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<|newrecord|> nctId: NCT06343441 id: SH9H-2024-T29-2 briefTitle: Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: intraoral scan name: open tray impression measure: Grade of framework passive fit sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06343428 id: IEO 1519 briefTitle: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients acronym: TAPIOCA overallStatus: RECRUITING date: 2021-07-19 date: 2024-07-19 date: 2026-07-19 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.
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The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).
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However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed. conditions: Neuroendocrine Neoplasm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Immunohistochemical characteristics analysis measure: Review of the functional imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan zip: 20141 country: Italy name: Francesca Spada, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06343415 id: H-23052844 briefTitle: Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness overallStatus: RECRUITING date: 2024-04-16 date: 2025-04-30 date: 2025-07-31 date: 2024-04-02 date: 2024-04-17 name: Christina Kruuse class: OTHER briefSummary: The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic brain injury and disorders of consciousness. The main questions it aims to answer are:
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* Is the protocol feasible concerning inclusion in the study?
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* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.
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The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail. conditions: Traumatic Brain Injury conditions: Disorders of Consciousness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: AB - BA primaryPurpose: OTHER masking: SINGLE maskingDescription: Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised".
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Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results. whoMasked: OUTCOMES_ASSESSOR count: 17 type: ESTIMATED name: GAIT-assisted training name: STEP-assisted training measure: Inclusion Rate measure: Completion Ratio of protocols measure: Exploratory Safety Outcomes measure: Disability Rating Scale (DRS) measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness measure: Early Functional Abilities (EFA) measure: Functional Independence Measure (FIM) measure: Physical activity intensity measure: Mean arterial pressure (MAP) measure: Heart Rate Variability (HRV) measure: Behavioural Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of brain and spinal cord injury status: RECRUITING city: Glostrup state: Greater Copenhagen zip: 2600 country: Denmark name: Christina Kruuse, Professor role: CONTACT email: [email protected] name: Vibeke Wagner, MSc role: PRINCIPAL_INVESTIGATOR lat: 55.6666 lon: 12.40377 hasResults: False
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<|newrecord|> nctId: NCT06343402 id: TBBO8520-101 id: ONKORAS-101 type: OTHER domain: TheRas briefTitle: Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer overallStatus: RECRUITING date: 2024-04 date: 2027-08 date: 2028-02 date: 2024-04-02 date: 2024-04-22 name: TheRas, Inc class: INDUSTRY briefSummary: A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer conditions: Non-small Cell Lung Cancer conditions: Metastatic Non-Small Cell Lung Cancer conditions: NSCLC conditions: KRAS G12C conditions: Metastatic Lung Cancer conditions: Advanced Lung Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Phase 1a: sequential/parallel, Phase 1b: parallel primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: BBO-8520 name: Pembrolizumab measure: Adverse Events measure: Dose-limiting toxicities (DLTs) measure: To evaluate preliminary antitumor activity of BBO-8520 measure: To evaluate preliminary antitumor activity of BBO-8520 measure: Overall Survival (OS) measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 measure: To characterize the pharmacokinetics (PK) of BBO-8520 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: SCRI Oncology Partners status: RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 facility: Peter MacCallum Cancer Centre status: RECRUITING city: Melbourne state: Victoria zip: 3051 country: Australia lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06343389 id: Soh-Med-24-03-14MS briefTitle: Acute Kidney Injury in Patients With Liver Cirrhosis overallStatus: RECRUITING date: 2024-04 date: 2024-10 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Sohag University class: OTHER briefSummary: In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital. conditions: Acute Kidney Injury in Patients With Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: serum creatinine measure: Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag University Hospital status: RECRUITING city: Sohag country: Egypt name: Magdy M Amin, professor role: CONTACT lat: 26.55695 lon: 31.69478 hasResults: False
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<|newrecord|> nctId: NCT06343376 id: I-3641523 id: NCI-2024-01818 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: I-3641523 type: OTHER domain: Roswell Park Cancer Institute briefTitle: Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-02 date: 2024-04-02 name: Roswell Park Cancer Institute class: OTHER briefSummary: This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies. conditions: Recurrent Chronic Lymphocytic Leukemia conditions: Recurrent Diffuse Large B-Cell Lymphoma conditions: Recurrent Follicular Lymphoma conditions: Recurrent High Grade B-Cell Lymphoma conditions: Recurrent Mantle Cell Lymphoma conditions: Recurrent Transformed Chronic Lymphocytic Leukemia conditions: Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma conditions: Refractory Chronic Lymphocytic Leukemia conditions: Refractory Diffuse Large B-Cell Lymphoma conditions: Refractory Follicular Lymphoma conditions: Refractory High Grade B-Cell Lymphoma conditions: Refractory Mantle Cell Lymphoma conditions: Refractory Transformed Chronic Lymphocytic Leukemia conditions: Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Bone Marrow Aspiration name: Bone Marrow Biopsy name: Computed Tomography name: Cyclophosphamide name: Echocardiography name: EGFRt/19-28z/IL-12 CAR T-lymphocytes name: Fludarabine Phosphate name: Leukapheresis name: Multigated Acquisition Scan name: Positron Emission Tomography measure: Incidence of adverse events measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi) measure: Incidence of CR/CRi + partial response (PR) (ORR) measure: Event free survival measure: Overall survival measure: Progression-free survival measure: Modified T-cell persistence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Roswell Park Cancer Institute city: Buffalo state: New York zip: 14263 country: United States name: Francisco J. Hernandez-ILizaliturri role: CONTACT phone: 716-845-1642 email: [email protected] name: Francisco J. Hernandez-ILizaliturri role: PRINCIPAL_INVESTIGATOR lat: 42.88645 lon: -78.87837 hasResults: False
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<|newrecord|> nctId: NCT06343363 id: 318352 briefTitle: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety acronym: EARLY-Edge overallStatus: RECRUITING date: 2023-05-01 date: 2025-05 date: 2025-12 date: 2024-04-02 date: 2024-04-02 name: Oxford University Hospitals NHS Trust class: OTHER name: Edwards Lifesciences briefSummary: Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.
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Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.
