Record stringlengths 1 197k |
|---|
<|newrecord|> nctId: NCT06375616 id: KY2024-023 briefTitle: Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Shen Lei class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Nafamostat Mesylate name: Unfractionated Heparin measure: Platelet decline rate measure: Satisfaction of filter anticoagulation measure: All-cause mortality at 28 days sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University city: Shanghai state: Shanghai country: China name: Lei Shen, MD role: CONTACT phone: 86-021-52887920 email: sh_leisen@126.com lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375603 id: SMARTALPHA-NERVEBLOX-1001 briefTitle: Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software overallStatus: COMPLETED date: 2022-12-01 date: 2023-05-01 date: 2023-05-01 date: 2024-04-19 date: 2024-04-19 name: Smart Alfa Teknoloji San. ve Tic. A.S. class: INDUSTRY name: Ankara University briefSummary: 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 conditions: Nerve Block studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Ultrasound scans measure: Assessment of image quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University School of Medicine city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False |
<|newrecord|> nctId: NCT06375590 id: 2024-NavIIcusp briefTitle: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-19 date: 2024-04-19 name: Didier TCHETCHE class: OTHER name: Abbott briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Transcatheter Aortic Valve Implantation measure: 30-day device success (Rate) measure: 1 year at least moderate bioprosthetic valve deterioration measure: 1 year severe patient-prosthesis mismatch measure: 30 days and 1 year all-cause and cardiovascular mortality measure: 30 days and 1 year stroke sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Pasteur city: Toulouse state: Occitanie zip: 31076 country: France name: Didier Tchétché, MD role: CONTACT name: Didier Tchétché role: PRINCIPAL_INVESTIGATOR name: Chiara De Biase, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False |
<|newrecord|> nctId: NCT06375577 id: LMS-24-Dean-1 briefTitle: Speed of Absorption overallStatus: RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-19 date: 2024-04-22 name: Lancaster University class: OTHER briefSummary: 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 conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This will be a double-blind randomised crossover design. There will be 1 group of participants who will complete all three conditions at random: |
Condition 1 - consume Voom Pocket Rocket. Condition 2 - consume SIS Isotonic Energy Gel. Condition 3 - consume Maurten Gel 160. |
All participants will undergo the same measures - blood sampling for blood glucose, blood lactate, and insulin, and monitoring of gas exchange during each study visit. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Both the participants and investigators will be blinded to what supplement they are consuming on each visit. Each supplement will taste the same, and be placed into identical packaging, and be randomly labelled (e.g., A, B, C). This will be done to avoid potential bias. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: 45 grams Voom Pocket Rocket Electro Energy name: 45 grams SIS Go Isotonic Energy Gel name: 45 grams Maurten Gel 160 measure: Blood Glucose measure: Blood Lactate measure: Insulin measure: Gas Exchange sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Lancaster University status: RECRUITING city: Lancaster state: Lancashire zip: LA1 4AT country: United Kingdom lat: 54.04649 lon: -2.79988 hasResults: False |
<|newrecord|> nctId: NCT06375564 id: XMYY-2020KY067-05 briefTitle: Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression overallStatus: RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-19 date: 2024-04-23 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 177Lu-AB-3PRGD2 radioligand therapy measure: Objective response rate (ORR) measure: Incidence of treatment-related adverse events (safety and tolerability) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Haojun Chen role: CONTACT phone: +8618659285282 email: leochen0821@foxmail.com name: Hao Fu, MD, PhD role: CONTACT phone: +8615959230059 email: fuhaonuclear@163.com name: Haojun Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hao Fu, MD, PhD role: SUB_INVESTIGATOR lat: 24.47979 lon: 118.08187 hasResults: False |
<|newrecord|> nctId: NCT06375551 id: 1171-0623 id: K01MH128761 type: NIH link: https://reporter.nih.gov/quickSearch/K01MH128761 briefTitle: K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions acronym: K-ORCA overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2027-07-31 date: 2027-07-31 date: 2024-04-19 date: 2024-04-19 name: Chestnut Health Systems class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: 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 conditions: Decision Making conditions: Child Welfare conditions: Decision Making, Shared conditions: Decision Support Technique conditions: Social Facilitation conditions: Implementation Science conditions: Policy conditions: Organizations conditions: Consensus conditions: Mental Health conditions: Family studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) name: Optimizing Responses with Collaborative Assessments-Live (ORCA-L) measure: Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention measure: Mean changes in decision experience quality pre-post intervention measure: Mean changes in decision commitment pre-post intervention measure: Mean changes in perceived potential community health impact pre-post intervention measure: Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA) measure: Qualitatively described rationale for program adoption from pre-post intervention measure: Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention measure: Descriptive, mean group-level changes in perceived acceptability of intervention for implementation measure: Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation measure: Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA measure: Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA measure: Qualitative changes in decision reasoning pre- post-intervention measure: Qualitative changes in decision goals pre- post-intervention measure: Qualitative changes in decision consensus pre- post-intervention measure: Time to adoption or re-adoption of interventions with ORCA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375538 id: B2022-527 briefTitle: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy overallStatus: RECRUITING date: 2022-10-21 date: 2025-08-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: 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 conditions: Ultrasound Evaluation conditions: Diaphragm and Intercostal Muscle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Ultrasound evaluation of diaphragm measure: Ultrasound evaluation of intercostal muscle movement index measure: The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation. measure: ICU stay measure: Hospital stay measure: all cause mortality measure: Oxygen saturation measure: respiratory rate measure: oxygen concentration measure: flow velocity of HFNC measure: VT measure: duration on HFNC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Wei Wu role: CONTACT phone: 13817976707 email: wu.wei1@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375525 id: SHEBA-15-2635-SMC briefTitle: 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 acronym: App ADHD overallStatus: COMPLETED date: 2015-11 date: 2017-08 date: 2017-08 date: 2024-04-19 date: 2024-04-19 name: Prof. Doron Gothelf MD class: OTHER_GOV briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Janssen's icon Application (App) measure: Attention Module of the Kiddie-SADS questionniare measure: MINI-KID measure: ADHD-Rating Scale Questionnaire (ADHD-RS) measure: Clinical Global Impression Scale (CGI) measure: the Barkley Side Effects Rating Scale measure: Drug accountability by reviewing the completed medication logs sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center city: Ramat-Gan country: Israel lat: 32.08227 lon: 34.81065 hasResults: False |
<|newrecord|> nctId: NCT06375512 id: IN001001 briefTitle: A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2026-06 date: 2024-04-19 date: 2024-04-19 name: Shenzhen Shenxin Biotechnology Co., Ltd class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: HZ Vaccine (IN001) name: Placebo name: Shingrix measure: Percentage of Participants Reporting Solicited Local Reactions measure: Percentage of Participants Reporting Solicited Systemic Reactions measure: Percentage of Participants With Unsolicited Adverse Events (AEs) measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) measure: 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 measure: Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) measure: Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA measure: Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA measure: Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot) measure: 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) sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375499 id: LT2769-004 briefTitle: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-04-28 date: 2025-04-28 date: 2024-04-19 date: 2024-04-19 name: Laboratoires Thea class: INDUSTRY briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: T2769 name: Hylo-Forte® measure: To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375486 id: AK112-IIT-TianjinCIH-LHK briefTitle: Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）. overallStatus: RECRUITING date: 2024-03-14 date: 2025-03-14 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: 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 conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） measure: Overall response rate (ORR) measure: Progress Free Survival （PFS） measure: Overall survival (OS) measure: Adverse Events（AEs） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300308 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: tjchlhk@126.com name: Yang Liu, MD role: CONTACT phone: 17694950696 email: tjchlhk@126.com lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06375473 id: MA-PC-RWS-011 briefTitle: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients acronym: MA-PC-RWS-011 overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2027-04-19 date: 2027-04-19 date: 2024-04-19 date: 2024-04-19 name: Peking Union Medical