hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06308991 id: IDU-SBF-SD-01 briefTitle: Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration overallStatus: COMPLETED date: 2022-07-01 date: 2023-06-01 date: 2023-06-01 date: 2024-03-13 date: 2024-03-13 name: Izmir Democracy University class: OTHER briefSummary: The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants. conditions: Endotracheal Aspiration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The order of the 2 different touching methods and routine care practices to be applied to the infants in the research group was determined by randomized method and 3 groups were created. Considering the order of application in each group, it was decided which touch method and routine care would be applied to the infants. Both touch techniques and routine care practices were applied once to each infant.
Group 1: Yakson touch, Routine care, Gentle HumanTouch Group 2: Routine care, Gentle HumanTouch, Yakson touch Group 3: Gentle HumanTouch, Yakson touch, Routine care primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Yakson touch name: Gentle Human Touch name: Routine care measure: Neonatal Pain Agitation and Sedation Scale (N-PASS) measure: Change in Oxygen saturation measure: Change in Heart rate measure: COMFORTneo Scale sex: ALL minimumAge: 26 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: Izmir Democracy University city: Karabağlar state: Izmir zip: 35140 country: Turkey lat: 38.37396 lon: 27.1352 hasResults: False
nctId: NCT06308978 id: FT819-102 briefTitle: FT819 in Moderate to Severe Active Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-02-24 date: 2027-09-30 date: 2042-09-30 date: 2024-03-13 date: 2024-03-13 name: Fate Therapeutics class: INDUSTRY briefSummary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: FT819 name: Fludarabine name: Cyclophosphamide name: Bendamustine measure: Number of participants with treatment-emergent adverse events (TEAEs) measure: Number of participants with serious TEAEs measure: Number of participants with adverse events of special interest (AESI) measure: Number of participants with TEAEs by severity measure: Number of participants with dose-limiting toxicities (DLTs) measure: Recommend Phase 2 dose (RP2D) of FT819 measure: Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time measure: Percentage of participants achieving DORIS clinical remission over time measure: Percentage of participants achieving lupus low disease activity state (LLDS) over time measure: Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time measure: Change in Physician Global Assessment (PGA) over time measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time measure: Change in estimated glomerular filtration rate (eGFR) over time measure: Change in urine creatinine over time measure: Change in urine protein over time measure: Change in protein to creatinine ratio over time measure: Concomitant lupus therapies prior to and following study intervention measure: Plasma concentration of FT819 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical School status: RECRUITING city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: University of Nebraska Medical Center status: RECRUITING city: Omaha state: Nebraska zip: 68198 country: United States lat: 41.25626 lon: -95.94043 hasResults: False
nctId: NCT06308965 id: Z-2023088 briefTitle: Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome? acronym: USP overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2027-03 date: 2024-03-13 date: 2024-03-13 name: Ziekenhuis Oost-Limburg class: OTHER briefSummary: During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.
The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower. conditions: Tensor Fasciae Latae Syndrome conditions: Arthroplasty Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This is a monocentric prospective randomized blinded clinical trial during a period of minimal 3 years or until 150% of sample size is included (100 patients). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be blinded and randomized into two cohorts. The selection and randomization protocol is as follows: participants eligible for the study are requested to participate and informed by the study nurse. If the patient agreed to participate, informed consent is obtained, and the patient is included in the study. At that time, the study nurse uses a mobile randomization application (Random, Dublin, Ireland) to allocate them either to the 'standard' (sacrificing the vessels) or 'vessel sparing' DAA.
Surgery will be performed by the surgeon. Data collection before and after surgery is collected by personal assistant who is unaware of group assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Vessel technique measure: a) Incidence of TFL tendinopathy measure: b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) measure: b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) measure: b-3) Patient-reported outcome 3: Forgotten Joint Score measure: b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). measure: c) Component placement (x-rays) measure: Vessel sparing succesfull sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuis Oost-Limburg city: Genk state: Limburg zip: 3600 country: Belgium name: Frans-Jozef Vandeputte, M.D. role: CONTACT lat: 50.965 lon: 5.50082 hasResults: False
nctId: NCT06308952 id: 2024SL0006 briefTitle: Effectiveness of Atorvastatin in Preventing Cerebrovascular Events After Flow Diverter Implantation overallStatus: NOT_YET_RECRUITING date: 2024-03-05 date: 2027-03-31 date: 2027-07-31 date: 2024-03-13 date: 2024-03-13 name: Zhujiang Hospital class: OTHER briefSummary: In recent years, with the development of medical technology and materials and instruments, flow diverter (FD) has gradually become the most important treatment method for the treatment of intracranial aneurysms (IA). It is a revolutionary treatment method, which has changed the concept of endovascular treatment of IA, and turned the previous endovascular embolization to the reconstruction of the parent artery.