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This prospective, observational cohort study will examine the safety and feasibility of this practice. conditions: Mitral Regurgitation conditions: Tricuspid Regurgitation conditions: Mitral Repair conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Early discharge protocol measure: Proportion of patients discharged 'early' after edge -to-edge repair measure: All - cause rehospitalisation after completion of procedure measure: All cause death after completion of procedure measure: Hospital length of stay measure: Proportion of patients requiring intensive care unit care measure: Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days measure: Symptomatic improvement measure: Heart failure hospitalisation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: John Radcliffe Hospital status: RECRUITING city: Oxford state: Oxfordshire zip: OX3 9DU country: United Kingdom name: Sam Dawkins, MBBS MRCP BSc DPhil role: CONTACT email: [email protected] lat: 51.75222 lon: -1.25596 hasResults: False
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<|newrecord|> nctId: NCT06343350 id: OPTDR01P briefTitle: OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Optain Health class: INDUSTRY briefSummary: In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.
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A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR. conditions: Diabetic Retinopathy conditions: Diabetes studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED name: OPTDR01 software application measure: Enrollment rate of eligible participants at clinical site sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Precision Research Institute city: San Diego state: California zip: 92114 country: United States name: Marie Inocentes role: CONTACT phone: 619-501-0371 phoneExt: 310 email: [email protected] lat: 32.71533 lon: -117.15726 hasResults: False
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<|newrecord|> nctId: NCT06343337 id: MSKUDİSCLİNİCALTRİALS_FYİLMAZ. briefTitle: The Effects of Pregnancy on Oral Health overallStatus: COMPLETED date: 2022-05-20 date: 2023-04-01 date: 2023-04-01 date: 2024-04-02 date: 2024-04-02 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status.
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The main questions it aims to answer are:
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* Does pregnancy affect caries experience and periodontal status?
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* Does pregnancy affect salivary pH and flow rate?
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* Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate?
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* Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate? conditions: Pregnancy Related conditions: Dental Caries conditions: Periodontal Diseases conditions: Saliva Altered studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The individual who evaluates the salivary pH and flow rate. whoMasked: OUTCOMES_ASSESSOR count: 198 type: ACTUAL name: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman measure: The effects of pregnancy on caries experience measure: The effects of pregnancy on periodontal status. measure: The effects of pregnancy on salivary pH. measure: The effects of pregnancy on salivary flow rate. sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fatma Yilmaz city: Mentese state: Mugla zip: 48000 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06343324 id: 2023/012 briefTitle: Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2024-02-01 date: 2024-04-01 date: 2024-04-02 date: 2024-04-03 name: KTO Karatay University class: OTHER briefSummary: Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV. conditions: Noninvasive Ventilation conditions: COPD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Web-based education measure: Patient Identifiable Characteristics Form measure: S³-NIV Questionnaire measure: insomnia severity index measure: Expected behavioral changes in the individual survey sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University Konya Beyhekim Training and Research Hospital city: Konya state: Selçuklu zip: 42060 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06343311 id: EBUS22CD19AR100 briefTitle: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) acronym: Starlight-1 overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-12-31 date: 2027-12-31 date: 2024-04-02 date: 2024-04-18 name: Estrella Biopharma, Inc. class: INDUSTRY name: Eureka Therapeutics Inc. briefSummary: This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase. conditions: B-Cell Non-Hodgkin's Lymphoma (NHL) conditions: Lymphoma, Non-Hodgkins conditions: Lymphomas Non-Hodgkin's B-Cell conditions: Non-Hodgkin Lymphoma conditions: Non-Hodgkin's Lymphoma conditions: Large B-Cell Lymphoma conditions: Lymphoma, Non-Hodgkin's, Adult conditions: Lymphoma conditions: Refractory Non-Hodgkin Lymphoma conditions: Relapsed Non-Hodgkin Lymphoma conditions: Lymphoma, Non-Hodgkin conditions: HIV Associated Lymphoma conditions: CNS Lymphoma conditions: High-grade B-cell Lymphoma conditions: Refractory B-Cell Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: EB103 measure: To assess the Dose Limiting Toxicities of EB103. measure: Incidence rates of Treatment-Emergent Adverse Events of EB103. measure: Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103. measure: To determine the Recommended Phase II Dose (RP2D) of EB103. measure: To assess the Overall Response Rate of EB103 in our study subject population. measure: To assess the Disease Control Rate of EB103 in our study subject population. measure: To assess the Duration of Response of EB103 in our study subject population. measure: To assess the Progression-Free Survival rate of EB103 in our study subject population. measure: To assess the Event-Free Survival rate of EB103 in our study subject population. measure: To assess the Overall Survival rate of EB103 in our study subject population. measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax). measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06343298 id: ES_MANP_2001 briefTitle: To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2025-08-01 date: 2024-04-02 date: 2024-04-10 name: E-Star BioTech, LLC class: INDUSTRY name: Mayo Clinic name: PPD briefSummary: This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action. conditions: Difficult to Control Hypertension studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: MANP name: Placebo Matched control measure: Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. measure: Incidence and severity of Adverse events through 4- weeks post end of treatment. measure: Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. measure: Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. measure: Change in Clinic sitting systolic blood pressure measure: Pharmacokinetics - Cmax measure: Pharmacokinetics - Tmax measure: Anti-drug Antibody measure: Differential Outcomes in African-American Subject versus Non-African American Subjects measure: Metabolic biomarkers - Glucose measure: Metabolic biomarkers - Insulin measure: Metabolic biomarkers - HbA1C measure: Lipid biomarkers - HDL measure: Lipid biomarkers - LDL measure: Lipid biomarkers - TG sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06343285 id: 20231215 briefTitle: Upper Limb Tremor Reduction in Essential Tremor Patients acronym: ULTRE overallStatus: RECRUITING date: 2024-01-01 date: 2024-05 date: 2024-06 date: 2024-04-02 date: 2024-04-03 name: Encora, Inc. class: INDUSTRY briefSummary: This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Three different arms in a randomized order primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization schedule maintained by non-Clinical personnel whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Encora Therapeutics Tremor Reduction Device measure: Tolerability measure: Safety measure: Bain & Findley Activity of Daily Living (BF-ADL) #2 measure: BF-ADL #4 measure: BF-ADL #17 measure: BF-ADL #21 measure: Patient Global Impression of Change (PGI-C) measure: Clinician Global Impression of Change (CGI-C) measure: Tremor power as measured by gyroscope measure: The Essential Tremor Rating Scale (TETRAS) #2.4 measure: TETRAS #2.6 measure: TETRAS #2.8 measure: Patient Global Impression of Severity (PGI-S) measure: Clinician Global Impression of Severity (CGI-S) measure: Tremor power as measured by accelerometer sex: ALL minimumAge: 22 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Encora Therapeutics status: RECRUITING city: Cambridge state: Massachusetts zip: 02139 country: United States name: Kristi Winterfeldt, MSHS role: CONTACT phone: 763-248-1210 email: [email protected] name: Taylor Robertson role: CONTACT phone: 7814221105 email: [email protected] name: Kristi Winterfeldt, MSHS role: PRINCIPAL_INVESTIGATOR name: Fatta Nahab, MD role: SUB_INVESTIGATOR lat: 42.3751 lon: -71.10561 hasResults: False
