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## A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults - NCT ID: NCT06375772 - Study ID: 2-DG-02 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-12-31 - Lead Sponsor: G.ST Antivirals GmbH ### Study Description 2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants. ### Conditions - Acute Nasopharyngitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 2-Deoxy-D-glucose - Placebo ### Outcomes Primary Outcomes - The difference in the rate of rhinovirus-associated illness between 2-DG and placebo Secondary Outcomes - Number of infected subjects - Difference in percent of infected subjects - Difference in percent of days virus positive - Difference in peak nasal virus load - Difference in AUC nasal virus load - Difference in Total Jackson Symptom Score - Duration of illness - Difference in percent of days Jackson Symptom Score positive - Difference in Peak Jackson Symptom Score - Difference in peak total WURSS-21 - Difference in AUC total WURSS-21 - Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs) - Biodistribution of multiple doses of 2-DG in plasma samples - Biodistribution of multiple doses of 2-DG in nasal wash samples ### Location - Facility: Centre for Human Drug Research, Leiden, N/A, 2333, Netherlands @@
## Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia - NCT ID: NCT06375759 - Study ID: XWSSB - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia. ### Conditions - Syringomyelia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Subarachnoid-Subarachnoid (S-S) Bypass - Intradural Adhesion Lysis ### Outcomes Primary Outcomes - complication Secondary Outcomes - improvement or resolution of the syrinx, - ASIA score - Klekamp and Sammi syringomyelia scale - modified Japanese Orthopaedic Association Scores (mJOA) - xuanwu syringomyelia scale ### Location - Facility: Fengzeng Jian, Beijing, Beijing, 100053, China @@
## The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial - NCT ID: NCT06375746 - Study ID: 0091-22-WOMC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-31 - Lead Sponsor: Wolfson Medical Center ### Study Description To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling. ### Conditions - Induction of Labor Affected Fetus / Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Personalized video ### Outcomes Primary Outcomes - STAI questionnaire score Secondary Outcomes - satisfaction questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL - NCT ID: NCT06375733 - Study ID: GFH009X1202 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-12-31 - Lead Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd. ### Study Description This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) ### Conditions - Large B-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GFH009 - Zanubrutinib - GFH009 - Zanubrutinib ### Outcomes Primary Outcomes - Phase Ib: adverse events(AEs) - Phase II: ORR Secondary Outcomes ### Location - Facility: Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute, Nanning, N/A, N/A, China @@
## Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment - NCT ID: NCT06375720 - Study ID: FujianUTCM-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2025-12-15 - Lead Sponsor: Lidian Chen ### Study Description To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lower frequency, shorter period of Tai Chi Chuan - Higher frequency, shorter period of Tai Chi Chuan - Lower frequency, longer period of Tai Chi Chuan - Higher frequency, longer period of Tai Chi Chuan - Standard Health Education ### Outcomes Primary Outcomes - Montreal Cognitive Assessment Secondary Outcomes - Montreal Cognitive Assessment - Wechsler Memory Scale - Digit Symbol Substitution Test - Trial Making Test part B - Stroop Color Word Test - Boston Naming Test - Rey-Osterrieth Complex Graphics Test - Rey Auditory Verbal Learning Test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer - NCT ID: NCT06375707 - Study ID: HERO-KC23 - Status: RECRUITING - Start Date: 2024-01-09 - Completion Date: 2025-12 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer. ### Conditions - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS - Ribociclib combined with NSAI±OFS ### Outcomes Primary Outcomes - Progression Free Survival Secondary Outcomes - Progression Free Survival2 - Time to treatment failure - Overall response rate (ORR) - Overall survival(OS) - Time To Response (TTR) - Clinical benefit rate(CBR) - Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire - Frequency/severity of adverse events, lab abnormalities ### Location - Facility: Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 210000, China @@
## Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN ) - NCT ID: NCT06375694 - Study ID: IRB00025485 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-05 - Lead Sponsor: Wake Forest University ### Study Description Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics. ### Conditions - Hypertension - Cardiovascular Diseases - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Herbiotics Oral + Ent Probiotic ### Outcomes Primary Outcomes - Dietary Nitrate Conversion to Plasma Nitrite Secondary Outcomes - Percentage Lactobaciluus ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Cognitive Training in Older and Younger Adults - NCT ID: NCT06375681 - Study ID: 2019-1378: R01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-01 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks. ### Conditions - Cognitive Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - Visual and / or Auditory Cognitive Tasks (1) - Visual and / or Auditory Cognitive Tasks (2) ### Outcomes Primary Outcomes - Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task - Change in the proportion of correctly reported sequences in the Corsi Complex task - Change in the proportion of correctly reported number and letter sets in the Letter-Number task - Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task - Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task - Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task - Change in the proportion of correct responses on the Useful Field of View (UFOV) Task - Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task - Change in the response time and percentage of correct responses in the Mental Rotation Task - Change in the percentage of correct responses in the Paper Folding task - Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task - Change in the sum of correctly solved items in the UC Matrix Reasoning task - Change in the percentage of accuracy in the Shipley Institute of Living Scale - Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale Secondary Outcomes - Big-5-Inventory 10-item version (BFI-10) Score - Behavioral Inhibition/Activation System (BIS/BAS) Score - Grit and Conscientiousness Score - Meta-Cognition Score - Theories of Intelligence - Mindset (Fixed vs Growth) Score - Schutte self-report emotional intelligence test (SSEIT) Score - Work and Family Orientation (WOFO) Score - Brief Pittsburgh Sleep Quality Index (B-PSQI) Score - Participant Experience Measure 1 - Participant Experience Measure 2 - Participant Experience Measure 3 - Participant Experience Measure 4 - Participant Experience Measure 5 ### Location - Facility: University of California, Riverside, Riverside, California, 92521, United States @@
## The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women - NCT ID: NCT06375668 - Study ID: CT/NB/140/2020/PR-MS - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-15 - Completion Date: 2024-06-15 - Lead Sponsor: Nordic Biotic Sp. z o.o. ### Study Description Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months. ### Conditions - Osteoporosis, Postmenopausal - Bone Density, Low ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic - Placebo ### Outcomes Primary Outcomes - The effect of intervention on bone mineral density Secondary Outcomes - Changes in the level of calcium - Changes in the level of phosphorus - Changes in the level of alkaline phosphatase - Changes in the level of vitamin D - Changes in the level of C-reactive protein - Changes in Body Mass Index (BMI) - Changes in type of stools - Changes in the number of bowel movements - Changes in severity of abdominal pain - Changes in severity of bloating - Occurrence of adverse events - Satisfaction with the intervention ### Location - Facility: Private Specialist Practice, Bytom, N/A, 41-902, Poland @@
## Texting to Promote Breastfeeding (TOPS) - NCT ID: NCT06375655 - Study ID: STUDY20240085 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2025-07-31 - Lead Sponsor: Lydia Furman ### Study Description The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Text4baby), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC. ### Conditions - Increased Breastfeeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Team2BF - Text4baby ### Outcomes Primary Outcomes - Percentage of participants who do not opt out of receipt of text messages - Percentage of participants who said texts were helpful as measured by questionnaire - Percentage of participants who would refer a friend/family to the texting program Secondary Outcomes - Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review - Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review - Percentage of participants who are partially breastfeeding as measured by participant report/chart review ### Location - Facility: Ahuja Rainbow Center for Women and Children, Cleveland, Ohio, 44103, United States @@
## A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC - NCT ID: NCT06375642 - Study ID: SHR1316-HMPL012-HAIC-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2026-08-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs.Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma.Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma.Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells.Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options. ### Conditions - Intrahepatic Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab ### Outcomes Primary Outcomes - Objective Response Rate - Disease Control Rate Secondary Outcomes - Overall Survival - Progress-Free Survival - Incidence and severity of AE and SAE - Dose suspension rate caused by adverse events - dose termination rate caused by adverse events ### Location - Facility: Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, 300308, China @@
## ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer - NCT ID: NCT06375629 - Study ID: EDAP TMS - Status: RECRUITING - Start Date: 2023-04-20 - Completion Date: 2027-04-20 - Lead Sponsor: EDAP TMS S.A. ### Study Description The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - FocalOne ### Outcomes Primary Outcomes - Evaluation of adverse events - Evaluation of quality of life - Evaluation of urinary incontinence - Erectile function assessment - Urinary Symptoms Secondary Outcomes ### Location - Facility: Hospital Universitario Puerta del Mar, Cadiz, N/A, 21 11009, Spain @@
## Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI - NCT ID: NCT06375616 - Study ID: KY2024-023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Shen Lei ### Study Description The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are:The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment.The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment.The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH.Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality.Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded. ### Conditions - Sepsis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nafamostat Mesylate - Unfractionated Heparin ### Outcomes Primary Outcomes - Platelet decline rate Secondary Outcomes - Satisfaction of filter anticoagulation ### Location - Facility: Huashan Hospital, Fudan University, Shanghai, Shanghai, N/A, China @@
## Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software - NCT ID: NCT06375603 - Study ID: SMARTALPHA-NERVEBLOX-1001 - Status: COMPLETED - Start Date: 2022-12-01 - Completion Date: 2023-05-01 - Lead Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S. ### Study Description The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices. ### Conditions - Ultrasound Imaging of Anatomical Structures - Nerve Block ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound scans ### Outcomes Primary Outcomes - Assessment of image quality Secondary Outcomes ### Location - Facility: Ankara University School of Medicine, Ankara, N/A, 06230, Turkey @@
## NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience - NCT ID: NCT06375590 - Study ID: 2024-NavIIcusp - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Didier TCHETCHE ### Study Description The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring). ### Conditions - Bicuspid Aortic Valve ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transcatheter Aortic Valve Implantation ### Outcomes Primary Outcomes - 30-day device success (Rate) Secondary Outcomes - 1 year at least moderate bioprosthetic valve deterioration - 1 year severe patient-prosthesis mismatch - 30 days and 1 year all-cause and cardiovascular mortality - 30 days and 1 year stroke ### Location - Facility: Clinique Pasteur, Toulouse, Occitanie, 31076, France @@
## Speed of Absorption - NCT ID: NCT06375577 - Study ID: LMS-24-Dean-1 - Status: RECRUITING - Start Date: 2024-06 - Completion Date: 2025-04 - Lead Sponsor: Lancaster University ### Study Description The purpose of this study is to look at how fast commercially available supplements containing carbohydrate can get into the bloodstream. If carbohydrate, in the form of glucose, gets into the blood faster, this can provide an instant energy source and help fuel the body during exercise. We will be testing three supplements, namely Voom Pocket Rocket, SIS Go Isotonic Energy Gel, and Maurten Gel 160. Each participant will complete all three conditions, consuming one of each supplement at random per condition. The study requires participation from male runners, cyclists and triathletes who are aged between 18-35.Each visit will take approximately 1 hour and 30 minutes, and three experimental visits per participant. The study will involve frequent blood sampling and the continuous monitoring of gas exchange (oxygen/carbon dioxide). Blood sampling via cannulation will be used to analyse the lactate, glucose, and insulin content of the blood. Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study.The investigators plan to carry out the study on 16 participants who will be a mix of male runners, cyclists and triathletes. ### Conditions - Healthy - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - 45 grams Voom Pocket Rocket Electro Energy - 45 grams SIS Go Isotonic Energy Gel - 45 grams Maurten Gel 160 ### Outcomes Primary Outcomes - Blood Glucose - Blood Lactate - Insulin - Gas Exchange Secondary Outcomes ### Location - Facility: Lancaster University, Lancaster, Lancashire, LA1 4AT, United Kingdom @@
## Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression - NCT ID: NCT06375564 - Study ID: XMYY-2020KY067-05 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-30 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD. ### Conditions - Refractory Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-AB-3PRGD2 radioligand therapy ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Incidence of treatment-related adverse events (safety and tolerability) ### Location - Facility: The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China @@
## K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions - NCT ID: NCT06375551 - Study ID: 1171-0623 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2027-07-31 - Lead Sponsor: Chestnut Health Systems ### Study Description This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention. ### Conditions - Child Abuse - Decision Making - Child Welfare - Decision Making, Shared - Decision Support Technique - Social Facilitation - Implementation Science - Policy - Organizations - Consensus - Mental Health - Family ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) - Optimizing Responses with Collaborative Assessments-Live (ORCA-L) ### Outcomes Primary Outcomes - Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention - Mean changes in decision experience quality pre-post intervention - Mean changes in decision commitment pre-post intervention - Mean changes in perceived potential community health impact pre-post intervention - Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA) - Qualitatively described rationale for program adoption from pre-post intervention - Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention - Descriptive, mean group-level changes in perceived acceptability of intervention for implementation - Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation - Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA - Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA Secondary Outcomes - Qualitative changes in decision reasoning pre- post-intervention - Qualitative changes in decision goals pre- post-intervention - Qualitative changes in decision consensus pre- post-intervention - Time to adoption or re-adoption of interventions with ORCA ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy - NCT ID: NCT06375538 - Study ID: B2022-527 - Status: RECRUITING - Start Date: 2022-10-21 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours. ### Conditions - High-flow Nasal Cannula - Ultrasound Evaluation - Diaphragm and Intercostal Muscle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ultrasound evaluation of diaphragm - Ultrasound evaluation of intercostal muscle movement index - The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation. Secondary Outcomes - ICU stay - Hospital stay - all cause mortality - Oxygen saturation - respiratory rate - oxygen concentration - flow velocity of HFNC - VT - duration on HFNC ### Location - Facility: Shanghai Zhongshan Hospital, Shanghai, Shanghai, 200032, China @@
## Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder - NCT ID: NCT06375525 - Study ID: SHEBA-15-2635-SMC - Status: COMPLETED - Start Date: 2015-11 - Completion Date: 2017-08 - Lead Sponsor: Prof. Doron Gothelf MD ### Study Description The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.Our specific hypotheses are:1. In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool).2. Adherent patients will show greater improvement of ADHD symptoms and related dysfunction. ### Conditions - Children Aged 6-18 Years With the Diagnosis of ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Janssen's icon Application (App) ### Outcomes Primary Outcomes - Attention Module of the Kiddie-SADS questionniare Secondary Outcomes - MINI-KID ### Location - Facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center, Ramat-Gan, N/A, N/A, Israel @@
## A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants - NCT ID: NCT06375512 - Study ID: IN001001 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-06 - Lead Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd ### Study Description The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age ### Conditions - Herpes Zoster ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HZ Vaccine (IN001) - Placebo - Shingrix ### Outcomes Primary Outcomes - Percentage of Participants Reporting Solicited Local Reactions - Percentage of Participants Reporting Solicited Systemic Reactions - Percentage of Participants With Unsolicited Adverse Events (AEs) - Percentage of Participants With Any Medically Attended AEs (MAAEs) - Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal Secondary Outcomes - Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) - Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA - Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA - Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay - Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay - Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay - gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot) - Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. - NCT ID: NCT06375499 - Study ID: LT2769-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-04-28 - Lead Sponsor: Laboratoires Thea ### Study Description The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.The investigation is defined as a post-market stage. The clinical investigation design is confirmatory. ### Conditions - Dry Eye Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - T2769 - Hylo-Forte® ### Outcomes Primary Outcomes - To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）. - NCT ID: NCT06375486 - Study ID: AK112-IIT-TianjinCIH-LHK - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-06-15 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first. ### Conditions - Hepatocellular Carcinoma Non-resectable - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） ### Outcomes Primary Outcomes - Overall response rate (ORR) Secondary Outcomes - Progress Free Survival （PFS） - Overall survival (OS) - Adverse Events（AEs） ### Location - Facility: Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin, 300308, China @@
## Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients - NCT ID: NCT06375473 - Study ID: MA-PC-RWS-011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2027-04-19 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen. ### Conditions - Pancreatic Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Irinotecan liposome II combination therapy regimen ### Outcomes Primary Outcomes - rwTEAE Secondary Outcomes - OS - PFS - ORR - TTP - DCR ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Real-time Engagement for Learning to Effectively Control Type 2 Diabetes - NCT ID: NCT06375460 - Study ID: STUDY24020141 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2029-06-30 - Lead Sponsor: University of Pittsburgh ### Study Description This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period. ### Conditions - Diabetes Mellitus, Type 2 - Lifestyle - Hyperglycemia - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Focused App Prompt - No App Prompt ### Outcomes Primary Outcomes - Glucose time above 180mg/dL - Mean daily glucose - Maximum daily glucose - Minimum daily glucose - Glucose coefficient of variability - Mean amplitude of glycemic excursions - Hemoglobin A1c - Fasting glucose - Objective physical activity (step count) - Objective physical activity (moderate-vigorous physical activity) - Self-reported physical activity - Diet quality - Capability - Healthmine app use - Continuous glucose monitor use use - Motivation to engage in diabetes self-management Secondary Outcomes - Body Mass Index (BMI) - Diabetes distress - Diabetes family support and conflict ### Location - Facility: Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States @@
