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## A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma - NCT ID: NCT06364059 - Study ID: aSDH-TT - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Charles University, Czech Republic ### Study Description Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. ### Conditions - Acute Subdural Hematoma - Acquired Brain Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Decompressive craniectomy with evacuation of subdural hematoma ### Outcomes Primary Outcomes - Level of consciousness at time of injury - Initial size of subdural hematoma - Initial midline shift - Chronic use of anti-clotting medication - Trauma severity analyzed using Injury Severity Score (ISS). - Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) - The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC). - The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months. - The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months. Secondary Outcomes - Number of revisions. - Time from injury to surgery. - Time of operation. - The need for reversal of the effects of anticoagulants. ### Location - Facility: Military University Hospital Prague, Praha, N/A, 16209, Czechia @@
## Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC - NCT ID: NCT06364046 - Study ID: ZJLS-KLDMIR-22006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: The Central Hospital of Lishui City ### Study Description This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice. ### Conditions - Carcinoma - Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Drug-eluting beads bronchial arterial chemoembolization - Serplulimab - Intravenous chemotherapy ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Progression Free Survival - Overall Survival - Time to tumor untreatable progression - Disease Control Rate - Duration of Overall Response - Tumor biomarkers - Tumor biomarkers - Tumor biomarkers - Tumor biomarkers - Eastern Cooperative Oncology Group Score - Recurrence rate of hemoptysis - Quality of life Questionare-Core score - The incidence of adverse events and serious adverse events - Pain assessment ### Location - Facility: Lishui central hospital, Lishui, Zhejiang, 323000, China @@
## Biological and Clinical Efficacy of Shingrix in Patients With CLL - NCT ID: NCT06364033 - Study ID: CLL2624 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-10 - Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto ### Study Description This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. ### Conditions - Chronic Lymphocytic Leukemia - Small Lymphocytic Lymphoma - CLL-like MBL - Varicella-zoster Virus Reactivation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - serologic response evaluation ### Outcomes Primary Outcomes - Serologic response evaluation Secondary Outcomes ### Location - Facility: UOC Ematologia ASST dei Sette Laghi, Varese, N/A, N/A, Italy @@
## Assessment of Risk Factors in Patients With Non-carious Cervical Lesions - NCT ID: NCT06364020 - Study ID: APHP230067 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies. ### Conditions - Anxiety - Stress - Non-carious Cervical Lesions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To investigate the association between anxiety/stress and the presence of NCCL. Secondary Outcomes - To investigate the association between bruxism and the presence of NCCL. - To investigate the association between eating disorders and the presence of NCCL. ### Location - Facility: Hôpital Rothschild - Service Odontologie, Paris, N/A, 75012, France @@
## HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC - NCT ID: NCT06364007 - Study ID: SLiu0401 - Status: RECRUITING - Start Date: 2024-03-03 - Completion Date: 2026-03-31 - Lead Sponsor: Sulai Liu ### Study Description The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC. ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HAIC+STRIDE+Len ### Outcomes Primary Outcomes - ORR Secondary Outcomes - PFS - OS - DCR - AE ### Location - Facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University), Changsha, Hunan, N/A, China @@
## A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL - NCT ID: NCT06363994 - Study ID: ICP-CL-00128 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-25 - Completion Date: 2035-12-25 - Lead Sponsor: InnoCare Pharma Inc. ### Study Description Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL) ### Conditions - Mantle Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Orelabrutinib - Bendamustine Injection - Rituximab - Orelabrutinib Placebo ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - Progression-free Survival (PFS) for Arm A vs. Arm C Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression - NCT ID: NCT06363981 - Study ID: JagiellonianU72 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-04 - Lead Sponsor: Jakub Antczak ### Study Description Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression. ### Conditions - Unipolar Depression - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active rTMS over the left DLPFC and over the left DMPFC - Active rTMS over the left DLPFC - Sham rTMS ### Outcomes Primary Outcomes - Beck Depression Inventory 2 - Froward digit span - Language part of Addenbrooke's Cognitive Examination Secondary Outcomes - Dimensional Anhedonia Rating Scale - Athens Insomnia Scale - Pittsburgh Sleep Quality Index - Epworth Sleepiness Scale ### Location - Facility: The Education of Research and Development Center, Babinski Clinical Hospital, Cracovia, N/A, 30393, Poland @@
## Biomarkers in the Retina for Prognosticating Mental Health Treatments - NCT ID: NCT06363968 - Study ID: 1743326 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2030-09-01 - Lead Sponsor: VA Puget Sound Health Care System ### Study Description Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot studyPosttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?Participants will be asked to:* Undergo ERG recordings before and after a single dose of sertraline.* Provide relevant clinical information related to PTSD symptoms and treatment history.Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording. ### Conditions - PTSD - Posttraumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - RETeval ### Outcomes Primary Outcomes - ERG b-wave amplitude response to SSRI Secondary Outcomes - Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score - Total PTSD Checklist for DSM-5 (PCL-5) ### Location - Facility: VA Puget Sound Health Care System, Seattle, Washington, 98108, United States @@
## Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief - NCT ID: NCT06363955 - Study ID: INTM-PMCF-UNIMOUTH - Status: COMPLETED - Start Date: 2023-04-25 - Completion Date: 2024-04-01 - Lead Sponsor: National and Kapodistrian University of Athens ### Study Description The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed. ### Conditions - Wound Heal - Oral Dryness - Postoperative Pain - Sjogren's Syndrome - Biopsy Wound - Mouth; Wound - Mouth Dryness - Dental Plaque - Gingival Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hydrogen Carbamide/Peroxide Mouthwash - Placebo mouthwash ### Outcomes Primary Outcomes - Assessment of wound healing based on the modified Landry Healing Index on day 14 - Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14 - Assessment of wound healing based on the modified Landry Healing Index on day 7 - Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7 Secondary Outcomes - Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) - Postoperative symptoms (pain, eating and speech difficulty) on day 7 - Postoperative symptoms (pain, eating and speech difficulty) on day 14 - Wound healing based on the incision/wound length - Subjective oral dryness symptoms (8-item VAS questionnaire) - Observed (objective) signs of oral dryness - Change in Unstimulated Saliva Flow Rate - Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index - Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index - Oral Health Related Quality of Life - Assessment of swelling in the biopsy area ### Location - Facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens, Athens, Attiki, 11527, Greece @@
## A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult - NCT ID: NCT06363942 - Study ID: 2024-5973 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-15 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not. ### Conditions - Fall Injury - Frailty - Old Age; Atrophy - Age-Related Atrophy - Age-Related Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SAFE program (exercise intervention) ### Outcomes Primary Outcomes - Objective 1 - Objective 2 Secondary Outcomes - Objective 4 ### Location - Facility: Royal Victoria Hospital - Glen site, Montréal, Quebec, H4A 3J1, Canada @@
## Continuous Glucose Monitoring in Neonatal Hyperinsulinism - NCT ID: NCT06363929 - Study ID: 341-23 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: MemorialCare Health System ### Study Description The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly. ### Conditions - Hyperinsulinism - Hypoglycemia Neonatal ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dexcom G6 continuous glucose monitor ### Outcomes Primary Outcomes - Mean absolute relative difference (MARD) Secondary Outcomes - Mean absolute difference (MAD) ### Location - Facility: Miller Children's Hospital, Long Beach, California, 90806, United States @@
## Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System - NCT ID: NCT06363916 - Study ID: 2023-A00335-40 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Medtrum France ### Study Description The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.The main question it aims to answer is :• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?Participants will be :* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system* Randomized to the Open Loop or Closed Loop group* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire statusResearchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group. ### Conditions - Type 1 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Insulin Management System in Manual mode of operation - Insulin Management System in Automatic mode of operation ### Outcomes Primary Outcomes - Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups Secondary Outcomes - Evolution of TIR - Evolution of coefficient of glycemic variation - Superiority in Glycated Haemoglobin (HbA1c) improvement - Evolution of Time spent Above Range (TAR) - Evolution of Time spent Below Range (TBR) - Body Mass Index change - Glucose sensor measurement change - Percentage of patients with TIR > 70% - Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1% - Evolution of glucose management indicator (GMI) - Evolution of dosage of insulin - Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop) - Evolution of Self-administered Questionnaires scores - Evolution of Diabetes Treatment Satisfaction score - Safety Events ### Location - Facility: CHU Angers, Angers, N/A, N/A, France @@
## ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation - NCT ID: NCT06363903 - Study ID: 2022-MMC-051 - Status: RECRUITING - Start Date: 2022-05-09 - Completion Date: 2025-05 - Lead Sponsor: Maxima Medical Center ### Study Description In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics. ### Conditions - Autoimmunity - Inguinal Hernia - Stress Urinary Incontinence - Pelvic Organ Prolapse - Implant Complication - Systemic Autoimmune Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - mesh allergy test - blood tests - Mesh removal ### Outcomes Primary Outcomes - Positive diagnostic tests Secondary Outcomes - Autoimmune complaints and objective findings in immunologic blood test - Autoimmune complaints and objective findings in mesh allergy test (MAT) - Mesh removal and subjective complaints - Mesh histopathology - Patient demographics ### Location - Facility: Maastricht University Medical Centre, Maastricht, Limburg, 6229HX, Netherlands @@
## Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia - NCT ID: NCT06363890 - Study ID: TD02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Lumen Bioscience, Inc. ### Study Description The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population. ### Conditions - Travelers Diarrhea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TAQMan Array Card ### Outcomes Primary Outcomes - Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections - NCT ID: NCT06363877 - Study ID: 5220078 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Loma Linda University ### Study Description This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds. ### Conditions - Surgical Site Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Povidone-Iodine - Normal Saline ### Outcomes Primary Outcomes - Surgical Site Infection Secondary Outcomes - Readmission - Return to the Operating Room - Ileus - Small Bowel Obstruction ### Location - Facility: Loma Linda University Health, Loma Linda, California, 92354, United States @@
## Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan - NCT ID: NCT06363864 - Study ID: LL-IRB-2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-14 - Completion Date: 2029-10-31 - Lead Sponsor: Leeuwenhoek Laboratories Co. Ltd. ### Study Description The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future. ### Conditions - Metabolic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Concentration changes of small molecules in blood. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Single-ascending Dose Study of Kylo-11 in Healthy Subjects - NCT ID: NCT06363851 - Study ID: Kylo-11-I-C01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2025-11-30 - Lead Sponsor: Kylonova (Xiamen) Biopharma co., LTD. ### Study Description This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. ### Conditions - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Kylo-11 - Placebo ### Outcomes Primary Outcomes - Incidence of adverse events Secondary Outcomes - Incidence of adverse events - Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) - PK parameter of time of maximum observed concentration (Tmax) - PK parameter of area under the concentration time curve (AUC) - Change in serum Lp(a) over time - Percent change in serum Lp(a) over time ### Location - Facility: Chengdu Xinhua Hospital, Chengdu, Sichuan, 610000, China @@
## Evaluation of Neuromuscular Morphometry of the Vaginal Wall - NCT ID: NCT06363838 - Study ID: ordu eah - Status: COMPLETED - Start Date: 2019-12-01 - Completion Date: 2020-06-30 - Lead Sponsor: Gaziosmanpasa Research and Education Hospital ### Study Description In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. ### Conditions - Pelvic Organ Prolapse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - epithelial thickness - smooth muscle density Secondary Outcomes ### Location - Facility: Hakan Timur, Ordu, N/A, N/A, Turkey @@
## A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma - NCT ID: NCT06363825 - Study ID: MRCTA,ECFAH Of FMU[2024]373 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-05-11 - Lead Sponsor: Fujian Medical University ### Study Description To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load ### Conditions - Advanced Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - camrelizumab ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Disease control rate (DCR) - Progression-free survival (PFS) - Tumor progression time (TTP) - Overall survival (OS) - AE ### Location - Facility: Xinhua Chen, Fuzhou, N/A, N/A, China @@
## Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology - NCT ID: NCT06363812 - Study ID: The POST - Status: ACTIVE_NOT_RECRUITING - Start Date: 2018-03-08 - Completion Date: 2024-12-31 - Lead Sponsor: Fondazione Sandro Pitigliani ### Study Description In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the proportion of tumor samples with a useful OncotypeDx Secondary Outcomes - the proportion of patients in which the result of the test has induced a modification in the initial treatment plan - the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx ### Location - Facility: Hospital of Prato, Prato, N/A, 59100, Italy @@
## Osteopathic Protocol for Insomnia in College Students - NCT ID: NCT06363799 - Study ID: OST1_010 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2024-12 - Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto ### Study Description In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique. ### Conditions - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 4th ventricle compression technique and diaphragmatic breathing - Sham Technique ### Outcomes Primary Outcomes - Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters - NCT ID: NCT06363786 - Study ID: GOOSEBERRY - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-09-30 - Lead Sponsor: Essity Hygiene and Health AB ### Study Description The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed. ### Conditions - Incontinence-associated Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Test patches ### Outcomes Primary Outcomes - Changes in skin microbiome as measured by molecular sequencing - Changes in skin microbiome diversity as measured by qPCR - Skin surface pH Secondary Outcomes - Change in Trans Epidermal Water loss - Change in skin hydration - Change in Skin water profile - Presence of low pH formula on the skin ### Location - Facility: Essity Study Site, Gothenburg, N/A, SE40503, Sweden @@
## A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer. - NCT ID: NCT06363773 - Study ID: RESTO-IMMUNO - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-06 - Lead Sponsor: Elsan ### Study Description This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases. ### Conditions - Metastatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stereotactic Radiotherapy ### Outcomes Primary Outcomes - Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. Secondary Outcomes - Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy. - Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. - Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. - Duration until new systemic treatment start. - Incidence of Adverse Events (safety) - Progression-Free Survival - Overall Survival - Objective Response Rate according to iRECIST criteria on the irradiated lesion only. - Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only. - Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect). - Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect). - Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect). - Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect). ### Location - Facility: Centre Clinical, Soyaux, Charente, 16800, France @@
## A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301 - NCT ID: NCT06363760 - Study ID: EDIT-301-LTFU-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-04 - Completion Date: 2040-08 - Lead Sponsor: Editas Medicine, Inc. ### Study Description The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301. ### Conditions - Sickle Cell Disease - Transfusion-dependent Beta-Thalassemia - Hemoglobinopathies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Safety and efficacy assessments ### Outcomes Primary Outcomes - Adverse events of special interest (AESI) - Adverse events of interest (AEI) - All-cause mortality - Adverse events (AEs) related to EDIT-301 - Serious adverse events (SAEs) Secondary Outcomes - Proportion of SCD participants with severe vaso-occlusive events (sVOEs) over time post-EDIT-301 infusion - Proportion of SCD participants with vaso-occlusive events (VOEs) over time post-EDIT-301 infusion - Frequency of SCD-related transfusions over time post-EDIT-301 infusion for SCD participants - Proportion of TDT participants with sustained transfusion independence (TI) over time - Proportion of TDT participants with sustained transfusion reduction (TR) over time - Frequency of TDT-related transfusions over time post-EDIT-301 infusion for TDT participants - SCD and TDT: Percent of peripheral red blood cells (RBCs) containing HbF (F-cells) over time - SCD and TDT: Total hemoglobin (Hb) concentration (g/dL) over time - SCD and TDT: Proportion of alleles with intended genetic modification present in peripheral blood nucleated cells and bone marrow derived CD34+ over time - Average HbF (pg) per RBC over time for SCD participants - Complete Blood Count (CBC) red cell indices assay over time for SCD participants - Average HbF (pg) per F-cell over time for SCD participants - HbF and HbS concentration (g/dL) over time for SCD participants - The level of HbF production determined by fractionation of different forms of Hb (including but not limited to HbA, HbA2, HbC, HbD, HbE, and HbS) over time for SCD participants. - Percentage of HbF over total non-transfused total Hb (non-transfused total Hb refers to the total g/dL of all Hb variants, excluding HbA) over time for TDT participants. - HbF concentration (g/dL) over time for TDT participants - Iron overload of TDT participants - Proportion of TDT participants receiving iron chelation therapy over time. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Medically Reproducing Bariatric Surgery (MRB) II Study - NCT ID: NCT06363747 - Study ID: 123456 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2025-06-03 - Lead Sponsor: Durham VA Medical Center ### Study Description Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB.The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB. ### Conditions - Type 2 Diabetes - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Very Low Calorie Diet ### Outcomes Primary Outcomes - Glycemic Control Secondary Outcomes - Weight lost - Medication Intensity - Health Related Quality of Life ### Location - Facility: Greenville VA Health Care Center, Greenville, North Carolina, 27834, United States @@
## Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial - NCT ID: NCT06363734 - Study ID: DAL20240409 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2026-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI. ### Conditions - Non-small Cell Lung Cancer - EGFR Activating Mutation - Cell Cycle Deregulation - EGFR-TKI Resistant Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Osimertinib plus Dalpiciclib ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - disease control rate (DCR) - Duration of Response (DoR) - Progression Free Survival (PFS) ### Location - Facility: Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, 300060, China @@
## A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health - NCT ID: NCT06363721 - Study ID: DFH00125 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Designs for Health ### Study Description The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice. ### Conditions - Oral Health ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PerioPull™ ### Outcomes Primary Outcomes - Plaque Index - Gingival Index - Pocket Depth Secondary Outcomes - Intraoral Photos - MyPerioPath® ### Location - Facility: Julian Center for Comprehensive Dentistry, Ellicott City, Maryland, 21042, United States @@
## Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer - NCT ID: NCT06363708 - Study ID: 2024050 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-30 - Lead Sponsor: Zhongnan Hospital ### Study Description The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer. ### Conditions - Endometrial Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - Paclitaxel - Carboplatin ### Outcomes Primary Outcomes - R0 resection rate (R0 %) Secondary Outcomes - Pathological complete response rate (pCR%） - Objective Response Rate (ORR%) - Progression free survival (PFS) - Recurrence free survival (RFS) - Overall survival (OS) - Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0 ### Location - Facility: The Central Hospital of Wuhan, Wuhan, Hubei, 430014, China @@
## Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya - NCT ID: NCT06363695 - Study ID: 131-22 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2028-05 - Lead Sponsor: Pacific University ### Study Description The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are:* Will SafeCare Kenya improve child and parent outcomes?* Is virtual delivery as effective as in-person delivery of SafeCare Kenya?* Is SafeCare Kenya feasible to deliver by community health volunteers?Mothers will:* Complete study assessments at three timepoints: baseline, 6 months and 18 months* Mothers in the SafeCare Kenya group will receive the program from their community health volunteerResearchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life. ### Conditions - Child Maltreatment - Parenting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SafeCare Kenya - Care as Usual by Community Health Volunteers ### Outcomes Primary Outcomes - Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months - Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months - Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months - Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months - Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months - Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months - Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months - Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months Secondary Outcomes - Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months - Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months - Change from Baseline in scores on Parenting Stress Index at 6 months - Change from Baseline in scores on Parenting Stress Index at 18 months - Change from Baseline in score on Childhood injuries at 6 months - Change from Baseline in score on Childhood injuries at 18 months - Change from Baseline in score on Child Quality of Life at 6 months - Change from Baseline in score on Child Quality of Life at 18 months - Change from Baseline in score on Parent Quality of Life at 6 months - Change from Baseline in score on Parent Quality of Life at 18 months ### Location - Facility: Africa Mental Health Research and Training Foundation, Nairobi, N/A, N/A, Kenya @@
## Interventional Reference Levels (IRL) in Digestive Endoscopy - NCT ID: NCT06363682 - Study ID: 2023PI225 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-11 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.Secondary objective(s) :* Application of regulatory texts* Assessment of patient radiation protection* Radiation protection assessment for workers ### Conditions - Each Endoscopic Intervention Using X-rays ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ERCP - endoscopic ultrasound - gastroscopy - Colonoscopy - placement of a nasojejunal tube ### Outcomes Primary Outcomes - To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. Secondary Outcomes - Application of regulatory texts - Assessment of patient radiation protection - Radiation protection assessment for workers ### Location - Facility: Hospital University of Nancy, Nancy, Meurthe-et-Moselle, 54000, France @@
## Effects of Caffeine-based Supplement on Physical Performance - NCT ID: NCT06363669 - Study ID: 1_CAF_AWF - Status: COMPLETED - Start Date: 2018-01-15 - Completion Date: 2024-03-30 - Lead Sponsor: University School of Physical Education, Krakow, Poland ### Study Description The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men ### Conditions - Muscle Power ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - multi-ingredient pre-workout dietary supplement (caffeine-based) ### Outcomes Primary Outcomes - anaerobic power - aerobic power Secondary Outcomes ### Location - Facility: University School of Physical Education in Cracow, Krakow, N/A, 31-571, Poland @@
## Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol - NCT ID: NCT06363656 - Study ID: 76455623.5.0000.0068 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2024-07-30 - Lead Sponsor: University of Sao Paulo General Hospital ### Study Description The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.The main question it aims to answer is:- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep? ### Conditions - Insomnia - Sleep Initiation and Maintenance Disorders - Health Status - Wearable Electronic Devices - Sleep ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires ### Outcomes Primary Outcomes - Concordance between the smartwatch application and clinical assessment Secondary Outcomes ### Location - Facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, São Paulo, N/A, 05403-900, Brazil @@
## Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. - NCT ID: NCT06363643 - Study ID: Prehab01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-07-26 - Lead Sponsor: University of Pavia ### Study Description Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations. ### Conditions - Osteo Arthritis Knee and Hip - Lower Limb Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ELECTROSTIMULATION (ES) - EXERCISE (C) ### Outcomes Primary Outcomes - Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4 Secondary Outcomes - Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4. ### Location - Facility: "Città di Pavia Healthcare Institute", Pavia, N/A, 27100, Italy @@
## A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants - NCT ID: NCT06363630 - Study ID: CA073-1000 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-08-19 - Lead Sponsor: Celgene ### Study Description The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Itraconazole - Rifampin - Golcadomide ### Outcomes Primary Outcomes - Maximum observed plasma concentration (Cmax) - Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) - Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Secondary Outcomes - Number of participants with adverse events (AEs) - Number of participants with physical exam abnormalities - Number of participants with vital sign abnormalities - Number of participants with clinical laboratory safety test abnormalities - Number of participants with electrocardiogram abnormalities - Number of participants with concomitant medications - Number of participants with concomitant procedures - Time of maximum observed plasma concentration (Tmax) - Apparent terminal phase half-life (T-HALF) - Apparent total body clearance (CLT/F) - Apparent volume of distribution (Vz/F) ### Location - Facility: Local Institution - 0001, Lenexa, Kansas, 66219, United States @@
## Implementation of the Fatty Liver Index in Primary Care - NCT ID: NCT06363617 - Study ID: CSAPG-58 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf ### Study Description This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared. ### Conditions - Hepatic Steatosis - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - FLI ### Outcomes Primary Outcomes - Lifestyle Intervention Secondary Outcomes - Low-density lipoprotein cholesterol - Triglycerides - Gamma-glutamyl transpeptidase - Medical and nursing visits - Analytical checks in the first year - Lipid-lowering drugs - Healthcare spending - FLI administration ### Location - Facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, Vilanova I La Geltrú, Barcelona, N/A, Spain @@
## Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation - NCT ID: NCT06363604 - Study ID: XHEC-C-2023-128-2 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-11 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VOMEI + PVI + linear ablation of mitral isthmus - Posterior wall isolation ### Outcomes Primary Outcomes - Recurrence of atrial arrhythmias Secondary Outcomes - Procedural complications ### Location - Facility: Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, Shanghai, 200092, China @@
## Single- vs Two-staged Excisions of Thin Melanoma - NCT ID: NCT06363591 - Study ID: Wise vs wide - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2034-12-31 - Lead Sponsor: Vastra Gotaland Region ### Study Description The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period. ### Conditions - Melanoma (Skin) - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Wise vs wide ### Outcomes Primary Outcomes - Recurrence rate at 5 years. Secondary Outcomes - Recurrence rate at 10 years. - Postoperative complications - Scar length, width and quality - Scar length, width and quality - Patients' quality of life - Patient satisfaction - Patients' quality of life - Patient satisfaction - Patients' quality of life - Patient satisfaction - Direct and indirect costs per patient ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy - NCT ID: NCT06363578 - Study ID: 36264PR604/3/24 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-10-01 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy. ### Conditions - Dexmedetomidine - External Oblique Intercostal Plane Block - Splenectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dexmedetomidine 0.5 μg/kg - Dexmedetomidine 1 μg/kg ### Outcomes Primary Outcomes - Time to the 1st rescue analgesia Secondary Outcomes - Intraoperative fentanyl consumption - Total morphine consumption - Degree of pain - Heart rate - Mean arterial pressure - The incidence of adverse events ### Location - Facility: Tanta University, Tanta, El-Gharbia, 31527, Egypt @@
## Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults - NCT ID: NCT06363565 - Study ID: MN-2022-11 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L. ### Conditions - Homocysteine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - supplementation of compound nutrients - placebo control ### Outcomes Primary Outcomes - levels of homocysteine Secondary Outcomes ### Location - Facility: SunYat-sen University, Guangzhou, Guangdong, 510080, China @@
## A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer - NCT ID: NCT06363552 - Study ID: WETARI - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Tianshu Liu ### Study Description The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer. ### Conditions - Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SC0191 - SC0191 + Bevacizumab - SC0191 + 5-FU/LV ### Outcomes Primary Outcomes - Objective Response Rate - Incidence and Severity of Dose Limiting Toxicities (DLTs) Secondary Outcomes ### Location - Facility: Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, 200032, China @@
## Silver Nitrate Versus Topical Steroid For Umbilical Granuloma - NCT ID: NCT06363539 - Study ID: Adeel5 - Status: COMPLETED - Start Date: 2022-09-20 - Completion Date: 2023-05-01 - Lead Sponsor: Children Hospital and Institute of Child Health, Lahore ### Study Description Umbilical granuloma is most frequent abnormality of umbilicus in infants that is defined as a moist, fleshy and pink granulation tissue at the center of umbilicus. The most commonly used treatment for umbilical granuloma is silver nitrate cauterization. Various other treatment options for umbilical granuloma include dressing with alcohol and antiseptic solutions, topical table salt, topical steroid application, suture ligation, surgical excision, electrocautery and cryotherapy. Topical steroid ointment is easily available in market, it is cheaper and safer than silver nitrate. OBJECTIVE: To compare the outcome of treatment with silver nitrate versus topical steroid for umbilical granuloma in terms of healing after 3 weeks of treatment. MATERIALS AND METHODS Study Design: Randomized Controlled Trial Setting: Department of Pediatric Surgery, Children Hospital, Lahore Duration: 6 months after approval of synopsis \[Sept 20, 2022 till March 20, 2023\] DATA COLLECTION PROCEDURE 2 After approval of study from hospital Ethical committee \& CPSP, all patients fulfilling the inclusion criteria were admitted through the pediatric surgery outpatient department of The Children's Hospital Lahore. 