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<|newrecord|> nctId: NCT06265727 id: CRB-701-01 briefTitle: A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors overallStatus: RECRUITING date: 2024-04-01 date: 2027-01-16 date: 2027-01-27 date: 2024-02-20 date: 2024-04-09 name: Corbus Pharmaceuticals Inc. class: INDUSTRY name: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. briefSummary: The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.
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The main questions it aims to answer are:
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What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?
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Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A three part study primaryPurpose: TREATMENT masking: NONE count: 420 type: ESTIMATED name: CRB-701 measure: Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 measure: Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR) measure: Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) measure: Parts A, B, % C: To characterize the safety profile of CRB-701 measure: Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax) measure: Maximum observed plasma concentration of free MMAE (Cmax) measure: Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax) measure: Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax) measure: Time to reach Cmax of free MMAE (Tmax) measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax) measure: Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax) measure: Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC) measure: Total Area Under the plasma concentration-time curve of free MMAE (AUC) measure: Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moores Cancer Centre at UC San Diego Health status: NOT_YET_RECRUITING city: San Diego state: California zip: 92037 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 32.71533 lon: -117.15726 facility: Helen Diller Family Comprehensive Cancer Center - UCSF status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94115 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 37.77493 lon: -122.41942 facility: Rocky Mountain Cancer Centres status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 39.73915 lon: -104.9847 facility: Yale Cancer Center status: NOT_YET_RECRUITING city: New Haven state: Connecticut zip: 06510 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 41.30815 lon: -72.92816 facility: Florida Cancer Specialists status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32806 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 28.53834 lon: -81.37924 facility: University of Chicago status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 41.85003 lon: -87.65005 facility: Hope and Healing Cancer Center status: RECRUITING city: Hinsdale state: Illinois zip: 60521 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 41.80086 lon: -87.93701 facility: Dana-Faber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Rodney Carter role: CONTACT lat: 42.35843 lon: -71.05977 facility: Nebraska Hematology Oncology status: RECRUITING city: Lincoln state: Nebraska zip: 68506 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 40.8 lon: -96.66696 facility: Carolina BioOncology Institute status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 35.41069 lon: -80.84285 facility: Texas Oncology status: NOT_YET_RECRUITING city: Tyler state: Texas zip: 75702 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 32.35126 lon: -95.30106 facility: Virginia Cancer Specialists status: NOT_YET_RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Rodney Carter role: CONTACT email: [email protected] lat: 38.84622 lon: -77.30637 facility: Barcelona IOB Hospital Quironsalud (NEXT) status: NOT_YET_RECRUITING city: Barcelona zip: 08023 country: Spain name: Rodney Carter role: CONTACT email: [email protected] lat: 41.38879 lon: 2.15899 facility: Vall d-Hebron Institut d'Oncologia status: NOT_YET_RECRUITING city: Barcelona zip: 08035 country: Spain name: Rodney Carter role: CONTACT email: [email protected] lat: 41.38879 lon: 2.15899 facility: Fundacion Jimenez Diaz (START) status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain name: Rodney Carter role: CONTACT email: [email protected] lat: 40.4165 lon: -3.70256 facility: Hospital Clinico Universitario de Valencia status: NOT_YET_RECRUITING city: Valencia zip: 46010 country: Spain name: Rodney Carter role: CONTACT email: [email protected] lat: 39.46975 lon: -0.37739 facility: Adana Numune Egitim ve Arastirma Hastanesi (Adana City Education and Research Hospital) status: NOT_YET_RECRUITING city: Adana zip: 83114 country: Turkey name: Rodney Carter role: CONTACT email: [email protected] lat: 37.00167 lon: 35.32889 facility: Ankara Etlik City Hospital status: NOT_YET_RECRUITING city: Ankara country: Turkey name: Rodney Carter role: CONTACT email: [email protected] lat: 39.91987 lon: 32.85427 facility: Ankara University status: NOT_YET_RECRUITING city: Ankara country: Turkey name: Rodney Carter role: CONTACT email: [email protected] lat: 39.91987 lon: 32.85427 facility: Istanbul Medeniyet University status: NOT_YET_RECRUITING city: Istanbul zip: 34720 country: Turkey name: Rodney Carter role: CONTACT email: [email protected] lat: 41.01384 lon: 28.94966 facility: University of Birmingham NHS Foundation Trust status: NOT_YET_RECRUITING city: Birmingham zip: B15 2TH country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 52.48142 lon: -1.89983 facility: University of Cambridge NHS Foundation Trust status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0QQ country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 52.2 lon: 0.11667 facility: Velindre Cancer Centre status: NOT_YET_RECRUITING city: Cardiff zip: CF15 7QZ country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 51.48 lon: -3.18 facility: Leeds University Hospitals NHS Trust status: NOT_YET_RECRUITING city: Leeds zip: LS9 7LP country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 53.79648 lon: -1.54785 facility: Guy's and St Thomas' Clinical Research Facility status: NOT_YET_RECRUITING city: London zip: SE1 9RT country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 51.50853 lon: -0.12574 facility: Imperial Experimental Cancer Medicine Centre status: NOT_YET_RECRUITING city: London zip: W12 0NN country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 51.50853 lon: -0.12574 facility: The Christie Hospital status: NOT_YET_RECRUITING city: Manchester zip: M20 4BX country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 53.48095 lon: -2.23743 facility: University of Southampton status: NOT_YET_RECRUITING city: Southampton zip: SO16 6YD country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 50.90395 lon: -1.40428 facility: University of Liverpool - Clatterbridge Medical Centre status: NOT_YET_RECRUITING city: Wirral zip: CH63 4JY country: United Kingdom name: Rodney Carter role: CONTACT email: [email protected] lat: 53.37616 lon: -3.10501 hasResults: False
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<|newrecord|> nctId: NCT06265714 id: LB.02.01/VII/005/KEP005/2022 briefTitle: The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia overallStatus: COMPLETED date: 2021-07-23 date: 2023-09-06 date: 2023-09-23 date: 2024-02-20 date: 2024-02-20 name: Indonesia University class: OTHER briefSummary: Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients. conditions: Cardiovascular Diseases conditions: Acute Coronary Syndrome conditions: Heart Failure conditions: Heart Disease, Coronary conditions: Infections conditions: Sepsis conditions: Stroke conditions: Shock conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12950 type: ACTUAL measure: Alive measure: Death measure: Readmitted to ICCU measure: Rehospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. dr. I.G.N.G. Ngoerah General Hospital city: Denpasar state: Bali country: Indonesia lat: -8.65 lon: 115.21667 facility: Dr. Kariadi General Hospital city: Semarang state: Central Java country: Indonesia lat: -6.99306 lon: 110.42083 facility: Dr. Saiful Anwar General Hospital city: Malang state: East Java country: Indonesia lat: -7.9797 lon: 112.6304 facility: Dr. Iskak General Hospital city: Tulung Agung state: East Java country: Indonesia lat: -5.3578 lon: 105.04623 facility: Prof. Dr. R. D. Kandou Manado General Hospital city: Manado state: North Sulawesi country: Indonesia lat: 1.48218 lon: 124.84892 facility: Dr. Wahidin Sudirohusodo General Hospital city: Makassar state: South Sulawesi country: Indonesia lat: -5.14861 lon: 119.43194 facility: Dr. M. Djamil Padang General Hospital city: Padang state: West Sumatra country: Indonesia lat: -0.94924 lon: 100.35427 facility: National Cardiovacular Center Harapan Kita city: Jakarta country: Indonesia lat: -6.21462 lon: 106.84513 facility: Sardjito General Hospital city: Yogyakarta country: Indonesia lat: -7.80139 lon: 110.36472 hasResults: False