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<|newrecord|> nctId: NCT06343272 id: LEGO briefTitle: Lymphocyte Enhancement in Gastroenteric Oncology overallStatus: RECRUITING date: 2022-03-22 date: 2024-12-22 date: 2025-02-28 date: 2024-04-02 date: 2024-04-03 name: Fondazione IRCCS Policlinico San Matteo di Pavia class: OTHER name: University of Pavia briefSummary: LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens. conditions: Advanced Gastrointestinal Cancers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: EAA supplementation name: Isocaloric placebo measure: Exit from lymphopenia measure: The change in the % of lymphocytes over time measure: The proportion of patients with G3-G5 toxicity measure: The percentage of chemotherapy dose administered compared to that expected for the patients. measure: plasma aminoacids composition chang during treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Policlinico San Matteo status: RECRUITING city: Pavia zip: 27100 country: Italy name: Alessandra Ferrari role: CONTACT phone: 0382.503689 phoneExt: +39 email: [email protected] name: Salvatore Corallo role: PRINCIPAL_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False
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<|newrecord|> nctId: NCT06343259 id: 2534 briefTitle: The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-01 date: 2024-08-14 date: 2024-04-02 date: 2024-04-02 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: In this prospective, randomized, single-blind study, we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery. Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery, with myocardial injury after non-cardiac surgery (MINS) being a significant concern. MINS, characterized by asymptomatic elevation of troponin levels without accompanying ECG findings, is closely associated with postoperative mortality. With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic, understanding the effects of different anesthesia types on postoperative myocardial injury is crucial. conditions: Myocardial Injury After Non-cardiac Surgery conditions: Hypotension During Surgery conditions: Anesthesia, General conditions: Anesthesia, Spinal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: General Anesthesia name: Spinal Anesthesia measure: Myocardial Injury After Non-Cardiac Surgery (MINS) measure: The duration of intensive care unit (ICU) stay measure: The duration of hospital stay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Training and Research Hospital city: Istanbul zip: 34396 country: Turkey name: Mustafa Bilgehan AYIK role: CONTACT phone: +905377247984 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06343246 id: MustafaKemalU briefTitle: Functional Inspiratory Muscle Training in Patients Diagnosed With Hypertension overallStatus: RECRUITING date: 2023-05-01 date: 2024-03-30 date: 2024-03-30 date: 2024-04-02 date: 2024-04-02 name: Mustafa Kemal University class: OTHER briefSummary: This study was planned to investigate the effectiveness of combined exercise training, that is, functional inspiratory muscle training, with breathing exercises to be applied with a portable, easy-to-use respiratory muscle strengthening device, on exercise capacity and peripheral muscle strength. conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective Randomized Controlled Study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Inspiratory muscle training with device measure: Change of the exercise capacity from baseline to 8 week measure: Change of the peripheral muscle strenght from baseline to 8 week measure: change of the upper extremity exercise capacity from baseline to 8 week measure: change of the postural balance from baseline to 8 week measure: change of the physical activity from baseline to 8 week measure: change of the quality of life from baseline to 8 week measure: change of the Fev1/Fvc sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay state: Antakya country: Turkey name: İrem hüzmeli role: CONTACT email: [email protected] lat: 38.40227 lon: 27.10486 hasResults: False
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<|newrecord|> nctId: NCT06343233 id: FATE briefTitle: FAiling HearT in the Elderly (FATE) Study acronym: FATE overallStatus: RECRUITING date: 2019-11-19 date: 2024-12 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: IRCCS Multimedica class: OTHER briefSummary: In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.
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The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure. conditions: Heart Failure conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: usual care measure: Hospitalization or death at 12 months measure: Hospitalization or death at 6-12-18 months measure: hospitalizations and/or death from cardiovascular causes measure: association between events and patient characteristics sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT) status: RECRUITING city: Montescano state: Italy/Pavia zip: 27040 country: Italy name: Maria Teresa La Rovere, MD role: CONTACT phone: +39 0385 247290 email: [email protected] lat: 45.03196 lon: 9.28366 facility: IRCCS Centro Cardiologico Monzino status: RECRUITING city: Milan state: MIlano zip: 20138 country: Italy name: PierGiuseppe Agostoni, MD role: CONTACT phone: +39 02 58002772 email: [email protected] lat: 45.46427 lon: 9.18951 facility: IRCCS Humanitas Research Hospital status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Cristina Panico, MD role: CONTACT phone: +39 0282241 email: [email protected] lat: 45.38193 lon: 9.1559 facility: IRCCS MultiMedica status: RECRUITING city: Sesto San Giovanni state: Milano zip: 20099 country: Italy name: Gaia Cattadori, MD role: CONTACT phone: +39 02 8687 8889 email: [email protected] lat: 45.53329 lon: 9.22585 facility: Ospedale Policlinico San Martino IRCCS status: RECRUITING city: Genova zip: 16132 country: Italy name: Pietro Ameri, MD role: CONTACT phone: +39 0103538928 email: [email protected] lat: 44.40478 lon: 8.94438 facility: IRCCS Auxologico status: RECRUITING city: Milano zip: 20149 country: Italy name: Gianluca Caldara, MD role: CONTACT phone: +39 02 61911 251 email: [email protected] lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan zip: 20100 country: Italy name: Marco Vicenzi, MD role: CONTACT phone: +39 02 503 20512 email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06343220 id: AWARE 2.0 briefTitle: Project AWARE 2.0 to Improve Awareness, Willingness and Ability for Research and Enrollment in Clinical Research overallStatus: RECRUITING date: 2024-04-10 date: 2024-09 date: 2024-09 date: 2024-04-02 date: 2024-04-29 name: Huntington Study Group class: NETWORK name: Roche Products Limited briefSummary: The Project AWARE 2.0 Survey is intended to gain knowledge about the feelings, attitudes, and beliefs of HD family members, care partners and others affected by HD towards the way drug trials and observational studies are communicated and conducted. conditions: Huntington Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Examine awareness measure: Provide the HD research community with the insight. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntington Study Group status: RECRUITING city: Rochester state: New York zip: 14618 country: United States name: Elise Kayson, MS role: CONTACT phone: 800-487-7671 email: [email protected] lat: 43.15478 lon: -77.61556 hasResults: False
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<|newrecord|> nctId: NCT06343207 id: 249637 briefTitle: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability overallStatus: COMPLETED date: 2022-11-22 date: 2023-02-02 date: 2023-02-02 date: 2024-04-02 date: 2024-04-02 name: Charles University, Czech Republic class: OTHER briefSummary: To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI). conditions: Ankle Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Trial primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: INVESTIGATOR count: 39 type: ACTUAL name: Percussive massage gun therapy measure: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability. sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculty of physical education and sport, Charles University city: Praha zip: 16252 country: Czechia lat: 50.08804 lon: 14.42076 hasResults: False
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<|newrecord|> nctId: NCT06343194 id: 6162 briefTitle: Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism acronym: EMG_BRUX overallStatus: RECRUITING date: 2023-02-09 date: 2024-05-31 date: 2024-12-22 date: 2024-04-02 date: 2024-04-11 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.
