcoholic steatohepatitis \[NASH\]). ### Conditions - Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pegozafermin - Placebo ### Outcomes Primary Outcomes - Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52 - Proportion of Participants With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52 Secondary Outcomes - Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52 - Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36 - Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events ### Location - Facility: 89bio Clinical Study Site, Little Rock, Arkansas, 72211-3859, United States @@
## Exploring the Distribution Patterns and Infrared Characteristics of Force-sensitive Acupoints in Different Lumbar Nerve Segments in Patients With LDH Based on "Press Quickly" Theory - NCT ID: NCT06318156 - Study ID: ZSLL-KY-2024-056-03 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-01-01 - Lead Sponsor: Zhou Xingchen ### Study Description Utilizing the "responsive acupoint palpation" technique and infrared thermography, we investigated the distribution patterns of pressure-sensitive acupoints across different lumbar spinal segments in patients with lumbar disc herniation (LDH). Methodology: The Finger TPS tactile pressure measurement system was employed to conduct sensitivity examinations on the acupoints of the L1\~L5 lumbar spine in 80 LDH patients (Group 1) and 80 healthy individuals (Group 2), applying a standardized force of 60N. When a sensation of comfort was elicited, the points were marked on a human cutaneous nerve segment map. We then utilized infrared thermography to collect and compare the temperature differences of the top 10 most frequently responsive acupoint areas in the experimental group against those in the control group. ### Conditions - Lumbar Disc Herniation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Infrared thermal imaging ### Outcomes Primary Outcomes - skin temperature Secondary Outcomes ### Location - Facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China @@
## mAnaging siCkle CELl disEase Through incReased AdopTion of hydroxyurEa in Nigeria - NCT ID: NCT06318143 - Study ID: U01HL168084 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-03 - Lead Sponsor: New York University ### Study Description Large knowledge gaps remain regarding strategies to promote the adoption of hydroxyurea (HU), particularly in sub-Saharan African countries including Nigeria, where more than 75% of annual sickle cell anemia births occur. The vast majority of people with SCD in Africa do not receive evidenced-based health care (e.g., newborn screening, health education, prophylaxis for infection, optimal nutrition and hydration, blood transfusion, transcranial Doppler screening, and HU therapy), despite its effectiveness in reducing SCD-related adverse outcomes and mortality. The use of HU in SSA is \<1% among SCD patients. The investigators' preliminary findings indicate that provider-level barriers are significant and must be addressed to improve HU adoption. To address HU adoption, the investigators will use the NIH-funded study (e.g., Realizing Effectiveness Across Continents with Hydroxyurea (REACH) Clinical Trial (NCT01966731)) that developed an evidence-informed, clinical, practical, and easy-to-follow algorithm to 1) Screen patients for sickle cell disease (SCD), 2) Initiate HU treatment, and 3) Maintain HU dosage over time (SIM) for the improved management of SCD as our intervention. The Nigerian government released guidelines supporting the SIM intervention for HU adoption for improved SCD management, and HU is on the list of essential medicines for Nigeria. The investigators' implementation strategy for improving SCD management in Nigeria uses a practical and replicable evidence-based task-sharing strategy, TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH), adopted from the TAsk-Strengthening Strategy for Hypertension control (TASSH) trials in Ghana and Nigeria containing the essential components of i) Training healthcare workers/providers to be more patient-centered in clinical consultations, ii) Clinical reminders, and iii) Practice facilitation (TCP) known as (TASSH TCP) for SCD management. Using a sequential exploratory mixed-methods study design, the investigators will conduct this study using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework in four sequential phases to assess the effectiveness of SIM adoption by providers in the context of the TASSH TCP implementation strategy in Nigeria. ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TASSH ### Outcomes Primary Outcomes - Patient numbers - screening - Patient numbers - proportion on HU - Patient numbers - dosage Secondary Outcomes - Mediators ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Pacing Lead Design on Left Bundle Branch Pacing Outcomes - NCT ID: NCT06318130 - Study ID: LEAD-LBP - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-06-30 - Lead Sponsor: National University Hospital, Singapore ### Study Description This trial seeks to evaluate the performance of the extendable helix, stylet-driven pacing lead (EHL) compared to the fixed helix, lumenless pacing lead (FHL) during left bundle branch pacing (LBBP), with respect to enduring left bundle branch capture on follow-up, incidence of acute lead failure, pacing characteristics including QRS duration, pacing thresholds, R-wave amplitudes and lead impedance, and finally, safety profile during LBBP implantation. These data will guide future lead selection during LBBP implantation in achieving improved procedural success and optimal lead performance. ### Conditions - Pacemaker DDD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fixed helix, lumenless pacing lead. - Extendable helix, stylet-driven pacing lead. ### Outcomes Primary Outcomes - Incidence of loss of left bundle branch capture Secondary Outcomes - Incidence of acute lead failure - Serial changes in pacing thresholds (V) - Serial changes in R-wave amplitude (mV) - Serial changes in lead impedance (ohm) - Serial changes in QRS duration (ms) - Incidence of peri-procedural complications ### Location - Facility: National University Heart Centre Singapore, Singapore, N/A, N/A, Singapore @@
## Reason for Prescribing Rice Infant Formula - NCT ID: NCT06318117 - Study ID: 3398-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2025-12-31 - Lead Sponsor: Mead Johnson Nutrition ### Study Description The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. ### Conditions - Infant Formula ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rice infant formula ### Outcomes Primary Outcomes - Questionnaire - reason for prescribing a RIF during the 1st year of life. Secondary Outcomes - Questionnaire - Reason for prescribing a RIF in first 6 months of life - Questionnaire - Diet characteristics - Growth z-scores body mass index (BMI)-for-age - Growth z-score - Growth z-score - Growth z-score - Growth z-score - Questionnaire - Evolution of digestive and allergic symptoms - Socio-demographic characteristics ### Location - Facility: Dr Christine REGIMBART - Private Practice, Bécon-les-Granits, Becon-les-Granits, 49026, France @@
## Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole - NCT ID: NCT06318104 - Study ID: DI/24/310/03/4 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-02-28 - Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga ### Study Description In Mexico, quadruple therapy is used to treat Helicobacter pylori (H.P.) at the expense of greater adverse effects, costs, and lower adherence to treatment. According to evidence, a competitive potassium channel blocker (P-CAB) is non-inferior to a proton pump inhibitor (PPI) and can improve the eradication rate of H.P. while maintaining triple therapy antibiotics (amoxicillin-clarithromycin) without increasing adverse effects, fewer drugs and better adherence to treatment. It is proposed to study the effect of a P-CAB in the eradication of H.P. as part of a triple therapy in Mexican patients, assuming that the efficacy and safety of a triple therapy of amoxicillin-clarithromycin-tegoprazan will be superior to amoxicillin-clarithromycin-esomeprazole. ### Conditions - Helicobacter Pylori Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tegoprazan - Esomeprazole 40mg ### Outcomes Primary Outcomes - Response to treatment by determining the eradication rate - Compared Treatment-related adverse events Secondary Outcomes - Brief Medication Questionnaire - Percentage of patients with adherence to treatment - Report all Treatment-related adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nanofat Versus Platelet Poor Plasma Gel for Infraorbital Rejuvenation - NCT ID: NCT06318091 - Study ID: MS.21.09.1640 - Status: COMPLETED - Start Date: 2021-06-01 - Completion Date: 2023-06-01 - Lead Sponsor: Mansoura University ### Study Description this study was conducted for evaluation of the clinical efficacy, safety, and potential side effects of platelet poor plasma gel versus nonfat injection in infraorbital rejuvenation ### Conditions - Tear Trough Eyelid Deformity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - platelet poor plasma gel - nanofat ### Outcomes Primary Outcomes - the degree of changes in the skin texture and homogeneity Secondary Outcomes ### Location - Facility: Manousra University, Faculty of Medicine, Mansoura, Dakahlia, 35511, Egypt @@
## Buikwe Electronic Community Health Information System Impact Study - NCT ID: NCT06318078 - Study ID: UG2024001 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-07 - Lead Sponsor: Malaria Consortium ### Study Description The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes. ### Conditions - Malaria - Diarrhea - Pneumonia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - eCHIS ### Outcomes Primary Outcomes - Out Patient Department attendance (due to malaria, pneumonia and diarrhoea) - Hospitalisation (due to malaria, pneumonia and diarrhoea) - malaria related mortality in the community and health facilities Secondary Outcomes ### Location - Facility: Buikwe, Buikwe, N/A, N/A, Uganda @@
## Surgical Resection Outcomes in Patients With Brain Metastasis - NCT ID: NCT06318065 - Study ID: B-ER111-370 - Status: RECRUITING - Start Date: 2010-01-01 - Completion Date: 2024-09-01 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM. ### Conditions - Brain Metastases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - survival outcome of patients undergoing surgery for brain metastasis - Functional outcome of patients undergoing surgery for brain metastasis Secondary Outcomes ### Location - Facility: Jung-Shun Lee, Tainan, None Selected, 70403, Taiwan @@
## The Effect Of Fractional CO2 Laser Therapy On Cancer Survivors With Genitourinary Syndrome Of Menopause (GSM) - NCT ID: NCT06318052 - Study ID: LUM-ABU-CO2-FemTouch-19-01 - Status: RECRUITING - Start Date: 2019-11-01 - Completion Date: 2024-11 - Lead Sponsor: Lumenis Be Ltd. ### Study Description Improvement in cancer therapies has led to an increase in the number of women surviving chemotherapy (and other treatments) and overcoming cancer. This patient population presents specific clinical needs as chemotherapy (and other cancer treatments) treatment side effects can lead to early appearance of menopause symptoms and conventional hormonal treatments are contraindicated for these patients. The use of CO2 laser treatment has been shown to provide relief of Genitourinary Syndrome Of Menopause (GSM) symptoms in women and might provide a significant improvement in the quality of life for cancer survivors. The current study is designed to demonstrate the safety and efficacy of CO2 laser for treatment of GSM symptoms in cancer survivors suffering from GSM symptoms, with limited access to hormonal treatment. ### Conditions - Vaginal Atrophy Patients With GSM ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The FemTouch delivery system - Gynomunal gel treatment ### Outcomes Primary Outcomes - To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment Secondary Outcomes - To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment - To demonstrate the efficacy of fractionated CO2 laser treatments in cancer survivor patients with GSM as compared to the standard treatment. ### Location - Facility: Frauenarztpraxis Heussweg, Hamburg, N/A, 20255, Germany @@
## Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06318039 - Study ID: IRB2022-06554-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2027-10-01 - Lead Sponsor: Linnaeus University ### Study Description Scientific Research QuestionOverall Purpose:Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.Specific Objectives:How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury? ### Conditions - Anterior Cruciate Ligament Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Novel program - Traditional program ### Outcomes Primary Outcomes - Isokinetic muscle strength - Single-leg hop performance Secondary Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) - ACL Return to Sport after Injury scale ### Location - Facility: Linnaeus University, Kalmar, Sverige, 39363, Sweden @@