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<|newrecord|> nctId: NCT06265701 id: IRB0148200 briefTitle: Does a Novel Intervention Targeting Derailment Decrease Depressive Symptoms? overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-15 date: 2024-03-12 date: 2024-03-12 date: 2024-02-20 date: 2024-03-13 name: Cornell University class: OTHER briefSummary: The goal of this clinical trial is to explore the efficacy of a reflective journaling intervention-"Me Through Time"- in decreasing levels of derailment, and its impact on downstream depressive symptoms. conditions: Depression conditions: Depressive Symptoms conditions: Derailment conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Investigators will utilize a single-blind approach where participants will not be made aware of the purpose of the intervention. Participants in both arms will be told that the purpose of the study is "to determine the efficacy of a novel five-session journaling intervention, which explores concepts related to self-continuity". This is partly true for those in the experimental arm. The main purpose of the study is twofold: (1) to explore the efficacy of the experimental journaling intervention's in reducing levels of derailment and (2) to test the hypothesis that decreasing derailment- a temporal discordance of the self- will lead to a decrease in depressive symptoms. whoMasked: PARTICIPANT count: 116 type: ACTUAL name: Derailment-Focused Reflective Journaling name: Everyday Tasks Reflective Journaling measure: Change from Pre-Assessment in Depressive Symptoms on the Beck Depression Inventory II (BDI-II) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Derailment on the Derailment Scale at Session 5 measure: Change from Pre-Assessment in Anxiety Symptoms on the Generalized Anxiety Disorder - 7 (GAD-7) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Positive and Negative Affect on the Positive and Negative Affect Schedule (PANAS) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Perceived Stress on the Perceived Stress Scale (PSS) at Week 2 (Session 6/Post-Assessment) measure: Change from Pre-Assessment in Levels of Optimism Versus Pessimism on the Life Orientation Test - Revised (LOT - Revised) at Week 2 (Session 6/Post-Assessment sex: ALL minimumAge: 18 Years maximumAge: 29 Years stdAges: ADULT facility: Cornell University city: Ithaca state: New York zip: 14850 country: United States lat: 42.44063 lon: -76.49661 hasResults: False
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<|newrecord|> nctId: NCT06265688 id: CTMX-2051-101 briefTitle: First In Human Study of CX-2051 in Advanced Solid Tumors overallStatus: RECRUITING date: 2024-04-02 date: 2027-11-30 date: 2029-03-31 date: 2024-02-20 date: 2024-04-18 name: CytomX Therapeutics class: INDUSTRY briefSummary: The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 124 type: ESTIMATED name: CX-2051 measure: Safety and tolerability of CX-2051 measure: Determine the recommended Phase 2 dose (RP2D) measure: Objective response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Duration of disease control (DODC) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dana-Farber Cancer Institute status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: Carolina BioOncology Institute, PLLC status: RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Sarah Cannon Research Institute, LLC status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False
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<|newrecord|> nctId: NCT06265675 id: E1-4066/2023 briefTitle: Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve overallStatus: RECRUITING date: 2024-01-24 date: 2025-01-24 date: 2025-06-24 date: 2024-02-20 date: 2024-02-20 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 88 type: ESTIMATED name: Phenol name: Celestone name: Lidocain measure: Numeric Rating Scale (NRS) measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC) measure: Patient Global Impression of Change (PGIC) measure: Sixt Minute Walk Test (6MWT) measure: The Timed-Up and Go test measure: Frequency of analgesic usage sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gaziler status: RECRUITING city: Ankara state: Çankaya country: Turkey name: Rabia Layık, Assist. Dr. role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06265662 id: 66701100301 briefTitle: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2025-09 date: 2024-02-20 date: 2024-02-20 name: Chulalongkorn University class: OTHER briefSummary: The goal of this quasi-experimental study is to test the effectiveness of a digital health program designed to prevent non-communicable diseases (NCDs) in employees within a workplace setting in Thailand. The main questions it aims to answer are:
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* Can a digital health program help participants lose weight?
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* Does the digital health program improve other health outcomes such as Body Mass Index (BMI), blood lipid levels (triglycerides and LDL), blood sugar levels (HbA1c or fasting plasma glucose), and blood pressure? Is the digital health program feasible and acceptable in the Thai workplace setting, as measured by participation rates, usage, and participant satisfaction?
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Participants will:
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* Attend four group health education sessions, each lasting one hour, scheduled over a six-month period.
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* Have unlimited access to individual chat consultations with a healthcare team, including doctors, dietitians, fitness coaches, and psychologists, available from 9:00 AM to 5:00 PM on workdays, excluding public holidays. conditions: Chronic Disease conditions: Noncommunicable Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-arm quasi-experimental study for evaluating the effectiveness of a digital health program in weight reduction for the prevention of non-communicable diseases in the Thai workplace setting. primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: A Digital Health Program for Non-Communicable Disease Prevention in a Workplace Setting in Thailand measure: Weight measure: BMI measure: Total cholesterol measure: Triglycerides measure: HDL measure: LDL measure: HbA1c measure: Fasting plasma glucose measure: blood pressure measure: Feasibility (number of consented participants to all eligible participants ratio) measure: Acceptability sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265649 id: NOM-ALCD briefTitle: Comparison of NOM for ACLD Between Medical and Surgical Ward overallStatus: RECRUITING date: 2024-01-01 date: 2024-03 date: 2024-03 date: 2024-02-20 date: 2024-02-20 name: Ospedali Riuniti Trieste class: OTHER briefSummary: In Europe, patients with acute left colon diverticulitis (ALCD) are usually admitted to surgical wards even when only medical treatment is required. The study compares ALCD non-operative management (NOM) between surgical and non-surgical environments regarding clinical outcomes, hospitalization length(LOS), and follow-up. conditions: Diverticulitis conditions: Colon Disease conditions: Acute Diverticulitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 175 type: ESTIMATED name: NOM measure: Hospitalization length measure: Follow-up and recurrences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manuela Mastronardi status: RECRUITING city: Trieste state: TS zip: 34149 country: Italy name: Manuela Mastronardi, MD role: CONTACT phone: 0403994152 phoneExt: 0039 email: [email protected] name: Alan Biloslavo, MD role: PRINCIPAL_INVESTIGATOR name: Margherita Sandano, MD role: SUB_INVESTIGATOR name: Paola Germani, MD role: SUB_INVESTIGATOR name: Stefano Fracon, MD role: SUB_INVESTIGATOR name: Davide Cosola, MD role: SUB_INVESTIGATOR name: Selene Bogoni, MD role: SUB_INVESTIGATOR name: Nicolò de Manzini, MD role: PRINCIPAL_INVESTIGATOR name: Marina Troian, MD role: SUB_INVESTIGATOR name: Nicola Artusi, MD role: SUB_INVESTIGATOR lat: 45.64953 lon: 13.77679 hasResults: False
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<|newrecord|> nctId: NCT06265636 id: 2006202325523 briefTitle: Electrical Stimulation of the Mandibular Nerve for Pain and Function Management in Temporomandibular Disorders acronym: Origenkine overallStatus: NOT_YET_RECRUITING date: 2024-02-17 date: 2024-12-20 date: 2026-05-15 date: 2024-02-20 date: 2024-02-20 name: OrigenKinesis fisioterapia class: OTHER name: Universidad Rey Juan Carlos briefSummary: Temporomandibular disorders (TMD) encompass dysfunction and pain of the masticatory muscles and temporomandibular joint (TMJ). Pain in the TMJ, restricted jaw movement, and joint sounds are common conditions in this disorder. This can impact patients' ability to perform daily activities such as eating, speaking, laughing, or yawning, significantly affecting their quality of life.
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The TMJ and masticatory muscles are innervated by the auriculotemporal branch and the mandibular nerve (V3), a branch of the trigeminal nerve. An estimated 60% to 70% of the population shows signs of TMD, of which up to 12% report intense symptoms requiring treatment.
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Percutaneous electrical nerve stimulation (PENS) could be a clinically relevant therapy in TMD patients applied through minimally invasive physiotherapy. To our knowledge, there are no trials evaluating the non-surgical clinical efficacy of PENS on the mandibular nerve.