College Hospital class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Irinotecan liposome II combination therapy regimen measure: rwTEAE measure: OS measure: PFS measure: ORR measure: TTP measure: DCR sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06375460 id: STUDY24020141 id: 1R01DK137803-01A1 type: OTHER_GRANT domain: NIDDK briefTitle: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes acronym: REFLECT2D overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-06-01 date: 2029-06-30 date: 2024-04-19 date: 2024-04-19 name: University of Pittsburgh class: OTHER name: Dartmouth College name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) name: University of Michigan name: San Diego State University briefSummary: 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 conditions: Lifestyle conditions: Hyperglycemia conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Focused App Prompt name: No App Prompt measure: Glucose time above 180mg/dL measure: Mean daily glucose measure: Maximum daily glucose measure: Minimum daily glucose measure: Glucose coefficient of variability measure: Mean amplitude of glycemic excursions measure: Hemoglobin A1c measure: Fasting glucose measure: Objective physical activity (step count) measure: Objective physical activity (moderate-vigorous physical activity) measure: Self-reported physical activity measure: Diet quality measure: Capability measure: Healthmine app use measure: Continuous glucose monitor use use measure: Motivation to engage in diabetes self-management measure: Body Mass Index (BMI) measure: Diabetes distress measure: Diabetes family support and conflict sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Children's Hospital of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 hasResults: False |
<|newrecord|> nctId: NCT06375447 id: Insomnia briefTitle: Intelligent Diagnosis and Treatment Model for Insomnia Disorder overallStatus: RECRUITING date: 2022-12-01 date: 2025-10-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: West China Hospital name: Beijing Tiantan Hospital name: Ningcheng Center Hospital name: Second Affiliated Hospital of Soochow University briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16000 type: ESTIMATED name: Routine clinical treatment measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: 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. measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100053 country: China name: Hongxing Wang, MD & PhD role: CONTACT phone: 01083198650 email: wanghongxing@xwh.ccmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Beijing Tiantan Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100070 country: China name: Yi Zhang, MD & PhD role: CONTACT phone: 15801203052 email: ttyyzy@126.com lat: 39.9075 lon: 116.39723 facility: The First Bethune Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun country: China name: Zan Wang, MD & PhD role: CONTACT lat: 43.88 lon: 125.32278 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu zip: 610041 country: China name: Lan Zhang, MD & PhD role: CONTACT phone: 18980601706 email: Zhanglan102@126.com lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Soochow University status: NOT_YET_RECRUITING city: Suzhou country: China name: Hua Hu, MD & PhD role: CONTACT phone: 051268282030 email: sz_huhua@126.com lat: 31.30408 lon: 120.59538 hasResults: False |
<|newrecord|> nctId: NCT06375434 id: 20240101-01 briefTitle: Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer acronym: GMRSC-LARC overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-15 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Jing-kun Liu class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Diameter of tumor measure: Change in Gut Microbiota Composition measure: Change in Plasma metabolites measure: Five-year survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375421 id: GR018280 briefTitle: Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Vanderbilt University Medical Center class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval name: Blocked Retrieval measure: Acceptability measure: Feasibility (Engagement) measure: Free Recall of Word Forms measure: Cued Recall of Word Forms measure: Cued Recall of Word Meanings measure: Number of Spatial Contexts sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False |
<|newrecord|> nctId: NCT06375408 id: KS2022212 briefTitle: Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage acronym: TACS overallStatus: RECRUITING date: 2024-03-24 date: 2026-02-24 date: 2026-03-24 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Real transcranial alternating electrical stimulation name: Sham transcranial alternating electrical stimulation measure: Incidence of delirium measure: Sleep quality score measure: Anxiety score measure: Duration of delirium measure: Cognitive function score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Jun Wang role: CONTACT phone: 18612583695 email: wangj229@126.com lat: 39.9075 lon: 116.39723 hasResults: False |
