hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06282159 id: DNTH103-MG-201 briefTitle: A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) acronym: MAGIC overallStatus: RECRUITING date: 2024-02-23 date: 2025-12 date: 2027-12 date: 2024-02-28 date: 2024-04-22 name: Dianthus Therapeutics class: INDUSTRY briefSummary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). conditions: Myasthenia Gravis, Generalized studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: DNTH103 name: Placebo measure: Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)] measure: Incidence, severity, and relationship of adverse events of special interest (AESI) measure: Number of participants with changes from baseline in ECG parameters measure: Number of participants with changes in clinical laboratory values over time measure: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score measure: Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score measure: Serum concentrations of DNTH103 measure: Change from baseline in complement total blood test (CH50) measure: Antidrug antibody (ADA) levels against DNTH103 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bradenton Research Center status: RECRUITING city: Bradenton state: Florida zip: 34205 country: United States name: Gloria Carlbert role: CONTACT email: gloriacarlbert@bradentonresearch.com lat: 27.49893 lon: -82.57482 facility: Texas Neurology status: RECRUITING city: Dallas state: Texas zip: 75206 country: United States name: Haley Rucker role: CONTACT email: hrucker@texasneurology.com lat: 32.78306 lon: -96.80667 facility: West Texas Neurology Clinic status: RECRUITING city: Lubbock state: Texas zip: 79414 country: United States name: Christie Long role: CONTACT email: research@westtexasneurologyclinic.com lat: 33.57786 lon: -101.85517 hasResults: False
nctId: NCT06282146 id: 2024P000252 briefTitle: Testing a Transdiagnostic TMS Treatment Target acronym: T5 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-02-28 date: 2024-02-28 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function. conditions: Major Depressive Disorder conditions: Depression conditions: Psychiatric Disorder conditions: Mood Disorders conditions: Mental Disorder conditions: Anxiety Disorders conditions: OCD conditions: PTSD studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 10 type: ESTIMATED name: transcranial magnetic stimulation measure: Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire measure: Feasibility as measured by number of the 50 treatments completed measure: Montgomery-Åsberg Depression Rating Scale (MADRS) measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC) measure: World Health Organization Disability Assessment Schedule II (WHODAS 2.0) measure: Beck Depression Inventory (BDI) measure: Beck Anxiety Inventory (BAI) measure: Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS) measure: Clinical Global Impression Scale (CGI) measure: Illness Intrusiveness Rating Scale (IIRS) measure: Perceived Stress Scale (PSS) measure: Positive and Negative Symptom Scale (PANSS) measure: Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) measure: Social Readjustment Rating Scale (SRRS) measure: Yale Brown Obsessive-Compulsive Scale (Y-BOCS) measure: Temperament and Character Inventory, Revised 140-item measure: Emotional Conflict Resolution Test measure: Learning, Multi-Source Interference Task (MSIT) measure: Penn Emotion Recognition Task (ER-40) measure: Death Suicide IAT measure: Young Mania Rating Scale (YMRS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06282133 id: 2024-1862 briefTitle: Behavioural Experiments for Generalized Anxiety in Adolescents - Pilot Study acronym: EC-II-Ado-P overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-01 date: 2025-01-01 date: 2024-02-28 date: 2024-02-28 name: Universite du Quebec en Outaouais class: OTHER briefSummary: Generalized Anxiety Disorder (GAD) is a chronic condition characterized by excessive and uncontrollable worry and anxiety. In adolescents, this condition can seriously impact their development, academic performance, and social relationships. In Canada, 3 to 4% of the population (between 0.9% and 2.7% among adolescents) suffers from GAD at any given time in their lives. These young individuals experience a reduced quality of life and are at risk for numerous medical conditions, as well as additional psychological issues. Research suggests that both pharmacological and psychological approaches are effective in treating GAD in the short term. However, psychological treatments appear to offer the greatest long-term benefits. There are a number of effective psychological treatments for GAD, most of which fall under cognitive-behavioural therapy (CBT) adapted for this age group.