## Systematic Implementation of Patient-centered Care for Alcohol Use Trial: Beyond Referral to Treatment - NCT ID: NCT06318026 - Study ID: R01AA031231 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2029-02 - Lead Sponsor: Kaiser Permanente ### Study Description The Systematic Implementation of Patient-centered Care for Alcohol Use Trial is a pragmatic, cluster-randomized, effectiveness-implementation trial testing two interventions to systematically implement shared decision-making with primary care patients with symptoms due to alcohol use: a primary care intervention and a centralized intervention. An anticipated 30 primary care clinics will be randomized to one of three conditions: usual care or the primary care or centralized interventions. ### Conditions - Alcohol Use Disorder - Unhealthy Alcohol Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Centralized Intervention - Primary Care Intervention ### Outcomes Primary Outcomes - Documentation of alcohol or substance use disorder treatment in the electronic health record (including insurance claims). - Continuous measure of change in alcohol use as documented on the AUDIT-C screening questionnaire. Secondary Outcomes ### Location - Facility: Kaiser Permanente Washington, Seattle, Washington, 98112, United States @@
## Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints - NCT ID: NCT06318013 - Study ID: 2022-KAEK-15427-04-204-2022101 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2024-07-01 - Lead Sponsor: Karamanoğlu Mehmetbey University ### Study Description Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use. ### Conditions - Impacted Third Molar Tooth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - vitality test ### Outcomes Primary Outcomes - Swelling - Duration of anesthesia Secondary Outcomes - Pain Score ### Location - Facility: Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry, Karaman, N/A, 70100, Turkey @@
## Physical Activity and Sports for People With Visual Impairments - NCT ID: NCT06318000 - Study ID: SN4/20/22 - Status: COMPLETED - Start Date: 2020-03-01 - Completion Date: 2022-12-31 - Lead Sponsor: Józef Piłsudski University of Physical Education ### Study Description Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination. ### Conditions - Blindness - Visual Impairment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Balance test, bilateral coordination test, fundamental motor skills test ### Outcomes Primary Outcomes - Center of pressure (CoP) path length was measured - Surface area of stabilogram was measured - Raw and scale score for each item - Qualitative performance criteria (points) Secondary Outcomes - Body mass in kg - Body height in cm ### Location - Facility: University of Physical Education, Warsaw, N/A, 00-968, Poland @@
## Addressing Barriers to Care for Substance Use Disorder Pilot Study - NCT ID: NCT06317987 - Study ID: 2068557 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-02 - Lead Sponsor: Kaiser Permanente ### Study Description The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) is a randomized pilot study that will precede a larger trial. The ABC-SUD Pilot is a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization.This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder.The experimental intervention, Care Navigation, will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center. The investigators note that Care Navigation will be delivered by study "care navigators", who are distinct from the health system's care coordinators. ### Conditions - Drug Use Disorders - Illicit Drug Use - Alcohol-Related Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Care Navigation ### Outcomes Primary Outcomes - Rate of patient interest in care navigation Secondary Outcomes - Feasibility of patient consent procedures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Breastfeeding Education on Breast Milk Perception and Self-Efficacy in the Pregnancy Health Belief Model - NCT ID: NCT06317974 - Study ID: 2022/210 - Status: COMPLETED - Start Date: 2022-06-30 - Completion Date: 2023-02-15 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Objective: The aim of this study was to evaluate the effect of breastfeeding education based on the Health Belief Model during the antenatal period on couples' perception and self-efficacy regarding breast milk. ### Conditions - Breastfeeding Education ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breastfeeding education based on the Health Belief model ### Outcomes Primary Outcomes - Mothers' and fathers' perception of breast milk, assessed using the Adults' Breast Milk Perception Scale. Secondary Outcomes - Breastfeeding self-efficacy of mothers evaluated using the Breastfeeding Self-Efficacy Scale-Short Form during Pregnancy ### Location - Facility: Istanbul University - Cerrahpasa, Istanbul, N/A, N/A, Turkey @@
## Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools - NCT ID: NCT06317961 - Study ID: INT200-22 - Status: RECRUITING - Start Date: 2023-04-05 - Completion Date: 2025-01-31 - Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano ### Study Description Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - SUS questionnaire Secondary Outcomes ### Location - Facility: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, N/A, 20133, Italy @@
## Improving the Quality of Radiotherapy by Multi-Institution Knowledge-Based Planning Optimization Models (Acronym: MIKAPOCo, Multi-Institutional Knowledge-based Approach in Plan Optimization for the Community) - NCT ID: NCT06317948 - Study ID: IG23150 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-10-28 - Completion Date: 2025-10-28 - Lead Sponsor: IRCCS Ospedale San Raffaele ### Study Description Investigators central hypothesis is that it is possible to create libraries of "consistent" Knowledge-Based plan-models derived from large Institutional experiences. These libraries can be used to guide automated RT planning and serve as tools to assist centers for plan quality assurance (QA) and plan prediction.Quantifying Inter-institute variability of RT planning and building libraries of interchangeable and validated multi-Institutional KB plan prediction models is expected to impact on the quality of planning at the national level. The project has the potential of facilitating the introduction of AI approaches in plan optimization, thus reducing intra and inter-Institute planning variability. Improving plan quality is expected to translate into better outcome after RT in terms of local control and, even more, of side effects and Quality of life. Positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the RT educational field. ### Conditions - Breast Cancer - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - treatment plan comparison ### Outcomes Primary Outcomes - model interchangeability Secondary Outcomes ### Location - Facility: IRCCS Ospedale San Raffaele, Milano, N/A, 20133, Italy @@
## The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP - NCT ID: NCT06317935 - Study ID: HU-ERG-BK-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-23 - Completion Date: 2024-10-29 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention. ### Conditions - Hemiplegic Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ArmeoSenso - Traditional Rehabilitation ### Outcomes Primary Outcomes - The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP. - The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP. Secondary Outcomes - Dosimetry of virtual reality applications ### Location - Facility: Ankara Bilkent City Hospital, Multiple Locations, Ankara, 06000, Turkey @@
## Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections - NCT ID: NCT06317922 - Study ID: DRYEYE-IVT Project - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2025-05-12 - Lead Sponsor: Francesco Bandello ### Study Description The goal of this interventional, monocentric, prospective, single-masked, case-control study is to evaluate the efficacy of Thealoz Duo (artificial tear containing trehalose 3 g and hyaluronic acid 0.15 g) in comparison to a saline solution (Hydrabak containing Sodium Chloride 0,9 g, Sodium Dihydrogen Phosphate Dihydrate, Disodium Hydrogen Phosphate Dodecahydrate), to reduce the signs of ocular discomfort and ocular side effects in patients who have received Intravitreal injections.The main questions it aims to answer are:* can ocular instillation of Thealoz Duo solution, 1 week before intravitreal injection, in a fixed dose regimen, prevent ocular surface changes and dry-eye signs?* can ocular instillation of Thealoz Duo solution, up 3 months after intravitreal injections, in a fixed dose regimen, reduce ocular surface changes, and dry-eye signs with improvement of quality of life and quality of vision?Each participant will be randomized into each of two arms:1. TREATMENT ARM: patients who will receive the instillation of Thealoz Duo, 10 ml, 1 drop, 4 times/day;2. CONTROL ARM: patients who will receive the instillation of saline solution (Hydrabak), 10 ml, 1 drop, 4 times /day;The decision of inclusion of a control group should minimize the risk of breaking the blinding condition by affecting the consistency and reliability of the outcome's achievement.In any case, the instillation of saline solution should not alter the ocular surface. ### Conditions - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thealoz Duo; - sham (Hydrabak) ### Outcomes Primary Outcomes - Administration of Ocular Surface Disease Index (OSDI) to the patient Secondary Outcomes - administration of Visual Analog Scale for Pain to the patient - evaluation of matrix metalloproteinase 9 gene expression - TearLab Osmolarity - Schirmer's test - tear film Break Up Time (tBUT) - conjunctival hyperemia according to Efron grading scale - fluorescein staining ### Location - Facility: IRCCS Ospedale San Raffaele _O.U. Ophthalmology, Milan, N/A, 20123, Italy @@