At present, FD has been used in more than 250,000 cases worldwide, and the overall 1-year complete occlusion rate of aneurysms can reach 75%-85.5%. However, although the current imaging prognosis of FD is encouraging, the perioperative complications of FD are as high as 12.9%, including ischemic complications, SAH, and parenchymal hemorrhage in 7.3%, 2.0%, and 2.0%, respectively. The postoperative mortality was 1.5%, of which 1.3% were caused by delayed aneurysm rupture, distal parenchymal hemorrhage and PED-related nerve compression symptoms. In addition, an in-stent stenosis of more than 50% within one year has been reported in 10.2 to 15.0% of patients. However, in addition to conventional dual antibody therapy, there is no relevant guideline recommendation or clinical evidence on how to prevent complications after FD implantation in IA patients.
Atorvastatin is widely used in the primary and secondary prevention of cardiovascular and cerebrovascular diseases. Its main effect is to improve the incidence of cardiovascular and cerebrovascular events by reducing blood lipids. Although the mechanism of clinical benefit of lipid-lowering by atorvastatin is not completely clear, a large number of clinical evidence has shown that atorvastatin can also reverse atherosclerosis, stabilize plate, reduce inflammation, reverse vascular endothelial dysfunction and reduce microthrombosis. It can reduce the incidence of cardiovascular and cerebrovascular events in patients with coronary heart disease and internal carotid artery stenosis after stent implantation in different degrees.
However, there is no high-quality clinical evidence for the use of atorvastatin in intracranial aneurysm stent implantation. Previous retrospective studies have shown that atorvastatin is the only protective factor for in-stent restenosis after flow diverter implantation in intracranial aneurysms. In a retrospective observational study involving 273 patients empirically treated with atorvastatin for unruptured IA in our center, the median follow-up period was 7.6 months. The incidence of cerebrovascular events was 3.27%, and the incidence of more than 50% in-stent stenosis was 8.4%, which was significantly lower than the incidence of related events reported at home and abroad.
Therefore, this study planned to conduct a randomized controlled clinical trial to confirm the efficacy and safety of oral atorvastatin in the prevention of cerebrovascular adverse events after stent implantation in patients with unruptured intracranial aneurysms, and to provide objective evidence for the treatment decision of patients with unruptured intracranial aneurysms to prevent cerebrovascular adverse events after flow diverter implantation. conditions: Efficacy Endpoint: no New Cerebrovascular Adverse Events Within 1 Year conditions: Safety Endpoint: no New Moderate or Serious Adverse Events Within 1 Year conditions: All-cause Mortality Events (Within 1 Year) conditions: Incident Ischemic Stroke Events (Within 1 Year) conditions: New Hemorrhagic Stroke Events (Within 1 Year) conditions: New Stent Thrombosis Events (Within 1 Year) conditions: New Symptomatic Stenosis Events (Within 1 Year) conditions: Occurrence of In-stent Stenosis 12th ±1 Month Annual Angiographic Follow-up conditions: Degree of In-stent Stenosis (as Measured by WASID Method) at the 12th ±1 Month Annual Angiographic Follow-up conditions: Target Aneurysm Embolization Rate at 12±1 Month Annual Angiographic Follow-up (Raymond and OKM Classification) studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 386 type: ESTIMATED name: Atorvastatin 20mg measure: Efficacy endpoint: no new cerebrovascular adverse events within 1 year measure: Safety endpoint: no new moderate or serious adverse events within 1 year sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06308939 id: IRB-2024-198 briefTitle: Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2026-08-31 date: 2024-03-13 date: 2024-03-13 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: Eribulin name: Sintilimab measure: Objective Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Clinical Benefit Rate (CBR) measure: Duration of Overall Response(DoR) measure: Time to response (TTR) measure: Overall survival (OS) measure: adverse event(AE) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: zhejiangCH city: Hangzhou state: Zhejiang zip: 310000 country: China name: Ying Xi Shao, doctor role: CONTACT phone: 15824113524 email: 15824113524@163.com name: Jia Xiao Wang, doctor role: CONTACT name: Jia Xiao Wang, doctor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False
nctId: NCT06308926 id: MRG23ARDS briefTitle: MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients acronym: SUMMIT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-02-01 date: 2026-07-01 date: 2024-03-13 date: 2024-03-13 name: MedRegen LLC class: INDUSTRY name: Vanderbilt University Medical Center briefSummary: This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.