<|newrecord|> nctId: NCT06375395 id: Memory Updating Tasks briefTitle: Boosting The Intervention Effect of Negative Memory Through tACS Stimulation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: Beijing Normal University briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Active tACS Device name: Sham tACS Device measure: Negative memory retention measure: The negative emotional intensity of negative memory measure: 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 measure: The negative emotional intensity of neutral memory sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06375382 id: ZYS2024-01 briefTitle: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease overallStatus: COMPLETED date: 2015-03-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: acupuncture name: Sham acupuncture measure: Abdominal pain remission rate measure: Crohn's disease activity index （CDAI） measure: Hospital anxiety and depression scale (HADS) measure: Inflammatory bowel disease questionnaire (IBDQ) measure: Safety evaluation (number of participants with abnormal routine blood tests) measure: Safety evaluation (number of participants with abnormal Liver function tests) measure: Safety evaluation (number of participants with abnormal Renal function tests) measure: Gut microbiota composition structure and function measure: Correlation between changes in relative abundance of gut microbes and abdominal pain sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian city: Shanghai zip: 200000 country: China lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375369 id: Pro00127121 briefTitle: Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy acronym: DECIDE-T overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-23 name: University of Alberta class: OTHER name: Alberta Innovates Health Solutions briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) measure: Hospital length of stay measure: ICU length of stay measure: ICU readmission measure: Mortality measure: Decannulation measure: Duration of tracheostomy measure: Tracheostomy adverse events measure: Hospital cost measure: Hospital readmission measure: Net-monetary benefit of DECIDE-T measure: Caregivers mental stress sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta country: Canada name: Karen Kam, MD role: CONTACT email: karen.kam@albertahealthservices.ca name: Karen Kam, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Stollery Children's Hospital city: Edmonton state: Alberta country: Canada name: Michael van Manen, MD role: CONTACT email: michaelv@ualberta.ca name: Michael van Manen, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False |
<|newrecord|> nctId: NCT06375356 id: 75119 briefTitle: Stronger: Muscle Strengthening for Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2026-08 date: 2024-04-19 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Resistance Training measure: number of strength exercises the participant logged over the intervention measure: Liking of the intervention measure: Number of participants completing post 3 month measure / those randomized and consented measure: Change in total seconds a participant can remain in a wall sit measure: Change in number of full body weight squats in 60 seconds sex: FEMALE minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False |
<|newrecord|> nctId: NCT06375343 id: SOPH240-0923/I briefTitle: Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2024-10-30 date: 2025-06 date: 2024-04-19 date: 2024-04-19 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: 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 conditions: Dry Eye Sensation conditions: Ocular Surface Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, single-blind, single-center, comparative clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: PRO-240 name: Optive® measure: Incidence of unexpected adverse events related to the interventions measure: Changes in the Ocular Comfort Index score measure: Adherence to treatment (adherence) Adherence to treatment (adherence) measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in tear film breakup time measure: Changes in intraocular pressure (IOP) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in lissamine green staining of the conjunctival surface sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375330 id: Poli.01 briefTitle: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. overallStatus: COMPLETED date: 2023-04-18 date: 2024-01-08 date: 2024-04-08 date: 2024-04-19 date: 2024-04-19 name: Sidoti & Tartaglia Srl class: OTHER briefSummary: 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 conditions: TMJ Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: PoliArt measure: Maximum mouth opening measure: Lateral movements improvements measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False |