354 Patients were divided in two equal groups randomly, using lottery method Group A (control group) in which silver nitrate was applied to the lesion once a week and Group B (experimental group) in which topical steroid ointment was applied to the lesion twice a day. Patients were followed after 3 weeks to see healing of umbilical granuloma. Photographs were taken before start of treatment and on regular intervals at each follow up visit. All data was collected by myself. ### Conditions - Umbilical Granuloma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION - Silver Nitrate ### Outcomes Primary Outcomes - healing Secondary Outcomes ### Location - Facility: Children Hospital, Lahore, Punjab, 42000, Pakistan @@
## Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. - NCT ID: NCT06363526 - Study ID: UMalagaDRIP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2024-11-30 - Lead Sponsor: University of Malaga ### Study Description The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy. ### Conditions - Duchenne Muscular Dystrophy - Becker Muscular Dystrophy - Muscular Dystrophy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Digital respiratory intervention program ### Outcomes Primary Outcomes - Analyze the improvement of the forced vital capacity (FVC). Secondary Outcomes - Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination. - Perform an anthropometric study of the patient's characteristics, taking into account age. - Perform an anthropometric study of the patient's characteristics, taking into account height. - Perform an anthropometric study of the patient's characteristics, taking into account sex. - Examine changes in forced expiratory pressure - Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). - Check if there are changes in the sniff nasal inspiratory pressure (SNIP) - Evaluate the fatigue in patients using an EPInfant test. - Evaluate the quality of life of patients using a scale called "Kindscreen-52". ### Location - Facility: Rocío Martín-Valero, Málaga, N/A, N/A, Spain @@
## The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial - NCT ID: NCT06363513 - Study ID: SUR2567-0150 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-05 - Lead Sponsor: Chiang Mai University ### Study Description Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4).Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage\[8\]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse.Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes. ### Conditions - Anorectal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aescin in Horse Chestnut - Flavonoid ### Outcomes Primary Outcomes - Cessation of bleeding Secondary Outcomes ### Location - Facility: Maharaj Chiang Mai hospital, Chiangmai, Maung, 50200, Thailand @@
## Characterization of HIV-1 Reservoirs in HIV-1 Non-B Infected Adolescents on ART in Cameroon - NCT ID: NCT06363500 - Study ID: ChantalIRCB - Status: COMPLETED - Start Date: 2021-11-01 - Completion Date: 2023-11-30 - Lead Sponsor: Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS ### Study Description Background: Combination antiretroviral therapy (cART) can bring HIV-1 in blood plasma to level undetectable by standard tests and allow a near-normal life expectancy for HIV-infected individuals. Unfortunately, cART is not curative, as within a few weeks of treatment cessation, HIV viremia in most patients rebounds except for rare elite or post-treatment controllers of viremia. The primary source of this rebound is the highly stable reservoir of latent yet replication-competent HIV-1 proviruses integrated into the genomic DNA of resting memory CD4+ T cells. To achieve a cure for HIV, understanding the cell reservoir environment is of paramount importance. The size and nature of viral reservoir might vary per timing of therapy, therapeutic response, ART duration, and immune response. Mechanisms of reservoir maintenance generally depend on levels/type of immune recognition, dynamics of viral persistence are different between pediatric and adult populations, owing to, but not limited to, types/numbers of target cells, efficiency in clearing HIV-infected cells, plasma viremia and HIV drug resistance patterns. This difference could become more evident as these children grow toward adolescence (increasing population due to ART benefits), a stage during which suboptimal adherence is frequent, leading to viral rebound and archiving of resistant patterns.Objectives: We plan to conduct a cross sectional study with the aim to characterize HIV reservoirs and their variability according to virological and immunological profiles of non-B HIV-1 vertically infected adolescents receiving antiretroviral therapy. Specifically, we shall (1) evaluate the size of HIV reservoir; (2) Determine HIV-1 genetic variability and drug resistance in cellular reservoirs; (3) Characterize immune activation/inflammation of HIV infected adolescents.Methods: We plan to conduct an observational and comparative study involving 90 HIV-1 non-B infected adolescents aged 10-19 years vertically infected, have been on ART for at least 12 months selected from a cohort of the ongoing EDCTP-READY study; intravenous blood will be collected for CD4/CD8 count, plasmatic viral load, PBMCs isolation, immune activation/inflammatory markers, genotyping and Viral reservoir quantification. We will as well recruit a group of 30 HIV-negative adolescents as control for immunological profiling.Overall impact: Our findings will help in advancing knowledge on HIV reservoir, in terms of size and genetic variability in adolescents living with HIV (ADLHIV). Such evidence will also help in understanding the effects of ART timing and duration on the size of reservoirs among ADLHIV, a unique population from whom findings generated will largely contribute in designing functional cure strategies in this vulnerable population. ### Conditions - Characterization of HIV Reservoirs in Adolescents ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - non applicable ### Outcomes Primary Outcomes - Archived HIV drug resistance mutations Secondary Outcomes - HIV-1 reservoirs measurement ### Location - Facility: Chantal Biya International Reference Centre, Yaounde, Centre, 99999, Cameroon @@
## Semaglutide and Cognition in Healthy Volunteers - NCT ID: NCT06363487 - Study ID: R87970/RE001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-06-08 - Lead Sponsor: University of Oxford ### Study Description Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA). It is a safe medication approved for use in type-2 diabetes mellitus (T2DM) and obesity. Primarily, it works by counteracting insulin-resistance and inducing weight loss. It also acts on several other interconnected neurobiological, immunological (esp. inflammatory), endocrine-metabolic, and gut-brain axis processes that play a role in depressive symptoms. Its effects on cognition and energy are currently unknown. In this study we are using semaglutide as an experimental tool to further investigate these relationships. ### Conditions - Cognitive Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Semaglutide, 0.5 mg/mL - Placebo, 0.9% NaCl 1.5mL ### Outcomes Primary Outcomes - Reward (learning) - Reward (effort-based) - Reward (primary) Secondary Outcomes - Emotional processing - Emotional impulsivity - Memory (short- and medium-term) processing - Memory (working) processing - Energy/activity ### Location - Facility: Department of Psychiatry, University of Oxford, Oxford, Oxfordshire, OX3 7JX, United Kingdom @@
## Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury - NCT ID: NCT06363474 - Study ID: UHS 5532 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: University of Health Sciences Lahore ### Study Description The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months ### Conditions - Severe Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Decompressive Craniectomy - Cisternostomy ### Outcomes Primary Outcomes - comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS). Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of TDM-180935 in Atopic Dermatitis Patients - NCT ID: NCT06363461 - Study ID: 239-13851-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-10-31 - Lead Sponsor: Technoderma Medicines Inc. ### Study Description Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TDM-180935 topical ointment 1.0% - TDM-180935 topical ointment 2.0% - TDM-180935 topical vehicle ointment 1 - TDM-180935 topical vehicle ointment 2 ### Outcomes Primary Outcomes - Change in m-EASI (modified Eczema Area and Severity Index) score Secondary Outcomes - Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score) - Change in m-EASI (modified Eczema Area and Severity Index) score - Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score - Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score - Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score - Change in BSA (body surface area) affected - Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score ### Location - Facility: Site 3, Rolling Meadows, Illinois, 60008, United States @@
## Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia - NCT ID: NCT06363448 - Study ID: Soh-Med-24-3-04PD - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-07-30 - Lead Sponsor: Sohag University ### Study Description The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique. ### Conditions - Aphakia, Postcataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia ### Outcomes Primary Outcomes - Best corrected visual acuity (BCVA) in LogMAR Secondary Outcomes ### Location - Facility: Ophthalmology department, Sohag University, Sohag, N/A, 82511, Egypt @@
## AI-based Measurements of Tumour Burden in PSMA PET-CT - NCT ID: NCT06363435 - Study ID: #2022-01302-02-PSMA - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2033-03 - Lead Sponsor: Elin Tragardh ### Study Description The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans ### Outcomes Primary Outcomes - Tumour burden (cm3) in relation to overall survival Secondary Outcomes - Tumour burden (cm3) in relation to biochemical recurrence - Number of tumours/metastases in relation to OS - Comparing two different segmentation methods in relation to OS - Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod ### Location - Facility: Skåne University Hospital, Lund, N/A, N/A, Sweden @@
## The Value of Epicanthoplasty on the Modification of Upper-eyelid Appearance - NCT ID: NCT06363422 - Study ID: JY2024-012 - Status: COMPLETED - Start Date: 2024-01-01 - Completion Date: 2024-04-01 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description In East Asian populations, the combination of an epicanthic fold and mono-eyelid is one of their anatomical characteristics. Misalignment of the orbicularis oculi muscle and fibrous connections leads to longitudinal tension, forming the epicanthic fold. The epicanthic fold may diminish the aesthetic effects of eyelid cosmetic surgery, shorten the horizontal length, and affect the postoperative shape of double eyelids. As upper eyelid cosmetic surgery is one of the most common cosmetic procedures in Asia, there is increasing attention on the modification of the epicanthic fold and its impact on the formation of double eyelids. ### Conditions - Patient Satisfaction - Epicanthus; Fold ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Epicanthoplasty ### Outcomes Primary Outcomes - inter-epicanthal distance (IED) Secondary Outcomes ### Location - Facility: Shanghai ninth people's hospital, Shanghai, N/A, N/A, China @@
## The Acute and Accumulative Effects of Snack Foods on Exercise Recovery - NCT ID: NCT06363409 - Study ID: 2023-1353 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-01-01 - Lead Sponsor: San Diego State University ### Study Description The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations. ### Conditions - Muscle Strength ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Cereal Bar as a recovery food snack - Almond ### Outcomes Primary Outcomes - delayed onset of muscle soreness - markers of muscle damage - changes in strength - changes in body composition Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study - NCT ID: NCT06363396 - Study ID: K 2023-7081 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2027-02-22 - Lead Sponsor: Karolinska Institutet ### Study Description This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods:* by using mass spectrometry-based proteomics approaches* Olink technologyPET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand \[ 11C\]PBR28 as well as the SV2A radioligand \[ 11C\]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties. ### Conditions - Fatigue - Cognitive Dysfunction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Results of cognitive tests - Potential biomarkers for fatigue and cognitive dysfunction - PET results Secondary Outcomes - Global analyses of the neural connections ### Location - Facility: Karolinska, Stockholm, N/A, 14186, Sweden @@
## A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants - NCT ID: NCT06363383 - Study ID: MB-001-101 - Status: RECRUITING - Start Date: 2024-05-09 - Completion Date: 2025-05 - Lead Sponsor: Mage Biologics ### Study Description The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are:Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug.Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose. ### Conditions - Ulcerative Colitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MB-001 ### Outcomes Primary Outcomes - Incidence and severity of adverse events (AEs) - Clinically significant changes from baseline in vital signs - Clinically significant changes from baseline in physical examination findings - Clinically significant changes from baseline in clinical laboratory assessments - Clinically significant changes from baseline in ECG parameters Secondary Outcomes - Area under the concentration-time curve - Maximum plasma concentration - Time to reach observed maximum plasma concentration after administration - Trough concentration ### Location - Facility: CMAX, Adelaide, South Australia, 5000, Australia @@
## Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections - NCT ID: NCT06363370 - Study ID: KXZY-GB05-201 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2026-06-30 - Lead Sponsor: Kexing Biopharm Co., Ltd. ### Study Description To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection. ### Conditions - Respiratory Syncytial Virus Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Human interferon α1b Inhalation Solution - Inhalation Solution Placebo ### Outcomes Primary Outcomes - Wang bronchiolitis score chanced by percentage from baseline - Wang bronchiolitis score chanced by percentage from baseline - Wang bronchiolitis score of 0 in proportion - Wang bronchiolitis score total score < 5 points - Wang bronchiolitis score, the first time the total score reaches < 5 points Secondary Outcomes - RSV viral load ### Location - Facility: Children's Hospital, Capital Institute of Pediatrics, Beijing, Beijing, 100000, China @@
## The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy - NCT ID: NCT06363357 - Study ID: 24B-007-0000 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy.The main questions it aims to answer are:* What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy?* Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not?Participants will:* Receive education on how to wear and use the shoulder orthosis.* Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues.Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography. ### Conditions - Muscular Dystrophy, Duchenne - Orthotic Devices - Upper Extremity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Shoulder orthosis ### Outcomes Primary Outcomes - Performance of the upper limb module 2.0 (PUL 2.0) - Active Range of motion - Functional workspace - Goal Attainment Scale (GAS) - Surface electromyography (sEMG) Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, Jongno-gu, 03080, Korea, Republic of @@
## Follow-up in Pediatric Intensive Care Unit - NCT ID: NCT06363344 - Study ID: APHP231022 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.Intermediate objectives are to study:* The needs of the children and their families which should be met by this management* The acceptability of this organizational innovation for all the actors involved* The cooperation between actors of the hospital and city health system + social professionals involved* The costs of implementation and the budgetary impact of such a systemMethods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinionsPerspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care ### Conditions - Intensive Care Psychosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999) ### Outcomes Primary Outcomes - Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012) Secondary Outcomes - Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire - Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire - Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire ### Location - Facility: Robert Debre Hospital, Paris, N/A, 75019, France @@
## Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders - NCT ID: NCT06363331 - Study ID: 2020I054 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-12-30 - Lead Sponsor: Fundacin Biomedica Galicia Sur ### Study Description Drug use, substance use disorders (SUD) and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used in healthcare practice.Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions, it is necessary to be able to detect, evaluate and have specific therapies for these dysfunctions and investigate, among other issues, the role they play in the onset and course evolutionary. After implementing neuropsychological evaluation techniques for diagnostic improvement, addresses the search for procedures that allow working on cognitive and executive deficits, as a specific therapeutic target.To characterize the presence of alterations in the domains that make up social cognition (SC) in patients with SUD and test in our healthcare units the ET® program already tested both experimentally and at beta level. It is an online self-training program for CS rehabilitation that includes modules for emotion recognition (RE), Theory of Mind (ToM) and attributional style (AS).To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM, in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training, using advanced LC-ESI proteomics techniques. MS/MS in saliva since previous studies in a population with schizophrenia, subjected to different neurorehabilitation therapies. It is also intended to subsequently improve the instrument (ET®) through the implementation of big data analysis and machine learning and the introduction of automated user management. At this level, the objective is to determine, after the first games, the type of game and the intensity required to improve the user's performance until it reaches normality.From the perspective of the State Plan for Scientific and Technical Research and Innovation, this project combines CLINICAL AND TRANSLATIONAL RESEARCH, based on the evidence of scientific and technological knowledge, and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services. Health for people with SUD. ### Conditions - Social Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Emotional Training ### Outcomes Primary Outcomes - Assess the presence of dysfunctions in the subdomains of social cognition Secondary Outcomes - Accuracy and efficacy of ET® in patients with SDB ### Location - Facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro, Vigo, Pontevedra, 36213, Spain @@
## Comparison of Open and Laparoscopic Appendectomy in Pediatric Population - NCT ID: NCT06363318 - Study ID: 0003 - Status: COMPLETED - Start Date: 2019-07-01 - Completion Date: 2019-11-30 - Lead Sponsor: King Edward Medical University ### Study Description Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay. ### Conditions - Appendicitis Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laparoscopic appendicectomy ### Outcomes Primary Outcomes - Operative time - wound infection - Hospital stay - Postoperative pain Secondary Outcomes ### Location - Facility: Muhammad Sharif, Lahore, Punjab, 53711, Pakistan @@
## Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health - NCT ID: NCT06363305 - Study ID: 2402-1139 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Skidmore College ### Study Description The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials. ### Conditions - Pre Hypertension - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Dietary capsules ### Outcomes Primary Outcomes - Blood Pressure and Vascular Stiffness - Heart Rate (HR) and HR variability (HRV) - Flow Mediated Dilation - Passive Leg Movement Hyperemia - Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test Secondary Outcomes - Urinary Capsaicinoids - Blood Lipids ### Location - Facility: Skidmore College, Saratoga Springs, New York, 12866, United States @@
## Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. - NCT ID: NCT06363292 - Study ID: SOPH231-1221/I - Status: RECRUITING - Start Date: 2024-01-30 - Completion Date: 2024-05-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®. ### Conditions - Ophthalmological Agent Toxicity - Bacterial Conjunctivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRO-231 - VIGAMOXI® ### Outcomes Primary Outcomes - Incidence of unexpected adverse events related to the interventions - Incidence of conjunctival hyperemia and chemosis - Changes in Best Corrected Visual Acuity (BCVA) - Changes in the integrity of the ocular surface (fluorescein staining) - Changes in the Ocular Comfort Index (OCI) score between interventions. Secondary Outcomes - Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis) - To assess the tolerability of PRO-231 ophthalmic solution ### Location - Facility: IIMET Investigación e Innovación en Medicina Traslacional, Guadalajara, Jalisco, 44610, Mexico @@
## Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation. - NCT ID: NCT06363279 - Study ID: 2024/24JAN/044 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-10 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations (Guillemin, Bombardier and Beaton, 1993; Tsang et al., 2017), but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation.The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Conducting questionnaires ### Outcomes Primary Outcomes - ATI - affinity technology interaction scale Secondary Outcomes - Scale for assessing a person's readiness to use technological tools as part of their rehabilitation ### Location - Facility: Clinique Universitaires Saint-Luc, Brussel, Woluwé-Saint-Lambert, 1200, Belgium @@