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The project's objective is to assess the effectiveness of PENS on the mandibular nerve in this type of condition. conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects who participate in the study will receive, in the case of the experimental group, 10 minutes of manual therapy and exercises and 10 minutes of percutaneous electrical nerve stimulation (PENS) guided by ultrasound. In the case of the control group, they will receive 20 minutes of manual therapy and exercises. The treatment will consist of one session per week for three weeks (a total of 3 sessions). Each session will last 30 minutes, of which 10 minutes will be used for the initial evaluation and 20 minutes for the assigned treatment. Two weeks after the last session, a final evaluation without treatment will be performed. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Percutaneous nerve stimulation name: Manual therapy name: exercise measure: pain intensity measure: Pressure pain thresholds (PPT) measure: Pain-free mandibular opening range of motion measure: Self-reported quality of life (SF-12) measure: Electromyographic activation rate of the masseter muscle. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-25 uploadDate: 2024-02-10T07:04 filename: Prot_SAP_000.pdf size: 142975 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-25 uploadDate: 2024-02-10T07:19 filename: ICF_001.pdf size: 185452 hasResults: False
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<|newrecord|> nctId: NCT06265623 id: UKE-IKPT 2024/01 briefTitle: Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study). acronym: PROSA overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-09-30 date: 2029-09-30 date: 2024-02-20 date: 2024-02-20 name: Universitätsklinikum Hamburg-Eppendorf class: OTHER briefSummary: This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 148 type: ESTIMATED name: No active intervention, but observational follow-up measure: Difference in FEV1(% of LLN) between baseline and end-of-follow-up measure: Difference in all-cause mortality during follow-up between groups measure: Difference in COPD-related mortality during follow-up between groups measure: Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups measure: Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups measure: Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients measure: Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients measure: Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients measure: Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway measure: Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology city: Hamburg zip: 20246 country: Germany name: Rainer Böger, MD role: CONTACT email: [email protected] name: Juliane Hannemann, PhD role: CONTACT email: [email protected] lat: 53.57532 lon: 10.01534 hasResults: False
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<|newrecord|> nctId: NCT06265610 id: 2022/186 briefTitle: A Comparison Of The Effect Of Target-Controlled Infusion Anesthesia And Inhalation Anesthesia overallStatus: COMPLETED date: 2022-03-01 date: 2023-09-01 date: 2023-10-01 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER briefSummary: A total of 70 patients who underwent angiographic examination, ASD closure, VSD closure, PDA closure and aortic balloon dilatation were included in this study. conditions: Pediatric Patients conditions: Cardiology studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 70 type: ACTUAL name: TIVA/TCI measure: intraoperative period measure: postoperative period measure: hemodynamic parameters measure: Modified Aldrete Recovery Score sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Sibel Seçkin Pehlivan city: Kayseri state: Talas zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 hasResults: False
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<|newrecord|> nctId: NCT06265597 id: EU-SBE-DŞ-01 briefTitle: The Effect of Healthy Nutrition and Yoga Program on Obese Children overallStatus: ENROLLING_BY_INVITATION date: 2022-09-14 date: 2024-08-02 date: 2024-12-02 date: 2024-02-20 date: 2024-02-20 name: TC Erciyes University class: OTHER briefSummary: This study was planned to examine the effects of a healthy nutrition and yoga program given to obese children on nutritional behavior, physical activity and anthropometric measurements. conditions: Obesity, Childhood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There is a control and intervention group. primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Healthy Nutrition and Yoga Program measure: Anthropometric Measurements and Child Follow-up Form measure: Family Nutrition and Physical Activity Scale measure: Adolescent Identification Form sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD facility: Karaman Provincial Directorate of National Education city: Karaman zip: 70200 country: Turkey lat: 37.18111 lon: 33.215 hasResults: False
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<|newrecord|> nctId: NCT06265584 id: IRB-300011730 (UAB2370) briefTitle: Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2028-02 date: 2028-05 date: 2024-02-20 date: 2024-04-03 name: University of Alabama at Birmingham class: OTHER briefSummary: In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution. Preliminary data where 80% of the ATG dose is given on days -6,-5,-4 and 20% given on day -1, showed effective prevention of severe acute GVHD, chronic GVHD and favorable early immune reconstitution. We hypothesize that our 2 step ATG dosing platform when combined with standard tacrolimus and mini methotrexate can prevent grade III-IV acute GVHD and chronic GVHD, resulting in improvement of GVHD/relapse free survival at one year post transplant. conditions: Acute Leukemia conditions: Myelodysplastic Syndrome conditions: Myeloproliferative Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: ATG dosing platform when combined with standard tacrolimus and mini methotrexate measure: Rate of GRFS (graft versus host disease GVHD, relapse free survival) at one year post transplant. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Zaid Al Kadhimi, MD role: PRINCIPAL_INVESTIGATOR name: Manuel Espinoza-Gutarra, MD role: SUB_INVESTIGATOR name: Donna Salzman, MD role: SUB_INVESTIGATOR name: Antonio Di Stasi, MD role: SUB_INVESTIGATOR name: Lauren Shea, MD role: SUB_INVESTIGATOR name: Omar Jamy, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06265571 id: EskisehirUO briefTitle: Postoperative Pain in Shoulder Surgery overallStatus: COMPLETED date: 2020-11-15 date: 2021-06-15 date: 2021-07-15 date: 2024-02-20 date: 2024-02-20 name: Eskisehir Osmangazi University class: OTHER briefSummary: After the approval of the ethics committee, the files of the patients who underwent arthroscopic shoulder surgery between 01.01.2019 and 01.03.2020 were evaluated retrospectively.
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Data were recorded including age, gender, duration of anesthesia, duration of surgery, postoperative analgesia consumption, complications such as respiratory distress due to hemidiaphragmatic paralysis and complications such as hematoma and nerve damage due to block intervention. conditions: Pain, Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: perineural injection measure: rescue analgesia measure: difference between the analgesic methods sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferda YAMAN city: Eskişehir state: Odunpazarı zip: 26040 country: Turkey lat: 39.77667 lon: 30.52056 hasResults: False
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<|newrecord|> nctId: NCT06265558 id: PROICM 2023-08 TPN briefTitle: Prevention of Postoperative Complications by Negative Pressure Therapy After Complex Breast Cancer Surgery acronym: TPN-SEIN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-02 date: 2027-02 date: 2024-02-20 date: 2024-04-04 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.
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That strategy of treatment-reconstruction has expanded increasingly since the last years.
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The current literature reports only 3 studies on the use of preventive negative pressure therapy in oncologic breast surgery.
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Moreover, all three are retrospective, case-control studies with serious limitations.
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The largest published series reports a reduction in the overall complication rate from 15.9% to 8.5%, and a significant reduction in several criteria: infection, scar dehiscence and necrosis. However, the study presents significant biases, with non-comparable populations in terms of comorbidities, surgical procedure performed, inclusion periods (and therefore experience in performing oncological surgery).
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There was also a high probability of under-assessment or postponement of post-operative complications, which is typical of published retrospective surgical studies.