<|newrecord|> nctId: NCT06375317 id: HCC-HAIC-001 briefTitle: HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-10-30 date: 2024-04-19 date: 2024-04-19 name: Yehua Shen class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets measure: Objective Response Rate measure: Disease Control Rate (DCR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375304 id: MP-37-2024-10384 briefTitle: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-19 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: B/F/TAF measure: Feasibility of the switch measure: Acceptability measure: acceptability of the regimen measure: Acceptability of the intervention measure: Fidelity measure: ART initiation (HIV care cascade milestones) measure: Viral suppression (HIV care cascade milestones) measure: Retention in HIV care (HIV care cascade milestones) measure: consultations at the study site (Nature of clinical pathways) measure: consultations at other care centres or organizations (Nature of clinical pathways) measure: healthcare coverage sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of the McGill University Health Centre city: Montréal state: Quebec zip: H4A3T2 country: Canada name: Bertrand Lebouché, MD, PhD role: CONTACT phone: +1-514-843-2090 email: bertrand.lebouche@mcgill.ca name: Ashkan Baradaran, MD, MSc role: CONTACT phone: +1 514-863-4468 email: ashkan.baradaran@muhc.mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False |
<|newrecord|> nctId: NCT06375291 id: MersinTRHpregcts briefTitle: Pregnancy-Related Carpal Tunnel Syndrome Treatment overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-22 name: Mersin Training and Research Hospital class: OTHER_GOV briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: splint /steroid injection/both measure: Symptom severity measure: function severity measure: pregnancy and postpartum depression sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Suna Aşkın Turan city: Mersin state: Yenişehir zip: 33020 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False |
<|newrecord|> nctId: NCT06375278 id: DC019586 id: 5R44DC019586 type: NIH link: https://reporter.nih.gov/quickSearch/5R44DC019586 briefTitle: Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-03-31 date: 2024-04-19 date: 2024-04-19 name: Restorear Devices LLC class: INDUSTRY name: University of Miami name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: 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 conditions: Cochlear Implantation conditions: Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Intra-Ear Canal Cooling Catheter name: Intra-Ear Canal Cooling Catheter (Sham) measure: Cochlear Implant (CI) Device Performance Following Hypothermia Treatment measure: Residual Hearing measure: Electrophysiological Impedance measure: Electrically Evoked Compound Action Potential (ECAP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06375265 id: 2024P000780-1 briefTitle: Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients acronym: SLEEP-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-05-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Massachusetts General Hospital class: OTHER briefSummary: 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 conditions: Postoperative Delirium conditions: Delayed Neurocognitive Recovery conditions: Postoperative Neurocognitive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) name: Sleep Health Education measure: Adherence measure: Insomnia Severity measure: Sleep Diary Completion measure: Homework Completion measure: Utility measure: Satisfaction with intervention measure: Cognition measure: Pain severity measure: Mood measure: Anxiety measure: Function measure: Postoperative Delirium Incidence measure: Postoperative Delirium Severity measure: Delayed Neurocognitive Recovery measure: Postoperative Neurocognitive Disorders (NCD) measure: Sleep Efficiency measure: Circadian Rest-Activity Rhythms sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False |
<|newrecord|> nctId: NCT06375252 id: sbughfyaseminozkan1985 briefTitle: Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use acronym: CJVClumen overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-05-16 date: 2024-05-30 date: 2024-04-19 date: 2024-04-19 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder. conditions: Central Venous Catheterization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: Central Jugular Vein Catheter Lumen Holder Apparatus measure: demographic information measure: comfort effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375239 id: RTx-VRAI-NHS01 briefTitle: Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients overallStatus: RECRUITING date: 2024-04-05 date: 2026-04-30 date: 2026-04-30 date: 2024-04-19 date: 2024-04-19 name: Ray Therapeutics, Inc. class: INDUSTRY name: The Vision Research and Assessment Institute (VRAI) briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments measure: To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) measure: To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vision Research and Assessment Institute status: RECRUITING city: Irvine state: California zip: 92612 country: United States name: Shawn Yu, OD role: CONTACT phone: 949-264-3793 email: info@vr-ai.com lat: 33.66946 lon: -117.82311 hasResults: False |
<|newrecord|> nctId: NCT06375226 id: 2023.17 id: 2023.0871 type: OTHER domain: METC Amsterdam UMC briefTitle: Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults. acronym: ASDA overallStatus: RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-19 date: 2024-04-23 name: Parnassia Groep class: OTHER briefSummary: The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: The Social Responsiveness Scale - Adult version (SRS-A) measure: The Attachment Styles Questionnaire (ASQ) measure: Experiences in Close Relationships - Revised questionnaire (ECR-r) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ParnassiaGroep Antes status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3083 AK country: Netherlands name: Stephanie Bohnen, MSc role: CONTACT phone: +31653386139 email: s.bohnen@anteszorg.nl name: Richard Vuijk, Dr. role: CONTACT phone: +31883585428 email: r.vuijk@anteszorg.nl lat: 51.9225 lon: 4.47917 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-19 uploadDate: 2024-03-29T08:28 filename: Prot_SAP_000.pdf size: 287252 hasResults: False |