The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges. conditions: Acute Respiratory Distress Syndrome conditions: Respiratory Failure conditions: Respiratory Distress Syndrome conditions: Respiratory Tract Diseases conditions: Cytokine Storm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MRG-001 (Low-dose) name: MRG-001 (High-dose) name: Placebo measure: Hemopoietic stem cell mobilization measure: Organ Failure measure: Pharmacokinetics measure: Pharmacokinetics measure: Pharmacodynamics measure: Cytokine Changes measure: Respiratory-Free Days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06308913 id: 2023-1722 id: UW23121 type: OTHER domain: UWCCC id: A534260 type: OTHER domain: UW Madison id: Protocol Version 2/15/2024 type: OTHER domain: UW Madison id: P50DE026787 type: NIH link: https://reporter.nih.gov/quickSearch/P50DE026787 id: P50CA278595-07 type: NIH link: https://reporter.nih.gov/quickSearch/P50CA278595-07 briefTitle: Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2026-08 date: 2024-03-13 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER name: National Institute of Dental and Craniofacial Research (NIDCR) name: National Cancer Institute (NCI) briefSummary: This study is evaluating INCB081776 when given in combination with the checkpoint inhibitor pembrolizumab and palliative radiation therapy in patients with metastatic or recurrent metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). 12 participants will be enrolled and can expect to be on study for up to 12 months. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: INCB081776 name: Pembrolizumab name: Palliative RT measure: Incidence of Adverse Events (AEs) measure: Duration of Adverse Events measure: Severity of Adverse Events measure: Overall response rate (ORR) measure: Disease control rate (DCR) measure: Duration of response (DoR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Carbone Cancer Center city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 hasResults: False
nctId: NCT06308900 id: CL_SIMULATION_01 briefTitle: Non-technical Skills of Clinical Simulation in Physiotherapy Students overallStatus: RECRUITING date: 2024-02-26 date: 2024-03-31 date: 2024-04-30 date: 2024-03-13 date: 2024-03-15 name: University of Valencia class: OTHER briefSummary: Clinical simulation has gained great importance in recent times in health sciences. Since it is a pedagogical strategy that is being used more and more in health degrees and is very useful for the acquisition of both technical and non-technical skills.
For all this, and for the situation of need generated in recent years, in which internships in hospitals and clinical centers were completely abolished, the need for our research is justified, which will allow the acquisition of non-technical skills among novice students. in physiotherapy, without the need for contact with real patients. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Clinical simulation measure: Ottawa Scale sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: David Hernández-Guillén status: RECRUITING city: Valencia zip: 46010 country: Spain name: David Hernández-Guillén, PT, PhD role: CONTACT phone: +34644217578 phoneExt: 51232 email: david.hernandez@uv.es lat: 39.46975 lon: -0.37739 hasResults: False
nctId: NCT06308887 id: 01 briefTitle: Comparison of Ultrasound-Guided Perimeniscal Steroid and 5% Dextrose Injections in Knee Osteoarthritis overallStatus: COMPLETED date: 2023-10-02 date: 2024-02-02 date: 2024-03-02 date: 2024-03-13 date: 2024-03-13 name: Kastamonu University class: OTHER briefSummary: Introduction: The primary goal of treating knee osteoarthritis is to reduce pain and improve the patient's quality of life. Medial meniscal extrusion is a condition that is linked to pain and disability in knee osteoarthritis and can be identified through ultrasound. For patients with medial meniscal extrusion, perimeniscal corticosteroid injection has been shown to be a helpful addition to primary treatment for moderate to severe pain relief. Dextrose prolotherapy has also been found to provide periarticular benefits for knee osteoarthritis. This study aims to compare the effectiveness of ultrasound-guided perimeniscal corticosteroid and perimeniscal dextrose injections in patients with osteoarthritis, medial knee pain, and medial meniscal extrusion.
Method: Patients with medial knee pain and meniscal extrusion were randomly divided into two groups using the double-block randomization method. Group 1 included 15 patients who were administered an ultrasound-guided perimeniscal steroid injection, while Group 2 included 16 patients who were administered an ultrasound-guided perimeniscal dextrose injection. The patients' pain levels were evaluated using the Visual Analog Pain Scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before and one week, one month, and three months after the injection. conditions: Gonarthrosis conditions: Meniscus; Degeneration conditions: Pain, Chronic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 31 type: ACTUAL name: Triamcinolone Hexacetonide name: Dextrose 5% in water measure: Visual Analogue Scale measure: Western Ontario and McMaster University Osteoarthritis Index sex: ALL minimumAge: 40 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gamze Gül Güleç city: Kastamonu zip: 37150 country: Turkey lat: 41.37805 lon: 33.77528 hasResults: False
nctId: NCT06308874 id: JH-222-101 briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PD of J2H-1702 in Healthy Females overallStatus: COMPLETED date: 2023-01-02 date: 2023-02-17 date: 2023-02-17 date: 2024-03-13 date: 2024-03-13 name: J2H Biotech class: INDUSTRY briefSummary: - Objectives: Primary objective_To evaluate the safety and tolerability after single oral administration of the investigational product (IP), J2H-1702 in healthy female subjects. Secondary objective_To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics after single oral administration of the IP, J2H-1702 in healthy female subjects. conditions: Non-alcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 16 type: ACTUAL name: Amg dose administration group name: Amg dose administration group- Placebo name: Bmg dose administration group name: Bmg dose administration group- Placebo measure: Cmax measure: Emax sex: FEMALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: J2H Biotech city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of lat: 37.29111 lon: 127.00889 hasResults: False
nctId: NCT06308861 id: JH-201-101 briefTitle: Phase 1 Study to Investigate Safety, Tolerability, PK/PK of J2H-1702 in Healthy Males overallStatus: COMPLETED date: 2020-08-12 date: 2021-06-25 date: 2021-07-13 date: 2024-03-13 date: 2024-03-13 name: J2H Biotech class: INDUSTRY briefSummary: 1. Research Purpose: To evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic properties of J2H-1702 (a candidate for treatment of non-alcoholic steatohepatitis) in healthy men.