## Intelligent Diagnosis and Treatment Model for Insomnia Disorder - NCT ID: NCT06375447 - Study ID: Insomnia - Status: RECRUITING - Start Date: 2022-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder. ### Conditions - Insomnia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Routine clinical treatment ### Outcomes Primary Outcomes - The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. Secondary Outcomes - The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. - The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, N/A, 100053, China @@
## Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer - NCT ID: NCT06375434 - Study ID: 20240101-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-08-31 - Lead Sponsor: Jing-kun Liu ### Study Description The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy. ### Conditions - Locally Advanced Rectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Diameter of tumor Secondary Outcomes - Change in Gut Microbiota Composition - Change in Plasma metabolites ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury - NCT ID: NCT06375421 - Study ID: GR018280 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-03 - Completion Date: 2024-12-31 - Lead Sponsor: Vanderbilt University Medical Center ### Study Description This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval - Blocked Retrieval ### Outcomes Primary Outcomes - Acceptability - Feasibility (Engagement) Secondary Outcomes - Free Recall of Word Forms - Cued Recall of Word Forms - Cued Recall of Word Meanings ### Location - Facility: Vanderbilt University Medical Center, Nashville, Tennessee, 37203, United States @@
## Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage - NCT ID: NCT06375408 - Study ID: KS2022212 - Status: RECRUITING - Start Date: 2024-03-24 - Completion Date: 2026-03-24 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is:• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage.Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS. ### Conditions - Subarachnoid Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Real transcranial alternating electrical stimulation - Sham transcranial alternating electrical stimulation ### Outcomes Primary Outcomes - Incidence of delirium Secondary Outcomes - Sleep quality score - Anxiety score - Duration of delirium - Cognitive function score ### Location - Facility: Xuanwu Hospital Capital Medical University, Beijing, Beijing, 100053, China @@
## Boosting The Intervention Effect of Negative Memory Through tACS Stimulation - NCT ID: NCT06375395 - Study ID: Memory Updating Tasks - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-12-31 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement. ### Conditions - Seizures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active tACS Device - Sham tACS Device ### Outcomes Primary Outcomes - Negative memory retention Secondary Outcomes - The negative emotional intensity of negative memory - The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test - The negative emotional intensity of neutral memory ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease - NCT ID: NCT06375382 - Study ID: ZYS2024-01 - Status: COMPLETED - Start Date: 2015-03-01 - Completion Date: 2024-03-31 - Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian ### Study Description Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients. ### Conditions - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - acupuncture - Sham acupuncture ### Outcomes Primary Outcomes - Abdominal pain remission rate Secondary Outcomes - Crohn's disease activity index （CDAI） - Hospital anxiety and depression scale (HADS) - Inflammatory bowel disease questionnaire (IBDQ) - Safety evaluation (number of participants with abnormal routine blood tests) - Safety evaluation (number of participants with abnormal Liver function tests) - Safety evaluation (number of participants with abnormal Renal function tests) ### Location - Facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian, Shanghai, N/A, 200000, China @@
## Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy - NCT ID: NCT06375369 - Study ID: Pro00127121 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Alberta ### Study Description The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program.The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families. ### Conditions - Tracheostomy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) ### Outcomes Primary Outcomes - Hospital length of stay - ICU length of stay - ICU readmission - Mortality - Decannulation - Duration of tracheostomy - Tracheostomy adverse events - Hospital cost - Hospital readmission - Net-monetary benefit of DECIDE-T Secondary Outcomes - Caregivers mental stress ### Location - Facility: Alberta Children's Hospital, Calgary, Alberta, N/A, Canada @@
## Stronger: Muscle Strengthening for Menopause - NCT ID: NCT06375356 - Study ID: 75119 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-08 - Lead Sponsor: Stanford University ### Study Description Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention. ### Conditions - Resistance Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Resistance Training ### Outcomes Primary Outcomes - number of strength exercises the participant logged over the intervention - Liking of the intervention Secondary Outcomes - Number of participants completing post 3 month measure / those randomized and consented - Change in total seconds a participant can remain in a wall sit - Change in number of full body weight squats in 60 seconds ### Location - Facility: Stanford University School of Medicine, Stanford, California, 94305-7240, United States @@
## Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® - NCT ID: NCT06375343 - Study ID: SOPH240-0923/I - Status: NOT_YET_RECRUITING - Start Date: 2024-10-30 - Completion Date: 2025-06 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®. ### Conditions - Dry Eye Disease - Dry Eye Sensation - Ocular Surface Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRO-240 - Optive® ### Outcomes Primary Outcomes - Incidence of unexpected adverse events related to the interventions Secondary Outcomes - Changes in the Ocular Comfort Index score - Adherence to treatment (adherence) Adherence to treatment (adherence) - Changes in Best Corrected Visual Acuity (BCVA) - Changes in tear film breakup time - Changes in intraocular pressure (IOP) - Changes in the integrity of the ocular surface (fluorescein staining) - Changes in lissamine green staining of the conjunctival surface ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. - NCT ID: NCT06375330 - Study ID: Poli.01 - Status: COMPLETED - Start Date: 2023-04-18 - Completion Date: 2024-04-08 - Lead Sponsor: Sidoti & Tartaglia Srl ### Study Description The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy. ### Conditions - TMJ Disease - TMJ Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PoliArt ### Outcomes Primary Outcomes - Maximum mouth opening Secondary Outcomes - Lateral movements improvements - Pain assessment ### Location - Facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, MI, 20122, Italy @@
## HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure - NCT ID: NCT06375317 - Study ID: HCC-HAIC-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-10-30 - Lead Sponsor: Yehua Shen ### Study Description For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value. ### Conditions - HCC - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets ### Outcomes Primary Outcomes - Objective Response Rate Secondary Outcomes - Disease Control Rate (DCR) - Progression-Free Survival (PFS) - Overall Survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study - NCT ID: NCT06375304 - Study ID: MP-37-2024-10384 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have). ### Conditions - HIV Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - B/F/TAF ### Outcomes Primary Outcomes - Feasibility of the switch - Acceptability - acceptability of the regimen - Acceptability of the intervention - Fidelity Secondary Outcomes - ART initiation (HIV care cascade milestones) - Viral suppression (HIV care cascade milestones) - Retention in HIV care (HIV care cascade milestones) - consultations at the study site (Nature of clinical pathways) - consultations at other care centres or organizations (Nature of clinical pathways) - healthcare coverage ### Location - Facility: Research Institute of the McGill University Health Centre, Montréal, Quebec, H4A3T2, Canada @@
## Pregnancy-Related Carpal Tunnel Syndrome Treatment - NCT ID: NCT06375291 - Study ID: MersinTRHpregcts - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2024-03-31 - Lead Sponsor: Mersin Training and Research Hospital ### Study Description The current retrospective study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone. To assess the primary outcome, The Boston Carpal Tunnel Symptom Severity Scale was used. The secondary aim was the efficacy of the treatment on the patient's function severity and depression assessed by The Boston Carpal Tunnel Symptom Function Scale Edinburgh Depression Scale. ### Conditions - Carpal Tunnel Syndrome Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - splint /steroid injection/both ### Outcomes Primary Outcomes - Symptom severity Secondary Outcomes - function severity - pregnancy and postpartum depression ### Location - Facility: Suna Aşkın Turan, Mersin, Yenişehir, 33020, Turkey @@
## Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation - NCT ID: NCT06375278 - Study ID: DC019586 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-03-31 - Lead Sponsor: Restorear Devices LLC ### Study Description The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:1. Is mild therapeutic hypothermia safe for use during cochlear implantation?2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy). ### Conditions - Cochlear Implants - Cochlear Implantation - Hearing Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intra-Ear Canal Cooling Catheter - Intra-Ear Canal Cooling Catheter (Sham) ### Outcomes Primary Outcomes - Cochlear Implant (CI) Device Performance Following Hypothermia Treatment - Residual Hearing Secondary Outcomes - Electrophysiological Impedance - Electrically Evoked Compound Action Potential (ECAP) ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients - NCT ID: NCT06375265 - Study ID: 2024P000780-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2026-08-31 - Lead Sponsor: Massachusetts General Hospital ### Study Description The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy). ### Conditions - Insomnia - Postoperative Delirium - Delayed Neurocognitive Recovery - Postoperative Neurocognitive Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) - Sleep Health Education ### Outcomes Primary Outcomes - Adherence - Insomnia Severity Secondary Outcomes - Sleep Diary Completion - Homework Completion - Utility - Satisfaction with intervention - Cognition - Pain severity - Mood - Anxiety - Function - Postoperative Delirium Incidence - Postoperative Delirium Severity - Delayed Neurocognitive Recovery - Postoperative Neurocognitive Disorders (NCD) - Sleep Efficiency ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use - NCT ID: NCT06375252 - Study ID: sbughfyaseminozkan1985 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2024-05-30 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder. ### Conditions - Central Venous Catheterization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Central Jugular Vein Catheter Lumen Holder Apparatus ### Outcomes Primary Outcomes - demographic information Secondary Outcomes - comfort effect ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients - NCT ID: NCT06375239 - Study ID: RTx-VRAI-NHS01 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-04-30 - Lead Sponsor: Ray Therapeutics, Inc. ### Study Description RayTx established The Vision Research and Assessment Institute (VRAI) with the express purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment to be performed by expert clinicians in an optimized environment. The proposed assessments or testing modalities to be evaluated in this non-interventional study are published in some capacity, and some of these publications already include patients with severe-to-profound vision loss from retinitis pigmentosa and other inherited retinal diseases. