hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06313697 id: GR2102-001 briefTitle: A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult overallStatus: NOT_YET_RECRUITING date: 2024-03-24 date: 2025-01-06 date: 2025-12-06 date: 2024-03-15 date: 2024-03-15 name: Genrix (Shanghai) Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。 conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: GR2102 injection name: placebo measure: Adverse events measure: Maximum Observed Serum Concentration measure: Terminal Elimination Half Life measure: anti-respiratory syncytial virus neutralizing antibodies titer levels sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affiliated Hospital of Shandong First Medical University city: Jinan state: Shandong zip: 250102 country: China name: linlin song, MD role: CONTACT phone: 18853169334 email: qylcsyllwyh@163.com lat: 36.66833 lon: 116.99722 hasResults: False
nctId: NCT06313684 id: Fondecyt 1230787 briefTitle: Comprehensive Hybrid Cardiac Rehabilitation Trial on Heart Failure acronym: COCREATIONHF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-03 date: 2024-03-15 date: 2024-03-26 name: Universidad de La Frontera class: OTHER name: University of Chile briefSummary: CO-CREATION-HF aims to evaluate the effectiveness of a comprehensive and hybrid cardiac rehabilitation model compared to supervised exercise alone. conditions: Heart Failure NYHA Class II conditions: Heart Failure NYHA Class III studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 152 type: ESTIMATED name: Comprehensive Initial Assessment name: Continuous evaluation name: Interval Exercise name: Psychosocial support name: Diet management name: Resistance exercise name: Continuous exercise name: Initial Assessment measure: Cardiorespiratory fitness measure: Functional capacity measure: Health Related Quality of Life measure: Program adherence and completion measure: Concentration of Pro-B-type Natriuretic Peptide measure: Functioning measure: Mortality and Hospital admission measure: Upper-body muscle strength measure: Lower-body muscle strength measure: Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Complejo Hospitalario San José city: Santiago country: Chile name: Manuel Galvez role: CONTACT lat: -33.45694 lon: -70.64827 facility: Hospital Clínico Universidad de Chile city: Santiago country: Chile name: Karen Rouliez role: CONTACT lat: -33.45694 lon: -70.64827 facility: Hospital San Borja Arriarán city: Santiago country: Chile name: Gonzalo Latin role: CONTACT lat: -33.45694 lon: -70.64827 facility: Universidad de La Frontera city: Temuco country: Chile name: Francisca Contreras role: CONTACT lat: -38.73965 lon: -72.59842 hasResults: False
nctId: NCT06313671 id: Perfusion Index - FR study briefTitle: Plethysmographic Perfusion Index and Fluid Responsiveness acronym: PPI-FR overallStatus: RECRUITING date: 2024-02-10 date: 2024-09 date: 2024-09 date: 2024-03-15 date: 2024-03-15 name: Avicenna Military Hospital class: OTHER briefSummary: The objective of this study is to assess the reliability of the perfusion index to predict fluid responsiveness in patients with acute circulatory failure in intensive care. conditions: Fluid Responsiveness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Perfusion index measure: Reliability and accuracy of the perfusion index to discriminate fluid-responsiveness. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Avicenna Military Hospital status: RECRUITING city: Marrakesh state: Marrakesh Tensift El Haouz zip: 40000 country: Morocco name: Younes Aissaoui, MD role: CONTACT phone: +21266140333 email: younes.aissaoui@live.fr name: Chaimae Abouelkemhe, MD role: CONTACT phone: +212694830675 email: chaimaeabouelkemhe@gmail.com lat: 31.63416 lon: -7.99994 hasResults: False
nctId: NCT06313658 id: Total BPBI briefTitle: Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-03-15 date: 2024-03-15 name: Assiut University class: OTHER briefSummary: Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. conditions: Brachial Plexus Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: Total brachial plexus exploration and reconstruction measure: Active Movement Scale (AMS) measure: Al-Qattan pronation/Supination score measure: Raimondi hand score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University Hospitals status: RECRUITING city: Assiut zip: 71526 country: Egypt name: Yousif T El-Gammal, MD role: CONTACT phone: 5023797500 email: yousif.elgammal@med.aun.edu.eg lat: 27.18096 lon: 31.18368 hasResults: False
nctId: NCT06313645 id: B83C22004880006 briefTitle: Vascular Senescence and Atherosclerotic Plaque Vulnerability acronym: VICTORIA overallStatus: RECRUITING date: 2023-07-01 date: 2025-07-01 date: 2025-12-31 date: 2024-03-15 date: 2024-03-19 name: Niguarda Hospital class: OTHER name: Istituto di Fisiologia Clinica CNR briefSummary: Chronological aging significantly contributes to structural and functional alterations in the vasculature, making it a major risk factor for atherosclerotic disease and its acute thrombotic events. DNA damage, including telomeric, non-telomeric, and mitochondrial damage, is recognized as a key initiator of vascular aging and atherogenesis. There is abundant evidence indicating the presence of oxidative DNA lesions, telomere erosion, and mitochondrial DNA damage in both experimental and human plaques, as well as in the peripheral cells of atherosclerotic patients.
