hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06266143 id: Y101D03 briefTitle: A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-08 date: 2024-07-30 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients. conditions: Advanced Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 71 type: ACTUAL name: Y101D measure: Dose Limiting Toxicities (DLTs) measure: RP2D measure: Objective Response Rate (ORR) measure: Peak Serum Concentration (Cmax) measure: Trough Serum Concentration (Ctrough) measure: Area under the serum concentration versus time curve (AUC) during one treatment cycle (21 days) measure: The TGF-β concentration in serum measure: The CA19-9 concentration in serum measure: The positive rate of Anti-Drug Antibody (ADA) and Neutralizing antibody (Nab) measure: Disease control rate (DCR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 hasResults: False
nctId: NCT06266130 id: EM-11-050087 briefTitle: Digital Bonding vs. Direct Bonding Study overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: 3M class: INDUSTRY briefSummary: This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets. conditions: Orthodontic Brackets studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are two groups, treatment group (digital bonding) and control group (direct bonding). Subjects will be enrolled and randomized into treatment or control group at each orthodontic practice. primaryPurpose: OTHER masking: NONE maskingDescription: Due to the nature of the devices, Investigator blinding is not feasible for the study. count: 178 type: ESTIMATED name: Treatment Group Digital Bonding Tray name: Control Group Direct Bonding measure: Prep-and-bonding time measure: Number of adjustment visits to complete treatment measure: Overall chair time sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06266117 id: SBF-HMS-GES-03 briefTitle: Pain, Anxiety, and Comfort Levels in Coronary Angiography overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-03-30 date: 2024-07-30 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit. conditions: Pain conditions: Anxiety conditions: Nursing Caries studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 216 type: ESTIMATED measure: Pain level measure: Anxiety measure: Comfort sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Abant Izzet Baysal University Faculty of Health Science city: Bolu state: Merkez zip: 14100 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False
nctId: NCT06266104 id: Protocol V1.4_04012024 briefTitle: Image Enhanced Endoscopy IBD overallStatus: RECRUITING date: 2024-04-03 date: 2025-12-31 date: 2026-03-01 date: 2024-02-20 date: 2024-04-12 name: Royal Perth Hospital class: OTHER briefSummary: Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future. conditions: Inflammatory Bowel Diseases conditions: Dysplasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: INVESTIGATOR count: 270 type: ESTIMATED name: Image Enhanced Endoscopy Filters measure: Dysplasia Detection Rate measure: Withdrawal times measure: Characterisation of lesions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Perth Hosptial status: RECRUITING city: Perth state: Western Australia zip: 6000 country: Australia name: Sherman Picardo, MBBS role: CONTACT phone: 92242244 lat: -31.95224 lon: 115.8614 hasResults: False
nctId: NCT06266091 id: M70102 briefTitle: Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody overallStatus: ACTIVE_NOT_RECRUITING date: 2021-11-24 date: 2024-03-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Wuhan YZY Biopharma Co., Ltd. class: INDUSTRY briefSummary: A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy. conditions: Malignant Ascites studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: M701 name: paracentesis measure: Puncture-free survival, PuFS measure: objective response rate (ORR) of malignant ascites measure: Progression-free Survival, PFS measure: Overall survival, OS measure: Quality of Life, QoL measure: Safety profiles measure: Positive rate of ADA and Nab in serum measure: The EpCAM expression in ascites measure: Trough serum concentration (Ctrough) measure: Peak serum concentration (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100141 country: China lat: 39.9075 lon: 116.39723 hasResults: False
nctId: NCT06266078 id: School of Nursing briefTitle: A Human Factors Simulation Study Protocol for the Assessment of Usability of Innovative Personal Protective Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-12-15 date: 2024-02-20 date: 2024-02-20 name: University of Campinas, Brazil class: OTHER briefSummary: Background: Many factors influence Personal Protective Equipment (PPE) compliance for use in health care, specifically the PPE usability and related human factors. It is known that issues related to the usability of new technologies, including professional behavioral and attitudinal patterns, the technologies adoption within the workflow and teamwork strengths can be investigated by using Simulation-Based Research (SBR) before its implemented. This study aims to develop and validate a simulation protocol for the assessment of human factors and usability of innovative PPEs used in critical care units. The ultimate goals is to define a standard method for PPEs assessment and comparison worldwide. Method: methodological study with a quantitative approach to be carried out in two phases: a) development and validation by experts of a simulation protocol; b) piloting of the simulation protocol. For the protocol validation phase, 14 experts with experience in the themes of infection prevention and control or clinical simulation will be included. The experts will be invited via email and will assess the simulation protocol content using the criteria of pertinence, clarity and relevance. To ensure that the simulation protocol is feasible and reliable, a piloting phase will take place at the simulation center in São Paulo and 36 health professionals with work experience in critical care units will be included. The health professionals will perform specific tasks assigned to them, wearing pre-defined PPEs in each simulation round. Errors and difficulties during PPE assembly, donning and doffing; performance of individual and team activities, as well as communication problems and self-contamination risk, will be observed during the tasks. At the end of the simulation round, the participants will take part in a debriefing, where they will answer questionnaires about comfort, perception of safety, thermal sensations, usability and perceived workload related to the PPE used. Content validity index (CVI) and intraclass correlation coefficient (ICC) will be calculated. This study protocol was approved by the Research Ethics Committee of the School of Nursing, University of São Paulo. The informed consent form will be applied both to the experts and to the health care workers. conditions: Personal Protective Equipment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Firstly, a minimum of 14 experts will validate the content, using the Delphi technique of two tools (A) The innovative PPE assessment tool; and B) the simulation scenario script.
