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## Quality of Life in Patients With Hemorrhagic Telangiectasia - NCT ID: NCT06261333 - Study ID: 23-11519-BO - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-22 - Completion Date: 2025-12-31 - Lead Sponsor: University Hospital, Essen ### Study Description Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used. ### Conditions - Hereditary Hemorrhagic Telangiectasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires ### Outcomes Primary Outcomes - Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire Secondary Outcomes ### Location - Facility: Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen, Essen, NRW, 45147, Germany @@
## Mesotherapy Treatment of Irritable Bowel Syndrome - NCT ID: NCT06261320 - Study ID: 2023-506950-18-00 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2026-01-31 - Lead Sponsor: Polyclinique de l'Europe ### Study Description Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate ### Outcomes Primary Outcomes - Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS) Secondary Outcomes - Functional Digestive Disorders Quality of Life questionnaire (FDDQL) - Pain evaluation - Global satisfaction - Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale" ### Location - Facility: Polyclinique de l'Europe, Saint-Nazaire, N/A, 44600, France @@
## Language Development Deficits and Early Interactive Music Intervention - NCT ID: NCT06261307 - Study ID: 13462111 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2027-03 - Lead Sponsor: University of Helsinki ### Study Description Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated. ### Conditions - Dyslexia, Developmental - Language Development Disorders - Language Development ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Music intervention - Circus intervention ### Outcomes Primary Outcomes - Infant-Toddler Checklist (ITC) - MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo - Mismatch response (MMR) speech, amplitude - Mismatch response (MMR) speech, latency - Mismatch response (MMR) speech, laterality - Obligatory event-related potential (ERP) speech, amplitude - Obligatory event-related potential (ERP) speech, latency - Obligatory event-related potential (ERP) speech, laterality Secondary Outcomes - Infant-Toddler Checklist (ITC) follow-up - MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up - Mismatch response (MMR) speech, amplitude follow-up - Mismatch response (MMR) speech, latency follow-up - Mismatch response (MMR) speech, laterality follow-up - Obligatory event-related potential (ERP) speech, amplitude follow-up - Obligatory event-related potential (ERP) speech, latency follow-up - Obligatory event-related potential (ERP) speech, laterality follow-up - Reynell Developmental Language Scales III (RDLS-III) - Infant Behavior Questionnaire Revised short form (IBQ-R-sf) - Early Childhood Behavior Questionnaire short form (ECBQ-sf) - Parenting Stress Index Short Form (PSI-sf) - Brief Infant-Toddler Social Emotional Assessment (BITSEA) ### Location - Facility: University of Helsinki, Helsinki, N/A, 00014, Finland @@
## OncoSweep Cancer Spotlight and Spectrum Product Line - NCT ID: NCT06261294 - Study ID: CPIP-LUN-A001 - Status: RECRUITING - Start Date: 2023-05-23 - Completion Date: 2026-03-20 - Lead Sponsor: Pharus Taiwan, Inc. ### Study Description CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line' ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OncoSweep Lung Spotligh ### Outcomes Primary Outcomes - To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight. Secondary Outcomes ### Location - Facility: Mackay Memorial Hospital, Taipei, Zhongshan Dist, 104217, Taiwan @@
## Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient - NCT ID: NCT06261281 - Study ID: TBI cancel - Status: WITHDRAWN - Start Date: 2024-02-10 - Completion Date: 2024-07-10 - Lead Sponsor: Zeng Changhao ### Study Description This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Intermittent Oro-esophageal Tube Feeding - Nasogastric tube feeding ### Outcomes Primary Outcomes - Concentration of hemoglobin - Concentration of albumin - Concentration of prealbumin - Nutritional status-body mass index Secondary Outcomes - Decannulation of tracheostomy tube-placement duration - Decannulation of tracheostomy tube-Successful removal - Level of consciousness - Feeding Amount ### Location - Facility: Zheng Da yi Yuan Hospital, Zhengzhou, Henan, 450000, China @@
## Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa - NCT ID: NCT06261268 - Study ID: Strip vs FGG - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2025-07-15 - Lead Sponsor: Universidad Complutense de Madrid ### Study Description The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM.Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS). ### Conditions - Peri-Implantational Loss - Surgical Wound - Healing Surgical Wounds - Thin-gingiva ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Strip graft with Mucograft - Free gingival graft ### Outcomes Primary Outcomes - Changes in peri-implant keratinized mucosa width (mm) Secondary Outcomes - Vascularization (in Laser Speckle perfusion units [LSPU]) - Changes in soft tissue thickness (STT) (mm) - Vestibule depth (VD) (mm) - Probing pocket depth (PPD) (mm) - Dehiscence (mm) - Full-mouth plaque score (FMPS) - Volumetric changes - Patient reported outcome measures (PROMS) - Esthetic analysis - Intra-surgical parameters - Intra-surgical time - Demographic data - Anamnesis data - Smoking habit - Full-mouth bleeding score (FMBS) (%) ### Location - Facility: Complutense University, Madrid, N/A, 28040, Spain @@
## Autotransplantation and Enamel Matrix Derivatives Case Series - NCT ID: NCT06261255 - Study ID: ATT_CS - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2023-12-01 - Lead Sponsor: Universidad Complutense de Madrid ### Study Description The goal of this prospective case series is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level.The main question it aims to answer is:- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus. ### Conditions - Tooth Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATT + EMD ### Outcomes Primary Outcomes - Clinical attachment level (CAL) Secondary Outcomes ### Location - Facility: Universidad Complutense de Madrid, Madrid, N/A, 28003, Spain @@
## Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment - NCT ID: NCT06261242 - Study ID: TWM-C-2201 - Status: RECRUITING - Start Date: 2023-06-16 - Completion Date: 2025-07-31 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures. ### Conditions - Osteoporotic Vertebral Compression Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix) ### Outcomes Primary Outcomes - Proportion of participants with study success Secondary Outcomes ### Location - Facility: National Cheng Kung University Hospital Department of Orthopedics, Tainan, N/A, 704, Taiwan @@
## The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients - NCT ID: NCT06261229 - Study ID: MURA2022/230 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-04-18 - Completion Date: 2024-06-30 - Lead Sponsor: Mahidol University ### Study Description This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.The study protocol will be explained to the eligible participant and informed written consent will be obtained.The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease. ### Conditions - Intermittent Fasting - Weight Loss - Behavioral Economic - Obese - HOMA-IR ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent fasting - Intermittent fasting + Behavioral economic - Intensive Lifestyle Modification ### Outcomes Primary Outcomes - HOMR-IR (index) - Body mass index (kg/m^2) Secondary Outcomes - FBS (mg/dl) - HbA1C (%) - Albumin (g/L) - Creatinine (mg/dL) - Alanine transaminase (ALT) U/L - Aspartate transaminase (AST) U/L - Uric acid (mg/dL) - Total cholesterol (mg/dL) - HDL-C (mg/dL) - LDL-C (mg/dL) - Triglycerides (mg/dL) - Blood Urea Nitrogen (BUN) (mg/dL) - Urine albumin-creatinine ratio (UACR) (mg/g) - Energy from food (kilocalories) ### Location - Facility: Mahidol University, Ratchathewi, Bangkok, 10400, Thailand @@
## Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy - NCT ID: NCT06261216 - Study ID: 01/2023/LPA-wtATTR/NVNS - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2025-02 - Lead Sponsor: Medical University of Graz ### Study Description The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy. ### Conditions - Amyloid Cardiomyopathy - Wild Type ATTR Amyloidosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - Association between lifetime physical activity and disease development Secondary Outcomes - Association between lifetime athletic activity and disease development ### Location - Facility: Medical University of Graz, Graz, N/A, N/A, Austria @@
## Low Dose Aspirin for Prevention of Early Pregnancy Loss - NCT ID: NCT06261203 - Study ID: Hany Hosny - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2025-07-15 - Lead Sponsor: Egymedicalpedia ### Study Description Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries ### Conditions - Pre-Eclampsia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Aspirin ### Outcomes Primary Outcomes - Prevention of pregnancy loss Secondary Outcomes ### Location - Facility: Assuit University hospitals, Asyūţ, Assuit, N/A, Egypt @@
## Active Surveillance for Low-risk Papillary Thyroid Carcinoma - NCT ID: NCT06261190 - Study ID: H-2308-182-1463 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2032-12-31 - Lead Sponsor: National Cancer Center, Korea ### Study Description This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer. ### Conditions - Thyroid Cancer - Papillary Thyroid Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Progression free survival of the patients with low-risk Papillary Thyroid Cancer who choose Active Surveillance Secondary Outcomes - Disease progression - Rate of Participants in the Active Surveillance Group that change to surgery without disease progression - Comparison of Quality of Life between the Active Surveillance group and immediate surgery group - Measure of Anxiety and Depression - Measure of Satisfaction with the treatment - Factors influencing patients' decisions regarding disease management ### Location - Facility: National Cancer Center, Goyang-si, N/A, N/A, Korea, Republic of @@
## Take-home Functional Electrical Stimulation for MDD - NCT ID: NCT06261177 - Study ID: 22-175 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-04 - Completion Date: 2025-03 - Lead Sponsor: Unity Health Toronto ### Study Description The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery. ### Conditions - MDD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Functional Electrical Stimulation (FES) - Sham FES ### Outcomes Primary Outcomes - Feasibility of the FES for MDD - Tolerability and safety of the FES for MDD Secondary Outcomes - Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17) - Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16) - Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7) - Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5) - Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI) ### Location - Facility: St. Michael's Hospital, Toronto, Ontario, N/A, Canada @@
## Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients - NCT ID: NCT06261164 - Study ID: 01-19-373- 2/23 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-01-31 - Lead Sponsor: University Clinical Centre of Republic of Srpska ### Study Description The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. ### Conditions - Sepsis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cytosorb® and Oxiris® adsorbents ### Outcomes Primary Outcomes - Development of population pharmacokinetic model Secondary Outcomes ### Location - Facility: Department of Medical Intensive Care Medicine, Banja Luka, N/A, 78000, Bosnia and Herzegovina @@
## Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy - NCT ID: NCT06261151 - Study ID: Zhongshan-HHY-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention. ### Conditions - Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Clinical data collection ### Outcomes Primary Outcomes - The preoperative nutritional status of elderly patients underwent gastrectomy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Survival Analysis: TACE vs. Combination Therapy in HCC - NCT ID: NCT06261138 - Study ID: RSR-HCC-2019-001 - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2023-10-31 - Lead Sponsor: Zhejiang University ### Study Description This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transarterial chemoembolization - Systemic treatment ### Outcomes Primary Outcomes - Progression Free Survival (PFS) per mRECIST Secondary Outcomes - 12 months PFS rate - Overall survival (OS) - Objective Response Rate (ORR) per mRECIST - Disease Control Rate (DCR) per mRECIST - Adverse events (AEs) ### Location - Facility: First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, Zhejiang, 310003, China @@
## Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401) - NCT ID: NCT06261125 - Study ID: SL-B2023-718 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2028-06-30 - Lead Sponsor: Mian XI ### Study Description Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stereotactic body radiotherapy - Adebrelimab - Lenvatinib ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Overall response rate (ORR) - Disease control rate (DCR) - Duration of response (DOR) - Treatment-related adverse events ### Location - Facility: Mian Xi, Guangzhou, Guangdong, 510060, China @@
## The Effect of Using a Kaleidoscope on Fear and Pain in Children - NCT ID: NCT06261112 - Study ID: B.30.2.ATA.01.11/285 - Status: RECRUITING - Start Date: 2022-05-07 - Completion Date: 2024-05-01 - Lead Sponsor: Mihriban Culha ### Study Description The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data. ### Conditions - Fracture; Complication Orthopedic Procedure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - kaleidescope ### Outcomes Primary Outcomes - Child Fear Scale (CFS) Secondary Outcomes - Facial Expressions Rating Scale ### Location - Facility: Ataturk University, Erzurum, N/A, 25240, Turkey @@
## Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients - NCT ID: NCT06261099 - Study ID: 037 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2025-11-27 - Lead Sponsor: Suleyman Demirel University ### Study Description Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic. ### Conditions - Stroke, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - control + working group ### Outcomes Primary Outcomes - Mini Mental Test - Fugl Meyer Motor Function Scale - Laser-pointer Assisted Angle Reproduction Test - Modified Barthel Index - Reaching Performance Scale Secondary Outcomes ### Location - Facility: Güler Ertuğrul, Kocaeli, İ̇zmi̇t, N/A, Turkey @@
## Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study - NCT ID: NCT06261086 - Study ID: soh-med-24-01-06MS - Status: NOT_YET_RECRUITING - Start Date: 2024-02-24 - Completion Date: 2024-08-24 - Lead Sponsor: Sohag University ### Study Description Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.It can affect ethnic groups and people of all skin types with no predilection (4).Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo. ### Conditions - Vitiligo ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) ### Outcomes Primary Outcomes - GASDM-D - IL 1β - IL-18 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients - NCT ID: NCT06261073 - Study ID: Soh-Med-24-01-08MS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-01 - Lead Sponsor: Sohag University ### Study Description Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling. ### Conditions - Vitiligo ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - blood sample and tissue biopsy ### Outcomes Primary Outcomes - Cathepsin L Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder - NCT ID: NCT06261060 - Study ID: 2023-0918 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2028-06-11 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD. ### Conditions - Familial Platelet Disorder - Hematopoietic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sirolimus ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer - NCT ID: NCT06261047 - Study ID: SDZLEC2023-389-02 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Shandong Cancer Hospital and Institute ### Study Description Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches. ### Conditions - Hepatocellular Carcinoma - Radiotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - radiotherapy ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes - Overall response rate - Overall survial - Disease control rate - Duration of control ### Location - Facility: Jinbo Yue, Jinan, Shandong, 250000, China @@
## A Study of Sex Differences in Neurocirculatory Control - NCT ID: NCT06261034 - Study ID: 23-008765 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-03 - Lead Sponsor: Mayo Clinic ### Study Description The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA). ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Blood pressure - Arterial stiffness - Endothelial function Secondary Outcomes - Sympathetic nerve burst frequency - Sympathetic nerve burst incidence - Sympathetic nerve burst amplitude (AU) - Total muscle sympathetic nerve activity (MSNA) ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus - NCT ID: NCT06261021 - Study ID: INNO-6051 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-02 - Lead Sponsor: Innovaderm Research Inc. ### Study Description This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. ### Conditions - Discoid Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ruxolitinib 1.5% cream - Application without occlusion in Area 1 - Application under occlusion at night in Area 2 - Application under occlusion at night in Area 1 - Application without occlusion in Area 2 ### Outcomes Primary Outcomes - Change from baseline in target lesion CLASI-A score Secondary Outcomes - Change from baseline in target lesion CLASI-A score - Proportion of subjects with an erythema score of 0 (absent) - Change from baseline in target lesion SADDLE-A - Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear) ### Location - Facility: Innovaderm Research Inc., Montréal, Quebec, H2X 2V1, Canada @@
## Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening - NCT ID: NCT06261008 - Study ID: 2023.553 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-06-26 - Lead Sponsor: Chinese University of Hong Kong ### Study Description In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour. ### Conditions - CRC, Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - TI group ### Outcomes Primary Outcomes - adherence rate Secondary Outcomes - the number of days to repeat FIT - costs incurred in each study arm - uptake rate in positive FIT - detection rate in positive FIT - qualitative factors associated with repeat FIT adherence ### Location - Facility: Centre of Digestive Health, Prince of Wales Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol - NCT ID: NCT06260995 - Study ID: Ref: 230603 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-06-30 - Lead Sponsor: University of Dublin, Trinity College ### Study Description Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time.This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future. ### Conditions - Physical Inactivity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Social Prescribing Link Worker Intermediary Intervention - Local Sports Partnership Community Development Officer Intervention ### Outcomes Primary Outcomes - International Physical Activity Questionnaire - Short Form - Self-Efficacy for Exercise Scale - Short Warwick Edinburgh Mental Well-being Scale Secondary Outcomes - Demographics and Health Status - Semi-structured Interviews - Intervention Participants - Overall Acceptability of the Intervention - Gatekeeper Recruitment Logs - Semi-structured Interviews - Gatekeepers ### Location - Facility: University of Dublin, Trinity College Dublin, Dublin 8, N/A, D08 W9RT, Ireland @@
## Cognitive Disorders in Hereditary Spastic Paraplegia Type 4 - NCT ID: NCT06260982 - Study ID: 2021PI148 - Status: RECRUITING - Start Date: 2022-01-01 - Completion Date: 2025-01-02 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized. ### Conditions - Spastic Paraplegia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 18-FDG-PET ### Outcomes Primary Outcomes - cognitive testing Secondary Outcomes - Correlations between neuropsychological tests, clinical examination, PET and general data. - Genotype/Phenotype correlations ### Location - Facility: Centre hospitalier régional universitaire, Nancy, N/A, 54000, France @@
## Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis - NCT ID: NCT06260969 - Study ID: TJHH-2023-WM13 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2025-09-30 - Lead Sponsor: Tianjin Huanhu Hospital ### Study Description The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment. ### Conditions - Large Vessel Occlusion - Intracranial Artery Occlusion With Cerebral Infarction - Endovascular Treatments - Acute Ischemic Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - balloon dilatation ### Outcomes Primary Outcomes - Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days Secondary Outcomes - Proportion of patients with a good prognosis early after treatment - Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR - Vascular recanalization ### Location - Facility: Tianjin Huanhu Hospital, Tianjin, Tianjin, N/A, China @@
## Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg - NCT ID: NCT06260956 - Study ID: U01-ROC-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2029-09 - Lead Sponsor: University of Rochester ### Study Description Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding. ### Conditions - Allergy and Immunology - Peanut and Nut Allergy - Egg Allergy - Food Allergy in Infants - Food Allergy Peanut ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Avoidance - Consumption ### Outcomes Primary Outcomes - Egg sensitization Secondary Outcomes - Peanut and egg specific IgG and IgG4 - Antibodies in maternal blood - Egg allergy - Antigen concentrations ### Location - Facility: University of Rochester, Rochester, New York, 14642, United States @@
## Targeted Navigation in Hepatocellular Carcinoma (HCC) - NCT ID: NCT06260943 - Study ID: 20221220 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2026-10-31 - Lead Sponsor: University of Miami ### Study Description The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment. ### Conditions - Hepatocellular Carcinoma - Cholangiocarcinoma - Hepatobiliary Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Target Navigation Pilot Program ### Outcomes Primary Outcomes - Number of Days to First Contact - Number of Hours for Each Contact - Number of Days to First Appointment - Number of Days to First Treatment - Number of Months of Total Navigation - Number of Participants that Die Within One Year - Proportion of Participants Enrolled in Clinical Research Secondary Outcomes ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Value of Chest Ultrasonography in ILD Screening - NCT ID: NCT06260930 - Study ID: Value of chest ultrasonography - Status: COMPLETED - Start Date: 2017-01 - Completion Date: 2019-12 - Lead Sponsor: Aswan University ### Study Description The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation. ### Conditions - Interstitial Lung Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sensitivity and specificity of the lung sonography for interstitial lung disease screening Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS - NCT ID: NCT06260917 - Study ID: E2-23-4148 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2023-12-31 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined. ### Conditions - Benign Prostatic Hyperplasia - Micturition Disorder - Urinary Obstruction - Urinary Tract Disease - Urologic Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - position of urination ### Outcomes Primary Outcomes - Qmax - PVR - Qave - Duration of voiding Secondary Outcomes ### Location - Facility: Ankara Bilkent City Hospital, Ankara, N/A, N/A, Turkey @@
## Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus - NCT ID: NCT06260904 - Study ID: AIIMS BBSR/PGThesis/23-24/112 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2025-05-31 - Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar ### Study Description Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients. ### Conditions - Oral Lichen Planus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Prednisolone - Apremilast - Methotrexate ### Outcomes Primary Outcomes - Pain by Visual Analogue Scale (VAS) score Secondary Outcomes - Severity by Physician global assessment of disease (PGA) score - Severity and pain by oral mucosal disease severity score - serum IL 6 level - Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 ) - Incidence of treatment-emergent adverse events of both test and control group ### Location - Facility: AIIMS Bhubaneswar, Bhubaneswar, Odisha, 751019, India @@