## Development of a Novel Non-invasive Inflammometry Following Allergen Challenge in Patients With Mild Allergic Asthma - NCT ID: NCT06317909 - Study ID: 23-03 DONNER-2 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-09 - Lead Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine ### Study Description The goal of this exploratory method-development study is to to establish and evaluate novel non-invasive methods to monitor airway inflammation induced by allergen challenge (both by instillation during bronchoscopy and by inhalation) in patients with mild allergic asthma.The investigator wants to further profile and develop the allergen challenge model by investigating the utility of various non-invasive monitoring methods. The hypothesis of the project is that local inflammatory changes in the lung induced by allergen can be captured by gas-enhanced magnetic resonance imaging (MRI) and analysis of exhaled breath.The validation of cellular outcome measures and non-invasive inflammometry can be used in future clinical trials for proof of concept of novel anti-inflammatory medications.Participants will undergo* methacholine challenge* 2 inhaled allergen challenges* 2 MRI with hyperpolarized xenon and gadolinium based contrast agent* 2 bronchoscopies with bronchoalveolar lavage (BAL)* segmental allergen challenge during the first bronchoscopy* spirometry* skin prick test and skin prick dilution tests* measurement of particles in exhaled air* nasal filter* nasal lavage* sputum induction* peak flow meter tests* exhaled NO (nictric oxide)* blood sampling (in total approx. 190 ml) ### Conditions - Mild Allergic Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - allergen challenge ### Outcomes Primary Outcomes - Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, INF-alpha, MMP-9, CXCL1, SP-D, albumin] in Bronchoalveolar lavage (BAL) after segmental allergen challenge - Exploratory (1. priority) Changes in soluble mediators [i.e. IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin] in Sputum after inhalative allergen challenge - Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after inhalative allergen challenge - Exploratory (1. priority) Changes in non-invasive exhaled particles [i.e.IL-4, IL-5, IL-8, IL-13, IL-33, TSLP, IL-1, IL-6, NF-alpha, MMP-9, CXCL1, SP-D, albumin]after segmental allergen challenge - Exploratory (1. priority) Changes in cell analyzation in BAL [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after segmental allergen challenge - Exploratory (1. priority) Changes in cell analyzation in Sputum [i.e.total cells, neutrophil granulocytes, eosinophil granulocytes, basophil granulocytes, monocytes/macrophages, lymphocytes and dendritic cells] after inhalative allergen challenge Secondary Outcomes - Exploratory (2. priority) Detection of Ribonucleic acid (RNA) in exhaled particles - Exploratory (2. priority) Changes in Fractional exhaled nitric oxide (FeNO) after inhalative allergen challenge - Exploratory (2. priority) Changes in FeNO after segmental allergen challenge - Exploratory (2. priority) Quantification of regional ventilation, perfusion, and diffusion by magnetic resonance imaging (MRI) ### Location - Facility: Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Lower Saxony, 30625, Germany @@
## Value of Dynamic Monitoring of Early Recurrence of Hepatocellular Carcinoma After Radical Resection Based on CTCS - NCT ID: NCT06317896 - Study ID: 2024-KY-048-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Zhujiang Hospital ### Study Description On the basis of previous retrospective studies, the Task Force will further optimize the CTCs longitudinal surveillance model and initially validate the subclonal origin (CTC-DNA) of recurrent/metastatic foci derived from CTCs at the molecular level in hepatocellular carcinoma, prospective clinical trials will be conducted to further validate the predictive value of the CTCS longitudinal monitoring model in predicting postoperative recurrence of hepatocellular carcinoma, and to verify whether it is earlier than imaging to indicate recurrence, to explore the clinical feasibility of CTCs in guiding postoperative adjuvant therapy of liver cancer, and to provide new ideas for early intervention strategy of liver cancer after operation, to establish a set of standardized clinical scheme of auxiliary treatment for patients with liver cancer after operation for accurate and individualized"Early diagnosis and treatment". ### Conditions - Hepatocellular Carcinoma - Circulating Tumor Cell - Recurrence - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - circulating tumor cells ### Outcomes Primary Outcomes - 2-year recurrence-free survival rate Secondary Outcomes - Correlation between CTCs status dynamic changes and relapse - Correlation between metastasis，primary tumor and CTCs in blood through NGS and CTC-DNA ### Location - Facility: The Sixth Affiliated Hospital of South China University of Technology, Foshan, Guangdong, N/A, China @@
## Childhood Obesity Risk Assessment Longitudinal Study - NCT ID: NCT06317883 - Study ID: CORALS - Status: ACTIVE_NOT_RECRUITING - Start Date: 2019-05-27 - Completion Date: 2032-07-14 - Lead Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) ### Study Description Childhood obesity is a major public health problem worldwide. Europe has a high prevalence of obesity, which is accentuated in Mediterranean countries. Spain has a high prevalence of both overweight (percentage: 21.5 in boys and 22.2 in girls) and obesity (percentage: 10.6 in boys and 11.8 in girls) in children aged 6-9 years.From childhood, obesity is associated with an increased risk of diseases such as insulin resistance, type 2 diabetes, hypertension, metabolic syndrome, musculoskeletal problems, sleep disorders and mental health problems. Obesity is a complex, multi-causal problem involving individual risk factors such as behavior and genetics. Behavioral factors include diet, physical activity, sedentary lifestyle, sleep, and others. It is therefore important to study each of the individual risk factors for obesity. There are few large sample studies in European/Spanish children and no longitudinal studies estimating the incidence of obesity in preschool children based on exposure to different risk factors, considering not only the effect of food consumption but also dietary habits and patterns.The aim of the present study is to identify risk factors for childhood obesity through long-term longitudinal follow-up. ### Conditions - Child Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of dietary intake and habits - Assessment of physical activity, sedentary behavior and sleep pattern - Early risk factors - Body composition: Height - Body composition: Weight - Body composition: Body mass index - Body composition: Waist circumference - Psychosocial and neuropsychological behavioral assessment - Verbal fluency - Muscular strength - Cardiorespiratory endurance Secondary Outcomes - Association between genetic polymorphisms, metabolomic and metagenomic profiles with the development of obesity. - Body composition: Waist height - Body composition: Fat mass - Body composition: Fat mass index - Body composition: Fat-free mass - Body composition: Total body water - Systolic blood pressure measurement - Diastolic blood pressure measurement - Heart rate measurement - Hematological analysis: Hemoglobine - Hematological analysis: Hematocrite - Hematological analysis: Erythrocytes - Hematological analysis: Mean corpuscular volume - Hematological analysis: Mean corpuscular hemoglobin - Hematological analysis: Mean corpuscular hemoglobin concentration - Hematological analysis: Red cell blood distribution width - Hematological analysis: White blood cells - Hematological analysis: Neutrophils - Hematological analysis: Lymphocytes - Hematological analysis: Monocytes - Hematological analysis: Eosinophils - Hematological analysis: Basophiles - Hematological analysis: Platelets - Hematological analysis: Mean platelet volume - Biochemical analysis: Glucose - Biochemical analysis: Bilirubin - Biochemical analysis: Creatinine - Biochemical analysis: Urate - Biochemical analysis: Urea - Biochemical analysis: Total protein - Biochemical analysis: Aspartate aminotransferase - Biochemical analysis: Alanine aminotransferase - Biochemical analysis: Gamma-glutamyl transferase - Biochemical analysis: Alkaline phosphatase - Biochemical analysis: Total cholesterol - Biochemical analysis: High density lipoproteins - Biochemical analysis: Non-HDL cholesterol - Biochemical analysis: Low density lipoproteins - Biochemical analysis: Apolipoprotein A1 - Biochemical analysis: Apolipoprotein B - Biochemical analysis: Calcium - Biochemical analysis: Potassium - Biochemical analysis: Sodium - Biochemical analysis: Phosphorus - Biochemical analysis: Iron - Biochemical analysis: Magnesium - Biochemical analysis: Zinc - Biochemical analysis: Insulin - Biochemical analysis: Insulin resistance - Biochemical analysis: C-reactive protein - Biochemical analysis: Tumor necrosis factor alpha - Biochemical analysis: Adiponectin - Biochemical analysis: Energy - Biochemical analysis: Carbohydrates - Biochemical analysis: Sugars - Biochemical analysis: Fiber - Biochemical analysis: Polysaccharides - Biochemical analysis: Total fat - Biochemical analysis: Saturated fatty acids - Biochemical analysis: Monounsaturated fatty acids - Biochemical analysis: Polyunsaturated fatty acids - Biochemical analysis: Vitamin B1 - Biochemical analysis: Vitamin B2 - Biochemical analysis: Vitamin B3 - Biochemical analysis: Vitamin B6 - Biochemical analysis: Vitamin B9 - Biochemical analysis: Vitamin B12 - Biochemical analysis: Vitamin C - Biochemical analysis: Vitamin A - Biochemical analysis: Vitamin D - Biochemical analysis: Vitamin E - Biochemical analysis: Carotenes - Biochemical analysis: Retinol - Biochemical analysis: Water ### Location - Facility: University of Santiago de Compostela, Santiago De Compostela, La Coruña, 15782, Spain @@
## Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty - NCT ID: NCT06317870 - Study ID: CHUV_PENGIT - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Centre Hospitalier Universitaire Vaudois ### Study Description The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain.Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding. ### Conditions - Analgesia - Hip Arthropathy - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intrathecal morphine - Pericapsular nerve group block (PENG) ### Outcomes Primary Outcomes - Cumulative postoperative morphine consumption at day 1 Secondary Outcomes - Morphine consumption in the recovery room - PCA administered morphine consumption at day 2 - rest and dynamic pain scores - Incidence of postoperative nausea and vomiting - Incidence of pruritus - Incidence of urinary retention requiring bladder catheterisation - Duration of analgesia - operated limb quadriceps strength - Walking test ### Location - Facility: University Hospital of Lausanne, Lausanne, Vaud, 1011, Switzerland @@