<|newrecord|> nctId: NCT06375213 id: 425/66 briefTitle: Investigating Neurocognitive Disorders Epidemiology acronym: INDE overallStatus: RECRUITING date: 2023-08-24 date: 2035-08-24 date: 2035-08-24 date: 2024-04-19 date: 2024-04-22 name: King Chulalongkorn Memorial Hospital class: OTHER name: Health Systems Research Institute,Thailand briefSummary: 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 conditions: Cognitive Decline conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 990 type: ESTIMATED name: Plasma tau phosphorylated at Thr217 name: Neurocognitive examination measure: Progression to dementia measure: Changes in Sum of Boxes of the Clinical Dementia Rating Scale measure: Changes in the Montreal Cognitive Assessment measure: Changes in the Montreal Cognitive Assessment - Memory Index Score measure: Changes in the Mini Mental State Examination measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score measure: Biological diagnosis of Alzheimer's disease measure: Biological staging of Alzheimer's disease measure: Quantitative amyloid PET uptake. measure: Quantitative tau PET uptake in various cortical regions. measure: Future diagnosis of Alzheimer's disease dementia. measure: Quality of life (WHOQOL-BREF) measure: Quality of life (EQ-5D-5L) measure: Number of modifiable risk factors sex: ALL minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Pathum Wan state: Bangkok zip: 10330 country: Thailand name: Adipa Chongsuksantikul, D.Eng. role: CONTACT phone: +66 (0)84 1134443 email: adipar@gmail.com lat: 13.73649 lon: 100.5239 hasResults: False |
<|newrecord|> nctId: NCT06375200 id: ONZ-2024-0066 briefTitle: Healthcare for Men With Suicidal Thoughts: Needs Assessment acronym: KUJK2NEEDS overallStatus: RECRUITING date: 2024-04-25 date: 2024-07-01 date: 2024-10-10 date: 2024-04-19 date: 2024-04-29 name: University Ghent class: OTHER briefSummary: The aim of the current project is twofold, namely |
1. 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 conditions: Help-Seeking Behavior conditions: Men studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 586 type: ESTIMATED measure: STUDY 1: Help-seeking behavior measure: STUDY 1: Experienced need measure: STUDY 1: Emotional Openness measure: STUDY 1: Barriers measure: STUDY 1: Self-reliance measure: STUDY 1: Stigma measure: STUDY 1: needs of individuals with suicidal ideation measure: STUDY 2: needs of healthcare providers measure: STUDY 1: Socio-demographic characteristics measure: STUDY 1: Suicidality measure: STUDY 2: socio-demographic variables measure: STUDY 2: Professional experience with men with suicidal thoughts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Eva De Jaegere, MSc role: CONTACT phone: +3293320775 email: eva.dejaegere@ugent.be lat: 51.05 lon: 3.71667 hasResults: False |
<|newrecord|> nctId: NCT06375187 id: GC203 TIL-ST-Ⅰ briefTitle: Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors acronym: KUNLUN-001 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-23 name: Shanghai Juncell Therapeutics class: INDUSTRY briefSummary: 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 conditions: Gynecologic Cancer conditions: Breast Cancer conditions: Gastrointestinal Cancer conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Engineering Tumor Infiltrating Lymphocytes measure: Maximal Tolerance Dose measure: Dose Limiting Toxicity measure: Adverse Events measure: Objective Response Rate measure: Duration of Response measure: Disease Control Rate measure: Progression-Free Survival measure: Overall Survival measure: Quality of Life Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375174 id: NSISTRCR_2202 briefTitle: PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY) acronym: SWISS-PRECISE overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-09 date: 2026-02-28 date: 2026-02-28 date: 2024-04-19 date: 2024-04-19 name: Dr. med. Carlo Cereda class: OTHER_GOV briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Thrombectomy measure: mRS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocenter of Southern Switzerland, Ospedale Civico city: Lugano state: Ticino zip: CH-6900 country: Switzerland lat: 46.01008 lon: 8.96004 hasResults: False |
<|newrecord|> nctId: NCT06375161 id: CD19-CN-A6 briefTitle: Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. overallStatus: RECRUITING date: 2023-12-11 date: 2025-12-10 date: 2039-12-10 date: 2024-04-19 date: 2024-04-19 name: Shanghai Tongji Hospital, Tongji University School of Medicine class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: anti-CD19-CAR-T cells measure: Incidence of dose-limiting toxicity sex: ALL minimumAge: 18 Weeks maximumAge: 70 Weeks stdAges: CHILD facility: Shanghai Tongji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200333 country: China name: Aibin Liang role: CONTACT phone: +8618601670600 email: lab7182@tongji.edu.cn name: Ping LI role: CONTACT phone: +86 135 6418 1131 email: lilyforever@126.com lat: 31.22222 lon: 121.45806 hasResults: False |