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The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
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The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
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The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients. conditions: Sleep Bruxism conditions: Masseter Muscle Hypertrophy conditions: Grinding Teeth studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: bruxism patients and non-bruxism patients primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Bruxoff ® measure: Change in potentials recorded by Bruxoff ® in bruxism patients. measure: Change of signs and symptoms of bruxism sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UOC Odontoiatria Generale e Ortodonzia, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Massimo Cordaro, professor role: CONTACT phone: +39 0630154286 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06343181 id: IEO 1824 briefTitle: A Qualitative Study on Treatment Adherence in Patients With Metastatic Breast Cancer overallStatus: RECRUITING date: 2022-10-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: Qualitative observational study with the aim to explore medication adherence in a sample of patients with metastatic breast cancer.
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Patients with metastatic breast cancer receiving or having received oral oncologic therapy, and attending the Division of Medical Senology at the European Institute of Oncology, will be included and enrolled in this research project." conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Evaluation of factors influencing patients' adherence to medical therapy sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Gabriella Pravettoni role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06343168 id: frailty briefTitle: Prevalence of Frailty and Associated Factors in Coronary Artery Bypass Patients overallStatus: COMPLETED date: 2021-02-18 date: 2022-02-18 date: 2022-02-18 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: This study aimed to determine the prevalence of and factors affecting frailty in patients with coronary artery bypass graft.
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The main question it aims to answer are:
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What are the prevalence of and factors affecting frailty in patients with coronary artery bypass graft Type of study: descriptive cross-sectional study Participant population: coronary artery bypass grafting patients conditions: Frailty studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 96 type: ACTUAL name: prevalence of frailty measure: Prevalence of frailty measure: Activities of Daily Living measure: Nutritional Assessment measure: Comorbidity measure: Cognitive Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak University city: Usak state: Center zip: 64200 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
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<|newrecord|> nctId: NCT06343155 id: E-10840098-202.3.02-235 briefTitle: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder" overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2024-05-27 date: 2024-06-03 date: 2024-04-02 date: 2024-04-03 name: Medipol University class: OTHER briefSummary: According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated. conditions: Temporomandibular Disorder conditions: Chronic Low-back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups: Therapeutic group and Rocabado's group. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Therapeutic Group name: Rocabado's Group measure: Temporomandibular Joint Range of Motion Measurement (ROM) measure: The Jaw Functional Limitation Scale 20 (JFLS-20) measure: Oral Health Impact Profile - 14 (OHIP-14) measure: The short-form McGill Pain Questionnaire (SF-MPQ) measure: Graded Chronic Pain Scale 2.0 total (GCPS 2.0) measure: Visual Analog Scale sex: ALL minimumAge: 23 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Medipol University city: Istanbul country: Turkey name: İkra Çakıcı role: CONTACT phone: +90 05426696487 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06343142 id: 42038 briefTitle: Effects of Time of Day and Nut Intake on Cognitive Performance overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-28 date: 2025-06-30 date: 2024-04-02 date: 2024-04-04 name: Monash University class: OTHER briefSummary: This is a 2 x 2-factor crossover design study to investigate the effects of time of day and nuts on post-meal cognitive performance. conditions: Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 2 x 2-factor crossover design study primaryPurpose: PREVENTION masking: NONE count: 25 type: ESTIMATED name: Nuts name: Nut-free meal measure: N-back task - accuracy measure: N-back task - matched responses measure: N-back task - false alarm measure: N-back task - reaction time measure: Stroop test - congruent measure: Stroop test - incongruent measure: Stroop test - interference measure: Multitasking - pure blocks measure: Multitasking - mixed blocks measure: Multitasking - mixing cost measure: Satiety - hunger measure: Satiety - fullness measure: Satiety - satisfaction measure: Satiety - eating capacity measure: Satiety index sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Department of Nutrition, Dietetics and Food - Monash University status: RECRUITING city: Notting Hill state: Victoria zip: 3168 country: Australia name: Barbara R Cardoso, PhD role: CONTACT phone: +61499840472 email: [email protected] name: Maxine Bonham, PhD role: CONTACT phone: +61418 234 292 email: [email protected] lat: -37.905 lon: 145.1427 hasResults: False
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<|newrecord|> nctId: NCT06343129 id: 3817 briefTitle: Effects of a Whole-food, Plant-based Nutrition Program on BP and Potassium in Subjects With CKD overallStatus: COMPLETED date: 2020-10-26 date: 2022-12-12 date: 2022-12-12 date: 2024-04-02 date: 2024-04-17 name: University of Rochester class: OTHER name: Rochester Lifestyle Medicine Institute briefSummary: The purpose of this study is to determine if an educational program emphasizing a whole food plant based diet favorably impacts blood pressure while not significantly increasing blood potassium levels, by comparing a group of patients receiving the educational program with a control group of patients receiving no specific education. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 43 type: ACTUAL name: Dietary education program measure: Mean change in systolic blood pressure measure: Mean change in diastolic blood pressure measure: Mean change in potassium levels measure: Proportion of participants developing hyperkalemia measure: Mean Change in energy/day measure: Mean change in energy/kg of body mass measure: Mean change in total fat measure: Mean change in % calories from fat measure: Mean change in % calories from carbohydrates measure: Mean change in % calories from protein measure: Mean change in Animal protein measure: Mean change in Vegetable protein measure: Mean change in cholesterol measure: Mean change in Total dietary fiber measure: Mean change in Total fiber per 1000 kcal measure: Mean change in calcium measure: Mean change in phosphorous measure: Mean change in magnesium measure: Mean change in sodium measure: Mean change in potassium measure: Mean change in body mass measure: Mean change in body mass index measure: Mean change in sodium measured in blood measure: Mean change in chloride measured in blood measure: Mean change in bicarbonate measured in blood measure: Mean change in blood urea nitrogen (BUN) measured measure: Mean change in creatinine measured in blood measure: Mean change in glucose measured in blood measure: Mean change in calcium measured in blood measure: Mean change in phosphorous measured in blood measure: Mean change in parathyroid hormome (PTH) measured in blood measure: Mean change in albumin measured in blood measure: Mean change in magnesium measured in blood measure: Mean change in erythrocyte sedimentation rate (ESR) measured in blood measure: Mean change in fibroblast growth factor (FGF)-23 measured in blood measure: Mean change in total cholesterol measured in blood measure: Mean change in low density lipoprotein (LDL) measured in blood measure: Mean change in high density lipoprotein (HDL) measured in blood measure: Mean change in triglycerides measured in blood measure: Mean change in 8-isoprostane measured in urine measure: Mean change in symptoms measure: Mean change in effects of kidney disease measure: Mean change in burden of kidney disease measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) physical composite measure: Mean change in Medical Outcomes Study Short Form (MOS SF-12) mental composite sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center of the University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: University of Rochester Medical Center city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 hasResults: False