## Clinical Performance of an Alkasite-based Restorative Material - NCT ID: NCT06317857 - Study ID: 14422021443228 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-30 - Lead Sponsor: Cairo University ### Study Description The evolution of restorative dental materials and technology has enabled the use of tooth-colored restorative materials in dental restorations, with all dentists hoping for the presence of materials that combine biocompatible qualities and aesthetics . Although resin composite materials' mechanical and aesthetic properties have greatly improved over the past 20 years, research is currently on to find ways to prevent secondary caries from forming beneath and at the margins of restorations. In order to circumvent these problems, there is a growing tendency towards the use of resin-based bioactive and remineralizing restorative materials to strengthen and lengthen the lifespan of bonded dental restorations. ### Conditions - Caries, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Centio Forte ### Outcomes Primary Outcomes - Retention success rate % with modified USPH criteria Secondary Outcomes - Marginal adaptation with modified USPH criteria marginal discolouration, recurrent caries, anatomic form and postoperative sensitivity. - Postoperative sensitivity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Examination of Psychological and Physiological Pathways Linking Gratitude and Pain - NCT ID: NCT06317844 - Study ID: BlackHillsHealthPsych - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2027-05 - Lead Sponsor: Black Hills State University ### Study Description The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes. ### Conditions - Acute Pain - Positive Thinking - Emotions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Behavioral Writing Intervention ### Outcomes Primary Outcomes - Change in Subjective Pain Ratings from Baseline to 10-minutes Post Cold Pressor Test - Differences in Pain Tolerance to Cold Pressor Test - Differences in Pain Onset to Cold Pressor Test Secondary Outcomes - Differences in Pain-Related Cognition - Differences in Autonomic Nervous System Responsivity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease - NCT ID: NCT06317831 - Study ID: 2023.03936.BDANA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-07-30 - Lead Sponsor: Aveiro University ### Study Description This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index. ### Conditions - Interstitial Lung Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Short physical performance battery (SPPB) Secondary Outcomes - Six Minute Walk Test (6MWT) - The 1-minute sit-to-stand - The grocery shelving task - The Physical Performance Test (PPT) - Handgrip strenght - Peripheral muscle strength - The Tilburg Frailty Indicator (TFI) - The Canadian Occupational Performance Measure (COPM) - Symptoms of fatigue - Symptoms of fatigue - Symptoms of dyspnoea - The Pulmonary Functional Status and Dyspnea Questionnaire Modified version (PFSDQ-M) - Health-related quality of life (HRQOL) - Health-related quality of life (HRQOL) - London Chest Activities of Daily Living (LCADL) - Daily physical activity - Qualitative data: Interviews - Number of hospitalizations - Acute exacerbations - Non-invasive ventilation - Oxygen therapy - Medication - Mortality ### Location - Facility: University of Aveiro, Aveiro, N/A, 3810-193, Portugal @@
## Is Local Injection of Mesenchymal Stem Cells After Endoscopic Dilation Safe and Does it Improve the Outcome of Intestinal Stricture in Patients With Crohn's Disease? - NCT ID: NCT06317818 - Study ID: TJT2301 - Status: RECRUITING - Start Date: 2023-06-06 - Completion Date: 2025-08 - Lead Sponsor: Centre Hospitalier Universitaire de Liege ### Study Description This is an exploratory phase II study, to evaluate the impact of these Mesenchymal Stem Cells (MSCs) on strictures in Crohn's disease patients with symptomatic intestinal stricture eligible to endoscopic dilatation. The impact of combined treatment by endoscopic dilation and local injection of MSCs will be compared with that of a control group. ### Conditions - Safety Issues - Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mesenchymal Stem Cells - Comparative placebo ### Outcomes Primary Outcomes - Assessment of safety of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease. - Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating symptomatic clinical response - Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating endoscopic response - Assessment of efficacy of local MSCs injection, in association with endoscopic dilation, in strictures of patients with Crohn's disease by evaluating radiological response Secondary Outcomes - Evaluation of studying, in addition to biomarkers (CRP and fecal calprotectin), ### Location - Facility: CHU de Liège, Liège, N/A, 4000, Belgium @@
## Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients - NCT ID: NCT06317805 - Study ID: TREV1-10P.401 - Status: RECRUITING - Start Date: 2023-12-06 - Completion Date: 2027-06-30 - Lead Sponsor: AOP Orphan Pharmaceuticals AG ### Study Description TripleTRE investigates the effect of initial triple combination therapy (oral endothelin receptor antagonist (ERA) + oral phosphodiesterase tyüe-5 inhibitor (PDE-5i) + parenteral treprostinil) compared to double oral therapy (oral ERA + oral PDE-5i) in pulmonary arterial hypertension (PAH) patients (group I) with intermediate-high risk or patients with intermediate-low risk with severe hemodynamic impairment at baseline in a prospective, randomized, unblinded setting with scope of increasing evidence for optimization of therapy concepts in PAH.The effect of initial triple combination therapy vs initial double oral therapy (standard of care (SoC)) will be measured by primary endpoint: (non)response to the assigned treatment. ### Conditions - Pulmonary Arterial Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Generic treprostinil sodium + Standard of Care (Double Oral) - Standard of Care - Double Oral ### Outcomes Primary Outcomes - Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status Secondary Outcomes - Change in hemodynamic parameters by means of right heart catheterization (RHC) - PVR - Change in hemodynamic parameters by means of right heart catheterization (RHC) - mPAP - Change in hemodynamic parameters by means of right heart catheterization (RHC) - mRAP - Change in hemodynamic parameters by means of right heart catheterization (RHC) - CI - Change in hemodynamic parameters by means of right heart catheterization (RHC) - CO - Change in hemodynamic parameters by means of right heart catheterization (RHC) - RAP - Change in right heart structure and function assessed by echocardiography - TAPSE/sPAP - Change in right heart structure and function assessed by echocardiography - RVEDA - Change in right heart structure and function assessed by echocardiography - RVESA - Change in right heart structure and function assessed by echocardiography - RVFAC - Change in right heart structure and function assessed by echocardiography - RA - Change in right heart structure and function assessed by echocardiography - Pericardial effusion - Time to achievement of low-risk status - Rate of change of risk status - Change in the number of low-risk criteria based on the French PH Network Registry (FPHR) risk assessment tool - Change in REVEAL 2.0 risk score - Rate of change in WHO-FC - Rate of change in 6MWD - Rate of change in NT-proBNP/BNP levels - Total number of clinical worsening(s) - Overall and transplant free survival - Rate of change in quality of life - emPHasis-10 - Rate of change in quality of life - EQ-5D-5L ### Location - Facility: Ordensklinikum Linz, Linz, N/A, N/A, Austria @@
## The Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease - NCT ID: NCT06317792 - Study ID: 202201719B0 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study. ### Conditions - Parkinsonism in Diseases Classified Elsewhere ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - online exergaming-based physiotherapy programs ### Outcomes Primary Outcomes - Unified Parkinson's Disease Rating Scale score assessment - Tinetti balance and gait score assessment Secondary Outcomes - Fall Risk assessment using Berg Balance Scale - Depression severity assessment ### Location - Facility: Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, N/A, 83304, Taiwan @@
## Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair - NCT ID: NCT06317779 - Study ID: abdominal laparotomy - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-01 - Lead Sponsor: Assiut University ### Study Description Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy. ### Conditions - Abdominal Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair Secondary Outcomes - Secondary outcomes measures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Histological Study of the Effects of a 2910 nm Fiber Laser Technology - NCT ID: NCT06317766 - Study ID: UC 20-2023 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-05 - Completion Date: 2024-05 - Lead Sponsor: FA Corporation ### Study Description The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device\'s capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.Part 1 Pre-Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.Part 2 Clinical Study Procedure:* 1 healthy adult (male or female)* 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.* Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.* The study team will utilize the specific setting based off the results of Part 1.* Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.* At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.* On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis. ### Conditions - Skin Laxity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation - 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation ### Outcomes Primary Outcomes - TUNEL Staining - Mason's Trichrome Secondary Outcomes ### Location - Facility: UT Soutwestern Medical Center, Dallas, Texas, 75390, United States @@
## Can Exercise Rewire the Brain Addiction Circuitry? - NCT ID: NCT06317753 - Study ID: UMinho1 - Status: NOT_YET_RECRUITING - Start Date: 2025-01 - Completion Date: 2027-12 - Lead Sponsor: University of Minho ### Study Description The aim of the present study is to apply neuroimaging techniques to investigate how physical exercise may influence the addiction circuitry, ultimately reducing alcohol consumption and craving in youth binge drinkers. This proposal will advance knowledge on how exercise may modulate the neurocircuitry of addiction. Uncovering the neurobiological mechanisms underlying the interactive neural effects of exercise and alcohol intake may provide additional scientific insights for the development of preventive and intervention programs for youth BD and AUD. ### Conditions - Physical Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Aerobic Exercise - Agility-Cognitive Exercise - Stretching/relaxation ### Outcomes Primary Outcomes - Behavioral: alcohol consumption - Behavioral: binge episodes - Behavioral : drunkenness - Psychological (craving levels) - Brain structure - Brain structural connectivity- FA - Brain structural connectivity - MD - Brain structural connectivity - AD - Brain structural connectivity - RD - Brain function - Brain function-resting state Secondary Outcomes - Monetary Incentive Delay Task (included in the fMRI paradigm) - hits - Monetary Incentive Delay Task (included in the fMRI paradigm) - reaction time - Maximal oxygen consumption (VO2max) - Brain-derived neurotrophic factor (BDNF) - Dopamine ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Green Management Intervention Program For Nurse Managers - NCT ID: NCT06317740 - Study ID: 0306369 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-12-31 - Lead Sponsor: Matrouh University ### Study Description Green management is the organization-wide strategy that aims to integrate environmental sustainability development into organizational management procedures for maintaining safety and striving high quality of care. The study aimed to examine the effect of a randomized trial of a green management intervention program on nurse manager outcomes. ### Conditions - Intervention - Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - green management intervention program ### Outcomes Primary Outcomes - Questionnaire to measure nurse managers' knowledge - Questionnaires to measure nurse manager outcomes Secondary Outcomes ### Location - Facility: Faculty of Nursing, Matrouh