## Zinc Supplementation in Sickle Cell Disease - NCT ID: NCT06260891 - Study ID: ZnSCD - Status: NOT_YET_RECRUITING - Start Date: 2025-04-01 - Completion Date: 2026-09-30 - Lead Sponsor: University of California, San Francisco ### Study Description The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS. ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 25 mg/day zinc - 40 mg/day zinc ### Outcomes Primary Outcomes - Biomarker of Bone Formation (PINP) - Biomarker of Bone Resorption (CTx) Secondary Outcomes - Biomarker of Bone Formation (BSAP) - Biomarker of Bone Resorption (TRAP 5b) ### Location - Facility: UCSF Benioff Children's Hospital Oakland, Oakland, California, 94609, United States @@
## Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis - NCT ID: NCT06260878 - Study ID: REB23-0625 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2028-06-30 - Lead Sponsor: University of Calgary ### Study Description This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative. ### Conditions - Post-ERCP Acute Pancreatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intravenous Ringer's lactate ### Outcomes Primary Outcomes - Serum amylase Secondary Outcomes - Pancreatitis - Bleeding - Cholangitis - Cardiorespiratory adverse event - Serum lipase - Electrolytes - Creatinine - Brain natriuretic peptide ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome - NCT ID: NCT06260865 - Study ID: E-ETH-01K-CI02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2024-08-30 - Lead Sponsor: EverEx Inc. ### Study Description This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome. ### Conditions - Patellofemoral Pain Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MORA Cure - Treatment as Usual ### Outcomes Primary Outcomes - Usual pain severity assessed by the Visual Analogue Scale (VAS) Secondary Outcomes - Usual pain severity assessed by the Visual Analogue Scale (VAS) - Worst pain severity assessed by the Visual Analogue Scale (VAS) - Functional disability assessed by the Kujala Patellofemoral Scale - Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D) - Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) - Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS) - Flexion and extension strength of knee - Treatment adherence ### Location - Facility: Myongji Hospital, Goyang-si, Gyeonggi-do, 10475, Korea, Republic of @@
## Identification of Minimum Focal Points in Vision Curve Formation - NCT ID: NCT06260852 - Study ID: ES20/Th8/23-11-2023 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-08 - Lead Sponsor: Democritus University of Thrace ### Study Description The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery. ### Conditions - Presbyopia - Pseudophakia - Cataract - Refractive Errors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Diagnostic Test: Visual Acuity Assessment ### Outcomes Primary Outcomes - Visual curves interpolation - Area of the curve (AOC) assessment - Visual acuity assessment Secondary Outcomes ### Location - Facility: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Evros, 68100, Greece @@
## the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography - NCT ID: NCT06260839 - Study ID: KY20232442-F-1 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-12-31 - Lead Sponsor: He Xiang ### Study Description The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). The main question it aims to answer are: magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture.Participants will underwent preoperative magnetic resonance examination according to different groups, and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings. In the control group, preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture, and the magnetic resonance results were not used to assist in the design of surgical approach. In the control group, non-MRN-assisted minimally invasive release was performed. The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect. ### Conditions - Orthopedic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - magnetic resonance neurography - no magnetic resonance neurography ### Outcomes Primary Outcomes - Hip joint outcome score(HOS) scale - Objective hip function scoring scale Secondary Outcomes - Hip joint function of patients - Imaging data of patients with gluteal muscle contracture - Record the duration of the patient 's surgery - The record of the length of the surgical incision of the patient - Measurement of intraoperative blood loss - The first ambulation time after operation - postoperative pain score - Postoperative patients were satisfied with the appearance - The record of postoperative wound infection - The occurrence of postoperative wound fat liquefaction - Postoperative wound peripheral nerve vascular injury - Postoperative incision hematoma formation ### Location - Facility: Xijing Hospital, the Fourth Military Medical University, Xian, Shaanxi, 710032, China @@
## CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery - NCT ID: NCT06260826 - Study ID: 3977/QĐ-HVQY - Status: COMPLETED - Start Date: 2021-12-01 - Completion Date: 2022-08-30 - Lead Sponsor: Nguyen Dang Thu ### Study Description Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery. ### Conditions - Continuous Positive Airway Pressure - Pulmonary Function - Older People ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Auto CPAP via nasal mask (JPAP machine) - Constant CPAP via facial mask (O2-Max Trio system) ### Outcomes Primary Outcomes - The oxygenation-PaO2/FiO2 Secondary Outcomes - The forced vital capacity (FVC) - The forced expiratory volume in the first second-FEV1 - The FEV1/FVC ratio - The peak expiratory flow-PEF ### Location - Facility: VietXo Friendship Hospital, Hanoi, N/A, 12108, Vietnam @@
## Biomechanical and Morphological Characterization of PTTD - NCT ID: NCT06260813 - Study ID: S66277 - Status: RECRUITING - Start Date: 2022-08-22 - Completion Date: 2028-08-01 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity.Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint).Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients.The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients. ### Conditions - Posterior Tibial Tendon Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Radiography - Ultrasound - MRI - CT-scan - Gait analysis ### Outcomes Primary Outcomes - Kinematic characteristics during Gait analysis - Center of pressure during Gait analysis - Angular velocity during Gait analysis - Moment during Gait analysis - Power absorption during Gait analysis - Power generation during Gait analysis - Bone morphology Secondary Outcomes - American Orthopaedic Foot & Ankle Society (AOFAS) score - European Foot and Ankle Society (EFAS) score - 36-item Short Form Health Survey (SF36) - Visual Analogue Scale (VAS) pain - Visual Analogue Scale (VAS) satisfaction ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Spanish Version of Credibility and Expectancy Questionnaire in Patients With Musculoskeletal Injuries - NCT ID: NCT06260800 - Study ID: PI 23-3405 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-11-30 - Lead Sponsor: University of Valladolid ### Study Description Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire. ### Conditions - Validation Study ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Validation CEQ ### Outcomes Primary Outcomes - Content validity - Construct validity - Reliability - Criterion validity Secondary Outcomes ### Location - Facility: Silvia Lahuerta Martín, Soria, N/A, 42004, Spain @@
## Clinical Profiles And In Vitro Fertilization Success - NCT ID: NCT06260787 - Study ID: OBGY-202401.01 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Universitas Padjadjaran ### Study Description This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021. ### Conditions - in Vitro Fertilisation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In Vitro Fertilisation ### Outcomes Primary Outcomes - Pregnancy rate Secondary Outcomes ### Location - Facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran, Bandung, Jawa Barat, 40161, Indonesia @@
## Study of TTX-MC138 in Subjects With Advanced Solid Tumors - NCT ID: NCT06260774 - Study ID: TTX-MC138-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2027-02-01 - Lead Sponsor: TransCode Therapeutics ### Study Description A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TTX-MC138 ### Outcomes Primary Outcomes - Dose Escalation - Adverse Events - Dose Escalation - Overall Response Rate (ORR) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT - NCT ID: NCT06260761 - Study ID: Dh3108103/64 - Status: COMPLETED - Start Date: 2021-10-05 - Completion Date: 2023-02-05 - Lead Sponsor: Police General Hospital, Thailand ### Study Description The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches. ### Conditions - Radius; Fracture, Lower or Distal End ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MIPO - Conventional ### Outcomes Primary Outcomes - Pain Visual analogue scale Secondary Outcomes - Quick Disabilities of the Arm, Shoulder and Hand - Grip strength - Pinch strength - Range of motion - Aesthetics - Satisfy - Volar tile - ulnar variance - radial inclination - operation time - skin incision - morphine IV use - complication ### Location - Facility: Police general hospital, Pathum Wan, Bangkok, 10330, Thailand @@
## A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX) - NCT ID: NCT06260748 - Study ID: LBI-CDCA-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Leadiant Biosciences, Inc. ### Study Description This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA. ### Conditions - Cerebrotendinous Xanthomatoses ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chenodeoxycholic acid - Chenodeoxycholic acid Placebo ### Outcomes Primary Outcomes - Change from baseline at Week 4 in average number of stools with a BSS score of 6 or 7 per day Secondary Outcomes - Change in plasma cholestanol levels from baseline to Week 12 - Change in urine and/or plasma bile alcohol levels from baseline to Week 12 - Incidence of, severity/intensity of, and relationship to study drug of AEs - Incidence of, severity/intensity of, and relationship to study drug of SAEs - Incidence of, severity/intensity of AESIs - Incidence of, severity/intensity of, and changes in laboratory values - Incidence of, severity/intensity of, and changes in physical examination - Incidence of, severity/intensity of, and changes in vital signs - Number of participants with discontinuations due to AEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Non-invasive Spinal Cord Stimulation After Spinal Cord Injury - NCT ID: NCT06260735 - Study ID: HS25897 (H2023:073) - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2024-11-15 - Lead Sponsor: University of Manitoba ### Study Description Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods. ### Conditions - Spinal Cord Injuries - Spinal Cord Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Trans-spinal electrical stimulation - Electrical muscle activation - Treadmill walking ### Outcomes Primary Outcomes - Neurophysiological markers or stepping - Electromyography (EMG) of ankle extensor muscles - Metabolic function testing Secondary Outcomes - 6 Min Walk Test - SCIM-Spinal Cord Independence Measure- Mobility scores - Autonomic scores - Rate or Perceived Exertion (RPE) of Submaximal VO2 testing ### Location - Facility: University of Manitoba, Winnipeg, Manitoba, R3E 0W2, Canada @@
## Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) - NCT ID: NCT06260722 - Study ID: 18805 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2027-03-30 - Lead Sponsor: Eli Lilly and Company ### Study Description The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Retatrutide - Semaglutide ### Outcomes Primary Outcomes - Change from Baseline in Hemoglobin A1c (HbA1c) (%) Secondary Outcomes - Change from Baseline in HbA1c (%) - Percentage of Participants Who Achieve HbA1c ≤ 6.5% - Percentage of Participants Who Achieve HbA1c < 5.7% - Percent Change from Baseline in Body Weight - Change from Baseline in Body Weight - Percentage of Participants Who Achieve Weight Reduction of ≥ 5% - Percentage of Participants Who Achieve Weight Reduction of ≥ 10% - Percentage of Participants Who Achieve Weight Reduction of ≥ 15% - Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction - Percent Change from Baseline in Triglycerides - Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol - Change from Baseline in Systolic Blood Pressure (SBP) ### Location - Facility: University of Alabama - Department of Nutrition Sciences, Birmingham, Alabama, 35294, United States @@