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<|newrecord|> nctId: NCT06343116 id: BPL-Nim-CRC-3001 briefTitle: Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer acronym: NOTABLE-308 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-02 date: 2024-04-02 name: Biotech Pharmaceutical Co., Ltd. class: OTHER briefSummary: This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine/tipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS). conditions: Refractory Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Nimotuzumab injection name: Placebo name: Trifluridine/tipiracil measure: overall survival (OS) measure: dose-limiting toxicity (DLT) measure: Progression free survival (PFS) measure: time to progress (TTP) measure: overall response rate (ORR) measure: disease control rate (DCR) measure: duration of response (DoR) measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) measure: Adverse Events measure: tumor-related markers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06343103 id: IEO 1735 briefTitle: Study Evaluating Occupational Exposure to Antineoplastic Drugs acronym: BRIC overallStatus: RECRUITING date: 2022-08-02 date: 2025-12-31 date: 2025-12-31 date: 2024-04-02 date: 2024-04-02 name: European Institute of Oncology class: OTHER briefSummary: The multicenter study involves comparing two groups (an exposed group and a control group). The exposed group is selected from workers who perform their activities in drug handling areas (DH) or units for antineoplastic preparation (UFA), while the control group involves the voluntary participation of non-exposed workers (administrative staff).
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The control group is selected based on the characteristics of the exposed group to ensure a homogeneous sample in terms of size and characteristics. conditions: Cytotoxicity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 500 type: ESTIMATED name: Workers exposed name: Workers not exposed measure: Evaluation of the difference in micronuclei frequency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova country: Italy name: Sabrina Beltramini role: CONTACT lat: 44.40478 lon: 8.94438 facility: European Institute of Oncology status: RECRUITING city: Milan country: Italy name: Emanuela Omodeo Salè role: CONTACT lat: 45.46427 lon: 9.18951 facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" status: RECRUITING city: Napoli country: Italy name: Piera Maiolino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Istituto Oncologico Veneto Irccs status: RECRUITING city: Padova country: Italy name: Nicoletta Rigamonti role: CONTACT lat: 45.40797 lon: 11.88586 facility: Fondazione Policlinico Universitario Campus Bio-Medico status: RECRUITING city: Roma country: Italy name: Andrea Di Mattia role: CONTACT lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06343090 id: BJGBYY-IIT-LCYJ-2023-003 briefTitle: Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients overallStatus: RECRUITING date: 2024-04-12 date: 2042-12-01 date: 2043-09-30 date: 2024-04-02 date: 2024-04-18 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled. conditions: B-cell Acute Lymphoblastic Leukemia conditions: Acute Lymphoblastic Leukemia, in Relapse conditions: Refractory Acute Lymphoid Leukemia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: NONE count: 353 type: ESTIMATED name: CD19 CAR T-cell name: CD22 CAR T cells name: hematopoietic stem-cell transplantation measure: EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) measure: ORR in Sequential CAR group and CAR+HSCT group measure: DOR in Sequential CAR group and CAR+HSCT group measure: OS in Sequential CAR group and CAR+HSCT group measure: Adverse events (AEs) in Sequential CAR group and CAR+HSCT group measure: Levels of CD19 and CD22 CAR-T cells in Sequential CAR group measure: Levels of CD19 CAR-T cells in CAR+HSCT group measure: Levels of CD19 and CD22 CAR transgene in Sequential CAR group measure: Levels of CD19 CAR transgene in CAR+HSCT group measure: Quantification of B cells in Sequential CAR group and CAR+HSCT group measure: EFS in CD19 CAR T-cell infusion without consolidation therapies (Single CAR group) measure: DOR in Single CAR group measure: OS in Single CAR group measure: ORR in Single CAR group measure: Adverse events (AEs) in Single CAR group measure: Levels of CD19 CAR-T cells in Single CAR group measure: Levels of CD19 CAR transgene in Single CAR group measure: Quantification of B cells in Single CAR group sex: ALL minimumAge: 1 Year maximumAge: 39 Years stdAges: CHILD stdAges: ADULT facility: Beijing GoBroad Hospital status: RECRUITING city: Beijing state: Beijing zip: 102206 country: China name: Tengyu Wang role: CONTACT phone: 86+18333186020 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06343077 id: STUDY-22-00106 briefTitle: Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance overallStatus: RECRUITING date: 2024-01-16 date: 2026-12-31 date: 2026-12-31 date: 2024-04-02 date: 2024-04-02 name: Ashutosh Kumar Tewari class: OTHER name: Oncovir, Inc. briefSummary: This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance. conditions: Prostate Cancer Patients on Active Surveillance studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Poly-ICLC intramuscular (IM) injection name: Poly-ICLC, Intertumoral (IT) injection measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group upgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Proportion of subjects without Gleason group downgrade after treatment measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who experience adverse events per NCI-CTCAE 5.0 measure: Number of subjects who receive prostate cancer treatment measure: Number of subjects who receive prostate cancer treatment sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai (ISMMS) status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Monali Fatterpekar, PhD role: CONTACT email: [email protected] name: Sujit S Nair, PhD role: CONTACT phone: 212-241-7005 email: [email protected] name: Ashutosh K Tewari, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06343064 id: PLB1001/PLB1004-NSCLC-Ib/II-01 briefTitle: Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI overallStatus: RECRUITING date: 2023-06-13 date: 2024-12-31 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC conditions: Non-Small-Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 156 type: ESTIMATED name: Vebreltinib name: PLB1004 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). measure: Incidence of dose-limiting toxicities (DLT) as defined in the protocol. measure: Overall Response Rate (ORR） measure: Pharmacokinetics of Vebreltinib and PLB1004 : Area under the concentration time curve (AUC) measure: Pharmacokinetics of Vebreltinib and PLB1004: Maximum plasma concentration of the study drug (C-max) measure: Pharmacokinetics of Vebreltinib and PLB1004: Time to maximum plasma concentration of the study drug (T-max) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Pulmonary Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Caichun Zhou, PHD role: CONTACT phone: +86-21-65115006 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06343051 id: STUDY-23-01681 briefTitle: USCOM in Newly Diagnosed FGR Cases acronym: USCOM FGR overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The purpose of this research study is to study the use of an ultrasound measurement system (USCOM) for patients with newly diagnosed fetal growth restriction (FGR). This system uses a technology to measure how much blood is being pumped in and out of the heart, which is important for understanding the heart's function in relation to pregnancy. conditions: Fetal Growth Restriction conditions: USCOM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: USCOM measure: Systemic vascular resistance obtained from USCOM sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai Hospital city: New York state: New York zip: 10029 country: United States name: Nicola F Tavella, MPH role: CONTACT phone: 212-241-3888 email: [email protected] name: Rachel J Meislin role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06343038 id: 2023-01868; th23Nicolas briefTitle: Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study acronym: PROGNOSTICS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-06 date: 2024-04-02 date: 2024-04-02 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before.