University, Marsa Matruh, N/A, 002, Egypt @@
## PULSed Field ablAtion of coloRectal Polyps - NCT ID: NCT06317727 - Study ID: IRAS 337105 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-05 - Lead Sponsor: King's College Hospital NHS Trust ### Study Description The goal of this observational study is to learn about the role of electroporation (the use of small electric pulses applied to tissue) in the treatment (ablation) of colorectal polyps. The main questions to answer in this pilot phase of the study are:1. The safety of pulsed field ablation (PFA) for the removal of colorectal polyps2. The efficacy and feasibility of PFA in the treatment of colorectal polyps using metrics such as treatment coverage, treatment time, post treatment fibrosis, post treatment recurrence and patient satisfaction ### Conditions - Colon Polyp ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Irreversible Electroporation using EndoVE(Endoscopic Vacuum Electrode) and electrical pulses generated using ePORE(electroporation device) ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events Secondary Outcomes - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Efficacy of pulsed field ablation in the treatment of colorectal polyps - Evaluation of Quality of Life following pulsed field ablation treatment of colorectal polyps ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Long-term Follow-up and Quality of Life of Patients Treated With Anticancer Drugs - NCT ID: NCT06317714 - Study ID: IR-2023/0002 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2027-03-08 - Lead Sponsor: Institut Rafael ### Study Description Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs. ### Conditions - Oncology - Quality of Life - Symptoms and Signs ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - questionnaires ### Outcomes Primary Outcomes - overall survival - progression free survival - incidence of adverse events - incidence of serious adverse events Secondary Outcomes - Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score - change from baseline in quality of life measured with the EQ5D5L questionnaire ### Location - Facility: Institute Rafaël, Levallois Perret, Institut Rafael, 92300, France @@
## Metabolic Endpoints for Obstructive Sleep Apnea Following Twelfth Cranial Nerve Stimulation - NCT ID: NCT06317701 - Study ID: IRB23-1801 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2028-04 - Lead Sponsor: University of Chicago ### Study Description The purpose of this study is to determine if the treatment of Obstructive sleep apnea (OSA) by hypoglossal nerve stimulation (HGNS) will alter glucose metabolism. The study team will also determine if the treatment of Obstructive sleep apnea (OSA) by (hypoglossal nerve stimulation) HGNS will alter predictors of cardiovascular outcomes. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hypoglossal Nerve Stimulation (HGNS) ### Outcomes Primary Outcomes - Glycemic variability - Mean systolic BP (daytime and nocturnal) - Glycemic variability Secondary Outcomes - mean blood glucose levels - mean ambulatory glucose excursions - time blocks - Morning fasting insulin, including calculated insulin resistance (HOMA-IR) - Mean norepinephrine levels - Morning fasting blood glucose - Hemoglobin A1c - Insulin levels - c-peptide levels - fasting lipid profile (triglycerides) - heart rate indices by activity monitor - sympathetic activity by plasma norepinephrine - Morning fasting insulin of c-peptide level - fasting lipid profile (HDL- cholesterol) - fasting lipid profile ( LDL-cholesterol) ### Location - Facility: The University of Chicago, Chicago, Illinois, 60637, United States @@
## Effectiveness of Highly Purified Anhydrous (HPA) Lanolin Versus Extra-Virgin Coconut Oil in Preventing Subacute Lactation Mastitis - NCT ID: NCT06317688 - Study ID: TWU IRB-FY2023-157 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-06 - Completion Date: 2024-08-14 - Lead Sponsor: Texas Woman's University ### Study Description Problem of the Study This study was designed to test the effectiveness of the application of extra-virgin coconut oil versus Highly Purified Anhydrous (HPA) Lanolin in ameliorating nipple pain, cracking and eventually the prevention of subacute lactation mastitis in breastfeeding women. It is theorized that the nipple crack, nipple pain are early warning signs of subacute clinical lactation mastitis. Goal is after application of extra-virgin coconut oil comparative analysis will be done at one week, three weeks, and six weeks. These complications associated with development of subacute mastitis can be addressed early during the first six weeks of lactation. ### Conditions - Lactation Mastitis - Breast Feeding - Staphylococcus Aureus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extra-Virgin Coconut Oil ### Outcomes Primary Outcomes - Measurement of change in pain level (Numeric Pain Rating Scale McCaffery, 1989) - Measurement of Development of Nipple Crack (Nipple Tenderness Scale Storr 1988) Secondary Outcomes ### Location - Facility: Harris Health System, Houston, Texas, 77030, United States @@
## Osteopathic Manipulative Treatment for Gastro-oesophageal Reflux Disease - NCT ID: NCT06317675 - Study ID: ct9873 - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2026-04 - Lead Sponsor: Studio Osteopatico Busto Arsizio ### Study Description To evaluate the effects of osteopathic manipulative treatment in patients affected by symptoms related to gastro-oesophageal reflux disease (GERD) ### Conditions - Gastro-oesophageal Reflux Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osteopathic manipulative treatment (OMT) ### Outcomes Primary Outcomes - Mean change in GERD-HRQL - Adverse effects Secondary Outcomes - Exercise adherence - Change in drugs use ### Location - Facility: CTFO, Saronno, Varese, 21047, Italy @@
## Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia - NCT ID: NCT06317662 - Study ID: NCI-2024-01994 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2027-12-21 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL. ### Conditions - Acute Leukemia of Ambiguous Lineage - B Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Asparaginase Erwinia chrysanthemi - Biospecimen Collection - Blinatumomab - Bone Marrow Aspiration - Calaspargase Pegol - Computed Tomography - Cyclophosphamide - Cytarabine - Daunorubicin - Dexamethasone - Doxorubicin - Echocardiography - FDG-Positron Emission Tomography - Leucovorin - Lumbar Puncture - Magnetic Resonance Imaging - Mercaptopurine - Methotrexate - Multigated Acquisition Scan - Pegaspargase - Prednisolone - Prednisone - Therapeutic Hydrocortisone - Thioguanine - Venetoclax - Vincristine ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (DLTs) (safety phase) - Incidence of DLTs (expansion phase) - Minimal residual disease (MRD)-negative remission rate Secondary Outcomes - Event free survival (EFS) rates of infants with KMT2A-R acute lymphoblastic leukemia (ALL) - 3-year EFS of infants with KMT2A-R ALL - Proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance - Pharmacokinetics (PK) of venetoclax in infants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) - NCT ID: NCT06317649 - Study ID: NCI-2024-01987 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2025-10-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Azacitidine - Biospecimen Collection - Bone Marrow Aspiration - Bone Marrow Biopsy - Gilteritinib - Venetoclax ### Outcomes Primary Outcomes - Rate of measured residual disease (MRD) negative complete remission (CR) Secondary Outcomes - Overall survival - Event-free survival - Incidence of adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression - NCT ID: NCT06317636 - Study ID: 73487 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Stanford University ### Study Description The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during sedation in adults with chronic pain and depression. This study aims to:* Evaluate whether ketamine is more effective than a placebo in treating chronic pain and depression* Confirm that propofol sedation is a safe way to keep participants blinded to treatment* Assess patients' comfort with the sedation process to improve future studies* Explore whether patient expectations affects their pain and depressionParticipants will:* Need to qualify for the study based on stringent medical criteria* Undergo sedation with propofol* Randomly receive either a ketamine or a placebo (saline) infusion during sedation* Complete several study assessments over 5-7 weeks ### Conditions - Chronic Pain - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketamine - Normal saline ### Outcomes Primary Outcomes - Pain Intensity (past 24 hours) Secondary Outcomes - Depression severity - Pain Intensity (current) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Urinary Tract Dilations in Prenatal and Postnatal Life - NCT ID: NCT06317623 - Study ID: 0292/21/2023-00590 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2026-06 - Lead Sponsor: SonoClinic ### Study Description The goals of this study are to use a questionnaire survey to determine the state of awareness of the diagnosis and management of patients with urinary tract dilation across several medical professionals, to predict the severity of the postnatal course and surgical intervention in fetuses with urinary tract dilation detected during pregnancy, and to create a model of prenatal and postnatal care for patients with dilation of the urinary tract for multidisciplinary use. ### Conditions - Urinary Tract Dilatation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prenatal and postnatal ultrasound examination ### Outcomes Primary Outcomes - The goal is the prediction of severe postnatal course and surgical intervention in fetuses with dilatation of the urinary tract according to the UTD classification created in 2014. Secondary Outcomes ### Location - Facility: Svetlana Jánošová, Záborské, N/A, 08253, Slovakia @@