## A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers - NCT ID: NCT06363266 - Study ID: 190211_1 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2028-08-31 - Lead Sponsor: St. Mary's Research Center, Canada ### Study Description Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes. ### Conditions - Cancer of the Prostate - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - TEMPO - Active Monitoring dyads' anxiety ### Outcomes Primary Outcomes - HADS-Anxiety Secondary Outcomes - TEMPO's key mechanisms of action ### Location - Facility: St. Mary's Research Centre, Montreal, Quebec, H3T1M5, Canada @@
## Pilot Study of the Human Metagenome in Metabolic Diseases - NCT ID: NCT06363253 - Study ID: CIRB Ref: 2023/2073 - Status: RECRUITING - Start Date: 2023-08-14 - Completion Date: 2027-12-31 - Lead Sponsor: Sengkang General Hospital ### Study Description This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine. ### Conditions - Obesity - Sarcopenia - Sarcopenic Obesity - Chronic Inflammation - Metabolic Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No specific intervention ### Outcomes Primary Outcomes - Metagenomic alterations - Metabolomic alterations Secondary Outcomes ### Location - Facility: Sengkang General Hospital, Singapore, N/A, 544886, Singapore @@
## Evaluation of Broadband Light Treatment for Solar Lentigines - NCT ID: NCT06363240 - Study ID: CBBLCIP001 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-01-30 - Lead Sponsor: Sciton ### Study Description Broadband light treatment for Solar Lentigines ### Conditions - Solar Lentigo ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Broadband Light ### Outcomes Primary Outcomes - Changes in skin post treatment Secondary Outcomes ### Location - Facility: Sanctuary Plastic Surgery, Boca Raton, Florida, 33431, United States @@
## Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients - NCT ID: NCT06363227 - Study ID: ANEST-0003 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-04 - Lead Sponsor: Schulthess Klinik ### Study Description The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery. ### Conditions - Postoperative Pain, Acute ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Standardized pain management ### Outcomes Primary Outcomes - Perioperative pain trajectories - Increased risk for postoperative pain Secondary Outcomes - Total amount of opioids administered - Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Patient Blood Management (PBM) at the Schulthess Clinic - NCT ID: NCT06363214 - Study ID: ANEST-0002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-04 - Lead Sponsor: Schulthess Klinik ### Study Description Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic. ### Conditions - Patient Blood Management ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient blood management ### Outcomes Primary Outcomes - Perioperative transfusion rates - Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion Secondary Outcomes - Perioperative rates of coagulation products administered - Clinical outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours - NCT ID: NCT06363201 - Study ID: CAT2024/PED01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-28 - Completion Date: 2025-12-15 - Lead Sponsor: Catalysis SL ### Study Description Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours. ### Conditions - Advanced Cancer - Advanced Solid Tumor - Lymphoma, Hodgkin - Central Nervous System Tumor - Sarcoma - Germ Cell Tumor - Pediatric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Ocoxin Oral solution ### Outcomes Primary Outcomes - Quality of Life Secondary Outcomes - Degree of toxicity related to oncospecific treatment - Nutritional Status - Presence of Adverse Events (AE) - Metabolic Status - Physical Status - Response to oncospecific treatment ### Location - Facility: Hospital Escuela, Tegucigalpa (Honduras), Tegucigalpa, Francisco Morazan, 504, Honduras @@
## The Impact of ESWT on Healing of Fractured Mandible - NCT ID: NCT06363188 - Study ID: effect of ESWT on fractures - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-08-30 - Lead Sponsor: Cairo University ### Study Description studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws. ### Conditions - Fractured Mandible Due to Trauma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Radial Extracorporeal shockwave ### Outcomes Primary Outcomes - bone healing (denisty of bone) Secondary Outcomes - pain sensation ### Location - Facility: Cairo Univeristy, Cairo, N/A, N/A, Egypt @@
## PREMs In Vascular SurgERy Enhancement Study - NCT ID: NCT06363175 - Study ID: 8737 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-06-01 - Lead Sponsor: Cardiff and Vale University Health Board ### Study Description THE PROBLEM:Patient Reported Experience Measures (PREMs) ask patients about their healthcare service experience. It gives them a voice to share their views. PREMs allow healthcare providers (HCPs) to see where care is good, and where they could improve. Vascular surgery is a surgical speciality looking after people's blood vessels (arteries and veins).There is no PREM available for vascular patients. The research team want to create a PREM for this patient group.WHY IT IS IMPORTANT:A PREM allows HCPs to record and understand patients' experiences of their treatment. It gives patients a way to provide feedback on their healthcare experience. PREMs can help HCPs make changes to patients' care, identifying areas of good practice and areas for improvement. The Welsh Government is keen to support the use of PREMs.AIMS:To develop a PREM specific to vascular surgery patients.RESEARCH PLAN:The research team will summarise the literature about PREMs in surgery. The research team will then run focus groups and interviews with patients and staff to create a 'draft' PREM for vascular patients in Wales. The 'draft' PREM will be translated into Welsh.In the second phase, a larger number of vascular patients (100-300 depending on how long the 'draft' PREM is) from hospitals across Wales will complete the questionnaire. Statistical tests will look at the results to see if the questionnaire works well to capture patients' experiences. Based on these results, small changes will be made to make the 'draft' PREM better. This will make sure the 'final PREM' is ready for widespread use in Wales and beyond.PATIENT AND PUBLIC INVOLVEMENT:The patients' experience team at CAVUHB has reviewed our patients' materials. Our research team includes PPI co-applicants (DC and AH). DC a double amputee who has had many vascular operations. DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales. AH has issues with her leg due to smoking and had a keyhole operation to help with that. She had some problems after the procedure This is her first time as a PPI representative. DC and AH supported our research design and will be steering group members. Also, our research focuses on giving patients a voice and will include patients across Wales. A diverse group of patients will be involved across all stages of the PREM development. ### Conditions - Vascular Diseases - Patient Empowerment - Patient Satisfaction - Patient Engagement - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Degree of Validity of the PREM - Degree of Reliability of the PREM - Degree of Responsiveness of the PREM - Degree of Feasibility of implementing the PREM in clinical practice Secondary Outcomes ### Location - Facility: Southeast Wales Vascular Network-Cardiff and Vale University Health Board, Cardiff, Wales, N/A, United Kingdom @@
## Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery - NCT ID: NCT06363162 - Study ID: LRR202404 - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples. ### Conditions - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Immunohistochemistry or genetic test ### Outcomes Primary Outcomes - Area Under the Curve - Accuracy Secondary Outcomes - Sensitivity - Specificity - Kappa coefficient - Time consumption for the Raman analyzer in detection - Adverse Event Incidence Rate - Serious Adverse Event Incidence Rate - Operator adverse events ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100071, China @@
## Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients - NCT ID: NCT06363149 - Study ID: 2024-11-DM-136 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2025-09 - Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences ### Study Description Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock.Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC.Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock. ### Conditions - Septic Shock - Disseminated Intravascular Coagulation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7 Secondary Outcomes - Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14 ### Location - Facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India @@
## Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness - NCT ID: NCT06363136 - Study ID: 14.06.2023-111176 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-30 - Lead Sponsor: Bezmialem Vakif University ### Study Description Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not.In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness. ### Conditions - Gastrocnemius Tightness - Postural Control - Muscle Strength - Functional Performance - Foot Posture ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Postural Control Assessment - Lower extremity muscle strength measurement Secondary Outcomes - Foot posture assessment - Functional performance assessment ### Location - Facility: Bezmialem Vakif University, Istanbul, N/A, N/A, Turkey @@
## Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis - NCT ID: NCT06363123 - Study ID: BFHHZML20240009 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-04 - Lead Sponsor: Beijing Friendship Hospital ### Study Description The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer. ### Conditions - Lung Cancer - Breast Cancer - Colorectal Cancer - Thyroid Cancer - Gastric Cancer - Cervical Cancer - Liver Cancer - Pancreatic Cancer - Cholangiocarcinoma - Prostate Cancer - Esophageal Cancer - Ovarian Cancer - Renal Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Plasma metabolite content Secondary Outcomes ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, 100021, China @@
## An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States - NCT ID: NCT06363110 - Study ID: 22724 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-30 - Lead Sponsor: Bayer ### Study Description This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly.The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better.It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:* starting dose of vericiguat* daily changes in dosage pattern* time taken to reach the target dose* number and percentage of participants:* with specific changes in dosage pattern* reaching the target dose of vericiguatThey will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.Researchers will only look at the health records of participants in the US.Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.In this study, only available data from routine care are collected. No visits or tests are required as part of this study. ### Conditions - Chronic Heart Failure With Reduced Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vericiguat (Verquvo, BAY1021189) ### Outcomes Primary Outcomes - Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date - Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation - Days from index date to first occurrence of 10 mg/day dose - Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period - Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation - Number of patients having specific titration scenarios within the 90 days after vericiguat initiation Secondary Outcomes - Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals ### Location - Facility: Bayer, Whippany, New Jersey, 07981, United States @@
## Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease - NCT ID: NCT06363097 - Study ID: ΔΔ5032 - Status: RECRUITING - Start Date: 2023-09-04 - Completion Date: 2025-06 - Lead Sponsor: Aristotle University Of Thessaloniki ### Study Description In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients. ### Conditions - Chronic Kidney Disease - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure. - Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. Secondary Outcomes - Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure. - Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. - Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure. - Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure. - The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion. - The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion. - The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion. - The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion. - The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion. - Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). - Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). - Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). - Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). - Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). - Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). - Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). - Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). - Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). - Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). - Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). - Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). - Effect of 24-hour urinary sodium excretion on hydration status (US-B lines). - Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines). - Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines). - Effect of 24-hour urinary sodium excretion on MMSE score. - Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score. - Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score. - Effect of 24-hour urinary sodium excretion on PSQI score. - Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score. - Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score. - Effect of 24-hour urinary sodium excretion on ESS score. - Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score. - Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score. - Effect of 24-hour urinary sodium excretion on nocturnal urinations. - Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations. - Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations. ### Location - Facility: 1st Department of Nephrology, Thessaloníki, Central Macedonia, 54642, Greece @@
## A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer - NCT ID: NCT06363084 - Study ID: IST-Nim-PC-6 - Status: COMPLETED - Start Date: 2016-05-01 - Completion Date: 2023-06-30 - Lead Sponsor: Ruijin Hospital ### Study Description This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS). ### Conditions - Resectable Pancreatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nimotuzumab ### Outcomes Primary Outcomes - overall survival (OS） Secondary Outcomes - disease-free survival (DFS) - locoregional recurrence-free survival (LRRFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## APA and PAS Training for Gait Initiation in Parkinson's Disease - NCT ID: NCT06363071 - Study ID: 202000495A3 - Status: RECRUITING - Start Date: 2022-06-13 - Completion Date: 2025-05-31 - Lead Sponsor: Chang Gung University ### Study Description Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Weight shift training and APA feedback - Paired associative stimulation ### Outcomes Primary Outcomes - Balance Performance - COP Path Length in Balance Tasks - COP Displacement in Balance Tasks - Motor Evoked Potentials (MEPs) - Intracortical Facilitation (ICF) - Intracortical Inhibition (ICI) - Walking Speed - Step Length - Step Time Secondary Outcomes - COP Velocity in Balance Tasks - COP Area in Balance Tasks - Double Support Time - Single Support Time - Swing Time - Stance Time - Cadence ### Location - Facility: Chang Gung University, Taoyuan, N/A, 333, Taiwan @@
## Electrical Stimulation Cycling Training Effects on SCA - NCT ID: NCT06363058 - Study ID: 201902166B0 - Status: RECRUITING - Start Date: 2022-04-08 - Completion Date: 2025-07-31 - Lead Sponsor: Chang Gung University ### Study Description To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies. ### Conditions - Spinocerebellar Ataxia (SCA) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - ES Cycling Training ### Outcomes Primary Outcomes - Overall Response Time - Overall Error Rate - Motor Evoked Potentials (MEPs) - Intracortical Facilitation (ICF) - Intracortical Inhibition (ICI) - Total Scale for the Assessment and Rating of Ataxia (SARA) Score - Total Berg Balance Scale (BBS) Score - Total Time to Complete the Time Up and Go test (TUG test) - Walking Speed - Step Length - Step Time Secondary Outcomes - Double Support Time - Single Support Time - Swing Time - Stance Time - Cadence ### Location - Facility: Chang Gung University, Taoyuan, N/A, 333, Taiwan @@
## Comparative Study of the NIDEK TONOREF III With Predicate Devices - NCT ID: NCT06363045 - Study ID: NIDEK-TONOREF-UK-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Nidek Co. LTD. ### Study Description The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices. ### Conditions - Intraocular Pressure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - NIDEK TONOREF III - Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER - NIDEK CEM-530 ### Outcomes Primary Outcomes - Equivalent to legally-marketed devices - Equivalent to the pachymeter function Secondary Outcomes - The numbers of adverse events ### Location - Facility: Aston University, Birmingham, N/A, B4 7ET, UK, United Kingdom @@
## Elastography in Predicting Renal Outcome - NCT ID: NCT06363032 - Study ID: 202110104RINB - Status: RECRUITING - Start Date: 2021-12-27 - Completion Date: 2025-12-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required. ### Conditions - Kidney Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - elastography ### Outcomes Primary Outcomes - collect medical record of blood urea nitrogen and Creatinine Secondary Outcomes ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, N/A, Taiwan @@
## Supporting At-Risk Mothers Across Perinatal Period - NCT ID: NCT06363019 - Study ID: 2023/00158 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-07-06 - Lead Sponsor: National University of Singapore ### Study Description The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.The main questions this study aims to answer are:1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes?3. What is the cost-effectiveness of using SMART as compared to standard routine care?Researchers will compare results with a control group that will undergo standard routine care. ### Conditions - Perinatal Depression - Parents - Anxiety - Self Efficacy - Stress - Infant Development ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application ### Outcomes Primary Outcomes - Postnatal depression Secondary Outcomes - Infant physical development - Infant cognitive development - Infant emotional development - Anxiety - Perceived stress - Perceived social support - Maternal-infant bonding - Parental satisfaction - Parental efficacy - Objective stress - Emotional availability - Health services and utilization - Infant Physical Development - Infant Social Development - Infant Social Development - Infant Social Development - Infant Emotional Development ### Location - Facility: Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore, N/A, 117597, Singapore @@
## Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer - NCT ID: NCT06363006 - Study ID: K23C3280 - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2027-01-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are:* Objective response rate (ORR) for evaluation* Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。 ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TKI+Cardunilimab ### Outcomes Primary Outcomes - ORR Full single-arm, open, multicenter prospective clinical study - Progression-free Survival (PFS) Secondary Outcomes - Disease Control Rate (DCR) - Overall Survival (OS) - Duration of Response (DOR) - Stable Disease (SD) - Progression free survival rate ### Location - Facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), Beijing, Beijing, 100730, China @@
## Breast Cancer Screening in Ghana - NCT ID: NCT06362993 - Study ID: STUDY00021561 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Penn State University ### Study Description This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim. ### Conditions - Breast Cancer Female ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Bundling - MEGH ### Outcomes Primary Outcomes - Clinical breast exam (CBE) utilization at the local clinic Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations - NCT ID: NCT06362980 - Study ID: BPI-1178-IIT01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: National Cancer Center, China ### Study Description BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations. ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BPI-1178 - Osimertinib ### Outcomes Primary Outcomes - Number of patients with dose-limiting toxicity (DLT) Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DoR) - Progression-Free Survival (PFS) - Overall Survival (OS) - Intracranial ORR (iORR) - Intracranial DCR (iDCR) - Intracranial DoR (iDoR) - Intracranial Time to Progression (iTTP) - Intracranial PFS (iPFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT - NCT ID: NCT06362967 - Study ID: Anti-HLA antibody - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-30 - Lead Sponsor: Anhui Provincial Hospital ### Study Description Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation ### Conditions - High Titers of Anti-HLA Antibody (MFI ≥5000) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG ### Outcomes Primary Outcomes - Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment Secondary Outcomes - Incidence of primary graft failure - Incidence of TRM after allo-HSCT - Incidence of ineffective platelet transfusion after allo-HSCT - Cumulative incidence of neutrophil engraftment after allo-HSCT - Cumulative incidence of II-IV° acute GVHD - Cumulative incidence of relapse at 1 year post-transplant - Probability of overall survival post transplantation - Incidence of allergies and allergic reactions - Incidence of haemorrhagic events - Incidence of viral, bacterial and fungal infections - Incidence of hypocalcaemia ### Location - Facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, Anhui, 230036, China @@
## The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients - NCT ID: NCT06362954 - Study ID: AnkaraMedipolU-FTR-SS-01 - Status: RECRUITING - Start Date: 2023-12-31 - Completion Date: 2024-06-01 - Lead Sponsor: Ankara Medipol University ### Study Description Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow.This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients. ### Conditions - Stroke - Hemiparesis;Poststroke/CVA - Spasticity as Sequela of Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessment ### Outcomes Primary Outcomes - Plantar Flexors Muscle Oxygenation Secondary Outcomes - Spasticity - Motor Function - 6-Minute Walk Test - Stair Climbing Test - Adipose tissue thickness ### Location - Facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation, Ankara, Çankaya, N/A, Turkey @@
## Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men - NCT ID: NCT06362941 - Study ID: NW-HGN-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-30 - Lead Sponsor: Nutraceutical Wellness Inc. ### Study Description A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning. ### Conditions - Hair Thinning ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Nutrafol Women's Hair Growth Supplemnt - Nutrafol Women's Balance Hair Growth Supplement - Nutrafol Women's Vegan Hair Growth Supplement - Nutrafol Women's Postpartum Hair Growth Supplement - Nutrafol Men's Hair Growth Supplement ### Outcomes Primary Outcomes - Change in hair shaft diameter compared to baseline at Day 180. - Change in hair shaft diameter compared to baseline at Day 90. Secondary Outcomes - Change in broken hairs recovered from the hair pull test compared to baseline at Day 180 - Change in broken hairs recovered from the hair pull test compared to baseline at Day 90 - Change in hair breakage during the hair pull test compared to baseline at Day 180 - Change in hair breakage during the hair pull test compared to baseline at Day 90 - Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 - Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 - Subject Self-Perceived Improvement in Hair Quality at Day 180 - Subject Self-Perceived Improvement in Hair Quality at Day 90 ### Location - Facility: Dermatology Consulting Services, High Point, North Carolina, 27262, United States @@
## Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism - NCT ID: NCT06362928 - Study ID: CP-60005 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-08 - Lead Sponsor: Akura Medical ### Study Description This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE). ### Conditions - Pulmonary Embolism Acute ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ATC System ### Outcomes Primary Outcomes - Effectiveness - Safety: Composite of Major Adverse Device-Related Events Secondary Outcomes - Safety: Composite of Major Adverse Events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study) - NCT ID: NCT06362915 - Study ID: FMASUR66/2024 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2024-08-30 - Lead Sponsor: Ain Shams University ### Study Description The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI ### Conditions - Anesthesia, Local ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lidocaine - Bupivacain ### Outcomes Primary Outcomes - Extra Demand of sedation Secondary Outcomes - Patient and surgeon satisfaction ### Location - Facility: maha sadek El Derh, Cairo, Heliopolis, 11721, Egypt @@
## Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer - NCT ID: NCT06362902 - Study ID: NOSES-VIII B - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-09-01 - Lead Sponsor: National Cancer Center, China ### Study Description The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients. ### Conditions - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Laparoscopic right hemicolectomy with transrectal specimen extraction ### Outcomes Primary Outcomes - The rate of postoperative complications Secondary Outcomes - Operating time - Estimated blood loss - The time of first flatus - Postoperative hospitalization ### Location - Facility: National Cancer Center, Beijing, Beijing, 100000, China @@
## Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy - NCT ID: NCT06362889 - Study ID: HealMD-CBD-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: Rejuva Medical Aesthetics ### Study Description This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne. ### Conditions - Acne Vulgaris (Disorder) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Microneedling with CBD ### Outcomes Primary Outcomes - Primary efficacy endpoints Secondary Outcomes - Secondary efficacy endpoints ### Location - Facility: Rejuva Medical Aesthetics, Los Angeles, California, 90025, United States @@
## The Effect of Breastfeeding Counseling Based on Motivational Interviewing - NCT ID: NCT06362876 - Study ID: BAlis - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-15 - Completion Date: 2024-12-15 - Lead Sponsor: Mersin University ### Study Description This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section. ### Conditions - Breastfeeding Counseling Based on Motivational Interviewing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Breastfeeding Counseling Based on Motivational Interviewing - Standard Breastfeeding Consultancy ### Outcomes Primary Outcomes - Level of breastfeeding self-efficacy - Level of breastfeeding self-efficacy - Level of breastfeeding self-efficacy - Level of breastfeeding self-efficacy - Level of breastfeeding self-efficacy - Breastfeeding Results Evaluation Form - Breastfeeding Results Evaluation Form - Breastfeeding Results Evaluation Form - Breastfeeding Results Evaluation Form Secondary Outcomes ### Location - Facility: Mersin University, Mersin, N/A, 33180, Turkey @@
## Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease - NCT ID: NCT06362863 - Study ID: WDRY2024-K027 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Ping An ### Study Description By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions. ### Conditions - Crohn's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - enteral nutrition biscuits ### Outcomes Primary Outcomes - Crohn's disease activity index, CDAI Secondary Outcomes - Induced remission success rate - Gastrointestinal Symptom Rating Scale (GSRS) score - Gastrointestinal symptom remission - Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics - Incidence and severity of perianal lesions in both groups - Rate of endoscopic remission of small bowel and colon lesions in both groups - Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups - Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Tele-Support for Emergency Medical Technicians - NCT ID: NCT06362850 - Study ID: 1253/2023 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12-01 - Lead Sponsor: Medical University of Vienna ### Study Description In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed. ### Conditions - Cardiac Arrest ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Tele-support ### Outcomes Primary Outcomes - guideline adherence Secondary Outcomes - gaze behavior - teamwork performance - cognitive load - Performance of cardiopulmonary resuscitation - Technical feasibility - Usability ### Location - Facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services - NCT ID: NCT06362837 - Study ID: P0117910-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2030-05-24 - Lead Sponsor: McGill University ### Study Description This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators. ### Conditions - Stunting - Gender Equality - Acceptability of Health Care - Diet; Deficiency - Empowerment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights - school-based iron-folic acid supplement program - Health service training on equitable access to nutrition, health, and sexual and reproductive services - bio-fortified crops ### Outcomes Primary Outcomes - Gender equality - Child anthropometry Secondary Outcomes - Antenatal care - Contraception use by women and partners - Child diet - Sexual and reproductive health services for adolescents - Gender equitable health services for nutrition, health, and sexual and reproductive health ### Location - Facility: Brac University, Dhaka, N/A, N/A, Bangladesh @@
## Promoting Physical Activity in Older Hispanic/Latino(a) Adults - NCT ID: NCT06362824 - Study ID: 2094138 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2029-09-30 - Lead Sponsor: Kaiser Permanente ### Study Description In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week). ### Conditions - Sedentary Behavior - Physical Inactivity - Alzheimer Disease, Protection Against ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - De Pie Intervention - Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) ### Outcomes Primary Outcomes - Change in Moderate Intensity Physical Activity (MIPA) minutes/day Secondary Outcomes - Meet MIPA guidelines of 150 minutes physical activity per week ### Location - Facility: University of California San Diego, San Diego, California, 92093, United States @@
## Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies - NCT ID: NCT06362811 - Study ID: 483730 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Istanbul University ### Study Description The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia. ### Conditions - Analgesia - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sacral Erector Spinae Plane Block ### Outcomes Primary Outcomes - Postoperative pain scores - Analgesia requirement Secondary Outcomes - Complications ### Location - Facility: Istanbul University Cerrahpasa, Istanbul, N/A, 34098, Turkey @@
## Effect of Support for Low-Income Mothers of Preterm Infants - NCT ID: NCT06362798 - Study ID: IRB22-0729 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-12-01 - Lead Sponsor: Harvard School of Public Health (HSPH) ### Study Description Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development. ### Conditions - Preterm Birth - Low; Birthweight, Extremely (999 Grams or Less) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Financial Transfers ### Outcomes Primary Outcomes - Provision of breast milk (proportion) - Provision of skin-to-skin care Secondary Outcomes - Duration of mother's milk expression - Gestational weight-for-age - Gestational length-for-age z-score - Gestational head circumference - Necrotizing enterocolitis (NEC) - Late-onset bacterial or fungal sepsis (LOS) - NICU Visitation - Postpartum Bonding - Provision of breast milk (volume) - Breastfeeding episode - Maternal physical health - Maternal mental health (anxiety) - Maternal mental health (depression) - Reaction Time Modified Flanker Task - Accuracy Performance Modified Flanker Task - Reaction Time Psychomotor Vigilance Task - Accuracy Psychomotor Vigilance Task - Happiness - Life satisfaction - Sleep - Routine postpartum care - Financial distress - Financial hardship - Food insecurity - Housing instability - Housing insecurity - Transportation insecurity - Length of stay - Mother readmission between 4-8 weeks post-discharge - Baby readmission between 4-8 weeks post-discharge - Mother emergency department visit between 4-8 weeks post-discharge - Baby emergency department visit between 4-8 weeks post-discharge - Sleep position - Sleep location - Breastfeeding expression continuation - Skin-to-skin care knowledge - Breastfeeding knowledge - Perception of hospital experience ### Location - Facility: Children's Healthcare of Atlanta and Emory University, Atlanta, Georgia, 30322, United States @@
## Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality - NCT ID: NCT06362785 - Study ID: Virtual Reality-Seniors - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-06 - Lead Sponsor: Universidade da Coruña ### Study Description The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:* What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls?* Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention?Participants will:* Answer questionnaires.* Perform physical laboratory tests through a camera-based motion capture system.* Execute task-based exercises in a virtual environment through virtual reality.Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk. ### Conditions - Musculoskeletal Pain - Task Performance and Analysis - Accidental Falls - Virtual Reality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality ### Outcomes Primary Outcomes - Presence of musculoskeletal pain - Pain Intensity - Initial positioning - Final positioning - Angular velocity - Acceleration - Movement execution time - Range of joint movement Secondary Outcomes - Neck disability - Lower back disability - Kinesiophobia - Falls history - General health status - Date of birth - Gender - Height - Weight - Body mass index (BMI) - Depressive symptoms - Cognitive capacity - Amount and type of medication consumed - Existence of comorbidity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer - NCT ID: NCT06362772 - Study ID: MR-36-24-010944 - Status: COMPLETED - Start Date: 2015-01-01 - Completion Date: 2023-04-01 - Lead Sponsor: Jiangxi Provincial Cancer Hospital ### Study Description A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance. ### Conditions - Thyroid Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Iodine-125 brachytherapy ### Outcomes Primary Outcomes - Tumor size - Serological assessment - Pain score - Adverse event Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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