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In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time.
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The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects.
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The performance of different prostate cancer diagnostic methods is also in scope of the study. conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In Phase Ia:
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Radiation dosimetry driven, head-to-head in cross-over design comparison of tumour and critical organ absorbed doses after sequential non-therapeutic injections of 161Tb-SibuDAB and 177Lu-PSMA-I\&T in the same mCRPC patients undergoing standard 177Lu-PSMA-I\&T RLT.
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In Phase Ib:
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Clinical and radiation dosimetry-based dose escalation study, with a classical 3+3 design, to identify the optimal biologic dose (injected activity) of 161Tb-SibuDAB for safe and effective RLT. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 25 type: ESTIMATED name: Injection, 161Tb-SibuDAB,1GBq name: Injection, 177Lu-PSMA-I&T, 1GBq name: Injection, 161Tb-SibuDAB, Dose Escalation measure: Phase Ia: Tumour absorbed dose measure: Phase Ib: Identification of the optimal biological dose of 161Tb-SibuDAB for mCRPC RLT measure: Phase Ia: Estimation of critical organ median absorbed doses measure: Phase Ia: Estimation of the median tumour-to-critical organ absorbed dose ratios measure: Phase Ib: Cumulative median tumour and organ absorbed doses after 4 cycles of 161Tb-SibuDAB RLT measure: Phase Ib: Estimation of the "therapy index" for 161Tb-SibuDAB RLT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Alin Chirindel, MD role: CONTACT phone: +41 61 328 63 75 email: [email protected] name: Guillaume Nicolas, MD role: CONTACT phone: +41 61 265 47 02 email: [email protected] lat: 47.55839 lon: 7.57327 hasResults: False
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<|newrecord|> nctId: NCT06343025 id: Hasan Kalyoncu University briefTitle: The Effects of Tai Chi and Pilates for Individuals With Prediabetes overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-02 date: 2024-04-02 name: Nigde Omer Halisdemir University class: OTHER name: Hasan Kalyoncu University briefSummary: The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and Control group. 3 groups. 3 groups will be measured at the same time and then the exercise part will begin. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes ,Assesor, who will make the evaluations in the first week and after 12 weeks, will not know which group the people are in. whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Pilates Exercises Group name: Tai Chi Exercises Group measure: Glisemic Control measure: Body Composition measure: Balance measure: Physical Activity Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06343012 id: 0305900 briefTitle: Caring Leadership Intervention Program for First-Line Nurse Managers overallStatus: COMPLETED date: 2022-07-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-02 date: 2024-04-02 name: Matrouh University class: OTHER briefSummary: Caring leadership can help first-line nurse managers create a healthy environment, resulting in a positive outcome for nurse staff, patients, and healthcare organizations. conditions: Intervention conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental study design utilized two groups, study and control groups primaryPurpose: OTHER masking: SINGLE maskingDescription: A quasi-experimental study design utilized two groups, study and control groups. whoMasked: PARTICIPANT count: 60 type: ACTUAL name: Caring leadership Intervention program measure: Questionnaire to measure first-line nurse managers' knowledge measure: Questionnaire to measure the managerial actions of first-line nurse managers measure: Questionnaire to assess nurses' perceived first-line nurse managers' caring behavior measure: questionnaire to measure nurse outcomes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Nursing, Matrouh University city: Marsa Matruh zip: 002 country: Egypt lat: 31.3529 lon: 27.23725 hasResults: False
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<|newrecord|> nctId: NCT06342999 id: 22-012399 briefTitle: Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2035-07 date: 2035-07 date: 2024-04-02 date: 2024-04-10 name: Mauro H. Schenone class: OTHER briefSummary: The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS). conditions: Hypoplastic Left Heart Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Fetal Aortic Valvuloplasty Procedure name: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter name: Trek RX and Mini Trek RX Coronary Dilatation Catheter measure: Number of cases in which the procedure was successful measure: Number of cases in which a biventricular repair was achieved measure: Number cases with pulmonary hypertension measure: Number of cases delivered prematurely measure: Number of cases with perinatal death measure: Number of maternal complications sex: FEMALE maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06342986 id: 2023LS185 id: P01CA111412 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA111412 briefTitle: Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-06-30 date: 2029-06-30 date: 2024-04-02 date: 2024-04-26 name: Masonic Cancer Center, University of Minnesota class: OTHER name: National Cancer Institute (NCI) briefSummary: This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer. conditions: Gynecologic Cancer conditions: Ovarian Cancer conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Cavity Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A minimum of 28 days must separate each Dose Cohort. A minimum of 30 days must separate the 1st and 2nd patient. All patients are assessed for Dose Limiting Toxicity (DLT) primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: FT536 name: Fludarabine name: CY measure: Progression free survival (PFS) measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06342973 id: 5591 briefTitle: Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Case Series overallStatus: RECRUITING date: 2024-03-27 date: 2025-05-30 date: 2025-05-30 date: 2024-04-02 date: 2024-04-02 name: Louisiana State University Health Sciences Center in New Orleans class: OTHER briefSummary: The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane. conditions: Alveolar Ridge Deficiency studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Xenograft and allograft measure: Horizontal bone gain measure: Vital bone percentage measure: Bone shrinkage measure: Surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LSUHSC School of Dentistry status: RECRUITING city: New Orleans state: Louisiana zip: 70119 country: United States name: Eswar Kandaswamy role: CONTACT phone: 504-941-8272 email: [email protected] name: Eswar Kandaswamy, BDS, MS role: PRINCIPAL_INVESTIGATOR name: Vinayak Joshi, BDS, MS, PhD role: SUB_INVESTIGATOR name: Jeanne St Germain, RDH role: SUB_INVESTIGATOR lat: 29.95465 lon: -90.07507 hasResults: False