## A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis - NCT ID: NCT06260709 - Study ID: NN6019-7565 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2028-02-29 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years). ### Conditions - Transthyretin Amyloid Cardiomyopathy (ATTR CM) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NNC6019-0001 ### Outcomes Primary Outcomes - Number of Treatment Emergent Adverse Events Secondary Outcomes - Change in 6-Minute Walk Test (6MWT) - Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) - Change in Myocardial Extracellular Volume (ECV) - Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) - Change in Troponin I - Change in Global Longitudinal Strain (GLS) on Echocardiography ### Location - Facility: Mayo Clinic Arizona, Phoenix, Arizona, 85054, United States @@
## Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender - NCT ID: NCT06260696 - Study ID: DAS-7626 - Status: COMPLETED - Start Date: 2023-08-10 - Completion Date: 2023-10-05 - Lead Sponsor: Novo Nordisk A/S ### Study Description The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life. ### Conditions - Overweight - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No treatment is given ### Outcomes Primary Outcomes - Score on IWQOL-Lite validated Secondary Outcomes ### Location - Facility: Novo Nordisk Investigational Site, Dubai, N/A, N/A, United Arab Emirates @@
## A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior - NCT ID: NCT06260683 - Study ID: OSU-22240 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2027-04-29 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health. ### Conditions - Cigarette Smoking-Related Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nicotine Replacement - Questionnaire Administration - Vaping - Vaping ### Outcomes Primary Outcomes - Biochemically verified 7-day point prevalence abstinence from cigarettes - Switching rate Secondary Outcomes - Cigarettes smoked per day - Change in nicotine dependence - Changes in cigarette craving and nicotine withdrawal - Number of days used - Product appeal - Continued purchase and use of ECs ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation - NCT ID: NCT06260670 - Study ID: CP0004 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2022-10-28 - Lead Sponsor: Ablacon, Inc. ### Study Description FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions. ### Conditions - Persistent Atrial Fibrillation - Longstanding Persistent Atrial Fibrillation - Atrial Fibrillation, Persistent - Arrhythmias, Cardiac ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter ### Outcomes Primary Outcomes - Descriptive correlation of electrogram patterns Secondary Outcomes ### Location - Facility: Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum), Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany @@
## Search for Olfactory Cells Within the Fetal Ethmoid Epithelium - NCT ID: NCT06260657 - Study ID: 2021PI124 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-10 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis.In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base.The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population.This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa. ### Conditions - Fetal Ethmoidal Mucosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Histological analysis on fetal ethmoids ### Outcomes Primary Outcomes - Immunohistological positive signal of primary olfactive neurons Secondary Outcomes - Concentration of primary olfactory neurons immunohistological signals ### Location - Facility: Centre Hospitalier Régional Universitaire - Service ORL, Nancy, N/A, N/A, France @@
## Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial) - NCT ID: NCT06260644 - Study ID: Repairing defective composite - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-10 - Lead Sponsor: Cairo University ### Study Description This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months. ### Conditions - Occlusal Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VertiseTM flowable composite (Kerr,USA) ### Outcomes Primary Outcomes - Restoration clinical performance using FDI criteria Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Cairo, N/A, 113311, Egypt @@
## Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain - NCT ID: NCT06260631 - Study ID: P.T.REC/012/004807 - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-08 - Lead Sponsor: Cairo University ### Study Description The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP). ### Conditions - Chronic Nonspecific Low-back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - high-intensity laser acupuncture and Exercise therapy program - Sham laser acupuncture ### Outcomes Primary Outcomes - peak torque - peak torque - Average Power - Average Power Secondary Outcomes - Pain Intensity - Pain Intensity - lumbar flexion and extension ROM assessment - lumbar flexion and extension ROM assessment - Disability - Disability - patient Satisfaction - patient Satisfaction ### Location - Facility: Doaa Ayoub Elimy, Giza, N/A, 11251, Egypt @@
## Effect of Chitodex Gel in Tympanoplasty Surgery - NCT ID: NCT06260618 - Study ID: 2021/HRE00065 - Status: RECRUITING - Start Date: 2021-11-20 - Completion Date: 2024-05-13 - Lead Sponsor: Central Adelaide Local Health Network Incorporated ### Study Description The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP). ### Conditions - Tympanic Membrane Perforation - Tympanic Membrane Inflammation - Surgery - Otitis Media ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Gelfoam - Chitodex ### Outcomes Primary Outcomes - Number of participants with tympanic membrane closure - rate of tympanic membrane closure Secondary Outcomes - Number of participants with improved hearing - Number of participants with improved eardrum function - Ease of use of product compared to active comparator - surgeon feedback - Time taken to complete surgery - Number of Participants with improved quality of life ### Location - Facility: The Queen Elizabeth Hospital, Adelaide, South Australia, 5011, Australia @@
## Complications of Diabetes With Puzzles - NCT ID: NCT06260605 - Study ID: Burcu Bayrak 1 - Status: COMPLETED - Start Date: 2023-12-19 - Completion Date: 2024-03-04 - Lead Sponsor: Bilecik Seyh Edebali Universitesi ### Study Description In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students. ### Conditions - Diabetes Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Education ### Outcomes Primary Outcomes - Education Secondary Outcomes ### Location - Facility: Bilecik Şeyh Edebali University, Bilecik, Merkez, N/A, Turkey @@
## Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses - NCT ID: NCT06260592 - Study ID: Aysun Acun 4 - Status: RECRUITING - Start Date: 2024-02-06 - Completion Date: 2024-03 - Lead Sponsor: Bilecik Seyh Edebali Universitesi ### Study Description Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient\'s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures. ### Conditions - Humanistic Care Skills ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ethical compliance of nurses in the intensive care unit Secondary Outcomes - Humanistic care skills of nurses in the intensive care unit ### Location - Facility: Bilecik Şeyh Edebali University, Bilecik, N/A, 11000, Turkey @@
## Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity - NCT ID: NCT06260579 - Study ID: S-number 66153 - Status: RECRUITING - Start Date: 2022-11-14 - Completion Date: 2029-12 - Lead Sponsor: KU Leuven ### Study Description This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent. ### Conditions - Physical Activity - Exercise Training - Kidney Transplantation - Physical Fitness - Cardiovascular Health - Gut Microbiome - Health-related Quality of Life - Implementation - Cost-effectiveness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Exercise/physical activity ### Outcomes Primary Outcomes - Changes in peak oxygen consumption (VO2peak) Secondary Outcomes - Health-related physical fitness ### Location - Facility: UZ Ghent, Ghent, N/A, 9000, Belgium @@
## Tolerability of Enteral NAC in Infants - NCT ID: NCT06260566 - Study ID: H-52570 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-02 - Lead Sponsor: Sanjiv Harpavat ### Study Description Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology.This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants. ### Conditions - Biliary Atresia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - N-Acetylcysteine ### Outcomes Primary Outcomes - No emesis within 30 minutes of administration of at least 3 of 4 total doses of oral NAC Secondary Outcomes - Oral NAC palatability compared to clinically indicated medications using the facial expression scale - Oral NAC-specific adverse event evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC - NCT ID: NCT06260553 - Study ID: SCOG008 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-07 - Completion Date: 2025-08-07 - Lead Sponsor: Fujian Cancer Hospital ### Study Description To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy. ### Conditions - EGFR/ ALK-negative Advanced NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - tislelizumab and metronomic oral vinorelbine ### Outcomes Primary Outcomes - PFS Secondary Outcomes - ORR - DCR - AE ### Location - Facility: Fujian cancer hospital, Fuzhou, Fujian, N/A, China @@
## Core Endurance in Healthy Young Adults - NCT ID: NCT06260540 - Study ID: Core Endurance - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-04-29 - Lead Sponsor: Karabuk University ### Study Description This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance.The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time. ### Conditions - Health Risk Behaviors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Side bridge test - Prone bridge test (plank) test - Trunk flexion endurance test - Sorensen test Secondary Outcomes - Purdue Pegboard test - Isometric hand dynamometer for muscle strength - Nelson hand reaction test ### Location - Facility: Karabuk University, Karabuk, N/A, 78000, Turkey @@
## Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers - NCT ID: NCT06260527 - Study ID: ARTS-011-101 - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2024-09-30 - Lead Sponsor: Allorion Therapeutics Inc ### Study Description This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers. ### Conditions - Chinese Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ARTS-011 - Placebo ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs - Number of Adverse Events (AEs) according to severity - Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature) - Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) - Number of participants with change from baseline physical examination - Incidence and magnitude of treatment emergent clinical laboratory abnormalities - Number of participants with change in 24-hour creatine clearance from baseline Secondary Outcomes - Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) - Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit - Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD) - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD) - Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of ARTS-011 in Single Ascending Dose (SAD) - Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of ARTS-011 in Multiple Ascending Dose (MAD) - Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort - Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort - Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Food Effect Cohort - Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort - Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit - Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China @@
## Study of APR-1051 in Patients With Advanced Solid Tumors - NCT ID: NCT06260514 - Study ID: APR-1051-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-06 - Lead Sponsor: Aprea Therapeutics ### Study Description The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - APR-1051 ### Outcomes Primary Outcomes - Treatment-related adverse events - Recommended dose of APR-1051 Secondary Outcomes - Pharmacokinetics: Cmax/Cmin of APR-1051 - Pharmacokinetics: Tmax of APR-1051 - Pharmacokinetics: AUC of APR-1051 - Pharmacokinetics: t1/2 of APR-1051 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures - NCT ID: NCT06260501 - Study ID: ATADEK-2023-13/463 - Status: COMPLETED - Start Date: 2021-09-01 - Completion Date: 2023-10-30 - Lead Sponsor: Acibadem University ### Study Description Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI\<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW\>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications ### Conditions - Liposuction - Obesity - Postoperative Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - super-wet technique ### Outcomes Primary Outcomes - Mean arterial pressure (MAP) was measured to detect hypertension and hypotension. - The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level Secondary Outcomes ### Location - Facility: Acibadem Altunizade Hospital, Istanbul, N/A, N/A, Turkey @@
## Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence - NCT ID: NCT06260488 - Study ID: 8925 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-08-15 - Lead Sponsor: University Hospital, Strasbourg, France ### Study Description The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications. ### Conditions - Peripheral Artery Disease - Femoropopliteal Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Endovascular surgery ### Outcomes Primary Outcomes - Assessing the feasibility of histological segmentation of the superficial femoral artery on preoperative microscanner using artificial intelligence Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions - NCT ID: NCT06260475 - Study ID: IUA - 246-18 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: Universidade do Porto ### Study Description This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II ### Conditions - Aortoiliac Atherosclerosis - Aortoiliac Occlusive Disease - Aortoiliac Atherosclerosis With Gangrene - Aortoiliac Atherosclerosis Without Gangrene - Aortoiliac Obstruction - Peripheral Arterial Disease - Peripheral Vascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Aortobifemoral bypass - aortoiliac stenting ### Outcomes Primary Outcomes - Major Amputation - Cardiovascular Death - acute myorcardial infartion Secondary Outcomes - Major Adverse Limb Events - Major adverse cardiovascular events - Death ### Location - Facility: Centro Hospitalar Universitário de São João, EPE, Porto, N/A, 4200-319, Portugal @@
## Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency - NCT ID: NCT06260462 - Study ID: 10 years adrenal insufficiency - Status: COMPLETED - Start Date: 2012-01-01 - Completion Date: 2023-12-30 - Lead Sponsor: University of Palermo ### Study Description The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period. ### Conditions - Adrenal Insufficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - dual-release hydrocortisone - Conventional glucocortidois ### Outcomes Primary Outcomes - Change of body weight Secondary Outcomes - Change of anthropometric parameters - Change of metabolic parameters - Change of insulin sensitivity parameters - Change of cardiovascular parameters - Change of bone metabolic parameters - Change of bone density - Change of vascular parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Different Treatment Approaches of Presumed Trematode-Induced Uveitis - NCT ID: NCT06260449 - Study ID: Trematode - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-21 - Completion Date: 2024-12-21 - Lead Sponsor: Assiut University ### Study Description Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment ### Conditions - Uveitis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surgical removal ### Outcomes Primary Outcomes - Surgical removal Secondary Outcomes ### Location - Facility: Assiut, Assiut, N/A, N/A, Egypt @@
## Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse - NCT ID: NCT06260436 - Study ID: Tharwat gamal Mohamed - Status: RECRUITING - Start Date: 2021-05-30 - Completion Date: 2024-12-30 - Lead Sponsor: Assiut University ### Study Description . The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. ### Conditions - Pelvic Organ Prolapse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms Secondary Outcomes - effect of surgical correction of pelvic organ prolapse on the quality of life ### Location - Facility: Assuit University, Assiut, Assuit, 2063045, Egypt @@
## The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer - NCT ID: NCT06260423 - Study ID: 18/1/2024 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-04-01 - Lead Sponsor: Al-Azhar University ### Study Description Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically. ### Conditions - Obturation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experienced dentist using lateral compaction with bioceramic sealer. - Unexperienced dentist using lateral compaction with bioceramic sealer. - Experienced dentist using Single cone with bioceramic sealer. - Unexperienced dentist using Single cone with bioceramic sealer. ### Outcomes Primary Outcomes - Postoperative pain assessment - Postoperative pain assessment - Postoperative pain assessment - Postoperative pain assessment - Postoperative pain assessment Secondary Outcomes - The quality of obturation and the voids within the root canal filling ### Location - Facility: Al-Azhar university, Cairo, N/A, 11651, Egypt @@
## Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics - NCT ID: NCT06260410 - Study ID: 10512 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2027-02-01 - Lead Sponsor: Erasmus Medical Center ### Study Description This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment. ### Conditions - Prostate Cancer Metastatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood draw for ctDNA and circulating tumor cell collection. ### Outcomes Primary Outcomes - Overall survival Secondary Outcomes - Progression free survival - Heterogeneity of PSMA-positivity - Effect of CTC PSMA expression on response to treatment. - Effect of biomarkers in blood on response to treatment. - PSMA-PET scan data and response to treatment. ### Location - Facility: Erasmus MC, Rotterdam, Zuid-Holland, 3015 CN, Netherlands @@
## Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries - NCT ID: NCT06260397 - Study ID: analgesia for MRM surgeries - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-03-30 - Lead Sponsor: Ain Shams University ### Study Description Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM. ### Conditions - Regional Anesthesia Morbidity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - serratus anterior plane block - costotransverse block - patient controlled analgesia ### Outcomes Primary Outcomes - Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain Secondary Outcomes - The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry) - NCT ID: NCT06260384 - Study ID: FMASU R 139/2022 - Status: RECRUITING - Start Date: 2022-05-01 - Completion Date: 2024-10-31 - Lead Sponsor: Ain Shams University ### Study Description The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.The exclusion criteria will be any participant who does not consent to the study.A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center. ### Conditions - Wolf Parkinson White Syndrome - Arrythmias ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - electrocardiogram ### Outcomes Primary Outcomes - No recurrence of symptoms - Assessment of performance outcome of each center Secondary Outcomes ### Location - Facility: Ain shams university, Cairo, Outside US, 11851, Egypt @@
## National Observatory of Mycoplasma Infections in Children Under 18 Ages in France - NCT ID: NCT06260371 - Study ID: ORIGAMI - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2030-09-01 - Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne ### Study Description This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management. ### Conditions - Mycoplasma Infections - Hospitalized Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients hospitalized for mycoplasma infections - medical characterisation of mycoplasma infections Secondary Outcomes - Identify risk factors of serious infection - Identify predictive signs of serious infection - Type of complications - Patients outcome - healthcare used for infected children - treatment used during hospitalisation - clinical description of infected children - Type of mycoplasma involved in infected children - performance of complementary diagnostic tests for lung disorders - compare medical data collected during hospitalisation ### Location - Facility: ACTIV, Créteil, N/A, 94600, France @@
## Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging - NCT ID: NCT06260358 - Study ID: 6043 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion ### Conditions - Cervical Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Efficacy of a contextual structured report Secondary Outcomes - Difference between satisfaction rate with narrative and structured report; - Comparison Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports; - Differences in the single 6-to-12 items response rate between structured and narrative reports. ### Location - Facility: Advanced Radiology Center, Rome, N/A, 00168, Italy @@
## CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit - NCT ID: NCT06260345 - Study ID: CAPRICE - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2030-01-01 - Lead Sponsor: Association Clinique Thérapeutique Infantile du val de Marne ### Study Description Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections. ### Conditions - Hospitalized Children - Severe Infection - Invasive Bacterial Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - number of pediatrics cases of severe communautary bacterial infections - medical characterisation of children hospitalized for severe communautary bacterial infection case Secondary Outcomes - Identify risk factors of serious infection - Identify predictive signs of severe cases in infected children. - healthcare used for infected children - Type of complications - Patients outcome - treatment used during hospitalisation - Bacterial strain characterization ### Location - Facility: Association Clinique Thérapeutique Infantile du val de Marne, Créteil, N/A, 94600, France @@
## Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors - NCT ID: NCT06260332 - Study ID: INST UNM 2302 - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2024-12-31 - Lead Sponsor: New Mexico Cancer Care Alliance ### Study Description This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Supportive Care (Fitbit) ### Outcomes Primary Outcomes - Recruitment rate (Feasibility) - Retention rate (Feasibility) - Adherence rate (Feasibility) - Incidence of adverse events Secondary Outcomes - Change in chronic post-surgical pain - Change in physical activity - Change in health-related quality of life (hrQOL) ### Location - Facility: University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, 87106, United States @@
## Decoding Developmental Disorders in Humams - NCT ID: NCT06260319 - Study ID: C19-64 - Status: COMPLETED - Start Date: 2019-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France ### Study Description The DEVO-DECODE project aims to align our currently limited knowledge currently limited knowledge of the genetic architecture of developmental with our more advanced knowledge of their "phenome".To this end, we aim to establish a homogeneous cohort of patients with with developmental disorders to identify new genetic variants genetic variants, and thus study the association between developmental and genetic variants. Secondary objectives are:2* Carry out WGS studies not only to refine exosomal sequencing data exome sequencing data, but above all to identify and validate non-coding non-coding DNA alterations, in both transcribed and non-transcribed transcribed or non-transcribed genomic domains* Develop precise preclinical models for functional studies of pathophysiological pathways ### Conditions - Genetic Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Whole genome sequencing and Genome-Epigenome-Phenome Associations ### Outcomes Primary Outcomes - Primary objectives Secondary Outcomes - secondary objectives 1 - secondary objectives 2 ### Location - Facility: Institut Imagine, Paris, N/A, 75015, France @@
## Hip Activation vs. Hip Activation + Core Stabilization - NCT ID: NCT06260306 - Study ID: STUDY00002568 - Status: COMPLETED - Start Date: 2024-01-24 - Completion Date: 2024-04-12 - Lead Sponsor: Louisiana State University Health Sciences Center Shreveport ### Study Description The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG. ### Conditions - Movement, Abnormal - Lower Extremity Problem ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hip activation home exercise program - Hip activation plus core stabilization home exercise program ### Outcomes Primary Outcomes - Forward Step Down Test (FSDT) Secondary Outcomes - Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax) - Mean activation of GMax via sEMG - Peak activation of GMax via sEMG - MVIC via sEMG of gluteus medius (GMed) - Mean activation of GMed via sEMG - Peak activation of GMed via sEMG - MVIC via of transversus abdominis (TA) - Mean activation of TA via sEMG - Peak activation of TA via sEMG - Peak external knee abduction moment during drop landing task - Compliance with Home Exercise Program ### Location - Facility: LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, 71103, United States @@
## The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study - NCT ID: NCT06260293 - Study ID: 4-2022-0208 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-03 - Completion Date: 2024-04-30 - Lead Sponsor: Yonsei University ### Study Description Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - exercise ### Outcomes Primary Outcomes - Shorts Physical Performance Battery(SPPB) Secondary Outcomes ### Location - Facility: Department of Surgery, Yonsei University College of Medicine, Seoul, N/A, N/A, Korea, Republic of @@
## Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume - NCT ID: NCT06260280 - Study ID: 4 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-06-01 - Lead Sponsor: Instituto Mexicano del Seguro Social ### Study Description Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training. ### Conditions - Sleep Deprivation - Hippocampal Atrophy - Cortical Irregularity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cerebral Nuclear Magnetic Resonance ### Outcomes Primary Outcomes - Change in Hippocampal volumetry. - Change in cortical volumetry Secondary Outcomes ### Location - Facility: Unidad Medica de Alta Especialidad No. 1, Bajío, Leon, Guanajuato, 37260,, Mexico @@