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The published results therefore strongly encourage further investigation of negative pressure therapy in oncological breast surgery. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 254 type: ESTIMATED name: Negative pressure therapy (NPT) name: Dressing measure: Rate of patients with post-operative scarring trouble measure: Rate of patients with a surgical site infection measure: Surgical revision rate measure: Rate of patients with at least one rehospitalization measure: Surgical complication rate by Clavien-Dindo classification measure: Time to initiation of adjuvant therapy measure: Quality of life evaluated by questionnaire QLQ-C30 (Version 3) measure: Quality of life evaluated by questionnaire QLQ-BReast cancer (BR23) measure: Patient satisfaction about cosmetic result evaluated using the BR23 questionnaire measure: Medical cost of post-surgery care sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Nîmes city: Nîmes state: Gard zip: 30900 country: France name: Fanny BECHARD, MD role: CONTACT email: [email protected] name: Fanny BECHARD, MD role: PRINCIPAL_INVESTIGATOR lat: 43.83333 lon: 4.35 facility: Centre Hospitalier de Montpellier city: Montpellier state: Hérault zip: 34090 country: France name: Martha DURAES, MD role: CONTACT email: [email protected] name: Martha DURAES, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: Institut régional du Cancer de Montpellier city: Montpellier state: Hérault zip: 34298 country: France name: Mathias NERON, MD role: CONTACT phone: 467614813 phoneExt: +33 email: [email protected] name: Mathias NERON, MD role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06265545 id: RR-AML-2023 briefTitle: Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-01-30 date: 2026-06-30 date: 2024-02-20 date: 2024-04-16 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens. conditions: AML conditions: Refractory conditions: Relapsed studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Ivosidenib,Venetoclax,gilteritinib,Selinexor measure: Complex response (CRc) rate (including CR and CRi) measure: mortality associated with salvage treatment (30 days, 60 days) measure: MRD-negative complete response rate measure: Overall survival measure: Event-free survival measure: Relapse-free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Blood Hospital city: Tianjin zip: 300020 country: China name: hui wei, MD role: CONTACT phone: 86-13132507161 email: [email protected] lat: 39.14222 lon: 117.17667 hasResults: False
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<|newrecord|> nctId: NCT06265532 id: Pro00060157 id: R33HL158540 type: NIH link: https://reporter.nih.gov/quickSearch/R33HL158540 briefTitle: Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect overallStatus: RECRUITING date: 2024-02-07 date: 2025-05-31 date: 2025-05-31 date: 2024-02-20 date: 2024-02-20 name: Hal Chapman class: OTHER name: Cornell University name: Massachusetts General Hospital name: University of Michigan name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection. conditions: Idiopathic Pulmonary Fibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is an optional substudy to the phase I study: "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect." Up to twenty-two participants participating in the aforementioned study will be enrolled into this sub-study. This substudy will be conducted at a select number of sites with capabilities for performing \[68Ga\]CBP8 PET. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All participants will be on one of the standard of care drugs (nintedanib or pirfenidone) and blindly given EGCG or placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: EGCG 300 mg name: Placebo for EGCG 300 mg name: EGCG 600 mg name: Placebo for EGCG 600 mg measure: Change in collagen probe uptake over the entire lungs measure: Change in peak enhancement over the entire lungs measure: Change in the rate of contrast washin over the entire lungs measure: Change in the area under the curve at 60 seconds over the entire lungs measure: Change in the full width at half maximum over the entire lungs measure: Change in the rate of contrast washout over the entire lungs sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Sydney Montesi, MD role: CONTACT phone: 617-724-4030 email: [email protected] name: Caroline Fromson role: CONTACT phone: 617-643-3260 email: [email protected] name: Sydney Montesi, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06265519 id: MAR.UAD.008 briefTitle: Association of Urine BDNF and NGF With Lower Urinary System Parameters overallStatus: RECRUITING date: 2024-02-01 date: 2025-02-01 date: 2025-07-01 date: 2024-02-20 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: Histologically, BPH is a benign proliferative process involving both epithelial and stromal elements and is characterised by progressive enlargement of the prostate. Symptom complex including increased frequency of urination, sudden feeling of urge to urinate, nocturia, difficulty in urinating, feeling of incomplete emptying of the bladder, decreased flow rate and intermittent urination are called lower urinary tract symptoms (LUTS). The most important cause of LUTS in men is BPH. Many structural and physiological changes occur in the lower urinary system with bladder outlet obstruction. Detrusor hypertrophy and bladder hyperactivity may occur due to bladder outlet obstruction. Although the density of afferent and efferent nerves in the bladder decreases after urethral obstruction, enlargement of their trunks indicates that changes occur in these nerves. In addition, changes also occur in the neural pathways of the central nervous system following lower urinary tract obstruction. Nerve growth factor (NGF) and brain derived neurotropin factor (BDNF) are trophic proteins that act as retrograde messengers between peripheral effector tissue and the nerves that innervate it. In peripheral tissues, the source of NGF and BDNF is presumed to be the target tissues innervated by nerves. Smooth muscle cells, fibroblasts, astrocytes and other cells synthesise NGF and BDNF in culture medium. Many potential stimuli that increase NGF in the lower urinary system have been identified. These are denervation, inflammation and mechanical tension. This information has led to the idea that autonomic innervation changes in the bladder may be related with changing NGF levels. Altered afferent and adrenergic innervation in the obstructed bladder increases the possibility that NGF plays an important role in this neural growth because this type of nerves are highly sensitive to this neurotrophin.
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In this study, we investigated NGF ve BDNF levels in urine samples obtained before surgery (Transurethral Prostate Resection, Prostate Enucleation with Holmium Laser and Prostate Enucleation with Thulium Fibre Laser) and after removal of obstruction in patients with bladder outlet obstruction secondary to benign prostatic enlargement using ELISA method, We aimed to determine the role of NGF and BDNF in bladder outlet obstruction and bladder changes secondary to obstruction by comparing with control patients without obstruction. conditions: Benign Prostatic Hyperplasia With Outflow Obstruction conditions: Lower Urinary Tract Obstructive Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: 0 count: 70 type: ESTIMATED name: Holmium laser enucleation of the prostate measure: Uroflowmetry measure: International prostate symptom score measure: Urodynamic sex: MALE minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Hospital status: RECRUITING city: Istanbul country: Turkey name: Haydar Kamil Çam, Prof. role: CONTACT phone: +905323259547 email: [email protected] name: Kader Ada Doğan, MD role: CONTACT phone: +905323845598 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06265506 id: 20320 id: R01AA031013 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031013 briefTitle: Virtual Incentive Treatment for Alcohol acronym: VITA overallStatus: NOT_YET_RECRUITING date: 2024-02-19 date: 2027-04-03 date: 2028-04-04 date: 2024-02-20 date: 2024-02-20 name: Washington State University class: OTHER name: The University of Texas Health Science Center at San Antonio name: Weill Medical College of Cornell University name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health. conditions: Alcohol Use Disorder conditions: Alcohol Drinking conditions: Alcohol Abuse conditions: Alcohol Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will test the efficacy of our CM model against an evidence-based online intervention, CBT4CBT, by randomizing participants to six months of:
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1. CBT4CBT and reinforcement for submitting blood samples (no requirement for abstinence) (Control Condition), or
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2. CBT4CBT and reinforcement for PEth tests that are consistent with alcohol abstinence (CM Condition). primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Contingency Management name: Computer Based Training for Cognitive Behavioral Therapy for AUD (CBT4CBT) measure: Aim 1) Alcohol Abstinence & Aim 3) Predictors: PEth-Defined Alcohol Abstinence During CM (Aim 1) and Follow-Up (Aim 3) measure: Aim 2) Alcohol-Related Harms: Addiction Severity Index (ASI) Lite measure: Aim 2) Alcohol-Related Harms: Patient Health Questionnaire-9 (PHQ-9) measure: Aim 2) Alcohol-Related Harms: Generalized Anxiety Disorder-7 (GAD-7) measure: Aim 2) Alcohol-Related Harms: Short Form Health Survey-12 (SF-12) measure: Aim 2) Alcohol-Related Harms & Aim 4) Cost Analysis: Non-study Medical and Other Services (NMOS) form measure: Aim 2) Alcohol Related Harms: Fagerstrom measure: Aim 2) Alcohol Related Harms: Urine Drug Tests measure: Aim 2) Alcohol Related Harms: Perceived Stress Scale (PSS-10) measure: Aim 3) Predictors: Demographics measure: Aim 3) Predictors: Addictions Neuroclinical Assessment (ANA) Questionnaire measure: Aim 3) Predictors: TestMyBrain measure: Aim 3) Predictors: Positive Negative Affect Schedule (PANAS) measure: Aim 3) Predictors: Situational Confidence Questionnaire-8 (SCQ-8) measure: Aim 3) Predictors: Alcohol Craving VAS measure: Aim 4) Cost Analysis: Drug Abuse Treatment Cost Analysis Program (DATCAP) measure: Aim 4) Cost Analysis: PROPr measure: Aim 1) Alcohol Abstinence: Regular excessive drinking measure: Aim 1) Alcohol Abstinence: uEtG-Defined Alcohol Abstinence measure: Aim 1) Alcohol Abstinence: Self-reported Alcohol Abstinence and Heavy Drinking measure: Additional Implementation Data: Attrition measure: Additional Implementation Data: CSQ-8 measure: Adverse Events measure: Computer Based Training for Cognitive Behavioral Health (CBT4CBT) Program Use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington State University city: Spokane state: Washington zip: 99201 country: United States name: Michael McDonell, PhD role: CONTACT phone: 509-368-6967 email: [email protected] lat: 47.65966 lon: -117.42908 hasResults: False
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<|newrecord|> nctId: NCT06265493 id: PLAGH-AOC-L02 briefTitle: Postoperative Infectious Complications Calculator for Elderly Patients overallStatus: COMPLETED date: 2021-06-01 date: 2023-06-30 date: 2023-09-30 date: 2024-02-20 date: 2024-03-19 name: Weidong Mi class: OTHER briefSummary: The investigators established a first-ever convenient scoring system for clinicians to assess the risk of Postoperative infectious complications (PICs) for elderly patients. Our scoring system can aid in the early detection of potential risks for postoperative infections. Higher-score patients were more likely to experience postoperative infections. conditions: Postoperative Infection conditions: Geriatrics conditions: Prediction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 37230 type: ACTUAL measure: Postoperative Infectious Complications Calculator for Elderly Patients sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06265480 id: 2023-04577-01 briefTitle: FallFitness Fallprevention Program for Older Adults overallStatus: RECRUITING date: 2024-03-01 date: 2025-07-01 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Dalarna University class: OTHER name: Sormland County Council, Sweden briefSummary: The overall aim with this project is to collaborate with four organisations for retired persons located in a small region of middle Sweden. The project aims to test and evaluate a newly developed group-based fall prevention exercise program regarding the effects and experiences of both leading and participating in the intervention. The design of the study is a randomised controlled trial including a total of 100 participants (60+), 50 participants in the intervention and 50 participants in the control group. conditions: Fall Injury conditions: Fall conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled Trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Study will be singled blinded (assessors) whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: FallFitness intervention group measure: Physical function by Short Physical Performance Battery measure: Self-efficacy (balance confidence) measure: Fear of Falling measure: EuroQoL-5 Dimension Questionnaire (EQ-5D) measure: Fallfrequency measure: Falling techniques measure: Handgrip strength sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marina Arkkukangas status: RECRUITING city: Eskilstuna state: Sormland country: Sweden name: Marina Arkkukangas, PhD role: CONTACT phone: +46 (0)706468868 email: [email protected] name: Michail Tonkonogi, Professor role: CONTACT phone: +46(0)708206435 email: [email protected] lat: 59.36661 lon: 16.5077 hasResults: False
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<|newrecord|> nctId: NCT06265467 id: 28909108800228 briefTitle: Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed . overallStatus: COMPLETED date: 2022-01-01 date: 2023-02-01 date: 2023-07-01 date: 2024-02-20 date: 2024-02-20 name: Misr International University class: OTHER name: Suez Canal University briefSummary: A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique. conditions: Alveolar Ridge Augmentation conditions: Sinus Floor Augmentation conditions: Maxillary Sinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: it is a double blinded study, both the outcome assessor and statistician will be blinded whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Closed Sinus Elevation name: Open Sinus Elevation measure: Implant Stability measure: Radiographic bone gain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suez Canal University city: Ismailia zip: 41522 country: Egypt lat: 30.60427 lon: 32.27225 hasResults: False
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<|newrecord|> nctId: NCT06265454 id: LDAED IN MC briefTitle: Low Dose Atropine Eye Drops in Myopic Egyptian Children acronym: LAMP overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-30 date: 2026-03-30 date: 2024-02-20 date: 2024-02-20 name: Ain Shams University class: OTHER briefSummary: Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression.