Given this discovery, researchers developed a new treatment that exclusively targets intolerance to uncertainty and then adapted it for adolescents: Behavioural Experiments for Intolerance to Uncertainty in Adolescents (EC-IIA). The aim of the current pilot study is to test the effectiveness of EC-IIA in adolescent individuals. A total of 8 participants with a primary diagnosis of GAD will receive EC-IIA and will be evaluated at 4 different times ranging from pre-treatment to a 6-month follow-up. Conditions will be compared in terms of treatment efficacy and mechanisms. Researchers will also examine predictors of change during the 6 months following treatment. The proposed study will produce data on the effectiveness and mechanisms of a treatment for GAD that is less costly, less complex, and easier to disseminate than currently available treatments. conditions: Generalized Anxiety Disorder conditions: Adolescent - Emotional Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open trial primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Behavioural Experiments for Intolerance of Uncertainty measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) measure: Worry and Anxiety Questionnaire (WAQ) measure: Penn State Worry Questionnaire (PSWQ) measure: Beck Anxiety Inventory (BAI) measure: Beck Depression Inventory-II (BDI-II) measure: Intolerance of Uncertainty Scale (IUS) measure: Safety Behaviors Questionnaire (SBQ) measure: Treatment Acceptance and Adherence Scale (TAAS) measure: Working Alliance Inventory (WAI) sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universite du Quebec en Outaouais status: RECRUITING city: Gatineau state: Quebec zip: J8X 3X7 country: Canada name: Sylvain C Lemay, B.A. role: CONTACT phone: +1 819-595-3900 phoneExt: 2501 email: sylvainclaude.lemay@uqo.ca lat: 45.47723 lon: -75.70164 hasResults: False
nctId: NCT06282120 id: CSPC-DNY-BTC briefTitle: Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-05 date: 2026-01-01 date: 2024-02-28 date: 2024-02-28 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER name: CSPC Ouyi Pharmaceutical Co., Ltd. briefSummary: The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:
* To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer. conditions: Metastatic Biliary Tract Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy measure: Progression Free Survival measure: Overall Survival measure: Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1 measure: EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300000 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: vianvianvip@163.com name: Xihao Zhang, Master role: CONTACT phone: 15510801035 email: zxh15510801035@163.com lat: 39.14222 lon: 117.17667 hasResults: False
nctId: NCT06282094 id: LUX briefTitle: ViSiGi LUX Bariatric Sizing and Calibration System overallStatus: RECRUITING date: 2024-01-26 date: 2024-03 date: 2024-03 date: 2024-02-28 date: 2024-03-13 name: Boehringer Labs LLC class: INDUSTRY briefSummary: This study investigates the new ViSiGi LUX. conditions: Bariatric Surgery Candidate studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Physician Feedback sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: WellSpan status: RECRUITING city: York state: Pennsylvania zip: 17405 country: United States name: Faiz Shariff role: CONTACT lat: 39.9626 lon: -76.72774 hasResults: False
nctId: NCT06282068 id: CS2-23178 briefTitle: AI Determine Malignancy of GGO on Chest CT overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-02-28 date: 2026-02-28 date: 2024-02-28 date: 2024-02-28 name: Chung Shan Medical University class: OTHER briefSummary: Research Objectives To use AI computer-aided detection software to assist physicians in reading CT scans of lung nodules, providing auxiliary diagnostic tools for medical decision-making. The software can mark nodule locations and related information during routine physician reading. This study will obtain prospective consent to use patient CT images for software reading and compare with clinical physician diagnosis, in order to enhance software training and improve recognition of lung lesions for early diagnosis and treatment.