<|newrecord|> nctId: NCT06375148 id: Yan2024-0052 briefTitle: A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position overallStatus: ENROLLING_BY_INVITATION date: 2024-03-20 date: 2024-05-30 date: 2024-06-30 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: 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 conditions: Prone Position studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Enteral nutrition measure: A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Zhenjiang country: China lat: 32.21086 lon: 119.45508 hasResults: False |
<|newrecord|> nctId: NCT06375135 id: R1MD017205 briefTitle: mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM acronym: Project STEP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-31 date: 2027-03-31 date: 2024-04-19 date: 2024-04-19 name: Florida International University class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Care Resource Community Health Centers briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We will enroll 250 adults Latino MSM with HIV with suboptimal ART adherence and randomize (1:1) into two arms: TXTXT (n=125) or TXTXT + e-Navigation (n=125). Those in Arm 1 who continue to have suboptimal adherence (\<90% pills taken) at 3-months will be re-randomized (1:1) to continue TXTXT or add e-Navigation; those in Arm 2 who have suboptimal adherence will be re-randomized (1:1) to continue TXTXT + e-Navigation or add EMA support. At 6-months, the intervention arms will cease to receive any intervention components and be followed for an additional 6-months. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: TXTXT name: e-Navigation name: Ecological Momentary Assessment (EMA) supported e-Navigation. measure: ART adherence measure: HIV viral load sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE city: Miami state: Florida zip: 331370000 country: United States name: Sheryl J Zayas, MD role: CONTACT phone: 305-576-1234 email: szayas@careresource.org name: Sheryl J Zayas, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False |
<|newrecord|> nctId: NCT06375122 id: 10001951 id: 001951-C briefTitle: Natural History Study of Kaposi Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-12-31 date: 2036-12-31 date: 2024-04-19 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: 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 conditions: HIV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype measure: To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count measure: To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: National Cancer Institute Referral Office role: CONTACT phone: 888-624-1937 email: ncimo_referrals@mail.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False |
<|newrecord|> nctId: NCT06375109 id: BJXK-2023-KY-53 id: NeoSCLC-001 type: OTHER domain: Beijing Chest Hospital, Capital Medical University briefTitle: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC acronym: NeoSCLC-001 overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2027-04-15 date: 2029-04-15 date: 2024-04-19 date: 2024-04-19 name: Beijing Chest Hospital, Capital Medical University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tislelizumab name: Carboplatin injection name: Cisplatin injection name: Etoposide injection measure: Pathologic Complete Response (pCR) Rate measure: Major Pathologic Response (MPR) Rate measure: Event-Free Survival (EFS) measure: Overall Survival (OS) measure: Objective response rate (ORR) measure: Safety: frequency of severe adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375096 id: Graves' disease briefTitle: Bone Mineral Density in Children With Graves' Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-25 date: 2025-06-25 date: 2025-06-25 date: 2024-04-19 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: to evaluate bone mineral density in children with graves' disease conditions: Bone Density, Low conditions: Bone Mineral Density in Children With Graves' Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: evaluate bone mineral density measure: bone mineral density sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False |
<|newrecord|> nctId: NCT06375083 id: 23-1231 briefTitle: Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-30 date: 2024-12-30 date: 2024-04-19 date: 2024-04-19 name: VA Eastern Colorado Health Care System class: FED briefSummary: 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 conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D) primaryPurpose: TREATMENT masking: NONE count: 472 type: ESTIMATED name: Cognitive Behavioral Therapy measure: Client Satisfaction Questionnaire measure: Internet Evaluation and Utility Questionnaire measure: Internet Impact and Effectiveness Questionnaire measure: Narrative Evaluation of Intervention Interview measure: Recruitment Rate measure: Completion of intervention measure: Beck Scale for Suicide Ideation measure: Patient Health Questionnaire-9 measure: Posttraumatic Stress Disorder Checklist-5 measure: Generalized Anxiety Disorder-7 measure: Computerized Adaptive Testing - Suicide Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Colorado Health Care System status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Lisa A Brenner, PhD role: CONTACT phone: 720-723-6488 email: Lisa.Brenner@va.gov name: Kelly A Stearns-Yoder, MA role: CONTACT phone: 720-723-6477 email: Kelly.Stearns@va.gov lat: 39.72943 lon: -104.83192 hasResults: False |