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purpose of the study is to compare changes in axial length, anterior chamber depth, choroidal thickness, central corneal thickness and anterior scleral thickness among myopic children receiving atropine 0.05% or 0.01% and placebo. conditions: Myopia Progression conditions: Axial Length, Eye conditions: Sclera Thickness studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: low dose atropine eye drops name: Placebo measure: change in the average Choroidal Thickness over follow up period. sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Ain shams university city: Cairo state: Abbasia zip: 11517 country: Egypt name: Aya MA Abd El wahab, Masters role: CONTACT phone: 1009192526 phoneExt: +20 email: [email protected] name: Marwa M Abd al Karim, MD role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06265441 id: MS42/2024 briefTitle: Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block vs. Adductor Canal Block Alone overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-10-01 date: 2024-02-20 date: 2024-02-26 name: Ain Shams University class: OTHER briefSummary: In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries focusing on VAS score assessment at 8 hours postoperative. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected name: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25% measure: Assessment of pain using the visual analogue scale (VAS) upon first ambulation after 8 hours from the completion of the surgical procedure and skin closure. measure: Total analgesics consumption measure: The time till first analgesic requirement measure: The range of movement (ROM) measure: The number of steps sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Ain Shams University city: Cairo state: Abbassia zip: 00202 country: Egypt name: Mohamed Morsi, M.B.B.CH role: CONTACT phone: +201116618163 email: [email protected] name: Mohamed Morsi, M.B.B.CH role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06265428 id: DB-1303-O-3001 id: CTR20233403 type: OTHER domain: CENTER FOR DRUG EVALUATION, NMPA briefTitle: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer overallStatus: RECRUITING date: 2024-01-29 date: 2026-02 date: 2026-02 date: 2024-02-20 date: 2024-02-20 name: DualityBio Inc. class: INDUSTRY name: BioNTech SE briefSummary: This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane. conditions: HER2-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 224 type: ESTIMATED name: DB-1303/BNT323 name: T-DM1 measure: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) measure: Overall Survival (OS) measure: Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 measure: Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 measure: Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 measure: PK parameters: maximum observed concentration (Cmax) measure: PK parameters: time to maximum concentration (Tmax) measure: Adverse events (AEs) measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 measure: Patient reported outcomes (PROs): EORTC QLQ-BR45 measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) measure: Anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fifth Medical Center of the Chinese People's Liberation Army General Hospital status: NOT_YET_RECRUITING city: Beijing state: Beijing zip: 100039 country: China name: Zefei Jiang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Jian Zhang role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06265415 id: Soh-Med-24-01-07MS briefTitle: Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2025-03-30 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE conditions: Severe Preeclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Labetalol name: Nitroglycerine name: Nifedipine measure: duration of control blood pressure sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265402 id: 36264 briefTitle: Retrolaminar Block Versus Tab Block in Abdomioasty overallStatus: RECRUITING date: 2024-01-15 date: 2025-10-15 date: 2025-12-15 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER briefSummary: The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery conditions: Block studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Tab block versus retrolaminar block in abdominal plastic surgery measure: Total dose of morphine consumption in the first postoperative 24hours sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TantaU U status: RECRUITING city: Tanta country: Egypt name: Hadeel Elsagheer, Master role: CONTACT lat: 30.78847 lon: 31.00192 hasResults: False
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<|newrecord|> nctId: NCT06265389 id: Pentoxifylline in pneumonia briefTitle: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-10-30 date: 2024-02-20 date: 2024-02-20 name: Tanta University class: OTHER briefSummary: Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Pentoxifylline Oral Tablet measure: Respiratory distress measure: Temperature measure: Oxygen saturation measure: CRP measure: LDH measure: D-dimer measure: Interleukin 6 measure: Hospital stays measure: Pneumonia complications measure: Surgical intervention sex: ALL minimumAge: 2 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265376 id: IRB22-046 briefTitle: Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy? overallStatus: RECRUITING date: 2023-03-13 date: 2024-05-01 date: 2024-07-01 date: 2024-02-20 date: 2024-02-20 name: Benaroya Research Institute class: OTHER briefSummary: The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Educational Video measure: Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy measure: Pain score at the time of survey completion (0=no pain 10=worst pain measure: Average pain score for the first 7 days as perceived by the patients (likert scale) measure: Number of post-op phone calls received measure: Number of post-op emergency room visits measure: Number of readmissions measure: Number of patients with steri-strips still in place measure: Number opioids taken since surgery measure: Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale) measure: ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Mason Medical Center status: RECRUITING city: Seattle state: Washington zip: 98101 country: United States name: Michelle Gruttadauria, MD role: CONTACT phone: 206-223-6191 email: [email protected] lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06265363 id: Turkey BigROP Study briefTitle: Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey. acronym: TR-BigROP overallStatus: RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-11-01 date: 2024-02-20 date: 2024-02-20 name: Baskent University Ankara Hospital class: OTHER name: Hacettepe University name: Gazi University name: Gaziosmanpasa Research and Education Hospital name: Celal Bayar University name: Selcuk University name: Recep Tayyip Erdogan University name: Karadeniz Technical University name: Istinye University name: Biruni University name: T.C. ORDU ÜNİVERSİTESİ name: Dr. Lutfi Kirdar Kartal Training and Research Hospital name: Pamukkale University name: Kanuni Sultan Suleyman Training and Research Hospital name: Konya City Hospital name: Kecioren Education and Training Hospital name: Ataturk University name: Meda Hospital name: Eskisehir Osmangazi University name: Necmettin Erbakan University name: Kırıkkale University name: Sisli Hamidiye Etfal Training and Research Hospital name: Acibadem Atakent University Hospital name: Balikesir Ataturk City Hospital name: Kocaeli University name: Acibadem Maslak Hospital name: Erzurum City Hospital name: Afyon Karahisar Hospital name: Ankara Koru Hospital name: University of Health Sciences Gulhane Hospital name: Bursa Yüksek İhtisas Education and Research Hospital name: Namik Kemal University name: Bursa City Hospital name: Kayseri City Hospital name: Ankara Etlik City Hospital name: Zonguldak Bulent Ecevit University name: Gazi Yasargil Training and Research Hospital name: Inonu University name: Dr. Behcet Uz Children's Hospital name: Ankara Training and Research Hospital name: Tepecik Training and Research Hospital name: Aydin Adnan Menderes University name: Dicle University name: Akdeniz University name: Umraniye Education and Research Hospital name: Ankara Bilkent City Hospital name: Afyonkarahisar University of Health Sciences Health Application and Research Center name: Harran University name: Sanliurfa Mehmet Akif