Keywords: lung nodules, early lung cancer, artificial intelligence, chest CT, minimally invasive surgery, lung image analysis software conditions: Lung Nodules, Early Lung Cancer, Artificial Intelligence, Chest CT, Minimally Invasive Surgery, Lung Image Analysis Software studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: AI computer-aided detection software measure: The accuricy of the diagnostic power. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung Shan Medical University Hospital city: Taichung state: South zip: 402 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
nctId: NCT06282055 id: TIMES briefTitle: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes acronym: TIMES overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: DCB Research AG class: OTHER briefSummary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements (insulin pump or smart pen data), glucose variability (CGM data), nutritional information, and menstrual cycle information (cycle tracking app, LH tests, and premenstrual symptoms)) to identify categories of cycle trajectories. conditions: Diabetes Mellitus, Type 1 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: No intervention measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle measure: Total daily Insulin dose throughout the menstrual cycle measure: Coefficient of glucose variability throughout the menstrual cycle measure: Estimated insulin sensitivity throughout the menstrual cycle measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle measure: Correlations between insulin sensitivity trajectories and confounders sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
nctId: NCT06282029 id: I-2720-0018-0003 briefTitle: ACT-group for Stroke Survivors (Pilot Study) overallStatus: RECRUITING date: 2024-02-01 date: 2024-05 date: 2024-05 date: 2024-02-28 date: 2024-02-28 name: Bielefeld University class: OTHER name: Bielefeld Young Researchers' Fund briefSummary: The goal of this clinical pilot trial is to test the feasibility, acceptance and preliminary efficacy of an adapted group psychotherapy manual in stroke survivors with psychological stress. The main questions it aims to answer are:
Participants will take part in 8 weekly group therapy sessions of 90 minutes each. conditions: Stroke conditions: Intracerebral Hemorrhage conditions: Depressive Symptoms conditions: Anxiety conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This pilot study includes a pre-/post test of a small intervention sample without control group. primaryPurpose: OTHER masking: NONE count: 12 type: ESTIMATED name: Group Therapy measure: Drop-out rate measure: Session adherence measure: Homework completion measure: Completion of outcome measures measure: Treatment fidelity measure: Group therapy session questionnaire - patients (Zoubek, 2013; Plain German) measure: Group therapy session questionnaire - therapists (Zoubek, 2013; Plain German) measure: Acceptance and Action Questionnaire-Acquired Brain Injury (Sylvester, 2011; Plain German) measure: Depression and Anxiety Stress Scales-21 (Lovibond, 1995; Plain German) measure: Valuing Questionnaire (Smout, 2014; Plain German) measure: Self-as-context scale (Zettle, 2018; Plain German) measure: Patient Health Questionnaire-9 (Kroenke, 2001; Plain German) measure: Generalized Anxiety Disorder-7 (Spitzer, 2006; Plain German) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Neuropsychological Outpatient Clinic status: RECRUITING city: Bielefeld zip: 33607 country: Germany name: Simon Ladwig, PhD role: CONTACT phone: 017664716035 email: simon.ladwig@uni-bielefeld.de lat: 52.03333 lon: 8.53333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-12 uploadDate: 2024-02-12T06:57 filename: Prot_SAP_000.pdf size: 260777 hasResults: False
nctId: NCT06282016 id: BKR-2024-001 briefTitle: Risk Factors for Neuroendocrine Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-07 date: 2025-07 date: 2024-02-28 date: 2024-03-06 name: Bavarian Cancer Registry class: OTHER_GOV name: Bavarian Association of Statutory Health Insurance Accredited Physicians briefSummary: Recent studies show an increase in neuroendocrine neoplasms, especially for the digestive tract. Previous studies suggest various risk factors that were observed for various tumor sites, e.g. a family history of cancer, tobacco and alcohol consumption as well as metabolic disorders including diabetes and obesity. A risk factor that has been little studied to date is depressive disorders, which could increase the risk of neuroendocrine neoplasms either independently or through associated risk behaviors and/or antidepressant medication. The aim of this study is to identify risk factors for neuroendocrine neoplasms based on a case-control study in order to better understand the increase of neuroendocrine neoplasms in recent decades. The study is based