<|newrecord|> nctId: NCT06375070 id: RMeng1 briefTitle: Anticoagulants for PFO Patients overallStatus: COMPLETED date: 2016-08 date: 2022-08 date: 2022-08 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 277 type: ACTUAL name: PFO closure name: anticoagulant measure: whether occur recurrent stroke or migraine relief sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False |
<|newrecord|> nctId: NCT06375057 id: asiamkfv49wurfpylld2m6g7cr4kz6 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study overallStatus: RECRUITING date: 2023-03-03 date: 2024-02-26 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: University of Roma La Sapienza class: OTHER briefSummary: 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 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: laparoscopic cholecystectomy measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: augusto.lauro@uniroma1.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-03 uploadDate: 2024-04-16T07:17 filename: Prot_SAP_000.pdf size: 179155 hasResults: False |
<|newrecord|> nctId: NCT06375044 id: SIM0500-101 briefTitle: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-06-30 date: 2028-12-30 date: 2024-04-19 date: 2024-04-19 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Xianxiang Medical Technology Co., Ltd. briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: SIM0500 measure: Dose-limiting toxicity (DLT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300000 country: China name: Yan Xu role: CONTACT email: xuyan1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 hasResults: False |
<|newrecord|> nctId: NCT06375031 id: HR011408-103 briefTitle: Comparison of HR011408 and NovoRapid® in Subjects With Diabetics overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07-01 date: 2024-07-15 date: 2024-04-19 date: 2024-04-19 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics. conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study was designed as a multi-center, randomized, double-blind, three-cycle crossover, positive drug control (NovoRapid ®) To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single injection of HR011408 or NovoRapid ® before or after a standard meal test in patients with type 1 or type 2 diabetes. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: HR011408 injection; HR011408 injection Placebo name: NovoRapid®; HR011408 injection Placebo name: HR011408 injection Placebo; HR011408 injection measure: Area under the serum concentration-time curve of insulin aspart measure: Area under the serum concentration-time curve of insulin aspart measure: Plasma glucose concentration measure: Number of subjects with adverse events and severity of adverse events sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230601 country: China name: 230601 Pan, Doctor role: CONTACT phone: 0551-65997421 email: ptr1968@163.com name: Wei Hu, Doctor role: CONTACT phone: 0551-65997421 email: ayefygcp@163.com lat: 31.86389 lon: 117.28083 hasResults: False |
<|newrecord|> nctId: NCT06375018 id: OST1_011 briefTitle: Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-19 date: 2024-04-19 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Placebo Technique name: Diaphragm Stretching measure: Change in level of inspiratory capacity immediately after intervention measure: Change in the level of disability derived from low back pain immediately after the intervention measure: Change in the level of functionality of the lumbar spine immediately after the intervention sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto city: Porto zip: 4200-072 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False |
<|newrecord|> nctId: NCT06375005 id: 2024-0381 briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Telitacicept name: Mycophenolate Mofetil measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 measure: Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Yangzhou University city: Yangzhou state: Jiangsu zip: 225009 country: China lat: 32.39722 lon: 119.43583 facility: Huashan Hospital of Fudan University city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Hangzhou First People's Hospital city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China name: Jing Xue, PhD role: CONTACT phone: 86-13858121751 email: jingxue@zju.edu.cn lat: 30.29365 lon: 120.16142 facility: Changxing People's Hospital city: Huzhou state: Zhejiang zip: 313100 country: China lat: 30.8703 lon: 120.0933 facility: The First Hospital of Jiaxing city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 facility: The First Affiliated Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang zip: 325000 country: China lat: 27.99942 lon: 120.66682 hasResults: False |
<|newrecord|> nctId: NCT06374992 id: Pro00114569 briefTitle: Family Involvement Hospital Ethnography overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-19 date: 2024-04-19 name: Duke University class: OTHER briefSummary: 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? |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.