## Artificial Intelligence Model for Growth Prediction of Ovarian Cancer Organoids - NCT ID: NCT06317610 - Study ID: CQGOG0206 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-05-30 - Lead Sponsor: Chongqing University Cancer Hospital ### Study Description The present study aims to collect early bright field image of patient-derived organoids with ovarian cancer. By leveraging artificial intelligence, this study will seek to construct and refine algorithms that able to predict growth of ovarian cancer organoids. ### Conditions - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - growth prediction of ovarian cancer organoids in the frame of bright field image by leveraging AI ### Outcomes Primary Outcomes - AUC of growth prediction performance using deep learning model - Accuracy of growth prediction using deep learning model Secondary Outcomes ### Location - Facility: Chongqing Cancer Hospital, Chongqing, Chongqing, 400030, China @@
## Efficacy of Short Time Intervals in Split-Dose Bowel Preparation of Oral Sulfate Solution for Colonoscopy - NCT ID: NCT06317597 - Study ID: OSS2024-0311 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-15 - Completion Date: 2024-12-30 - Lead Sponsor: Changhai Hospital ### Study Description To evaluate whether oral sulfate solution administered in a short time interval (6-8 hours) between the first and last dose of laxative is not inferior to a long time interval (10-12 hours) in bowel preparation quality. ### Conditions - Colonoscopy: Bowel Preparation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution - Magnesium Sulfate，Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution ### Outcomes Primary Outcomes - Bowel preparation adequate rate Secondary Outcomes - Acceptability of bowel preparation by questionnaire survey ### Location - Facility: Changhai Hospital, Shanghai, N/A, N/A, China @@
## Empowerment-based Complementary and Alternative Medicine (ECAM) - NCT ID: NCT06317584 - Study ID: NMRPF3M0042 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-31 - Lead Sponsor: Chang Gung University of Science and Technology ### Study Description This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes. ### Conditions - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Experimental: Empowerment Application for CAM Health Education - Written Paper for CAM Health Education ### Outcomes Primary Outcomes - Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire - Quality of life questionnaire - Diabetes Empowerment scale Secondary Outcomes - Blood Glucose (GLU) - Glycated Hemoglobin(HbA1c) - ALanine aminoTransferase，Glutamic Pyruvic Transaminase(ALT/GPT) - ASpartate aminoTransferase，Glutamic Oxaloacetic Transaminase (AST/GOT) - Blood Urea Nitrogen(BUN) - Creatinine(CREA) - High Density Lipoprotein(HDL) - Total Bilirubin(T.BIL) - Serum total cholesterol(TC) - Triglyceride (TG) - Glomerular filtration rate(GFR) - Albumin to Creatinine Ratio (ACR) ### Location - Facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou, Taoyuan City, Guishan District, 333, Taiwan @@
## Evaluation of The Effect of Fertility Support Education Given to Infertile Couples - NCT ID: NCT06317571 - Study ID: CelalBayarU-SBF-OT-01 - Status: COMPLETED - Start Date: 2021-03-15 - Completion Date: 2022-08-10 - Lead Sponsor: Celal Bayar University ### Study Description The aim of the this study was to evaluate the effect of fertility support education given to infertile couples before treatment. ### Conditions - Infertility ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - fertility support education ### Outcomes Primary Outcomes - Infertility Stress Scale - Infertility Self-Efficacy Scale-Short Form - Fertility Readiness Scale - Fertiqol Quality of Life Scale - Blood cortisol level Secondary Outcomes ### Location - Facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi, Manisa, N/A, 45060, Turkey @@
## Real-world Clinical Outcomes of NSCLC Patients Receiving Neoadjuvant Immunotherapy - NCT ID: NCT06317558 - Study ID: 22/492-3694 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description The goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of different neoadjuvant immunotherapies in NSCLC patients using the real-world data. The main questions it aims to answer are:* What the best setting for immune checkpoint inhibitors as the neoadjuvant treatment?* How to determine the subgroups of patients benefit from neoadjuvant immunotherapy? Participants will receive neoadjuvant immunotherapy the study will analyze the real-world data. ### Conditions - NSCLC ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neoadjuvant immunotherapy - Other drugs for neoadjuvant treatment ### Outcomes Primary Outcomes - Pathological Complete Response (pCR) - Disease-free survival(DFS) Secondary Outcomes - OS (overall survival) - EFS (event-free survival) - Major Pathological Response (MPR) - Relapse Patterns ### Location - Facility: Shugeng Gao, Beijing, Beijing, 100020, China @@
## Effects of Nerchal Exercises on Lateral Epicondylitis. - NCT ID: NCT06317545 - Study ID: REC/RCR&AH/23/0167/shan ali - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-03-28 - Lead Sponsor: Riphah International University ### Study Description Painful condition of lateral epicondyle of the humerus characterized by the inflammation of the tendons during loading of the wrist extensor muscles is a common musculoskeletal presentation in men and women between 35 and 54 years of age. The above symptom is associated with a clinical diagnosis of lateral elbow tendinopathy (LET), also known as tennis elbow or lateral epicondylalgia the two effective treatment approaches for lateral epicondylitis are Nirschl exercises and Mulligan taping. This study aims to evaluate the effectiveness of Nirschl exercises with or without Mulligan taping in treating lateral epicondylitis. The study design for this project employs a randomized controlled trial and a sample of individuals with lateral epicondylitis randomly assigned in one of the two groups i.e., Nirschl exercises only and Nirschl exercises with Mulligan taping. Nirschl exercises involve the eccentric strengthening of the wrist extensor muscles and forearm. The participants in both groups will receive Nirschl exercises while the second group will also receive Mulligan taping, which involves the application of tape to the lateral aspect of the elbow to offload stress during movement of the extensor tendons. Different outcome measures including pain intensity, functional disability, grip strength, range of motion will be evaluated using, PRTEE Scale, Visual Analogue Scale (VAS) and Calibrated Jammer hand held dynamometer. Statistical analysis, including independent t-tests or chi-square tests, will be conducted to compare the outcomes between the two groups. The significance level will be set at p \< 0.05. This study will contribute to the evidence base regarding the efficacy of Nirschl exercises and Mulligan taping in managing lateral epicondylitis and will help the clinicians and patients in deciding the best treatment approach for lateral epicondylitis. ### Conditions - Lateral Epicondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mulligan Taping ### Outcomes Primary Outcomes - Pain intensity - Grip strength Secondary Outcomes - Disability ### Location - Facility: BARKI Advanced Physiotherapy Center, Multan, Punjab, 60000, Pakistan @@
## Effect of Functional Exercises on Pain and Quality of Life in Females With Primary Dysmenorrhea - NCT ID: NCT06317532 - Study ID: P.T.REC/012/004766 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-05-20 - Lead Sponsor: Cairo University ### Study Description The aim of the study will be to investigate the effect of functional exercises on pain and quality of life in females with primary dysmenorrhea. ### Conditions - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lifestyle modification advice - Functional exercises ### Outcomes Primary Outcomes - Visual analogue scale (VAS) - The Menstrual Distress Questionnaire Secondary Outcomes - Quality of life enjoyment and satisfaction questionnaire - Pressure pain threshold assessment ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## Verify the Performance in Clinical Practice of the Immersive Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab) - NCT ID: NCT06317519 - Study ID: 09.2020-Oss - Status: RECRUITING - Start Date: 2021-04-12 - Completion Date: 2026-04-12 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description Gait pattern difficulties, balance and coordination deficits often characterize patients with congenital and acquired neuromotor disorders and have a significant impact on the quality of life of these subjects. There are various treatments used and in recent years, the advent of advanced technologies in rehabilitation and, in particular, devices based on virtual reality, has opened up new possibilities in rehabilitation. Virtual reality is a promising strategy that incorporates many principles crucial to motor learning, such as high-intensity, repetitive, goal-oriented tasks, enhanced synchronized sensory signals, and active participation. The virtual environment is also suitable for personalized treatment based on the needs of the individual patient.The GRAIL (Gait Real-time Analysis Interactive Lab) is a device that integrates immersive virtual reality with an instrumented treadmill and a motion capture system, which can be used with both rehabilitation and evaluation goals. To date, there are still few studies of this device in the pediatric field.The objective of the study is to verify the performance in clinical practice of the immersive virtual reality platform GRAIL and determine any secondary effects by evaluating whether they entail acceptable risks compared to the expected performances following the protocol defined at the IRCCS Medea by Bosisio Parini, in children and adolescents with congenital and acquired neuromotor pathology.Patients suffering from acquired and congenital brain injuries undergo a combined rehabilitation treatment consisting of 20 sessions with GRAIL and 20 physiotherapy sessions in four weeks. The same subjects undergo evaluations before and at the end of the treatmentThe study is prospective and involves the verification of performance through clinical and instrumental evaluations in the population of subjects treated with the GRAIL device at the IRCCS Medea-Bosisio Parini. ### Conditions - Acquired Brain Injury - Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Physical Rehabilitation - Gait Real-time Analysis Interactive Lab ### Outcomes Primary Outcomes - 6 minute walking test - Gross Motor Function Measure -total score Secondary Outcomes ### Location - Facility: Scientific Institute IRCCS Eugenio Medea, Bosisio Parini, Lecco, 23842, Italy @@
## Methylation Pattern and Pain Sensation in Children With Intellectual Disability - NCT ID: NCT06317506 - Study ID: RC 43/2022 - Status: COMPLETED - Start Date: 2022-05-30 - Completion Date: 2023-10-10 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Previous literature data indicate that children with intellectual disability (ID) experience more severe pain and more frequently than their cognitively healthy peers, during their daily life. Repeated and chronic pain exposure triggers a vicious circle of hyperalgesia and reduction of the impaired cognitive and adaptive function. Furthermore, these children are unable to rationalize any intervention targeted to contain potentially painful actions.Epigenetics studies mechanisms responsible for a set of modifications that regulate gene expression without altering the DNA sequence itself. DNA methylation and posttranslational modification of histones are the main epigenetic mechanisms. It is widely accepted that these mechanisms can be engaged by environmental experience, such as early life trauma, pain or addiction leading to the idea of epigenetics as 'a bridge' between genes and environment.Several epigenetic studies evaluated genes coding proteins involved in recycling of neurotransmitters (SCL6A4), in transmission of painful stimuli (TRPA1) and in response to analgesics (OPRM1). In particular, some studies assessed TRPA1 gene, coding for a cationic channel responsible for the transmission of thermal-painful sensations, and SCL6A4, a serotonin-recycling transmembrane protein presents at inter-synaptic level, have highlighted the importance of methylation in a pathological experience of chronic pain and anxiety disorder in the adult population. Opioid receptor OPRM1 is involved in the endogenous and exogenous opioid-mediated analgesia and a recent work in a group of adolescents treated for idiopathic scoliosis highlights a link between greater pain post-surgery and methylation of this gene. In this context, children with ID are at greater risk of undertreatment both for the difficulty in pain recognition and for the fear of medication-adverse reactions.The epigenetic study of the aforementioned genes in children with ID associated with an evaluation of painful experiences and clinical history, could help understanding a scenario that it is still complex nowadays before the eyes of parents and caregivers and healthcare workers.The finding of a different methylation pattern in children with ID could in part explain the different pain experience. ### Conditions - Intellectual Disability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Between groups differences in methylation levels Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment - NCT ID: NCT06317493 - Study ID: RC 15/2021 - Status: RECRUITING - Start Date: 2021-01-03 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description The results of the previous study on auditory effort in young children with cochlear implants show that pupils respond to the presence or the absence of the perceived stimuli. The investigators hypothesize that the perceived sounds will elicit increased pupil dilation compared to the non-perceived sounds and that the hearing threshold as measured with pure tone audiometry will correlate to the results in pupillometry test. The investigators hypothesize that the effect will be visible in all testing groups albeit the relative increase of pupil size with age. Hypothesis confirmed, the investigators will develop a standardised procedure for the auditory signal detection using pupillometry. Such a procedure could represent an important bridge between automatic and behavioral hearing tests. With a more precise test of auditory threshold of young children, post-operative monitoring and fitting of cochlear implants or hearing aids, and rehabilitation procedures, could be considerably more targeted and consequentially more efficient. ### Conditions - Hearing Impaired Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Stimuli ### Outcomes Primary Outcomes - Sensitivity index of pupillometry test Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Outcomes Comparison Between Bone Resection and Subperiosteal Dissection for Specific Type of Soft Tissue Sarcoma - NCT ID: NCT06317480 - Study ID: QH_2024 - Status: COMPLETED - Start Date: 2000-05-01 - Completion Date: 2023-09-01 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description the purpose of this study is to assess whether bone resection for thigh soft tissue sarcoma with cortical involvement of the adjacent bone result in better local control and survival compared to sub-periosteal dissection. Investigators also aim to find out the prognostic factors for clinical outcomes in this group of patients. ### Conditions - Soft Tissue Sarcoma - Cortical Contact ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - bone resection - subperiosteal excision ### Outcomes Primary Outcomes - survival - recurrence - metastasis Secondary Outcomes - functional outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Anti-C1q Autoantibodies in Pregnancy - NCT ID: NCT06317467 - Study ID: RC 01/2023 - Status: RECRUITING - Start Date: 2023-09-13 - Completion Date: 2026-12 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE.C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy.Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear ### Conditions - Pre-Eclampsia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sampling - Blood sampling ### Outcomes Primary Outcomes - Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies - Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## Determinants of Metabolic Control in Children With Type 1 Diabetes Mellitus - NCT ID: NCT06317454 - Study ID: GR-2019-12369573 - Status: RECRUITING - Start Date: 2021-11-11 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS Burlo Garofolo ### Study Description A good metabolic control of type 1 diabetes mellitus (T1DM) is crucial to avoid long-term complications associated with the disease. Although recent evidences suggest that a good metabolic control of T1DM is partly independent of management intensity and could be anticipated since onset, factors that influence glycated haemoglobin (HbA1c) patterns remain poorly understood and are likely to be genetic.While significant progress has been made in understanding of the genetic contribution to T1DM onset, very few studies have evaluated the role of genetic factors on T1DM metabolic control.This study aims to create a comprehensive database of genetic and phenotypic data in a cohort of children and young adults with T1DM and to evaluate genetic and environmental factors that might predict trajectories in glycemic control ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood and saliva analysis ### Outcomes Primary Outcomes - Identification of environmental factors affecting T1DM metabolic control - Identification of genetic factors affecting T1DM metabolic control Secondary Outcomes ### Location - Facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", Trieste, N/A, 34137, Italy @@
## The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms - NCT ID: NCT06317441 - Study ID: NIMCSF137 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Nimble Science Ltd. ### Study Description In this study, the goal is to evaluate whether a probiotic formula may reduce symptoms of bloating and abdominal distension in a population suffering from Small Intestinal Bacterial Overgrowth (SIBO) in comparison to a placebo. In addition to the incidence of SIBO, changes to other gastrointestinal symptoms will be assessed. Lastly, the associations between the SIBO status and microbiome from the small and large intestines will be explored using the SIMBA capsule. ### Conditions - Small Intestinal Bacterial Overgrowth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic ### Outcomes Primary Outcomes - Change in bloating/distension severity Secondary Outcomes - Median bloating-free days - Change in median bloating/distension severity - Change in abdominal discomfort/pain - Changes in gastrointestinal symptoms - Changes in stool frequency and consistency - Changes in the quality of life - Changes in reflux incidence and severity - Changes in the severity of IBS symptoms - Recovery rate of the probiotic strain - Microbiome changes within small intestine, fecal and saliva samples - Investigation how the microbiome and SIBO associate with each other though bacterial population analyses. - Change in SIBO positivity rate ### Location - Facility: Nimble Science, Calgary, Alberta, T2L 1Y8, Canada @@
## NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD. - NCT ID: NCT06317428 - Study ID: INRCA_001_2024 - Status: RECRUITING - Start Date: 2022-06-28 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani ### Study Description Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy. ### Conditions - COPD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in serum NT-pro-BNP levels Secondary Outcomes ### Location - Facility: INRCA Hospital, Ancona, N/A, N/A, Italy @@
## Intervention on Non-prescription Antibiotic Use Among the Public - NCT ID: NCT06317415 - Study ID: HuazhongU20240312 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2024-03-01 - Lead Sponsor: Huazhong University of Science and Technology ### Study Description The purpose of this study is to test the effectiveness of health education int led by community health workers for non-prescription antibiotic use among the public. In this two arm cluster randomised trial, In this two-arm cluster randomized controlled trial, 22 communities were randomly allocated in a 1:1 ratio to intervention and control groups. In the intervention group, family doctors will conduct WeChat-based health education on responsible use of antibiotic for the participants. In the control group, only routine public health education will be provided without any involvement in antibiotic use. The primary outcome is the incidence of antibiotic use without prescription in the past month. ### Conditions - Non-Prescription Drug Misuse - Antibiotic Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - WeChat-based health education on antibiotic use - Regular public health education ### Outcomes Primary Outcomes - Rate of non-prescription antibiotic use among the public Secondary Outcomes ### Location - Facility: Fuyong People's Hospital, Shenzhen, Guangdong, 518103, China @@
## Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods) - NCT ID: NCT06317402 - Study ID: APHP240133 - Status: RECRUITING - Start Date: 2024-03-09 - Completion Date: 2025-09-09 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age \<70 years) and 2021 (if age ≥ 70 years). ### Conditions - Malnutrition ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - malnutrition questionary ### Outcomes Primary Outcomes - Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients. Secondary Outcomes - Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years). - Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL. ### Location - Facility: Service de nutrition, Hôpital Pitié-Salpêtrière, Paris, N/A, 75013, France @@
## PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments - NCT ID: NCT06317389 - Study ID: 69HCL23_1237 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2037-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic drug risks. These medicinal problems or Drug Related Problems DRP linked to ATCO are sources of dosage modifications and lead to sub-therapeutic doses compared to clinical trials and consequently to a reduction, in life actual, dose-intensity and expected response. Furthermore, insufficiently controlled in an ambulatory environment and due to a lack of city-hospital coordination, DRPs lead to an increase in the consumption of care.Oncoral is the pioneering multidisciplinary city-hospital monitoring of outpatients treated with oral anticancer drugs. Set up in 2014 by the Hospices Civils de Lyon, this educational monitoring is based on a tripartite hospital intervention (oncologist, pharmacist, nurse) and a structured city-hospital link with private health professionals (attending doctor, community pharmacist and freelance nurse). Multidisciplinary interventions are focused on PROs and DRPs and combine an educational approach for the patient based on their needs and potential social vulnerabilities.The PACOME real-life database will describe the population of ambulatory patients treated by ATCO benefiting from the secure multidisciplinary city-hospital Oncoral pathway with the aim of improving knowledge on this population, on the real-life use of ATCO and on new methods of organizing ambulatory cancer care.The PACOME database collects sociodemographic, clinical and therapeutic data, and experiences in this population. Patients quality of life and other PROs (symptoms and adverse effects experienced by patients), social determinants, health care consumption, the caregiver-patient relationship, the use of digital technology in health, the organization of care, the city-hospital link (interventions of actors and their temporality).This base will make it possible to optimize the treatment of patients at the individual and population level and to generate evidence in addition to clinical trials, which are expected by health professionals and decision-makers. With patient data from the secure Oncoral pathway, PACOME brings together the three major and inseparable assets of real-life databases: quality, completeness and meaning of the data. It constitutes a basis for essential academic and private collaborations for studies on data and comparative observational or interventional studies, which will contribute to the animation of the new ecosystem of real-life health data in oncology. ### Conditions - Cancer - Oncology - Oncoral Program ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Questionnaires ### Outcomes Primary Outcomes - Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs Secondary Outcomes ### Location - Facility: Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique, Pierre-Bénite, N/A, 69495, France @@
## Group-based Cardiac Rehabilitation on Patients With Coronary Artery