## A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis - NCT ID: NCT06260267 - Study ID: 000417 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-09-15 - Lead Sponsor: Ferring Pharmaceuticals ### Study Description To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC). ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Microbiota suspension - Microbiota capsule - Placebo suspension - Placebo capsule ### Outcomes Primary Outcomes - Treatment-emergent adverse events from baseline to week 52 Secondary Outcomes ### Location - Facility: Ferring Investigational Site, North Little Rock, Arkansas, 72117, United States @@
## Effects of Railway Vibration on Sleep and Disease - NCT ID: NCT06260254 - Study ID: 244826201 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-12-31 - Lead Sponsor: Göteborg University ### Study Description This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes. ### Conditions - Noise Exposure - Sleep Disturbance - Sleep Hygiene - Metabolic Disturbance - Cognitive Change - Glucose Metabolism Disorders (Including Diabetes Mellitus) - Vibration; Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Railway noise - Low level railway vibration - Intermediate level railway vibration - High level railway vibration ### Outcomes Primary Outcomes - Fasting insulin resistance in the morning immediately after the Control night - Fasting insulin resistance in the morning immediately after the low vibration night - Fasting insulin resistance in the morning immediately after the intermediate vibration night - Fasting insulin resistance in the morning immediately after the high vibration night - Total sleep time during the Control night - Total sleep time during the low vibration night - Total sleep time during the intermediate vibration night - Total sleep time during the high vibration night - Total amount of N1 sleep during the Control night - Total amount of N2 sleep during the Control night - Total amount of N3 sleep during the Control night - Total amount of rapid eye movement (REM) sleep during the Control night - Total amount of N1 sleep during the low vibration night - Total amount of N2 sleep during the low vibration night - Total amount of N3 sleep during the low vibration night - Total amount of rapid eye movement (REM) sleep during the low vibration night - Total amount of N1 sleep during the intermediate vibration night - Total amount of N2 sleep during the intermediate vibration night - Total amount of N3 sleep during the intermediate vibration night - Total amount of rapid eye movement (REM) sleep during the intermediate vibration night - Total amount of N1 sleep during the high vibration night - Total amount of N2 sleep during the high vibration night - Total amount of N3 sleep during the high vibration night - Total amount of rapid eye movement (REM) sleep during the high vibration night - Wakefulness after sleep onset (WASO) during the Control night - Wakefulness after sleep onset (WASO) during the low vibration night - Wakefulness after sleep onset (WASO) during the intermediate night - Wakefulness after sleep onset (WASO) during the high vibration night - Number of awakenings during the Control night - Number of awakenings during exposure to low vibration - Number of awakenings during exposure to intermediate vibration - Number of awakenings during exposure to high vibration - Sleep onset latency (SOL) during the Control Night - Sleep onset latency (SOL) during the low vibration night - Sleep onset latency (SOL) during the intermediate vibration night - Sleep onset latency (SOL) during the high vibration night - Sleep efficiency during the Control night - Sleep efficiency during the low vibration night - Sleep efficiency during the intermediate vibration night - S Sleep efficiency during the high vibration night - Sleep depth assessed using the odds ratio product (ORP) during the Control night - Sleep depth assessed using the odds ratio product (ORP) during the low vibration night - Sleep depth assessed using the odds ratio product (ORP) during the intermediate vibration night - Sleep depth assessed using the odds ratio product (ORP) during the high vibration night - Maximal change of odds ratio product (ORP) during exposure to railway vibration events - Area under the curve of odds ratio product (ORP) during exposure to railway vibration events, calculated using the trapezoid rule - N-acetylglucosamine/galactosamine (GlycA) concentration after the Control night - N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night - N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration - N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration - Sialic acid (GlycB) concentration after the Control night - Sialic acid (GlycB) concentration after exposure to low vibration - Sialic acid (GlycB) concentration after exposure to intermediate vibration - Sialic acid (GlycB) concentration after exposure to high vibration - Supramolecular phospholipid composite (SPC) concentration after the Control night - Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration - Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration - Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration - Ethanol concentration (mmol/L) after the Control night - Ethanol concentration (mmol/L) after exposure to low vibration night - Ethanol concentration (mmol/L) after exposure to intermediate vibration night - Ethanol concentration (mmol/L) after exposure to high vibration night - Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night - Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night - Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night - Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night - 2-Aminobutyric acid concentration (mmol/L) after exposure to Control night - 2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night - 2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night - 2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night - Alanine concentration (mmol/L) after exposure to Control night - Alanine concentration (mmol/L) after exposure to low vibration night - Alanine concentration (mmol/L) after exposure to intermediate vibration night - Alanine concentration (mmol/L) after exposure to high vibration night - Asparagine concentration (mmol/L) after exposure to Control night - Asparagine concentration (mmol/L) after exposure to low vibration night - Asparagine concentration (mmol/L) after exposure to intermediate vibration night - Asparagine concentration (mmol/L) after exposure to high vibration night - Creatine concentration (mmol/L) after exposure to Control night - Creatine concentration (mmol/L) after exposure to low vibration night - Creatine concentration (mmol/L) after exposure to intermediate vibration night - Creatine concentration (mmol/L) after exposure to high vibration night - Creatinine concentration (mmol/L) after exposure to Control night - Creatinine concentration (mmol/L) after exposure to low vibration night - Creatinine concentration (mmol/L) after exposure to intermediate vibration night - Creatinine concentration (mmol/L) after exposure to high vibration night - Glutamic acid concentration (mmol/L) after exposure to Control night - Glutamic acid concentration (mmol/L) after exposure to low vibration night - Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night - Glutamic acid concentration (mmol/L) after exposure to high vibration night - Glutamine concentration (mmol/L) after exposure to Control night - Glutamine concentration (mmol/L) after exposure to low vibration night - Glutamine concentration (mmol/L) after exposure to intermediate vibration night - Glutamine concentration (mmol/L) after exposure to high vibration night - Glycine concentration (mmol/L) after exposure to Control night - Glycine concentration (mmol/L) after exposure to low vibration night - Glycine concentration (mmol/L) after exposure to intermediate vibration night - Glycine concentration (mmol/L) after exposure to high vibration night - Histidine concentration (mmol/L) after exposure to Control night - Histidine concentration (mmol/L) after exposure to low vibration night - Histidine concentration (mmol/L) after exposure to intermediate vibration night - Histidine concentration (mmol/L) after exposure to high vibration night - Isoleucine concentration (mmol/L) after exposure to Control night - Isoleucine concentration (mmol/L) after exposure to low vibration night - Isoleucine concentration (mmol/L) after exposure to intermediate vibration night - Isoleucine concentration (mmol/L) after exposure to high vibration night - Leucine concentration (mmol/L) after exposure to Control night - Leucine concentration (mmol/L) after exposure to low vibration night - Leucine concentration (mmol/L) after exposure to intermediate vibration night - Leucine concentration (mmol/L) after exposure to high vibration night - Lysine concentration (mmol/L) after exposure to Control night - Lysine concentration (mmol/L) after exposure to low vibration night - Lysine concentration (mmol/L) after exposure to intermediate vibration night - Lysine concentration (mmol/L) after exposure to high vibration night - Methionine concentration (mmol/L) after exposure to Control night - Methionine concentration (mmol/L) after exposure to low vibration night - Methionine concentration (mmol/L) after exposure to intermediate vibration night - Methionine concentration (mmol/L) after exposure to high vibration night - N,N-Dimethylglycine concentration (mmol/L) after Control night - N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night - N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night - N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night - Ornithine concentration (mmol/L) after exposure to Control night - Ornithine concentration (mmol/L) after exposure to low vibration night - Ornithine concentration (mmol/L) after exposure to intermediate vibration night - Ornithine concentration (mmol/L) after exposure to high vibration night - Phenylalanine concentration (mmol/L) after exposure to Control night - Phenylalanine concentration (mmol/L) after exposure to low vibration night - Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night - Phenylalanine concentration (mmol/L) after exposure to high vibration night - Proline concentration (mmol/L) after exposure to Control night - Proline concentration (mmol/L) after exposure to low vibration night - Proline concentration (mmol/L) after exposure to intermediate vibration night - Proline concentration (mmol/L) after exposure to high vibration night - Sarcosine concentration (mmol/L) after exposure to Control night - Sarcosine concentration (mmol/L) after exposure to low vibration night - Sarcosine concentration (mmol/L) after exposure to intermediate vibration night - Sarcosine concentration (mmol/L) after exposure to high vibration night - Threonine concentration (mmol/L) after exposure to Control night - Threonine concentration (mmol/L) after exposure to low vibration night - Threonine concentration (mmol/L) after exposure to intermediate vibration night - Threonine concentration (mmol/L) after exposure to high vibration night - Tyrosine concentration (mmol/L) after exposure toControl night - Tyrosine concentration (mmol/L) after exposure to low vibration night - Tyrosine concentration (mmol/L) after exposure to intermediate vibration night - Tyrosine concentration (mmol/L) after exposure to high vibration night - Valine concentration (mmol/L) after Control night - Valine concentration (mmol/L) after exposure to low vibration night - Valine concentration (mmol/L) after exposure to intermediate vibration night - Valine concentration (mmol/L) after exposure to high vibration night - 2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night - 2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night - 2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night - 2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night - Acetic acid concentration (mmol/L) after exposure to Control night - Acetic acid concentration (mmol/L) after exposure to low vibration night - Acetic acid concentration (mmol/L) after exposure to