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments Secondary Outcomes - To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) - To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) ### Location - Facility: Vision Research and Assessment Institute, Irvine, California, 92612, United States @@
## Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults. - NCT ID: NCT06375226 - Study ID: 2023.17 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Parnassia Groep ### Study Description The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Social Responsiveness Scale - Adult version (SRS-A) - The Attachment Styles Questionnaire (ASQ) - Experiences in Close Relationships - Revised questionnaire (ECR-r) Secondary Outcomes ### Location - Facility: ParnassiaGroep Antes, Rotterdam, Zuid-Holland, 3083 AK, Netherlands @@
## Investigating Neurocognitive Disorders Epidemiology - NCT ID: NCT06375213 - Study ID: 425/66 - Status: RECRUITING - Start Date: 2023-08-24 - Completion Date: 2035-08-24 - Lead Sponsor: King Chulalongkorn Memorial Hospital ### Study Description This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially. ### Conditions - Dementia - Cognitive Decline - Alzheimer Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Plasma tau phosphorylated at Thr217 - Neurocognitive examination ### Outcomes Primary Outcomes - Progression to dementia - Changes in Sum of Boxes of the Clinical Dementia Rating Scale Secondary Outcomes - Changes in the Montreal Cognitive Assessment - Changes in the Montreal Cognitive Assessment - Memory Index Score - Changes in the Mini Mental State Examination - Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score - Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score - Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score - Biological diagnosis of Alzheimer's disease - Biological staging of Alzheimer's disease - Quantitative amyloid PET uptake. - Quantitative tau PET uptake in various cortical regions. - Future diagnosis of Alzheimer's disease dementia. ### Location - Facility: King Chulalongkorn Memorial Hospital, Pathum Wan, Bangkok, 10330, Thailand @@
## Healthcare for Men With Suicidal Thoughts: Needs Assessment - NCT ID: NCT06375200 - Study ID: ONZ-2024-0066 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-10-10 - Lead Sponsor: University Ghent ### Study Description The aim of the current project is twofold, namely1. To gain insight into needs related to help-seeking among men with (previous) suicidal thoughts (STUDY 1). More specifically, this study examines help-seeking behaviour, possible barriers to seeking help and needs with regard to existing tools and health care among men who had suicidal thoughts. In other words, is there a difference in help-seeking behaviour between men and women with suicidal thoughts in the past and what factors contribute to this difference? More specifically: 1. To what extent do men with suicidal thoughts in the past recognize their need for help, compared to women with suicidal thoughts in the past? 2. What barriers and needs do men with suicidal thoughts in the past experience towards seeking help, compared to women with suicidal thoughts in the past? 3. What barriers and needs do men with suicidal thoughts in the past experience to remain engaged in help, compared to women with suicidal thoughts in the past?2. To map out needs of healthcare providers in working with men with suicidal thoughts and/or behaviour (STUDY 2). More specifically, how do healthcare providers experience working with men who are feeling suicidal and what are their experienced barriers and needs. Two main research questions were formulated: 1. How do health care providers experience working with men (in comparison to women or people of other genders) who are feeling suicidal? 2. What needs and barriers do health care providers experience when working with men (in comparison to women or people of other genders) who are feeling suicidal? ### Conditions - Suicide Prevention - Help-Seeking Behavior - Men ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - STUDY 1: Help-seeking behavior - STUDY 1: Experienced need - STUDY 1: Emotional Openness - STUDY 1: Barriers - STUDY 1: Self-reliance - STUDY 1: Stigma - STUDY 1: needs of individuals with suicidal ideation - STUDY 2: needs of healthcare providers Secondary Outcomes ### Location - Facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University, Ghent, N/A, 9000, Belgium @@
## Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors - NCT ID: NCT06375187 - Study ID: GC203 TIL-ST-Ⅰ - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Shanghai Juncell Therapeutics ### Study Description A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors ### Conditions - Solid Tumor - Gynecologic Cancer - Breast Cancer - Gastrointestinal Cancer - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Engineering Tumor Infiltrating Lymphocytes ### Outcomes Primary Outcomes - Maximal Tolerance Dose - Dose Limiting Toxicity - Adverse Events Secondary Outcomes - Objective Response Rate - Duration of Response - Disease Control Rate - Progression-Free Survival - Overall Survival - Quality of Life Assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY) - NCT ID: NCT06375174 - Study ID: NSISTRCR_2202 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-09 - Completion Date: 2026-02-28 - Lead Sponsor: Dr. med. Carlo Cereda ### Study Description We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS\>3 will not ### Conditions - Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thrombectomy ### Outcomes Primary Outcomes - mRS score Secondary Outcomes ### Location - Facility: Neurocenter of Southern Switzerland, Ospedale Civico, Lugano, Ticino, CH-6900, Switzerland @@
## Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. - NCT ID: NCT06375161 - Study ID: CD19-CN-A6 - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2039-12-10 - Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine ### Study Description This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.In this study phase, a traditional "3+3" trial design is employed for dose escalation. ### Conditions - B Cell Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anti-CD19-CAR-T cells ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicity Secondary Outcomes ### Location - Facility: Shanghai Tongji Hospital, Shanghai, Shanghai, 200333, China @@
## A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position - NCT ID: NCT06375148 - Study ID: Yan2024-0052 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-20 - Completion Date: 2024-06-30 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description Prone ventilation is an important treatment for respiratory failure with intractable hypoxia, and the Corona Virus Disease 2019(COVID-19 ) outbreak has further elevated the status of prone ventilation. Early enteral nutrition (EN) is also recognised as an important measure to improve the prognosis of critically ill patients. However, the administration of enteral nutrition during prone position is still quite controversial. In this paper, we analysed the tolerance and safety of enteral nutrition in the prone position by reviewing studies before and after the COVID-19 outbreak. Key strategies to improve the tolerability of enteral nutrition in the prone position are also summarised and discussed. ### Conditions - Enteral Nutrition - Prone Position ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Enteral nutrition ### Outcomes Primary Outcomes - A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position Secondary Outcomes ### Location - Facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhenjiang, N/A, N/A, China @@
## mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM - NCT ID: NCT06375135 - Study ID: R1MD017205 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-03-31 - Lead Sponsor: Florida International University ### Study Description The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up. ### Conditions - ART Adherence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TXTXT - e-Navigation - Ecological Momentary Assessment (EMA) supported e-Navigation. ### Outcomes Primary Outcomes - ART adherence Secondary Outcomes - HIV viral load ### Location - Facility: Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE, Miami, Florida, 331370000, United States @@
## Natural History Study of Kaposi Sarcoma - NCT ID: NCT06375122 - Study ID: 10001951 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2036-12-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description Background:Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.Objective:To learn more about the natural history of KS.Eligibility:People aged 18 years and older with KS.Design:Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:Eye exam.Ultrasound exam of the heart (electrocardiogram).Collection of saliva and urine samples.Biopsies of the skin or lymph nodes.Swabs of the anus and cervix.Photographs of skin lesions.Removal of fluid samples from the space around the lungs, intestine, or heart.The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.Participants will follow their standard treatment for KS during the study. ### Conditions - Kaposi Sarcoma - HIV ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype Secondary Outcomes - To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count - To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC - NCT ID: NCT06375109 - Study ID: BJXK-2023-KY-53 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-16 - Completion Date: 2029-04-15 - Lead Sponsor: Beijing Chest Hospital, Capital Medical University ### Study Description This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC. ### Conditions - Limited-stage