Bypass Graft Surgery - NCT ID: NCT06317376 - Study ID: REC/014131 Maria Haseen - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2024-01-18 - Lead Sponsor: Riphah International University ### Study Description 1. To determine the effect of Moderate intensity continuous training on Pulmonary function of CABG patients.2. To determine the effect of MICT on aerobic Capacity of CABG patients. ### Conditions - Post-cardiac Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MICT with Aerobic exercise on treadmill - standard hospital protocol ### Outcomes Primary Outcomes - Borg rating of perceived exertion scale - 6min walk test Secondary Outcomes ### Location - Facility: RMI, Peshawar, N/A, N/A, Pakistan @@
## Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients - NCT ID: NCT06317363 - Study ID: REC/RCR&AHS/23/0353 - Status: COMPLETED - Start Date: 2023-05-23 - Completion Date: 2024-02-15 - Lead Sponsor: Riphah International University ### Study Description Coronary artery bypass grafting (CABG) is a surgical procedure that is performed to improve blood flow to the heart by bypassing blocked or narrowed arteries. CABG is a major surgery that is associated with significant postoperative complications, including pulmonary complications such as atelectasis and pneumonia. Chest physiotherapy is commonly use to prevent and treat these complications, but its effectiveness in post-operative CABG patients is not well established.The purpose of this study is to evaluate the effects of Acapella device vs chest physiotherapy on pulmonary function, airway clearance and dyspnea in post-operative CABG patients. The group A will receive (baseline treatment aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition to using Acapella), while the group B will receive base line treatment. aerosol therapy, ACBT, Mobilization, breathing with arm elevation with addition chest physiotherapy percussing for 20 minute The primary outcome measures of the study will be pulmonary function tests, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and FEV1/FVC, and Modified Borg dyspnea scale . The secondary outcome measures will be the amount of sputum cleared. The study will be conducted over a period of 6 months after approval of synopsis.The study will be conducted in a tertiary care hospital in Lahore, Pakistan. Patients who have undergone CABG surgery will be screen for eligibility and those who meet the inclusion criteria will be enroll in the study. Patients who have a history of chronic lung disease, smoking, intubated patient or other respiratory conditions will be exclude from the study ### Conditions - CABG ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Base Line + ACEPELLA - Base Line + Manual Chest Physiotherapy ### Outcomes Primary Outcomes - Modified Borg Dyspnea Scale - FEV1 - FVC - FEV1/FVC - sputum volume Secondary Outcomes - body temperature(degree centigrade) - pulse rate (beats/minute) - respiratory rate( breaths/minute) - blood pressure (mmHg) - SpO2 (%) - SaO2 (%) - PaO2 (%) - PaCO2 (%) ### Location - Facility: Jinnah Hospital, Lahore, Punjab, 54600, Pakistan @@
## Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy - NCT ID: NCT06317350 - Study ID: GNS-212-E - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-03-31 - Lead Sponsor: Gunkang Pharmaceuticals, Inc ### Study Description This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial. ### Conditions - Colonoscopy - Bowel Preparation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GNS-212-E1 - GNS-212-E2 - GNS-212-ER ### Outcomes Primary Outcomes - To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale) Secondary Outcomes - Overall rate of bowel preparation - Overall patient satisfaction and compliance ### Location - Facility: Seoul National University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Focused Ultrasound Cavitation Augmented With Aerobic Exercise - NCT ID: NCT06317337 - Study ID: Sana Bshir - Status: COMPLETED - Start Date: 2022-04-15 - Completion Date: 2023-07-15 - Lead Sponsor: Riphah International University ### Study Description This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life. ### Conditions - Central Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - focused ultrasound cavitation augmented with aerobic exercises ### Outcomes Primary Outcomes - Borg rating of perceived exertion scale - girth - 6min walk test Secondary Outcomes ### Location - Facility: Bioflex Aesthetic Clinic, Peshawar, KPK, N/A, Pakistan @@
## Compare the Prognostic Differences Between SBRT and Surgery for NSCLC Patients With Interlobular Fissure Invasion. - NCT ID: NCT06317324 - Study ID: bc2023200 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2026-08-01 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description The goal of this observational study is to compare the prognostic differences between SBRT and Surgery for NSCLC patients with interlobular fissure invasion. The main questions it aims to answer are:1. Explore the survival differences.2. Explore of the lung function changes before and after different treatments. ### Conditions - NSCLC - Radiotherapy - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Different treatments ### Outcomes Primary Outcomes - OS - PFS - MRFS - LRFS Secondary Outcomes - VC - FVC - FEV1 - DLCO - PFR ### Location - Facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin, 300060, China @@
## A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recurrent Endometrial Cancer - NCT ID: NCT06317311 - Study ID: 221968 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2027-08-31 - Lead Sponsor: GlaxoSmithKline ### Study Description The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer ### Conditions - Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dostarlimab - Carboplatin - Paclitaxel ### Outcomes Primary Outcomes - Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR) Secondary Outcomes - DRR12 per RECIST 1.1, assessed by investigator - Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator - Overall survival (OS) - Overall response rate (ORR) per RECIST 1.1 assessed by BICR - ORR per RECIST 1.1 assessed by investigator - Disease control rate (DCR) per RECIST 1.1 assessed by BICR - DCR per RECIST 1.1 assessed by investigator - Duration of response (DOR) per RECIST 1.1 assessed by BICR - DOR per RECIST 1.1 assessed by investigator - Maximum concentration (Cmax) for dostarlimab - Minimum concentration (Cmin) for dostarlimab - Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity - Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation - Number of participants with AEs leading to death ### Location - Facility: GSK Investigational Site, Aichi, N/A, 464-8681, Japan @@
## Fruquintinib Plus Everolimus as 2nd Line Therapy of ccRCC Patients Progressed Post IO and TKI Therapy - NCT ID: NCT06317298 - Study ID: 2023-013-CH01 IIT-RCC - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2025-12-01 - Lead Sponsor: Peking University First Hospital ### Study Description This study will assess the efficacy and safety profile of fruquintinib in combination with everolimus as second line therapy of clear cell renal cell carcinoma patients who progressed after immunotherapy and tyrosine kinase inhibitor. ### Conditions - Renal Cell Carcinoma, Clear Cell, Somatic ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fruquintinib and Everolimus ### Outcomes Primary Outcomes - MTD (Maximum Tolerated Dose) - ORR (Objective Response Rate) Secondary Outcomes - PFS (Progression Free Survival) - DCR (Decease Control Rate ) ### Location - Facility: Peking University First Hospital, Beijing, N/A, N/A, China @@
## A Study to Evaluate the Efficacy and Safety of GSK3915393 in Participants With Idiopathic Pulmonary Fibrosis (IPF) - NCT ID: NCT06317285 - Study ID: 220929 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03-19 - Lead Sponsor: GlaxoSmithKline ### Study Description Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants. ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GSK3915393 - Placebo ### Outcomes Primary Outcomes - Absolute Change from Baseline in Forced Vital Capacity (FVC) in milliliters (mL) at Week 26 Secondary Outcomes - Absolute Change from Baseline in Forced Vital Capacity (mL) at Weeks 4, 8, 12 and 18 - Absolute Change from Baseline in Percent Predicted Forced Vital Capacity (%) at Weeks 4, 8, 12, 18 and 26 - Participants Achieving Relative Decline from Baseline in FVC (mL) Less than or Equal to (≤) 5 Percent (%) at Week 26 - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Number of Participants with Clinically Important Findings in Vital Signs - Number of Participants with Clinically Important Findings in Electrocardiogram (ECG) - Number of Participants with Clinically Important Findings in Haematology - Number of Participants with Clinically Important Findings in Hepatobiliary Parameters - Number of Participants with Clinically Important Findings in Clinical Chemistry - Maximum observed concentration (Cmax) of GSK3915393 in IPF Participants - Area under the time-concentration curve (AUC) from Zero (pre-dose) to 4 hours (h) post-dose sample [0-4 h]) of GSK3915393 - Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC- inf) of GSK3915393 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma - NCT ID: NCT06317272 - Study ID: RT2016-04-BROTHER Part 1 - Status: TERMINATED - Start Date: 2021-02-10 - Completion Date: 2023-09-19 - Lead Sponsor: University Medical Center Groningen ### Study Description The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study. ### Conditions - Esophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - DIBH using ABC technique - DIBH using VC technique ### Outcomes Primary Outcomes - Feasibility DIBH - Reproducibility DIBH Secondary Outcomes ### Location - Facility: UMC Groningen, Groningen, N/A, N/A, Netherlands @@
## Effects of Hypoxic Breathwork - NCT ID: NCT06317259 - Study ID: 809163 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: University of California, San Diego ### Study Description This project will study changes that occur during a short period of intensive daily slow-paced breathing and breath hold practice (i.e., "breathwork"). On the first and last days of the week-long practice, investigators will conduct high-density EEG recordings during breathwork to evaluate spectral power, coherence, and causality dynamics of the brain when it is naïve to breathwork and after adaptation to a breathwork practice. Breath, blood, urine, saliva, stool samples, biometric data, and sleep EEG will be collected before the start of daily breathwork practice and again after 1 week of breathwork practice to examine the effect of breathwork on full body biochemistry, molecular biology, and sleep. Investigators will also use questionnaires to assess the impact of breathwork on stress and sleep quality. ### Conditions - Hypoxic Breathwork With Music and Affirmative Messaging - Hypoxic Breathwork Only - Music and Affirmative Messaging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypoxic breathwork plus music and messaging - Hypoxic breathwork only - Music and messaging meditation ### Outcomes Primary Outcomes - EEG power and/or connectivity differences between groups - Group differences in sleep EEG power and/or stage changes from baseline to the intervention period Secondary Outcomes - Group differences between physiological changes in proteomics, microbiome, and other factors from baseline following intervention - Group differences in mood and stress from before to after the intervention ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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