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<|newrecord|> nctId: NCT06342960 id: KYV101-003 briefTitle: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3) overallStatus: RECRUITING date: 2022-12-01 date: 2028-10 date: 2029-01 date: 2024-04-02 date: 2024-04-02 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis conditions: Lupus Nephritis conditions: Lupus Nephritis - WHO Class III conditions: Lupus Nephritis - WHO Class IV studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: KYV-101 anti-CD19 CAR-T cell therapy name: Standard lymphodepletion regimen measure: Incidence adverse events (AEs) and laboratory abnormalities measure: Frequency of dose limiting toxicities measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacodynamics (PD) measure: To characterize the pharmacodynamics (PD) measure: To evaluate disease related biomarkers measure: To evaluate disease related biomarkers measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate efficacy measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Carl Gustav Carus Dresden status: RECRUITING city: Dresden country: Germany name: Study Coordinator role: CONTACT lat: 51.05089 lon: 13.73832 facility: University Hospital Erlangen status: RECRUITING city: Erlangen country: Germany name: Study Coordinator role: CONTACT lat: 49.59099 lon: 11.00783 facility: University Hospital Hamburg-Eppendorf status: RECRUITING city: Hamburg country: Germany name: Study Coordinator role: CONTACT lat: 53.57532 lon: 10.01534 hasResults: False
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<|newrecord|> nctId: NCT06342947 id: ALG-055009-303 briefTitle: ALG-055009 in Non-cirrhotic Adults With MASH (HERALD) acronym: HERALD overallStatus: RECRUITING date: 2024-04-01 date: 2024-11-25 date: 2024-12-23 date: 2024-04-02 date: 2024-04-25 name: Aligos Therapeutics class: INDUSTRY briefSummary: This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin \[softgel\] capsule) for 12 weeks. conditions: NASH conditions: MASH conditions: Metabolic Dysfunction-Associated Steatohepatitis conditions: Nonalcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: ALG-055009 name: Placebo measure: Percent relative change from baseline in liver fat content measure: Absolute change from baseline in liver fat content measure: Proportion of subjects with ≥30% relative reduction in liver fat content measure: Proportion of subjects with ≥50% relative reduction in liver fat content measure: Proportion of subjects with ≥70% relative reduction in liver fat content measure: Proportion of subjects with normalization (<5%) in liver fat content measure: Change from baseline (absolute/percent) in lipid/lipoprotein levels measure: Change from baseline (absolute/percent) in SHBG measure: Change from baseline (absolute/percent) alanine aminotransferase (ALT) measure: Change from baseline (absolute/percent) aspartate aminotransferase (AST) measure: Safety and tolerability will be assessed by monitoring TEAEs measure: Safety and tolerability will be assessed by monitoring 12-lead electrocardiograms (ECGs) measure: PK parameters of ALG-055009 in plasma, AUCs measure: PK parameters of ALG-055009 in plasma, Tmax measure: PK parameters of ALG-055009 in plasma, Cmax measure: PK parameters of ALG-055009 in plasma, Cmin sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aligos Clinical Study Site 18 status: RECRUITING city: Chandler state: Arizona zip: 85224 country: United States name: Central contact role: CONTACT lat: 33.30616 lon: -111.84125 facility: Aligos Clinical Study Site 15 status: RECRUITING city: Peoria state: Arizona zip: 85301 country: United States name: Central contact role: CONTACT lat: 33.5806 lon: -112.23738 facility: Aligos Clinical Study Site 17 status: RECRUITING city: Tucson state: Arizona zip: 85641 country: United States name: Central contact role: CONTACT lat: 32.22174 lon: -110.92648 facility: Aligos Clinical Study Site 35 status: RECRUITING city: Chula Vista state: California zip: 91902 country: United States name: Central contact role: CONTACT lat: 32.64005 lon: -117.0842 facility: Aligos Clinical Study Site 1 status: RECRUITING city: Lincoln state: California zip: 95648 country: United States name: Central contact role: CONTACT lat: 38.89156 lon: -121.29301 facility: Aligos Clinical Study Site 37 status: RECRUITING city: Poway state: California zip: 92025 country: United States name: Central contact role: CONTACT lat: 32.96282 lon: -117.03586 facility: Aligos Clinical Study Site 10 status: RECRUITING city: Rialto state: California zip: 92316 country: United States name: Central contact role: CONTACT lat: 34.1064 lon: -117.37032 facility: Aligos Clinical Study Site 26 status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Central contact role: CONTACT lat: 27.49893 lon: -82.57482 facility: Aligos Clinical Study Site 25 status: RECRUITING city: Clearwater state: Florida zip: 33755 country: United States name: Central contact role: CONTACT lat: 27.96585 lon: -82.8001 facility: Aligos Clinical Study Site 39 status: RECRUITING city: Fort Myers state: Florida zip: 33901 country: United States name: Central contact role: CONTACT lat: 26.62168 lon: -81.84059 facility: Aligos Clinical Study Site 2 status: RECRUITING city: Maitland state: Florida zip: 32751, 32794 country: United States name: Central contact role: CONTACT lat: 28.62778 lon: -81.36312 facility: Aligos Clinical Study Site 22 status: RECRUITING city: Ocoee state: Florida zip: 32703 country: United States name: Central contact role: CONTACT lat: 28.56917 lon: -81.54396 facility: Aligos Clinical Study Site 32 status: RECRUITING city: Port Orange state: Florida zip: 32119 country: United States name: Central contact role: CONTACT lat: 29.13832 lon: -80.99561 facility: Aligos Clinical Study Site 38 status: RECRUITING city: Sarasota state: Florida zip: 34230 country: United States name: Central contact role: CONTACT lat: 27.33643 lon: -82.53065 facility: Aligos Clinical Study Site 31 status: RECRUITING city: The Villages state: Florida zip: 32159 country: United States name: Central contact role: CONTACT lat: 28.93408 lon: -81.95994 facility: Aligos Clinical Study Site 3 status: RECRUITING city: Viera state: Florida zip: 32924 country: United States name: Central contact