on a record linkage of data from the Bavarian Cancer Registry and data from the Bavarian Association of Statutory Health Insurance Accredited Physicians. While the data from the Bavarian Cancer Registry enables the identification of neuroendocrine neoplasms on the basis of histopathological findings and thus is the basis for selecting cases, the claims data from the Bavarian Association of Statutory Health Insurance Accredited Physicians provides the source population as well data on diagnoses and thus enables the investigation of risk factors. conditions: Neuroendocrine Neoplasm of Lung conditions: Neuroendocrine Neoplasm of Gastrointestinal Tract (Disorder) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 7200 type: ESTIMATED name: Case-control study (no intervention) measure: Depression/Persistent mood disorder measure: Obesity measure: Metabolic syndrome measure: Previous malignant neoplasm measure: Alcohol buse measure: Diabetes measure: Ulcerative colitis measure: Crohn disease measure: Allergic rhinitis measure: Asthma measure: Area deprivation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06281990 id: BAUN-SBF-PO-01 briefTitle: Education and Information for Bariatric Surgery Patients overallStatus: COMPLETED date: 2022-12-01 date: 2023-11-01 date: 2024-01-05 date: 2024-02-28 date: 2024-02-28 name: Balikesir University class: OTHER name: The Scientific and Technological Research Council of Turkey briefSummary: The study aimed to investigate the effect of pre-admission education given to bariatric surgery (laparoscopic sleeve gastrectomy) patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs. conditions: Bariatric Surgeries conditions: Education of Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups in the research: control and intervention groups. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The researcher (YY) provided education in the outpatient clinic. The nurses and surgical team members working in the surgical ward were blinded (FÇ in the research group was blinded). whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 68 type: ACTUAL name: Education measure: Data collection form measure: Visual Analog Scale (VAS) measure: State-Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pınar Ongün city: Balıkesir zip: 38000 country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False
nctId: NCT06281977 id: ES613 briefTitle: Study Evaluating Dexmedetomidine in the Acute Treatment of Electrical Storm acronym: SEDATE overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-03-12 date: 2027-07-01 date: 2024-02-28 date: 2024-04-08 name: Ottawa Heart Institute Research Corporation class: OTHER briefSummary: The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit. conditions: Ventricular Tachycardia conditions: Ventricular Arrhythmias conditions: Ventricular Fibrillation conditions: Recurrent Ventricular Tachycardia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 192 type: ESTIMATED name: Dexmedetomidine name: Normal saline measure: The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation. measure: All-cause in-hospital death measure: Ventricular arrhythmia requiring treatment after study drug initiation measure: Resuscitated cardiac arrest after study drug initiation measure: Renal failure requiring new initiation of renal replacement therapy after study drug initiation measure: Intubation following study drug initiation measure: Length of stay in the intensive care unit measure: Length of stay in hospital measure: Need for mechanical circulatory support device after study drug initiation measure: Ventricular Arrhythmia requiring treatment only during active study drug treatment measure: Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06281964 id: PLB1004-III-01 briefTitle: Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2026-01-30 date: 2026-12-30 date: 2024-02-28 date: 2024-02-28 name: Avistone Biotechnology Co., Ltd. class: INDUSTRY briefSummary: Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion. conditions: Non-Small-Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 327 type: ESTIMATED name: PLB1004 name: Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab measure: Progression-Free Survival (PFS) by BICR measure: Progression-Free Survival (PFS) by the investigator measure: Intracranial Overall Response Rate（ORR） measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) measure: Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies measure: intracranial Progression-Free Survival（PFS） measure: second progression-free survival (PFS2) measure: Assess the Quality of Healthy Living About Patients measure: EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs measure: Gene mutation status in plasma ctDNA before and after medication, and its correlation with clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False