Inan Education and Research Hospital name: Istanbul University - Cerrahpasa (IUC) name: Uludag University name: şanlıurfa training and research Hospital name: Dokuz Eylul University name: Bursa Doruk Yıldırım Hospital name: Malatya Turgut Ozal University name: Abant Izzet Baysal University name: Alanya Training and Research Hospital name: İstanbul Training and Research Hospital name: Baskent Univeristy Adana Hospital name: Kahramanmaras Sutcu Imam University name: Batman Training and Research Hospital name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital name: Acıbadem Atunizade Hospital name: Adiyaman Training and Research Hospital name: Zeynep Kamil Maternity and Pediatric Research and Training Hospital name: Ondokuz Mayıs University name: Trakya University name: Trabzon Kanuni Education and Research Hospital name: Seyhan Hospital name: Esenyurt University Hospital name: Başakşehir Çam & Sakura City Hospital name: Sakarya University name: Mardin Training and Research Hospital name: Karabuk University name: Giresun Training and Research Hospital name: Koc University Hospital name: Tekirdağ City Hospital name: Medipol University Mega Hospital name: Adana City Training and Research Hospital name: Istanbul University name: Marmara University Pendik Training and Research Hospital name: Medikal Park Ankara Hospital name: Medipol University Bahcelievler Hospital name: Muğla Sıtkı Koçman University name: Yuzuncu Yıl University name: Sanko University name: Antalya Training and Research Hospital name: Firat University name: Ankara Güven Hospital name: Private Batman Hospital name: İstanbul Bağcılar Training and Research Hospital name: Istanbul Aydın University name: Mersin City Hospital briefSummary: The study includes preterm infants who are being screened for ROP between August 1,2023 and August 1, 2024 in 94 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of \>1500 g or ≥ 33 weeks' gestation who are screened for retinopathy of prematurity are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated. conditions: Retinopathy of Prematurity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Incidence of ROP measure: The role of being SGA in infants in the development of ROP measure: The role of sepsis in infants in the development of ROP measure: The role of mechanical ventilation in infants in the development of ROP measure: The role of chorioamnionitis in infants in the development of ROP measure: Laser photocoagulation treatment measure: Anti-VEGF treatment measure: Vitreoretinal surgery sex: ALL minimumAge: 28 Days stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Baskent University status: RECRUITING city: Ankara country: Turkey name: Sezin Unal role: CONTACT phone: 0090532 email: [email protected] name: Esin Koc, Prof role: PRINCIPAL_INVESTIGATOR name: Ahmet Y Bas, Prof role: PRINCIPAL_INVESTIGATOR name: İbrahim M Hirfanoğlu, Prof role: PRINCIPAL_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06265350 id: Liver Project 5 briefTitle: Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases overallStatus: RECRUITING date: 2024-02-02 date: 2026-01-30 date: 2027-01-30 date: 2024-02-20 date: 2024-02-20 name: Sun Yat-sen University class: OTHER briefSummary: This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases. conditions: Hepatocellular Carcinoma conditions: Liver Cancer Stage IV conditions: Pulmonary Metastases conditions: Cadonilimab conditions: Bevacizumab conditions: Cryoablation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Cadonilimab name: Bevacizumab name: Cryoablation measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guanzhou state: Guangdong zip: 510000 country: China name: Qunfang Zhou, MD role: CONTACT phone: 86 19868000115 email: [email protected] facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guanzhou state: Guangdong zip: 510000 country: China name: Qunfang Zhou, MD role: CONTACT phone: 8619868000115 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06265337 id: LAMETA-OGTT briefTitle: Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response? overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-20 name: University of Aarhus class: OTHER briefSummary: To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo.
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Hypothesis:
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Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption. conditions: PreDiabetes conditions: Metabolic Syndrome conditions: Insulin Resistance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In a randomized, double-blinded, placebo-controlled crossover trial, we will investigate the effect of addition of 25 g lactate vs. placebo to an OGTT on two trial days separated by a minimum of fourteen days and a maximum of one month. We will include 12 individuals with pre-diabetes \[9\], having HbA1c 39-47 mmol/L and being above 40 years of age. primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Lactate name: Placebo measure: Difference in integrated glucose concentrations between CTR and LAC following an OGTT measure: Difference in glucose absorption measure: Difference in insulin sensitivity measure: Difference in insulin secretion measure: Difference in free fatty acids concentration measure: Difference in ventricular emptying rate measure: Difference in subjective appetite sensation measure: Difference in integrated GLP-1 concentrations sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265324 id: Soh-Med-23-12-04MD briefTitle: Drug-coated Balloon Treatment in Coronary Lesions overallStatus: NOT_YET_RECRUITING date: 2024-02-10 date: 2024-06-10 date: 2025-02-10 date: 2024-02-20 date: 2024-02-20 name: Sohag University class: OTHER briefSummary: This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions conditions: Drug-coated Balloon studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Angioplasty measure: Major adverse cardiac events at 6 months sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag faculty of medicine city: Sohag country: Egypt name: Sharaf Eldin Shazly, PHD role: CONTACT phone: 0112 9999792 name: Imran Saber, MA role: PRINCIPAL_INVESTIGATOR lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06265311 id: 20221307-2 briefTitle: IDUS in CBD Stone Recurrence High Risk Patients overallStatus: RECRUITING date: 2021-11-02 date: 2024-01-31 date: 2024-06 date: 2024-02-20 date: 2024-04-19 name: Shanghai Municipal Hospital of Traditional Chinese Medicine class: OTHER briefSummary: This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.
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Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
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Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
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Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis. conditions: Choledocholithiasis conditions: Cholangiopancreatography, Endoscopic Retrograde conditions: Ultrasonography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: IDUS examination measure: recurrence of bile duct stone or cholangitis measure: need for a nasobiliary tube measure: need for stents measure: operation time measure: radiation time measure: hospitalization cost measure: Questionnaire of Symptoms and conditions after ERCP measure: White blood cell count measure: Red blood cell count measure: Platelet count measure: total bilirubin, direct bilirubin measure: Liver function test (ALT, AST) measure: albumin measure: total protein measure: Gamma-glutamyl transferase (GGT) test measure: An alkaline phosphatase (ALP) test measure: whether have a resection of gallbladder checklist sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shang General Hospital status: RECRUITING city: Shanghai zip: 200080 country: China name: Hang Zhao role: CONTACT phone: 18621186288 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06265298 id: RECHMPL23_0099 briefTitle: Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium acronym: TransBuCor overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-02 date: 2025-02 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Montpellier class: OTHER name: Institute for Neuroscience Montpellier briefSummary: Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients.
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Studies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients.