role: CONTACT lat: 28.24696 lon: -80.737 facility: Aligos Clinical Study Site 30 status: RECRUITING city: Winter Park state: Florida zip: 32789 country: United States name: Central contact role: CONTACT lat: 28.6 lon: -81.33924 facility: Aligos Clinical Study Site 23 status: RECRUITING city: Athens state: Georgia zip: 30601 country: United States name: Central contact role: CONTACT lat: 33.96095 lon: -83.37794 facility: Aligos Clinical Study Site 12 status: RECRUITING city: Topeka state: Kansas zip: 66546 country: United States name: Central contact role: CONTACT lat: 39.04833 lon: -95.67804 facility: Aligos Clinical Study Site 29 status: RECRUITING city: Louisville state: Kentucky zip: 40018 country: United States name: Central contact role: CONTACT lat: 38.25424 lon: -85.75941 facility: Aligos Clinical Study Site 24 status: RECRUITING city: Bastrop state: Louisiana zip: 71220 country: United States name: Central contact role: CONTACT lat: 32.75625 lon: -91.87235 facility: Aligos Clinical Study Site 5 status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Central contact role: CONTACT lat: 29.59577 lon: -90.71953 facility: Aligos Clinical Study Site 4 status: RECRUITING city: Marrero state: Louisiana zip: 70072 country: United States name: Central contact role: CONTACT lat: 29.89937 lon: -90.10035 facility: Aligos Clinical Study Site 6 status: RECRUITING city: Metairie state: Louisiana zip: 70001 country: United States name: Central contact role: CONTACT lat: 29.98409 lon: -90.15285 facility: Aligos Clinical Study Site 14 status: RECRUITING city: Chesterfield state: Michigan zip: 48047 country: United States name: Central contact role: CONTACT lat: 42.66281 lon: -82.84242 facility: Aligos Clinical Study Site 7 status: RECRUITING city: New York state: New York zip: 10001 country: United States name: Central contact role: CONTACT lat: 40.71427 lon: -74.00597 facility: Aligos Clinical Study Site 8 status: RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States name: Central contact role: CONTACT lat: 34.72294 lon: -76.72604 facility: Aligos Clinical Study Site 21 status: RECRUITING city: Columbus state: Ohio zip: 43004 country: United States name: Central contact role: CONTACT lat: 39.96118 lon: -82.99879 facility: Aligos Clinical Study Site 16 status: RECRUITING city: Westlake state: Ohio zip: 44145 country: United States name: Central contact role: CONTACT lat: 41.45532 lon: -81.91792 facility: Aligos Clinical Study Site 36 status: RECRUITING city: East Greenwich state: Rhode Island zip: 02818 country: United States name: Central contact role: CONTACT lat: 41.66038 lon: -71.45589 facility: Aligos Clinical Study Site 9 status: RECRUITING city: Nashville state: Tennessee zip: 37011 country: United States name: Central contact role: CONTACT lat: 36.16589 lon: -86.78444 facility: Aligos Clinical Study Site 19 status: RECRUITING city: Austin state: Texas zip: 73301 country: United States name: Central contact role: CONTACT lat: 30.26715 lon: -97.74306 facility: Aligos Clinical Study Site 33 status: RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Central contact role: CONTACT lat: 29.70579 lon: -95.45883 facility: Aligos Clinical Study Site 27 status: RECRUITING city: Brownsville state: Texas zip: 78520 country: United States name: Central contact role: CONTACT lat: 25.90175 lon: -97.49748 facility: Aligos Clinical Study Site 28 status: RECRUITING city: Edinburg state: Texas zip: 78504 country: United States name: Central contact role: CONTACT lat: 26.30174 lon: -98.16334 facility: Aligos Clinical Study Site 40 status: RECRUITING city: Farmers Branch state: Texas zip: 75006 country: United States name: Central contact role: CONTACT lat: 32.92651 lon: -96.89612 facility: Aligos Clinical Study Site 20 status: RECRUITING city: San Antonio state: Texas zip: 78015 country: United States name: Central contact role: CONTACT lat: 29.42412 lon: -98.49363 facility: Aligos Clinical Study Site 11 status: RECRUITING city: Waco state: Texas zip: 76633 country: United States name: Central contact role: CONTACT lat: 31.54933 lon: -97.14667 facility: Aligos Clinical Study Site 13 status: RECRUITING city: Manassas state: Virginia zip: 20108 country: United States name: Central contact role: CONTACT lat: 38.75095 lon: -77.47527 facility: Aligos Clinical Study Site 34 status: RECRUITING city: Seattle state: Washington zip: 98039 country: United States name: Central contact role: CONTACT lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06342934 id: INT157/20 briefTitle: Radiomics and Machine Learning in the Diagnosis of Ovarian Masses acronym: Multi-AROMA overallStatus: COMPLETED date: 2020-07-22 date: 2023-12-31 date: 2023-12-31 date: 2024-04-02 date: 2024-04-02 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER briefSummary: The correct differential diagnosis between benign and malignant adnexal masses is the main goal of preoperative ultrasound diagnostics and is very important to plan the correct treatment for the patient in terms of surgical team (gynecologist oncologist or benign pathology center), surgical access (laparoscopy / laparotomy) and type of surgery (conservative / demolitive).
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Several ultrasound models have been developed to help gynecologists define the risk of malignancy of adnexal masses. In order to use the predictive models, the examiner had to collect certain ultrasound features of the lesion which, integrated with the patient's clinical and / or biochemical characteristics, provided a risk of malignancy of the mass.
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Recently radiomics is emerging as an interesting tool to be applied to diagnostic imaging (computed tomography, magnetic resonance and even ultrasound). Radiomics is the evaluation of images through complex software that allows to 'read' the intrinsic characteristics of the tissue identifying aspects that are not visible by subjective interpretation of the operator, in a fully automated and therefore reproducible way.
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Radiomics applied to artificial intelligence for the creation of predictive models represents an interesting tool to overcome the limitations of previous models, at least partly dependent on the operator's experience.
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Among the serous ovarian cancer, those with BRCA gene mutation represent an interesting subgroup and are characterized by a different pathophysiological history than wild type tumors due to greater chemosensitivity and the possibility of targeted treatment with antiangiogenic drugs and PARP-inhibitors.
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