For the purpose of the development and piloting of this simulation protocol, the innovative PPE were selected according to compliance with the specifications required by the World Health Organization. It will enrolled 36 healthcare workers in piloting test. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 9 type: ESTIMATED name: Innovative PPE name: Traditional PPE measure: Content Validity of the items included in the "Innovative PPE assessment tool" and in the "Simulation scenario script" measure: Errors during PPE assembly/preparation, donning and doffing measure: Communication impairments while using PPE measure: Self-contamination risk in the professional while using and doffing the PPE measure: Influence of PPE on individual performance measure: Influence of PPE on team performance and behavioral changes measure: Changes in mobility and comfort while using PPE measure: Thermal sensations measure: Perception regarding safety and satisfaction of the PPE user measure: Perceived workload measure: Usability measure: Complementary Content Analysis - qualitative data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06266065 id: 8.1-23/260-2;02/013AG briefTitle: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia overallStatus: RECRUITING date: 2024-02-27 date: 2026-06 date: 2026-06 date: 2024-02-20 date: 2024-03-06 name: Clinical Hospital Centre Zagreb class: OTHER briefSummary: The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).
The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia. conditions: Coronary Artery Disease conditions: Angina Pectoris studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-Center Prospective Study primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Coronary Sinus Reducer measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation measure: Myocardial Ischemia assessment measure: Angina assessment measure: Functional capacity assessment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Centre Zagreb status: RECRUITING city: Zagreb zip: 10000 country: Croatia name: Josko Bulum, MD, PhD role: CONTACT phone: +385981714090 email: jbulum@gmail.com name: Luka Percin, MD role: CONTACT phone: +385917917252 email: luka.percin555@gmail.com lat: 45.81444 lon: 15.97798 hasResults: False
nctId: NCT06266052 id: 2019/04 briefTitle: Evaluation of the Effects of Four Different Flap Designs on Tissue Healing in Lower Third Molar Surgery overallStatus: ENROLLING_BY_INVITATION date: 2024-01-20 date: 2024-03-20 date: 2024-04-20 date: 2024-02-20 date: 2024-02-20 name: Recep Tayyip Erdogan University class: OTHER briefSummary: The aim of this study is to prospectively evaluate the effectiveness of 4 different flap types used during mandibular impacted wisdom teeth surgery on postoperative quality of life, soft tissue and hard tissue healing at the end of the 3rd month. conditions: Soft Tissue Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Triangular Flap name: Berwick Flap name: Saurez Flap name: Heitz Flap measure: Eudema Amount measure: Pain Level measure: Trismus Level measure: Halitosis Amount measure: bone healing condition sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: RTEU Faculty of Dentistry city: Rize country: Turkey lat: 41.02083 lon: 40.52194 hasResults: False
nctId: NCT06266039 id: 2022-0328-01 id: 2022-A02616-37 type: OTHER domain: French National Agency for the Safety of Medicines (ANSM) briefTitle: Introduction of Long Acting Buprenorphine in France acronym: OBAP overallStatus: RECRUITING date: 2023-03-31 date: 2024-09-30 date: 2024-09-30 date: 2024-02-20 date: 2024-02-20 name: University of Bordeaux class: OTHER briefSummary: The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.
The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbidities
2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline. conditions: Addiction Opiate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 223 type: ESTIMATED measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation measure: The change in addiction severity at 6 months after treatment initiation measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation measure: The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation measure: The change in other use at 6 months after treatment initiation measure: The change in craving at 6 months after treatment initiation measure: The change in other domains of addiction severity at 6 months after treatment initiation measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bordeaux status: RECRUITING city: Bordeaux state: Gironde zip: 33000 country: France name: Marc Auriacombe, Professor role: CONTACT phone: +33556561738 email: marc.auriacombe@u-bordeaux.fr lat: 44.84044 lon: -0.5805 hasResults: False
nctId: NCT06266026 id: ThermoBreast briefTitle: ThermoBreast - Non-contact Breast Cancer Imaging Using AI-enhanced Thermography. acronym: ThermoBreast overallStatus: RECRUITING date: 2023-12-11 date: 2028-12 date: 2029-12 date: 2024-02-20 date: 2024-02-20 name: ThermoMind Ltd. class: INDUSTRY name: Assuta Medical Centers Ltd. name: Hospital of Lithuanian University of Health Sciences Kaunas Clinics name: Institut Gustav Roussy name: M.D. Anderson Cancer Center name: Sheba Medical Center name: The Holy Family Hospital Nazareth name: University College Cork name: Univerzitetni klinicni center Maribor name: Academisch Ziekenhuis Groningen name: Technical University of Munich name: Technion, Israel Institute of Technology name: Vrije Universiteit Brussel name: Cancer Patients Europe name: University Hospital Heidelberg briefSummary: Breast cancer is one of the most worrisome health concerns facing women. Early detection and active patient monitoring are crucial to survival. The chances of a cure are high when detected and treated in the early stages. Standard breast cancer diagnostic methods such as mammography, ultrasound, and MRI have limitations such as ionizing radiation, high false-positive rates, and/or high expenses.
Medical Thermography might overcome these limitations: It is a non-invasive , adjunctive physiologic imaging technology that uses a high-resolution infrared camera and computer processing to produce an image (thermogram) of a patient's skin surface temperatures. It is a non-contact screening method, which does not involve radiation exposure or invasive procedures, and is safe for both the patient and the trained personnel performing the screening. While mammography and ultrasound depend primarily on structural and anatomical variation of the tumor from the surrounding breast tissue, thermography detects pathophysiological changes within the breast such as metabolic and vascular changes caused by cancer. The heat transfer in the body is conducted by the circulatory system; hence, pathologies identified by thermography are generally associated with changes in blood perfusion.