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Methodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the "Eye" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) \> 3% of stem cells in primary cultures, (ii) \<10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63). conditions: Limbal Stem Cell Deficiency studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: transversal and fondamental study primaryPurpose: OTHER masking: NONE count: 4 type: ESTIMATED name: Conjunctival reconstruction measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation measure: Successful Transdifferentiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Gui de Chauliac - Service d'Ophtamologie city: Montpellier state: Occitanie zip: 34295 country: France name: Vincent DAIEN, Pr role: CONTACT email: [email protected] name: Vincent Daien, Pr role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06265285 id: MC230716 id: NCI-2024-00637 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009663 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230716 type: OTHER domain: Mayo Clinic in Florida briefTitle: Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program overallStatus: RECRUITING date: 2024-03-13 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-03-15 name: Mayo Clinic class: OTHER briefSummary: This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and/or effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients. conditions: Advanced Esophageal Squamous Cell Carcinoma conditions: Advanced Renal Cell Carcinoma conditions: Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8 conditions: Clinical Stage IIB Cutaneous Melanoma AJCC v8 conditions: Clinical Stage IIC Cutaneous Melanoma AJCC v8 conditions: Clinical Stage III Cutaneous Melanoma AJCC v8 conditions: Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8 conditions: Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8 conditions: Esophageal Carcinoma conditions: Gastroesophageal Junction Adenocarcinoma conditions: Hepatocellular Carcinoma conditions: Locally Advanced Urothelial Carcinoma conditions: Lung Non-Small Cell Carcinoma conditions: Malignant Solid Neoplasm conditions: Metastatic Colorectal Carcinoma conditions: Metastatic Cutaneous Melanoma conditions: Metastatic Esophageal Squamous Cell Carcinoma conditions: Metastatic Head and Neck Squamous Cell Carcinoma conditions: Metastatic Urothelial Carcinoma conditions: Recurrent Esophageal Squamous Cell Carcinoma conditions: Recurrent Head and Neck Squamous Cell Carcinoma conditions: Renal Cell Carcinoma conditions: Stage III Renal Cell Cancer AJCC v8 conditions: Stage IV Colorectal Cancer AJCC v8 conditions: Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 conditions: Stage IV Renal Cell Cancer AJCC v8 conditions: Unresectable Cutaneous Melanoma conditions: Unresectable Esophageal Squamous Cell Carcinoma conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 50 type: ESTIMATED name: Home Health Encounter name: Nivolumab name: Patient Monitoring name: Questionnaire Administration measure: Change in patient-reported rating of Cancer CARE Cancer Connected Access and Remote Expertise (CARE) after 8 weeks measure: Patient preferred treatment location measure: Patient level of comfort with receiving injections at home measure: Patient-reported symptoms - PRO-CTCAE measure: Patient-reported function - EORTC QLQ-F17 measure: Patient-reported side effect impact - GP5 measure: Incidence of Adverse Events (AEs) measure: Emergency room visits and hospitalizations measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Roxana S. Dronca, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False
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<|newrecord|> nctId: NCT06265272 id: 2022P002594 briefTitle: Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis overallStatus: RECRUITING date: 2023-12-10 date: 2026-12-19 date: 2026-12-19 date: 2024-02-20 date: 2024-02-20 name: Massachusetts General Hospital class: OTHER briefSummary: A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.
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The specific hypotheses include:
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* Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients
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* Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.
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* Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments
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* Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis conditions: Liver Cirrhosis conditions: Hepatic Cell Carcinoma conditions: Portal Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Injection of a gadolinium contrast agen name: Radiotracer Injection name: Imaging measure: Assessment of LI-RADS with Ga-PSMA-PET/MRI measure: Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI measure: Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET measure: PET/MR protocol in liver cirrhosis sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Onforio Catalano, MD, Ph.D role: CONTACT phone: 617-724-4030 email: [email protected] name: Diandrea Galloway role: CONTACT phone: 617-643-1407 email: [email protected] lat: 42.37787 lon: -71.062 hasResults: False
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<|newrecord|> nctId: NCT06265259 id: 31-05-2023/25481 briefTitle: Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients overallStatus: RECRUITING date: 2023-12-15 date: 2025-12-31 date: 2026-01-31 date: 2024-02-20 date: 2024-03-06 name: University of Thessaly class: OTHER briefSummary: Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients. conditions: Circulatory Shock studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 145 type: ESTIMATED name: Initiation of vasopressine as a first vasoconstrictive drug name: Initiation of noradrenaline as a first vasoconstrictive drug measure: Multiorgan failure improvement assessment measure: Sepsis course measure: Sepsis course measure: Sepsis course measure: Duration of administration of vasoconstrictors measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: laboratory tests measure: Cardiac enzymes measure: Cardiac enzymes measure: renal function measure: renal function measure: renal function measure: Mechanical ventilation duration measure: length of ICU stay measure: 28 day mortality measure: ICU mortality measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General University Hospital of Larissa, Intensive Care Unit status: RECRUITING city: Larissa state: Thessaly zip: 41110 country: Greece name: Vasiliki Tsolaki role: CONTACT phone: 00306972804419 email: [email protected] name: Epaminondas Zakynthinos, Prof role: CONTACT phone: 00302413501280 email: [email protected] name: Vasiliki TSOLAKI, MD, PhD role: SUB_INVESTIGATOR name: Asimina Valsamaki, MD, Msc role: SUB_INVESTIGATOR name: Epaminondas Zakynthinos, Prof role: PRINCIPAL_INVESTIGATOR lat: 39.63689 lon: 22.41761 hasResults: False
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<|newrecord|> nctId: NCT06265246 id: 104993 briefTitle: Impact of Milk and Yogurt Supplementation on Bone Health, Body Composition, and Gut Microbiota in Canadian Young Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-15 date: 2024-02-20 date: 2024-02-20 name: University of Saskatchewan class: OTHER name: Dairy Farmers of Canada name: Agriculture and Agri-Food Canada briefSummary: Milk and dairy products contain significant amounts of nutrients that contribute to optimal health - nutrients like calcium, vitamin D, and high-quality protein. Fermented milk products or fermented dairy products are dairy foods that have been fermented with certain bacteria. Yogurt is a fermented dairy product containing millions of beneficial bacteria. In this study, the invesgitagtors will look at the effect of milk (a non-fermented dairy product) and yogurt (a fermented dairy product) supplementation on bone health and the amount of fat and muscle mass in Canadian young adults over a 24-month period. While dairy products contain significant amounts of nutrients, the scientific community does not know the impact of long-term supplementation of fermented (i.e., yogurt) or non-fermented (i.e., milk) dairy food on bone health and the amount of fat and muscle mass in young adults. To fill this knowledge gap, the investigators will recruit participants with low calcium intake and assign them to three different groups: 1) milk (intervention) group; 2) yogurt (intervention) group; and 3) control group. The investigators will ask the participants in the milk group to drink 1.5 servings (375 mL) of milk per day for 24 months. Participants in the yogurt group will consume 2 servings (350 g) of yogurt per day for 24 months. Those in the control group will continue their usual diets. Using a randomized controlled trial design, the investigators will measure bone health parameters, hormonal indices related to bone metabolism, body composition (e.g., muscle mass, fat mass), and the number and composition of bacteria living in the gastrointestinal (GI) tract. The hypothesis is that supplementation with yogurt will have more positive effects on bone health indices, particularly femoral neck BMD as the primary outcome, than milk in Canadian adults aged 19-30 years. The secondary hypothesis is that supplementation with yogurt, as a fermented milk product, will have a more beneficial effect than milk on body composition measures. The data will provide valuable information for developing targeted health initiatives and marketing strategies regarding the benefits of fermented and non-fermented dairy product consumption. conditions: Osteoporosis conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In this 24-month randomized controlled trial, the investigators will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Ninety-nine free-living adults aged 19-30 years with low dietary calcium intake will be randomly assigned to one of the following three intervention arms.
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1. Habitual diet (control) (n=33)
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2. Habitual diet + 1.5 servings of milk providing approx. 500 mg Ca/day (either 1% fat milk, or 2% fat milk) (n=33)
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3. Habitual diet + 2 servings of yogurt providing approx. 500 mg Ca/day (either 1% fat plain yogurt, 2% fat plain yogurt, 1% fat flavoured yogurt, 2% fat flavoured yogurt) (n=33) primaryPurpose: PREVENTION masking: NONE count: 99 type: ESTIMATED name: Habitual Diet + Milk name: Habitual Diet + Yogurt measure: Femoral neck bone mineral density measure: Bone mineral density (total hip, lumbar spine, whole body) measure: Bone mineral content (total hip, femoral neck, lumbar spine, whole body) measure: Bone structure measure: Bone geometry measure: Serum bone alkaline phosphatase (biochemical indices of bone turnover) measure: Serum osteocalcin (biochemical indices of bone turnover) measure: Serum procollagen type 1 N-propeptide (biochemical indices of bone turnover) measure: Serum N-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover) measure: Serum C-terminal telopeptide of type 1 collagen (biochemical indices of bone turnover) measure: Serum PTH (hormonal indices related to bone metabolism) measure: Serum 25(OH)D (hormonal indices related to bone metabolism) measure: Serum IGF-1 (hormonal indices related to bone metabolism) measure: Saliva IGF-1 (hormonal indices related to bone metabolism) measure: Fat mass and lean mass measure: Height measure: Weight measure: Gut microbiota via general lactobacillus and bifdobacterium measure: Dietary assessment measure: Physical activity sex: ALL minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06265233 id: 69668 briefTitle: ERP Plus Improv Group Therapy for OCD (IMPROVE Study) overallStatus: RECRUITING date: 2024-02-09 date: 2025-01 date: 2025-01 date: 2024-02-20 date: 2024-02-22 name: Stanford University class: OTHER briefSummary: The goal of this study is to pilot test a novel group therapy intervention for adults with OCD. conditions: Obsessive-Compulsive Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Group Improv sessions name: Group Exposure and Response Prevention (ERP) Therapy measure: Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) measure: Change in Intolerance of Uncertainty Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 401 Quarry status: RECRUITING city: Stanford state: California zip: 94304 country: United States name: Study Team role: CONTACT phone: 650-723-4095 email: [email protected] lat: 37.42411 lon: -122.16608 hasResults: False
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<|newrecord|> nctId: NCT06265220 id: AB-101-03 briefTitle: AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis overallStatus: RECRUITING date: 2024-02-24 date: 2026-10 date: 2026-10 date: 2024-02-20 date: 2024-02-20 name: Artiva Biotherapeutics, Inc. class: INDUSTRY briefSummary: AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies.