intermediate vibration night - Acetic acid concentration (mmol/L) after exposure to high vibration night - Citric acid concentration (mmol/L) after Control night - Citric acid concentration (mmol/L) after exposure to low vibration night - Citric acid concentration (mmol/L) after exposure to intermediate vibration night - Citric acid concentration (mmol/L) after exposure to high vibration night - Formic acid concentration (mmol/L) after exposure to Control night - Formic acid concentration (mmol/L) after exposure to low vibration night - Formic acid concentration (mmol/L) after exposure to intermediate vibration night - Formic acid concentration (mmol/L) after exposure to high vibration night - Lactic acid concentration (mmol/L) after exposure to Control night - Lactic acid concentration (mmol/L) after exposure to low vibration night - Lactic acid concentration (mmol/L) after exposure to intermediate vibration night - Lactic acid concentration (mmol/L) after exposure to high vibration night - Succinic acid concentration (mmol/L) after exposure to Control night - Succinic acid concentration (mmol/L) after exposure to low vibration night - Succinic acid concentration (mmol/L) after exposure to intermediate vibration night - Succinic acid concentration (mmol/L) after exposure to high vibration night - Choline concentration (mmol/L) after exposure to Control night - Choline concentration (mmol/L) after exposure to low vibration night - Choline concentration (mmol/L) after exposure to intermediate vibration night - Choline concentration (mmol/L) after exposure to high vibration night - 2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night - 2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night - 2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night - 2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night - 3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night - 3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night - 3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night - 3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night - Acetoacetic acid concentration (mmol/L) after exposure to Control night - Acetoacetic acid concentration (mmol/L) after exposure to low vibration night - Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night - Acetoacetic acid concentration (mmol/L) after exposure to high vibration night - Acetone concentration (mmol/L) after exposure to Control night - Acetone concentration (mmol/L) after exposure to low vibration night - Acetone concentration (mmol/L) after exposure to intermediate vibration night - Acetone concentration (mmol/L) after exposure to high vibration night - Pyruvic acid concentration (mmol/L) after exposure to Control night - Pyruvic acid concentration (mmol/L) after exposure to low vibration night - Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night - Pyruvic acid concentration (mmol/L) after exposure to high vibration night - D-Galactose concentration (mmol/L) after exposure to Control night - D-Galactose concentration (mmol/L) after exposure to low vibration night - D-Galactose concentration (mmol/L) after exposure to intermediate vibration night - D-Galactose concentration (mmol/L) after exposure to high vibration night - Glucose concentration (mmol/L) after exposure to Control night - Glucose concentration (mmol/L) after exposure to low vibration night - Glucose concentration (mmol/L) after exposure to intermediate vibration night - Glucose concentration (mmol/L) after exposure to high vibration night - Glycerol concentration (mmol/L) after exposure to Control night - Glycerol concentration (mmol/L) after exposure to low vibration night - Glycerol concentration (mmol/L) after exposure to intermediate vibration night - Glycerol concentration (mmol/L) after exposure to high vibration night - Dimethylsulfone concentration (mmol/L) after exposure to Control night - Dimethylsulfone concentration (mmol/L) after exposure to low vibration night - Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night - Dimethylsulfone concentration (mmol/L) after exposure to high vibration night - Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the control night - Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the low vibration night - Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the intermediate vibration night - Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the high vibration night - Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night - Response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night - Response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night - Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night - Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night - Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night - Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night - Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus - Glucose tolerance in the morning after exposure to intermediate vibration, assessed as glucose concentration 120 minutes after a glucose bolus - Glucose tolerance in the morning after exposure to high vibration, assessed as glucose concentration 120 minutes after a glucose bolus - Glucose tolerance in the morning after Control night, assessed as glucose concentration 120 minutes after a glucose bolus - Stumvoll Insulin sensitivity Index in the morning after control - Stumvoll Insulin sensitivity Index in the morning after exposure to low vibration - Stumvoll Insulin sensitivity Index in the morning after exposure to intermediate vibration - Stumvoll Insulin sensitivity Index in the morning after exposure to high vibration - Matsuda insulin sensitivity index in the morning after control exposure - Matsuda insulin sensitivity index in the morning after exposure to low vibration - Matsuda insulin sensitivity index in the morning after exposure to intermediate vibration - Matsuda insulin sensitivity index in the morning after exposure to high vibration Secondary Outcomes - Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control - Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration - Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration - Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration - Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control - Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration - Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration - Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration - Self-reported sleep disturbance by vibration after control exposure - Self-reported sleep disturbance by vibration after exposure to low vibration - Self-reported sleep disturbance by vibration after exposure to intermediate vibration - Self-reported sleep disturbance by vibration after exposure to high vibration - Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure - Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration - Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration - Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration - Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure - Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration - Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration - Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration - Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control - Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration - Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration - Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration - Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control - Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration - Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration - Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration - Event-related cardiovascular activation in response to control - Event-related cardiovascular activation in response to low vibration - Event-related cardiovascular activation in response to intermediate vibration - Event-related cardiovascular activation in response to high vibration - Evening neurobehavioural speed - Evening neurobehavioural accuracy ### Location - Facility: University of Gothenburg, Gothenburg, Västra Götaland, 42650, Sweden @@
## Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children. - NCT ID: NCT06260241 - Study ID: ShaikhZayedH - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-01-01 - Lead Sponsor: Shaikh Zayed Hospital, Lahore ### Study Description The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with \& without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis.The main question\[s\] it aims to answer is:• Gain in stretched penile length after phalloplasty with and without penile traction in children. ### Conditions - Concealed Penis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Traction Dressing - Without Traction Dressing ### Outcomes Primary Outcomes - The gain in stretched penile length (SPL) Secondary Outcomes ### Location - Facility: Sheikh Zayed Hospital, Lahore, Punjab, N/A, Pakistan @@
## HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's) - NCT ID: NCT06260228 - Study ID: STUDY02002270 - Status: RECRUITING - Start Date: 2024-01-05 - Completion Date: 2024-11-30 - Lead Sponsor: Dartmouth-Hitchcock Medical Center ### Study Description The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)The main questions it aims to answer are:1. Can the current HOBSCOTCH program be adapted for people with PD?2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?Participants will be asked to:* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach* complete a brief clinical questionnaire about their diagnosis of PD* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program ### Conditions - Parkinson Disease - Cognitive Dysfunction - Memory Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) ### Outcomes Primary Outcomes - Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention. - Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PD intervention. Secondary Outcomes ### Location - Facility: Dartmouth-Hitchcock, Lebanon, New Hampshire, 03756, United States @@
## Recovery Kinetics Following a Soccer Training in Middle-aged Males - NCT ID: NCT06260215 - Study ID: FFH - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-03-09 - Lead Sponsor: University of Thessaly ### Study Description This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training. ### Conditions - Skeletal Muscle Damage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - ST ### Outcomes Primary Outcomes - Change in White blood cell count - Change in Granulocyte cell count - Change in Platelets cell count - Change in Monocyte cell count - Change in Lymphocyte cell count - Change in percentage of Hematocrit level - Change Red blood cells count - Change in Hemoglobin level - Change in Creatine kinase activity - Change in Total antioxidant capacity - Change in Glutathione concentration in blood - Change in countermovement jump height - Change in Peak power during coutermovement jump test - Change in isometric peak torque of knee extensors and flexors - Change in sprint time of 10 m - Change in sprint time of 30 m - Change in delayed onset of muscle soreness Secondary Outcomes - Dietary intake - Peak Maximal oxygen consumption (Peak VO2) - Body Mass - Body Height - Body Fat - Lean body mass - Bone mass density - Bone mass content - Field activity during the soccer training - Heart rate during the soccer training - Systolic Blood Pressure - Dystolic Blood Pressure - Rest Heart Rate ### Location - Facility: University o Thessaly, School of Physical Education and Sports Science, Tríkala, N/A, 42100, Greece @@
## Nutrition Under Noninvasive Ventilation - NCT ID: NCT06260202 - Study ID: 308.273 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-31 - Lead Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro" ### Study Description Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes. ### Conditions - Noninvasive Ventilation - Nutrition Therapy - Respiratory Insufficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Caloric and protein gap Secondary Outcomes - Nutrition modalities outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment Of Serum And Tissue Levels Of Cold-Inducible RNA-Binding Protein In Patients With Lichen Planus - NCT ID: NCT06260189 - Study ID: Soh-Med-24-01-02MD - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2025-10 - Lead Sponsor: Sohag University ### Study Description Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology.Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls. ### Conditions - Assessment, Self ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of cold-inducible RNA binding protein levels in serum and tissue Secondary Outcomes ### Location - Facility: Aya Ahmed Elsayed, Sohag, N/A, 82511, Egypt @@
## Vending Labeling Sales and Intercepts Study - NCT ID: NCT06260176 - Study ID: 828722 - Status: COMPLETED - Start Date: 2019-02-01 - Completion Date: 2020-03-12 - Lead Sponsor: University of Pennsylvania ### Study Description The aim of this study is to compare the impact of 4 different types of front of package (FOP) food and beverage messages: 1) green labels on healthy foods, 2) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 3) physical activity calorie equivalent labels, and 4) posters reminding consumers of the sweetened beverage tax on consumers' beverage and snack selections. ### Conditions - Food Preferences - Obesity - Weight Gain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - exposure to healthy labels only - exposure to healthiness information - exposure to physical activity equivalents - exposure to sweetened beverage tax messaging ### Outcomes Primary Outcomes - Percentage of beverages sold with calories per month - Calories sold from beverages per month, if beverages with calories sold - Calories sold from snacks per month - Likelihood of selecting a healthy beverage - Likelihood of selecting a moderately healthy beverage - Likelihood of selecting a less healthy beverage - Likelihood of selecting a healthy snack - Likelihood of selecting a moderately healthy snack - Likelihood of selecting a less healthy snack - Total beverage units sold per month per machine. - Total snack units sold per month per machine Secondary Outcomes - Total revenue per month per beverage machine - Total revenue per month per snack machine - Total calories sold per customer trip ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis - NCT ID: NCT06260163 - Study ID: CR109251 - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2028-08-14 - Lead Sponsor: Janssen Research & Development, LLC ### Study Description The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders. ### Conditions - Colitis, Ulcerative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Guselkumab Subcutaneous - Matching Placebo - Guselkumab Intravenous ### Outcomes Primary Outcomes - Percentage of Participants with Clinical Remission at Week 56 Secondary Outcomes - Percentage of Participants with Clinical Remission at Week 12 - Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 - Percentage of Participants with Symptomatic Remission at Week 12 - United States: Percentage of Participants with Endoscopic Improvement at Week 12 - European Union: Percentage of Participants with Endoscopic Healing at Week 12 - Percentage of Participants with Clinical Response at Week 12 - Percentage of Participants with Symptomatic Remission at Week 56 - United States: Percentage of Participants With Endoscopic Improvement at Week 56 - European Union: Percentage of Participants With Endoscopic Healing at Week 56 - Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 - Percentage of Participants with Clinical Response at Week 56 - Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 - Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 - Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 - Percentage of Participants With PUCAI Remission at Week 56 - Serum Concentration of Guselkumab During Induction Phase - Serum Concentration of Guselkumab During Maintenance Phase - Number of Participants with Incidence of Anti-guselkumab Antibodies - Percentage of Participants with Adverse Events (AEs) - Percentage of Participants with Serious Adverse Events (SAEs) - Percentage of Participants with AEs Leading to Discontinuation of Study Intervention ### Location - Facility: Riley Hospital for Children, Indianapolis, Indiana, 46202, United States @@
## Application of IPC During Surgery to Prevent Venous Thrombosis in Gastrointestinal Surgery Patients. - NCT ID: NCT06260150 - Study ID: ZXT - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-01 - Completion Date: 2024-04 - Lead Sponsor: Feng Tian ### Study Description The goal of this clinical trial is to evaluate the effectiveness of intraoperative intermittent pneumatic compression (IPC) device usage in preventing lower extremity deep vein thrombosis (DVT) in patients undergoing gastrointestinal surgery.The main question it aims to answer is provide a reference basis for determining the efficacy of IPC application during gastrointestinal surgery for preventing lower extremity DVT in patients.Participants are patients who require gastrointestinal surgery, specifically for the resection of gastrointestinal tumors. They will be divided into a control group and an experimental group. The experimental group will use an Intermittent Pneumatic Compression (IPC) device during surgery, while the control group will receive standard treatment. The objective is to observe whether the use of IPC during surgery can prevent the formation of Deep Vein Thrombosis (DVT) or lower the Risk of DVT. ### Conditions - Gastrointestinal Neoplasms - Stomach Neoplasms - Intestinal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intermittent Pneumatic Compression Devices ### Outcomes Primary Outcomes - Incidence rate of DVT Secondary Outcomes - Length of surgery - Intraoperative body temperature - Amount of bleeding during surgery ### Location - Facility: Shandong Provincial Hospital, Jinan, Shandong, 250021, China @@
## Comparison of Two Different Methods for Reducing Pain After Lung Surgery - NCT ID: NCT06260137 - Study ID: UludagThorax - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-07-10 - Completion Date: 2024-08 - Lead Sponsor: Uludag University ### Study Description The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:Which of these two blocks more effectively reduces the patients' pain? ### Conditions - Postoperative Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Rhomboid intercostal block - Rhomboid intercostal and subserratus plane block ### Outcomes Primary Outcomes - Postoperative analgesia Secondary Outcomes ### Location - Facility: Hastane, Bursa, N/A, 16210, Turkey @@
## Acute Physiological Effects of Greek Traditional Dancing - NCT ID: NCT06260124 - Study ID: Greek Dancing-UTH - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-10-30 - Lead Sponsor: University of Thessaly ### Study Description In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order. ### Conditions - Menopause - Cardiovascular Health - Body Composition - Physical Performance - Muscle Damage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Slow tempo - Moderate tempo - Fast tempo ### Outcomes Primary Outcomes - Change in blood pressure - Change in perceived exertion - Change in blood lactate - Change in resting metabolic rate - Change in delayed-onset of muscle soreness (DOMS) - Change in maximal isometric voluntary contraction - Change in joint range of motion - Change in functional performance - Change in white blood cell count - Change in granulocyte count - Change in lymphocytes - Change in monocytes - Change in creatine kinase concentration - Change in reduced glutathione - Change in oxidized glutathione - Change in catalase activity - Change in protein carbonyls - Change in total antioxidant capacity - Change in heart rate - Change in oxygen consumption - Change in physical activity Secondary Outcomes - Change in red blood cell count - Change in hematocrit - Change in hemoglobin ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation - NCT ID: NCT06260111 - Study ID: SA23I0021 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-10-30 - Lead Sponsor: Universidad del Desarrollo ### Study Description The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment. ### Conditions - Hematologic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Photobiomodulation - Usual care ### Outcomes Primary Outcomes - Oral Mucositis - Level of Pain Secondary Outcomes - Handgrip strength - Exercise tolerance - Physical fitness - Health related quality of life - Length of hospital stay - Use of opioids - Body mass index - Nutritional status - Daily calorie intake - Arm circumference - Triceps skinfold ### Location - Facility: Clinica Dávila, Santiago, Metropolitana, 8431657, Chile @@
## StressLess Yoga Study - NCT ID: NCT06260098 - Study ID: H23-0617 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2024-05-30 - Lead Sponsor: University of Connecticut ### Study Description The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions. ### Conditions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yoga with High Breath work & meditation; Low movement/postures - Yoga with Low Breath work & meditation; High movement/postures ### Outcomes Primary Outcomes - The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits) - The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ) Secondary Outcomes ### Location - Facility: Bousfield Psychology Building, 406 Babbidge Road, Storrs, Connecticut, 06269, United States @@
## Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients - NCT ID: NCT06260085 - Study ID: 686 - Status: COMPLETED - Start Date: 2022-06-04 - Completion Date: 2023-09-04 - Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ ### Study Description The aim of the study was to evaluate the effect of listening to the voice recordings of relatives of patients with acute myocardial infarction (AMI) who were treated in the coronary intensive care unit on chest pain, anxiety and depression parameters of the patients.Methods In the study, which was conducted as a randomised, controlled, experimental study, voice recordings of the family members of the patients were created and played to the patients through a music pillow. The study was carried out with 60 patients, 30 experimental and 30 control groups. Three tests were applied to the patients 15 minutes before, 15 and 30 minutes after the application. The data of the study were collected using the "Patient Introduction Form", "Hospital Anxiety Depression Scale", "Visual Analogue Scale" and "Patient Follow-up Form". ### Conditions - Acute Myocardial Infarction - Intensive Care Unit Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Relatives vioce record ### Outcomes Primary Outcomes - Chest Pain Secondary Outcomes - Anxiety, and Depression ### Location - Facility: Yasemin Kalkan Uğurlu, Ordu, N/A, 52200, Turkey @@
## Magnesium and Riboflavin Treatment for Post-Concussion Headache - NCT ID: NCT06260072 - Study ID: IRB-HSR 21920 - Status: RECRUITING - Start Date: 2020-02-10 - Completion Date: 2024-12-31 - Lead Sponsor: University of Virginia ### Study Description This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person. ### Conditions - Concussion, Intermediate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - magnesium and riboflavin supplement ### Outcomes Primary Outcomes - Headache Intensity and Duration Secondary Outcomes ### Location - Facility: University of Virginia Student Health and Wellness Center, Charlottesville, Virginia, 22903, United States @@
## Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease - NCT ID: NCT06260059 - Study ID: STUDY23070148 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2027-06-01 - Lead Sponsor: Anita Saraf ### Study Description The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD). ### Conditions - Adult Congenital Heart Disease - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Empagliflozin 10 MG - Placebo ### Outcomes Primary Outcomes - Change in Ejection fraction (EF) - Change in Myocardial characteristics (T1 mapping of cMRI) - Change in Myocardial characteristics (Global strain on MRI) - Change in Myocardial characteristics (Global strain on echocardiogram) - Change in functional exercise capacity of participants. - Number of Participants Hospitalized for Cardiac Reasons or heart transplantation - Number of Deaths Secondary Outcomes - Change in inflammatory serum biomarkers - Change in functional Neuropsychological Testing - Change in New York Heart Association (NYHA) Class - Change Patient-Reported Outcomes Measurement Information System (PROMIS) - Change in Kansas City Cardiomyopathy (KCCQ) - Change in Neuro-QOL ### Location - Facility: Magee Women's Hospital, Pittsburgh, Pennsylvania, 15213, United States @@
## Effect of Sufentanil on the Postoperative Pain - NCT ID: NCT06260046 - Study ID: Robot Nx-SFTN - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-01-15 - Lead Sponsor: Seoul National University Hospital ### Study Description This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery. ### Conditions - Postoperative Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sufentanil - Remifentanil ### Outcomes Primary Outcomes - opioid consumption Secondary Outcomes - Richmond Agitation-Sedation scale - Incidence of postoperative nausea and vomiting - Number of patients who administered antiemetics - Pain score ### Location - Facility: Seoul National University Bundang Hospital, Seongnam, N/A, N/A, Korea, Republic of @@