Small-cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - Carboplatin injection - Cisplatin injection - Etoposide injection ### Outcomes Primary Outcomes - Pathologic Complete Response (pCR) Rate Secondary Outcomes - Major Pathologic Response (MPR) Rate - Event-Free Survival (EFS) - Overall Survival (OS) - Objective response rate (ORR) - Safety: frequency of severe adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bone Mineral Density in Children With Graves' Disease - NCT ID: NCT06375096 - Study ID: Graves' disease - Status: NOT_YET_RECRUITING - Start Date: 2024-06-25 - Completion Date: 2025-06-25 - Lead Sponsor: Assiut University ### Study Description to evaluate bone mineral density in children with graves' disease ### Conditions - Bone Density, Low - Bone Mineral Density in Children With Graves' Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - evaluate bone mineral density ### Outcomes Primary Outcomes - bone mineral density Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression - NCT ID: NCT06375083 - Study ID: 23-1231 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-12-30 - Lead Sponsor: VA Eastern Colorado Health Care System ### Study Description This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors. ### Conditions - Suicide - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy ### Outcomes Primary Outcomes - Client Satisfaction Questionnaire - Internet Evaluation and Utility Questionnaire - Internet Impact and Effectiveness Questionnaire - Narrative Evaluation of Intervention Interview - Recruitment Rate - Completion of intervention Secondary Outcomes - Beck Scale for Suicide Ideation - Patient Health Questionnaire-9 - Posttraumatic Stress Disorder Checklist-5 - Generalized Anxiety Disorder-7 - Computerized Adaptive Testing - Suicide Scale ### Location - Facility: Eastern Colorado Health Care System, Aurora, Colorado, 80045, United States @@
## Anticoagulants for PFO Patients - NCT ID: NCT06375070 - Study ID: RMeng1 - Status: COMPLETED - Start Date: 2016-08 - Completion Date: 2022-08 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality. ### Conditions - Patent Foramen Ovale ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PFO closure - anticoagulant ### Outcomes Primary Outcomes - whether occur recurrent stroke or migraine relief Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study - NCT ID: NCT06375057 - Study ID: asiamkfv49wurfpylld2m6g7cr4kz6 - Status: RECRUITING - Start Date: 2023-03-03 - Completion Date: 2025-12-31 - Lead Sponsor: University of Roma La Sapienza ### Study Description Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient. ### Conditions - Post Operative Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - laparoscopic cholecystectomy ### Outcomes Primary Outcomes - Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy - Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy - Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy - Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy - Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy Secondary Outcomes ### Location - Facility: Augusto Lauro, Roma, N/A, 000186, Italy @@
## Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma - NCT ID: NCT06375044 - Study ID: SIM0500-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2028-12-30 - Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. ### Study Description This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial. ### Conditions - Relapsed or Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SIM0500 ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) Secondary Outcomes ### Location - Facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300000, China @@
## Comparison of HR011408 and NovoRapid® in Subjects With Diabetics - NCT ID: NCT06375031 - Study ID: HR011408-103 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07-15 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics. ### Conditions - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HR011408 injection; HR011408 injection Placebo - NovoRapid®; HR011408 injection Placebo - HR011408 injection Placebo; HR011408 injection ### Outcomes Primary Outcomes - Area under the serum concentration-time curve of insulin aspart Secondary Outcomes - Area under the serum concentration-time curve of insulin aspart - Plasma glucose concentration - Number of subjects with adverse events and severity of adverse events ### Location - Facility: The Second Hospital of Anhui Medical University, Hefei, Anhui, 230601, China @@
## Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain - NCT ID: NCT06375018 - Study ID: OST1_011 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Escola Superior de Tecnologia da Saúde do Porto ### Study Description This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain. ### Conditions - Nonspecific Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo Technique - Diaphragm Stretching ### Outcomes Primary Outcomes - Change in level of inspiratory capacity immediately after intervention - Change in the level of disability derived from low back pain immediately after the intervention - Change in the level of functionality of the lumbar spine immediately after the intervention Secondary Outcomes ### Location - Facility: Escola Superior de Saúde do Porto, Porto, N/A, 4200-072, Portugal @@
## Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis - NCT ID: NCT06375005 - Study ID: 2024-0381 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-31 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment. ### Conditions - Diffuse Cutaneous Systemic Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telitacicept - Mycophenolate Mofetil ### Outcomes Primary Outcomes - Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 - Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary Outcomes - Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 - Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 - American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 - Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 - Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 - Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 - Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 - Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 - Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 - Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 - Change From Baseline in Tender Joint Counts at Week 24 and Week 48 - Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 - Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 ### Location - Facility: Affiliated Hospital of Yangzhou University, Yangzhou, Jiangsu, 225009, China @@
## Family Involvement Hospital Ethnography - NCT ID: NCT06374992 - Study ID: Pro00114569 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: Duke University ### Study Description The goal of this observational study is to learn about the role of family members in caring for hospitalized older adults with cognitive impairment. The main questions it aims to answer are:1. What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers?2. How do hospital leaders understand the facilitators and barriers to family involvement?Data collection will occur via semi-structure interviews, direct observation, and artifact analysis. ### Conditions - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Faciltators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis - NCT ID: NCT06374979 - Study ID: 2024-0047 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is:What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index. ### Conditions - Guttate Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ixekizumab ### Outcomes Primary Outcomes - PASI 90 response Secondary Outcomes - PGA 0/1 response - PASI 100 response - Relapse ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy - NCT ID: NCT06374966 - Study ID: 2024-0246 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition. ### Conditions - Epilepsies, Partial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Zonisamide ### Outcomes Primary Outcomes - Effective rate at 6 months of treatment Secondary Outcomes - Effective rate at 3 months of treatment - Total time to treatment failure - Incidence of side effects ### Location - Facility: Hangzhou Children's Hospital, Hangzhou, Zhejiang, 310005, China @@
## A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly - NCT ID: NCT06374953 - Study ID: 2024-0182 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-09-30 - Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University ### Study Description This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients. ### Conditions - Hyperfibrinolysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ultrasound-based viscoelastic hemostasis analysis ### Outcomes Primary Outcomes - Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30 Secondary Outcomes ### Location - Facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department, Hangzhou, Zhejiang, 310009, China @@
## Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy - NCT ID: NCT06374940 - Study ID: Lütfi Kırdar City Hospital - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-17 - Completion Date: 2024-05-18 - Lead Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital ### Study Description Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomyStudy design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.Primary outcomes: (1) Operation Time.Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications ### Conditions - Gynecologic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Manipulator-assisted Abdominal Hysterectomy ### Outcomes Primary Outcomes - Duration of the surgical procedure Secondary Outcomes - Postoperative pain at 6th hours - Postoperative pain at 24th hours - intraoperative complications - Postoperative complications ### Location - Facility: Dr.Lütfi Kırdar City Hospital, Istanbul, N/A, 34000, Turkey @@
## Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study - NCT ID: NCT06374927 - Study ID: PHRASE-2023 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-10-30 - Lead Sponsor: Donders Centre for Neuroscience ### Study Description The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientiﬁc principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Rehabilitation Gaming System (VR-based mobile application) ### Outcomes Primary Outcomes - Usability - User experience - Adherence - Acceptance Secondary Outcomes - The Montreal Cognitive Assessment (MoCA) - Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE) - Hamilton Depression Rating Scale (HDRS) - Fatigue Severity Scale (FSS) - Pain Visual Analogue Scale (VAS) - Barthel Index (BI) - EuroQol - 5 Dimension - 5 Level (EQ-5D-5L) - Modified Ashworth scale (MAS) ### Location - Facility: Centre hospitalier universitaire de Limoges, Limoges, N/A, 87000, France @@
## Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients - NCT ID: NCT06374914 - Study ID: TUO-UR-23-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2026-04-09 - Lead Sponsor: Dokuz Eylul University ### Study Description Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients. ### Conditions - Bladder Cancer - BCG - Gemcitabine - Docetaxel - Intravesical Instillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intravesical Solution ### Outcomes Primary Outcomes - Recurrence rate - Progression rate - Adverse effects of intravesical chemotherapy - Intravesical chemotherapy versus radical cystectomy Secondary Outcomes - treatment change ### Location - Facility: Dokuz Eylul University Faculty of Medicine Department of Urology, Izmir, Other (Non U.s.), 35330, Turkey @@
## Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. - NCT ID: NCT06374901 - Study ID: IRB-2024-311 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2028-03-31 - Lead Sponsor: Xiangdong Cheng ### Study Description To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR). ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - SOX/XELOX ### Outcomes Primary Outcomes - MRP (Main pathological response) Secondary Outcomes - pCR (pathologic complete response) - DFS (Disease free survival) - OS (Overall survival) ### Location - Facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, N/A, China @@
## Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases - NCT ID: NCT06374888 - Study ID: CVL009-2002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-07-30 - Lead Sponsor: Convalife (Shanghai) Co., Ltd. ### Study Description To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis. ### Conditions - Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Neratinib maleate in combination with capecitabine ### Outcomes Primary Outcomes - Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1 Secondary Outcomes - Central nervous response rate - Objective response rates outside the central nervous system - Disease control rate - Duration of reaction - Clinical benefit rate - overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fibrosis Lessens After Metabolic Surgery - NCT ID: NCT06374875 - Study ID: 24-213 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-12-31 - Lead Sponsor: Ali Aminian ### Study Description Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point. ### Conditions - Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) - Non-Alcoholic Fatty Liver Disease - Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Liver Fibrosis - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metabolic surgery - Incretin-Based Therapy ### Outcomes Primary Outcomes - Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy. Secondary Outcomes - MASH resolution in the repeat liver biopsy - MASH resolution and fibrosis improvement in the repeat liver biopsy - Fibrosis progression in the repeat liver biopsy - Average Weight loss percentage - Disease-specific Quality of Life (QoL) ### Location - Facility: Banner Health Center, Phoenix, Arizona, 85006, United States @@
## Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population - NCT ID: NCT06374862 - Study ID: PI2024_843_0008 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-10 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results ### Conditions - Musculoskeletal Manipulations - Range of Motion - Muscle Strength - Peripheral Joints in Upper Quarters ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - mobilization - no effect ### Outcomes Primary Outcomes - electrical activity assessment of the spine extensor muscles using EMG Secondary Outcomes ### Location - Facility: CHU Amiens Picardie, Amiens, Picardie, 80054, France @@
## Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery - NCT ID: NCT06374849 - Study ID: PI2023_843_0173 - Status: RECRUITING - Start Date: 2024-03-17 - Completion Date: 2026-07 - Lead Sponsor: Centre Hospitalier Universitaire, Amiens ### Study Description Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery. ### Conditions - Chronic Postsurgical Pain - Chronic Pain - Abdominal Surgery - Sufentanil - Risk Factors ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - phone interview ### Outcomes Primary Outcomes - Incidence of CPSP Secondary Outcomes - Post-operative pain intensity - Post-operative pain intensity ### Location - Facility: CHU Amiens-Picardie, Amiens, N/A, 80054, France @@
## The Contractile Response of the Thoracic Aorta to Vasoactive Substances - NCT ID: NCT06374836 - Study ID: nWMO 2024.040 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-12 - Lead Sponsor: Catharina Ziekenhuis Eindhoven ### Study Description Hypertension affects 32-35% of the global adult population. Despite many drugs being available hypertension is not controlled in 50% of the over 500 million treated people leaving patients with an elevated blood pressure for life.In the development of isolated systolic hypertension, the aorta plays a pivotal role. With each heartbeat, the heart empties its stroke volume into the large arteries. These arteries, particularly the thoracic part of the aorta, temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation: they have a Windkessel function. When this function is reduced (and arterial stiffness is increased), the heart needs to contract more forcefully during ejection, leading to isolated systolic hypertension.Likely, the aorta is not just a passive structure (the aorta as an elastic 'bicycle tube'). Rather, the smooth muscle cells in the aorta wall can presumably actively change the aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's Windkessel function and, since this Windkessel function directly influences the blood pressure flucturation, also for hypertension and its progression. Therefore, the aim of this study is to quantify the thoracic aorta's ability to vasoconstrict, and to assess whether this contractility is related to specific predictors.During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography (part of standard clinical care), before and after administration of vasoactive drugs (phenylephrine and norepinephrine; also part of standard clinical care). During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram (ECG, to monitor sympathetic activity as estimated using heart rate variability analysis). Measurements will be performed at Catharina Hospital Eindhoven, the Netherlands (NL), where patients undergo elective cardiac surgery. Using the data obtained, we will 1) establish and quantify the in vivo contractility of the human thoracic aorta, and 2) study whether and to which extent potential predictors (age, sex, smoking status, antihypertensive medication use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility ### Conditions - Human Thoracic Aorta Contractility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Phenylephrine ### Outcomes Primary Outcomes - To establish and quantify the in vivo contractility of the human thoracic aorta Secondary Outcomes - To quantify the magnitude of contractile response - To study whether and to which extent potential predictors influence contractility. ### Location - Facility: Catharina hospital, Eindhoven, Noord-Brabant, 5623 EJ, Netherlands @@
## Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke - NCT ID: NCT06374823 - Study ID: IIT2023-020-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Capital Medical University ### Study Description Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline. ### Conditions - Critical Care - Hyperchloremia - Hemorrhagic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Multiple Electrolyte - Normal Saline ### Outcomes Primary Outcomes - Hyperchloremia Secondary Outcomes - Hyperchloremia acidosis - Plasma osmolality - AKI - RRT - hospital length of stay - ICU length of stay - hospitalization expense ### Location - Facility: Beijing Shijitan Hospital, Beijing, Beijing, 100038, China @@
## Does Conscious Connected Breathwork Reduce Symptoms of Anxiety? - NCT ID: NCT06374810 - Study ID: CCB1 - Status: COMPLETED - Start Date: 2023-09-21 - Completion Date: 2023-12-20 - Lead Sponsor: Richard Blake ### Study Description The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.The main questions aims to answer:1. Does conscious connected breathwork reduce symptoms of anxiety?2. Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms.there is a comparison group: Researchers will compare whether people doing the breathwork to see if \[insert effects\].Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily. ### Conditions - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Conscious Connected Breathwork - Placebo waitlist ### Outcomes Primary Outcomes - Changes in anxiety symptoms Secondary Outcomes ### Location - Facility: CIIS, San Francisco, California, 94103, United States @@
## A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" - NCT ID: NCT06374797 - Study ID: CMZ-207 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-08 - Lead Sponsor: CalciMedica, Inc. ### Study Description Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. ### Conditions - Acute Kidney Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Auxora - Placebo ### Outcomes Primary Outcomes - Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30 Secondary Outcomes - Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days - MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days - Proportion of patients alive at Day 30 - Proportion of patients alive at Day 90 - Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30 - Days alive and KRT-free from SFISD through Day 30 - Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale - Proportion of patients receiving KRT at Day 30 - Proportion of patients receiving KRT at Day 90 - Number of patients with treatment-related adverse events (TEAE) - Number of patients with grade 3 TEAEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation - NCT ID: NCT06374784 - Study ID: perio2023ARP - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-11-20 - Lead Sponsor: Cairo University ### Study Description The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth ### Conditions - Alveolar Bone Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole - Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF - Alveolar ridge preservation using autogenous demineralized dentin graft alone ### Outcomes Primary Outcomes - Alveolar ridge apico-coronal height change in mm Secondary Outcomes - Alveolar ridge bucco-lingual width change in mm - Histological assessment ### Location - Facility: Faculty of Dentistry, Cairo, N/A, N/A, Egypt @@
## Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. - NCT ID: NCT06374771 - Study ID: MD-15-2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-27 - Completion Date: 2024-07-10 - Lead Sponsor: Cairo University ### Study Description The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision.This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause:* More reduction in total morphine consumption in the first 24 hours postoperatively* More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone.Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group.Researchers will compare:* The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption* The severity of postoperative pain, using the Numerical Rating Scale (NRS)* Patients' satisfaction with a three-point scale* The time of the first requirement for rescue analgesia* The effect on the incidence of chronic post-surgical pain. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Melatonin 10 MG - Vitamin C ### Outcomes Primary Outcomes - Total morphine consumption Secondary Outcomes - Numeric Rating Scale - Richmond Agitation Sedation Scale - Time to first analgesic request - chronic post-surgical pain - patient satisfaction using Likert three-point scale - systolic blood pressure - Heart rate - Intra-operative mean consumption of sevoflurane per hour. ### Location - Facility: Faculty of Medicine - Cairo University, Cairo, Manial, 11553, Egypt @@