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This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches.
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The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V.
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Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status.
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Patients may receive up to 2 cycles of treatment spaced 24 weeks apart. conditions: Lupus Nephritis - WHO Class III conditions: Lupus Nephritis - WHO Class IV studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AB-101 name: Cyclophosphamide name: Fludarabine name: Rituximab measure: Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events measure: AB-101 Clinical Activity sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Diego status: RECRUITING city: San Diego state: California zip: 92121 country: United States name: Bosco Trinh role: CONTACT name: Bethany Karl, DO role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06265207 id: ArdahanU-Simsekli-DS-02 briefTitle: The Effect of Virtual Reality on Pain, Anxiety and Satisfaction Level Before Mammography overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-15 date: 2025-04-15 date: 2024-02-20 date: 2024-02-20 name: Ardahan University class: OTHER name: Kafkas University briefSummary: In this study, it is planned to determine the effect of virtual reality applied to women before mammography on pain, anxiety and satisfaction levels. For this purpose, individuals applying for breast cancer screening will first be randomly divided into experimental and control groups. Pain, anxiety and satisfaction level evaluation forms will be applied to the experimental group before the mammography procedure. A relaxing video will be watched with virtual reality glasses and the mammography will be performed. At the end of the mammography, the relevant forms will be applied to the individuals again. The control group will not be subjected to any additional application that will continue with the applied routine. conditions: Mammography conditions: Early Diagnosis of Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Blind Parallel Group Randomized Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Since the researcher will be conducting the research, blinding will not be possible, and separate consent forms were prepared for the experimental and control groups, without specifying which group they were in, and it was planned to blind the participants in this way. In addition, in order to prevent statistical bias, it is planned to prevent bias in data analysis by coding the data as first group and second group, rather than experimental and control group, when entering the data into SPSS, and by not giving information about which group is the experiment and which is the control group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Virtual reality name: routine maintenance measure: Visual Comparison Scale measure: State Anxiety Inventory measure: Satisfaction Evaluation Scale sex: FEMALE minimumAge: 18 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265194 id: ZAT2024 briefTitle: Effect of EMDR in the Treatment of Fibromyalgia acronym: EMDR overallStatus: COMPLETED date: 2015-01-01 date: 2018-01-01 date: 2018-03 date: 2024-02-20 date: 2024-02-20 name: Academy of Therapeutic Sciences, Turkey class: OTHER briefSummary: The goal of this randomized-controlled study is to investigate the impact of EMDR therapy on fibromyalgia symptoms, depression, sleep quality, and traumatic stress in fibromyalgia patients.
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The main questions it aims to answer are:
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* Does EMDR become useful in relieving pain and complaints in fibromyalgia patients?
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* Is specific EMDR Fibromyalgia Protocol effective of fibromyalgia patients?
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* Does EMDR therapy decrease depression, sleep quality and traumatic stress symptoms of individuals with fibromyalgia? conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible participants were randomized into two groups: one receiving TAU treatment (control group) and the other receiving both TAU and EMDR (experimental group). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants do not have the knowledge of group interventions. whoMasked: PARTICIPANT count: 79 type: ACTUAL name: EMDR name: TAU measure: Fibromyalgia Impact Questionnaire (FIQ) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Trauma Symptom Checklist-40 (TSC-40) measure: Beck Depression Inventory (BDI) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265181 id: AIBU-SBF-SK-04 briefTitle: The Effect of Diabetes Coaching on Distress and Diabetes Self-Management overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2026-12-31 date: 2027-12-31 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.
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The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental and control group. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: When the researcher evaluates the participant according to the inclusion criteria, written consent will be obtained from the participant and pre-evaluation forms will be applied when compliance with the criteria is achieved. Afterwards, the participant's group will be notified to the researcher by the independent researcher and randomization will be carried out. With this; Data entries will be made by an independent researcher as group A and group B, without writing the group names. Until the data analysis and reporting is completed, the statistician will be blinded to which group is the intervention and which group is the control. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Diabetes coaching measure: Type 2 Diabetes Self-Management Scale measure: Diabetes Distress Scale measure: HbA1c Monitoring Form measure: Introductory Features Form sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265168 id: req-2023-01512; am23Sutter3 briefTitle: Comprehensive Observations and Multidisciplinary Approaches in the Management of Unconscious Patients acronym: COMA overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-20 date: 2024-04-11 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: This prospective observational high-fidelity simulation study aims to observe and better understand how physicians from different disciplines differentiate in the management of a comatose patient and how their diagnostic and treatment approaches adhere to current recommendations in a highly standardized simulated scenario. The results gained by this study will give more insight into the current quality of diagnostic procedures and treatment and help refine recommendations in this context. The investigators hypothesize that physicians do not strictly adhere (regarding diagnostic approach and treatment) to current guidelines/recommendations when confronted with a comatose patient. conditions: Coma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Simulation measure: To reveal diagnostic and treatment approaches of physicians from different disciplines when confronted with a comatose patient. measure: Physicians' grade of adherence to current recommendations regarding diagnostic procedures and treatment of a comatose patient measure: Participants' self-evaluation of their performance in hindsight sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel country: Switzerland name: Prof. Dr. Sutter role: CONTACT name: Liliane Nueesch role: CONTACT lat: 47.55839 lon: 7.57327 hasResults: False
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<|newrecord|> nctId: NCT06265155 id: SuzhouMHAnhui briefTitle: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-30 date: 2025-12-31 date: 2024-02-20 date: 2024-03-28 name: Anzhi Li class: OTHER briefSummary: Acute ischemic stroke has a high incidence, ischemic stroke caused by large vessel occlusion is serious and has a poor prognosis, and its triggers in the short term before onset are not clear. The aim of this study was to evaluate the short-term risk of acute ischemic stroke caused by multiple triggers. In this trial, through a case-crossover study design, patients were asked about the exposure to each trigger in the previous year and the exposure during the preictal risk period (the exposure observed during the risk period) for each potential trigger of acute ischemic stroke caused by large vessel occlusion. To evaluate the relative risk of ischemic stroke resulting from exposure to triggers, comparing exposure during the dangerous period with the usual frequency of exposure. Relative risks and corresponding 95% CIs were estimated for past-year exposure and past-year mean exposure (assessed as chronic risk factors) and time to last exposure (assessed as triggers). Scientifically evaluate exposure to a range of potential triggers, including infection, mood, smoking, alcohol consumption, diarrhea and vomiting, extreme temperature changes, and several factors that increase blood pressure and their risk of developing acute ischemic stroke. conditions: Triggers of Acute Ischemic Stroke Due to Large Vessel Occlusion studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 302 type: ESTIMATED measure: RR values for exposure during the risk period versus exposure in the past year for each trigger sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Suzhou Hospital Anhui Medical University status: RECRUITING city: Suzhou state: Anhui zip: 234000 country: China name: Anzhi Li, B.S. role: CONTACT phone: +8615903860581 email: [email protected] name: Zhengfei Ma, M.D. role: CONTACT phone: 13866586362 email: [email protected] lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06265142 id: MoH/CSR/23/26368 briefTitle: Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2024-09-01 date: 2024-12-01 date: 2024-02-20 date: 2024-02-20 name: Oman Medical Speciality Board class: OTHER_GOV briefSummary: Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents.
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Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique.
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Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics.
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Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice.
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Patient Population: young infants from 0 to 6 months of age
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Intervention: There will be two groups:
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1. Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
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2. Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.
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Clinical Measurement: All collected urine samples will be labeled and sent to the laboratory. All results will be retrieved from the medical records. Direct measurement will be for the duration of the procedures in both experiment and control group (stopwatch will be used). Pain score (Neonatal Infant Pain Scale) and parental satisfaction survey will be filled at the time of the procedure.
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