## Accelerated ART Initiation for PWHIV Who Are Out of Care - NCT ID: NCT06374758 - Study ID: MU-2096449 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-11-01 - Lead Sponsor: University of Missouri-Columbia ### Study Description The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care. ### Conditions - HIV Infections - ART - Noncompliance, Patient ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - The Accelerate model of care - bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg ### Outcomes Primary Outcomes - The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. - To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants. - To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants - To study the change over time in feasibility of the ACCELERATE model of care in patient and staff participants - To study the change over time in sustainability of the ACCELERATE model of care in patient and staff participants - Qualitative data Secondary Outcomes - To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care. - To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care - To assess change in health-related quality of life (HRQoL) - To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF - To measure Retention in Care - To assess the adherence to the study treatment - To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. - To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. - To assess staff impact of ACCELERATE model of care on staff satisfaction - To assess staff impact of ACCELERATE model of care on staff burnout ### Location - Facility: University of Missouri-Columbia, Columbia, Missouri, 65212, United States @@
## An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol - NCT ID: NCT06374745 - Study ID: 2020-01307; mu24Kappos - Status: RECRUITING - Start Date: 2015-01-02 - Completion Date: 2024-12-30 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema. ### Conditions - Lymphedema - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. - Date of follow-up procedure - Follow-up and type of lymphedema surgery - Circumferences of the affected and unaffected side - Postoperative complications - Surgery duration. - Type of lymphedema surgery - Date of lymphedema surgery - Use of compression stockings - Number of lymphedema drainages per week - Stage of lymphedema - Duration of lymphedema - Location of lymphedema - Subsequent cancer treatment - Date of cancer related surgery - Tumor staging - Tumor location - BMI - Comorbidities - Age - Gender Secondary Outcomes - Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema - Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer - Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history - Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history - Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS - Analysis of cohort subgroups: exploratory ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents - NCT ID: NCT06374732 - Study ID: TY2024002 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-10-01 - Lead Sponsor: University of Exeter ### Study Description A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-intensity interval training - Control group ### Outcomes Primary Outcomes - Cardiorespiratory fitness Secondary Outcomes - Muscular strength - Wellbeing - Enjoyment - Motivation - Affect - Academic performance - Height - Weight - BMI - Waist circumference - Body fat percentage - Physical activity - Bone health - Perceived physical ability - Flanker task - Visual 2-back task - Colour-shape switch task ### Location - Facility: University of Exeter, Exeter, Devon, EX1 2LU, United Kingdom @@
## WiTNNess - TNNT1 Myopathy Natural History Study - NCT ID: NCT06374719 - Study ID: WiTNNess - Status: RECRUITING - Start Date: 2018-09-23 - Completion Date: 2027-06-01 - Lead Sponsor: Clinic for Special Children ### Study Description WiTNNess is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the TNNT1 gene. The primary aim of the study is to specify meaningful outcome measures for future clinical trials. WiTNNess is open to children and adults worldwide. Participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort). ### Conditions - TNNT1-associated Myopathy - Infantile-onset Nemaline Rod Myopathy - Myopathies, Nemaline - Myopathy - Myopathy, Rod - Myopathy; Hereditary - Amish Nemaline Myopathy - Nemaline Myopathy 5 - NEM5 - Genetic Muscle Disease - Recessive Hereditary Disorder (Autosomal) - ANM ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Event-free survival Secondary Outcomes - Motor Milestones - Thriving ### Location - Facility: Clinic for Special Children, Strasburg, Pennsylvania, 17579, United States @@
## Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis - NCT ID: NCT06374706 - Study ID: 23-0129 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-30 - Lead Sponsor: The University of Texas Medical Branch, Galveston ### Study Description In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards. ### Conditions - Stroke - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Morning Walk training for stroke - Morning Walk training for healthy ### Outcomes Primary Outcomes - The Number of Participants with Kinematic representation of the temporal events during end-effector robot training - Muscle Activity in the lower extremities - Spatiotemporal Patterns of Walking, Speeds - Spatiotemporal Patterns of Walking, Parameters Secondary Outcomes ### Location - Facility: University of Texas Medical Branch, Galveston, Texas, 77555, United States @@
## Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage - NCT ID: NCT06374693 - Study ID: STH22772 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-14 - Completion Date: 2025-08 - Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust ### Study Description After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage.Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression.This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage.The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham.The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage.The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention.Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days.At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery.Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS.The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur.They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities. ### Conditions - Subarachnoid Haemorrhage From Cerebral Aneurism Rupture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Transcutaneous Vagus Nerve Stimulation - Sham Transcutaneous Vagus Nerve Stimulation ### Outcomes Primary Outcomes - Monitor tolerability for tVNS - Assess study feasibility Secondary Outcomes - Monitor safety criteria for tVNS - Rates of delayed cerebral ischaemia (DCI) - Inpatient mortality - Length of inpatient stay - Rates of inpatient complications - Modified rankin score - Barthel Index - Inflammatory markers - Headache scores - Cerebral functional near-infrared spectroscopy - Heart rate variability - Pupillary light reactivity ### Location - Facility: University of Sheffield, Sheffield, South Yorkshire, S10 2HQ, United Kingdom @@
## C3 Laminectomy With Cervical Laminoplasty - NCT ID: NCT06374680 - Study ID: C3 ectomy - Status: WITHDRAWN - Start Date: 2017-03-20 - Completion Date: 2021-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description 1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty. ### Conditions - Neck Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - laminectomy at C3 level ### Outcomes Primary Outcomes - neck pain Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 110-744, Korea, Republic of @@
## The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction - NCT ID: NCT06374667 - Study ID: KY2024-071-02 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-03-15 - Lead Sponsor: yilong Wang ### Study Description A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes. ### Conditions - Stroke, Acute Ischemic - Blood-Brain Barrier ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Y-3 ICO injection - Y-3 intravenous injection - Conventional treatment ### Outcomes Primary Outcomes - 90-day favorable clinical outcome Secondary Outcomes - Change of infarct volume from baseline to 8-day - Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) . - Patients with symptoms improvement from baseline to 14-day - Rate of decompressive hemicraniectomy - Depression scale scores at 90-day - Proportion of combined adverse events at 90-day ### Location - Facility: The first affiliated hospital of Wannan Medical College, Wuhu, Anhui, N/A, China @@
## RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy - NCT ID: NCT06374654 - Study ID: 2023P003272 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit. ### Conditions - Achilles Tendinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Home-based Exercise Protocol - Formal Physical Therapy ### Outcomes Primary Outcomes - Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A) Secondary Outcomes - PROMIS Pain Interference (4a) - PROMIS Pain Intensity (3a) - PROMIS Depression (4a) - Patient Acceptable Symptom State Questionnaire ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02130, United States @@
## The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function - NCT ID: NCT06374641 - Study ID: 5514255 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2025-08 - Lead Sponsor: University of Exeter ### Study Description The goal of this clinical trial is to compare the effects of taking a new supplement for 16 days on cognitive function and exercise performance, compared to a placebo (a supplement that looks and tastes the same, but doesn't have the same ingredients) in 40 healthy individuals - 20 young individuals (aged 18-30) and 20 older individuals (aged 50-65).The main questions it aims to answer are:* If taking the supplement for 16 days improves exercise performance, or the speed with which the body responds to the commencement of exercise.* If taking the supplement improves cognitive function.Participants will visit the lab on 5 separate occasions to:* complete some cognitive tests* complete exercise performance tests* provide blood samplesAll exercise tests will be on an exercise bike.After 28 (or 46 for pre-menopausal females) days to make sure the supplement has left the body fully, participants will consume the opposite supplement and repeat the tests. ### Conditions - Exercise Performance - Cognitive Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Mitochondrial Substrate Supplement - Placebo Supplement ### Outcomes Primary Outcomes - Exercise Capacity - VO2 kinetic response to exercise - Cognitive Function (Stroop test) - Cognitive Function (decision reaction test) - Grip Strength Secondary Outcomes - Capillary Blood Lactate - Questionnaire 1 - Questionnaire 2 - Venous Blood [Betaine] - Venous Blood [Choline] - Venous blood [S-Adenosyl methionine] - Venous blood [glucose]. - Venous blood [insulin]. - Venous blood [trimethylamine N-oxide]. ### Location - Facility: Richards Building St. Lukes Campus University of Exeter, Exeter, Devon, EX2 4TH, United Kingdom @@
## Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction - NCT ID: NCT06374628 - Study ID: 0001 - Status: RECRUITING - Start Date: 2019-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Rossella Elia, MD PhD ### Study Description The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - breast reconstruction ### Outcomes Primary Outcomes - Patient satisfaction Secondary Outcomes - Pain Evaluation ### Location - Facility: AOU Policlinico, Bari, BA, N/A, Italy @@
## Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy - NCT ID: NCT06374615 - Study ID: 2024-07 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2029-03 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is a monocentric, experimental, non-pharmacological and non-device no profit study.The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice. ### Conditions - Tick-Borne Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - IgG and IgM search for specific Tick-Borne Patogens ### Outcomes Primary Outcomes - Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP. Secondary Outcomes - Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks - Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period - Number of individuals who developed specific antibodies against a TBP after tick bite. - List of novel TBPs that were not previously found in the study areas. ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer - NCT ID: NCT06374602 - Study ID: 33 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2026-06-25 - Lead Sponsor: Saint Petersburg State University, Russia ### Study Description This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints. ### Conditions - Anaplastic Thyroid Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Pembrolizumab + Lenvatinib ### Outcomes Primary Outcomes - Objective response rate - Progression-Free Survival - Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) Secondary Outcomes - Overall survival - The assessment of conversion to resectability ### Location - Facility: Saint Petersburg State University Hospital, Saint Petersburg, N/A, 190020, Russian Federation @@
## Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) - NCT ID: NCT06374589 - Study ID: 202303123 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-21 - Completion Date: 2024-12-30 - Lead Sponsor: Başakşehir Çam & Sakura City Hospital ### Study Description High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \[Mauri et al, 2017; Möller et al, 2017\].As hyperoxia is considered not desirable \[Barbateskovic et al, 2019\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \[O'Driscoll et al, 2017; Beasley et al, 2015\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \[Roca et al, 2022\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO. ### Conditions - Acute Hypoxemic Respiratory Failure - Acute Hypercapnic Respiratory Failure - Respiratory Depression - Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Closed-loop FiO2 controller - Conventional ### Outcomes Primary Outcomes - Percentage of time spent in optimal SpO2 range Secondary Outcomes - Percentage of time with SpO2 signal available - Percentage of time with SpO2 below target range - Percentage of time with SpO2 above target range - Percentage of time with SpO2 outside optimal range - Percentage of time with with FiO2 below 40% - Percentage of time with with FiO2 above 60% - Percentage of time with with FiO2 = 100% - Mean SpO2/FiO2 - Number of events with SpO2 below of target range (duration >10 s) - Number of events with SpO2 below of target range (duration >60 s) - Number of events with SpO2 below the predefined low SpO2 emergency limit - Number of events with SpO2 above the predefined low SpO2 emergency limit - Total oxygen use ### Location - Facility: Dr.Suat Seren Chest Diseasees Hospital, Izmir, N/A, 35230, Turkey @@
## Improving eHealth Literacy of Older Adults in Hong Kong - NCT ID: NCT06374576 - Study ID: GCIEL - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: The University of Hong Kong ### Study Description This study is an randomized controlled trial (RCT) study to examine the feasibility and effectiveness of a community-based health promotion education intervention for improving the eHealth literacy of older adults ### Conditions - eHealth Literacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lecture on eHealth literacy - Digital intervention on eHealth literacy - Lecture on general health - Digital intervention on general health ### Outcomes Primary Outcomes - eHealth literacy Secondary Outcomes - Health Knowledge Learning Intention - Online Health Information Seeking - Online Health Information Scanning - Health-promotion behaviors - Health Decision Change ### Location - Facility: The University of Hong Kong, Hong Kong, N/A, N/A, China @@
## Tackling Pressure Ulcer Via Bee Venom Phonophoresis - NCT ID: NCT06374563 - Study ID: BUC-IACUC-221109-6 - Status: COMPLETED - Start Date: 2022-11-09 - Completion Date: 2024-03-01 - Lead Sponsor: Badr University ### Study Description This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer ### Conditions - Bee Venom - Pressure Ulcers - Phonophoresis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - group 1 received topical Bee venom gel - Group 2: Phonophoresis of Bee Venom gel ### Outcomes Primary Outcomes - wound surface area wound surface area - wound volume Secondary Outcomes ### Location - Facility: Badr University in Cairo, Cairo, N/A, 11837, Egypt @@
## Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children - NCT ID: NCT06374550 - Study ID: 20231026 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: University of Miami ### Study Description The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings. ### Conditions - Mental Health Wellness 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Jump Start on the Go - Jump Start Plus Coronavirus Support ### Outcomes Primary Outcomes - Change in classroom practices as measured by Health Environment Rating Scale Secondary Outcomes - Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA) - Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ) - Change in resiliency as measured by Brief Resiliency Coping Scale - Change in stress as measured by Childcare Worker Job Stress Index - Change in stress as measured by Everyday Stressors Index - Change in satisfaction as measured by Teacher Opinion and Satisfaction survey ### Location - Facility: University of Miami, Miami, Florida, 33136, United States @@
## Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients. - NCT ID: NCT06374537 - Study ID: 2017-0784 - Status: RECRUITING - Start Date: 2019-05-22 - Completion Date: 2027-05 - Lead Sponsor: University of Illinois at Chicago ### Study Description This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients. ### Conditions - Frailty - Pain, Chronic - Dialysis; Complications - Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Muscle Therapy ### Outcomes Primary Outcomes - Rate at which subjects will see changes in their physical abilities. Secondary Outcomes - Rate at which exercise will change body composition - Rate at which exercise will change handgrip strength. - Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being. - Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life. - Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. - Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. ### Location - Facility: University of Illinois at Chicago, Chicago, Illinois, 60612, United States @@
## Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension - NCT ID: NCT06374524 - Study ID: R24-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2026-06-01 - Lead Sponsor: University Health Network, Toronto ### Study Description SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak, with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years (1). The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life (2).Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics (3). The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair (4). These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered (5). In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer.The GONB has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine (6), cervicogenic headache, cluster headache (7), occipital neuralgia, and more recently, post-dural puncture headaches (PDPH) (8). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar (9), it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed.We propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs. ### Conditions - Spontaneous Intracranial Hypotension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - greater occipital nerve block ### Outcomes Primary Outcomes - Change in headache intensity Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prospective Cohort Study of Complications and Outcomes in Cirrhosis - NCT ID: NCT06374511 - Study ID: NFEC-2023-546 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Nanfang Hospital, Southern Medical University ### Study Description This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90. ### Conditions - Decompensated Cirrhosis - CMV Reactivation - Overt Hepatic Encephalopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Test for CMV reactivation ### Outcomes Primary Outcomes - Incidence of CMV reactivation - Incidence of hepatic encephalopathy Secondary Outcomes - Response to anti-CMV therapy - Response to treatment for hepatic encephalopathy (HE) - Survival ### Location - Facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, 510515, China @@
## Study to Determine the Clinical Significance of Intravascular OCT-NIRAF - NCT ID: NCT06374498 - Study ID: 2023P003247 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-04-30 - Lead Sponsor: Massachusetts General Hospital ### Study Description Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis. ### Conditions - Cardiovascular Diseases - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - OCT-NIRAF ### Outcomes Primary Outcomes - Plaque size estimation using OCT-NIRAF - Plaque progression estimate using OCT-NIRAF Secondary Outcomes ### Location - Facility: Massachusetts General Hospital, Boston, Massachusetts, 02114, United States @@
## Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment - NCT ID: NCT06374485 - Study ID: AU409-LEES-2021-03 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2026-08-28 - Lead Sponsor: Lee's Pharmaceutical Limited ### Study Description This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC. ### Conditions - Advanced Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AU409 capsules ### Outcomes Primary Outcomes - Dose Limiting Toxicity Secondary Outcomes - Maximum Tolerated Dose - Recommended Phase 2 Dose - Objective Response Rate - Disease Control Rate - Duration of Response - Progression-free Survival - Overall Survival ### Location - Facility: Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, N/A, N/A, China @@