It is increasingly evident that genomic instability activates signaling pathways that lead to a multitude of pathophysiological cellular and molecular changes. These changes promote inflammation, apoptosis, autophagy, and ultimately, cellular senescence, accompanied by the "senescence-associated secretory phenotype" (SASP). However, the precise mechanisms linking the DNA damage response (DDR) to senescence, SASP in vascular cells, and the pathogenesis of atherosclerosis and vulnerable atheroma are yet to be fully understood. Additional research is needed to delineate the underlying mechanisms through which mitochondrial dysfunction influences telomere length and vice versa, and how their interaction contributes to the vascular aging process. Progress in this area has the potential to uncover therapeutic targets and novel, more precise diagnostic, and prognostic indicators.
The objectives of the VICTORIA study are to examine the levels of aging-related non-coding RNA deregulation (specifically lncRNA TERRA and mitomiR) and peripheral markers of cell aging (including telomere length and mitochondrial DNA content) across the various spectra of angina pectoris (stable angina, unstable angina, NSTEMI, and STEMI). Additionally, the study aims to determine whether these markers are correlated with vulnerable plaque characteristics and major adverse cardiovascular events. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Several biomarkers measure: Telomere length measure: Mitochondrial DNA copy number (mtDNAcn) measure: MitomiR measure: Long non-coding (lnc) RNA TERRA measure: pro-oxidant cytokines sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST GOM Niguarda status: RECRUITING city: Milano state: Lombardia zip: 20162 country: Italy name: Jonica Campolo, MSc role: CONTACT phone: +39026444 phoneExt: 5578 email: jonica.campolo@ospedaleniguarda.it name: Emanuela Piccaluga, MD role: CONTACT phone: +39026444 phoneExt: 2308 email: emanuela.piccaluga@ospedaleniguarda.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06313632 id: STUDY-23-01105 briefTitle: Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy overallStatus: RECRUITING date: 2024-03-13 date: 2025-03 date: 2025-03 date: 2024-03-15 date: 2024-03-20 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone. conditions: Pleural Disease conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple blind study whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Bupivacaine injection name: Placebo name: Monitored Anesthesia Care measure: Visual Analog Scale (VAS) for Pain measure: Change in the Numerical Rating Scale measure: Type of Analgesic use measure: Number of Analgesic use measure: Dosage of Analgesic use measure: Quality of Recovery-15 (QoR-15) Survey Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai West Hospital status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Udit Chaddha, MBBS role: CONTACT phone: 212-824-8546 email: udit.chaddha@mssm.edu name: Udit Chaddha role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
nctId: NCT06313619 id: BSMMU/20236831 briefTitle: Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program overallStatus: RECRUITING date: 2023-10-23 date: 2024-03-31 date: 2024-03-31 date: 2024-03-15 date: 2024-03-15 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: The misuse, irrational, or overuse of antibiotics, antibiotic/antimicrobial resistance (AMR) is a global threat to human health. Even though the awareness of the potential threat from AMR is widespread, studies and monitoring programs describing the present situation are lacking. The presence of a 'pluralistic' health system and a large informal sector involving unqualified drug dispenser/providers/practitioners in Bangladesh is a matter of grave concern for the rising antimicrobial resistance situation in the country. An estimated 63% of antibiotic prescriptions are from unqualified providers. Besides, misconception about antibiotics is very common in Bangladesh. Meanwhile, the use of antibiotics in animal food production with insufficient veterinary supervision for therapeutic purposes which poses the risk of antimicrobial resistance transmission in the food chain. Without adherence to national regulations, unnecessary and inappropriate prescriptions become common practice, particularly in rural areas. Domestic drug industries contribute to easily accessible and affordable drugs. To tackle this problem, prescriptions and sales of antibiotics need to be regulated and integrated in a national HMIS. Awareness programs for antibiotic providers that promote understanding of antibiotics and antibiotic resistance through tailored interventions may be helpful in changing current antibiotic sales practices. Therefore, this study will attempt to identify the underlying causes of irrational anti-microbial usage in Bangladesh, which were grouped into four interlinked areas - lack of awareness among patients/ consumers (demand side), perverse incentives and lack of knowledge among providers (supply side), poorly regulated pharmaceutical marketing and retail sales (regulatory side) and lack of data and research evidence to support awareness raising and policymaking (enabler).
A before-after designed quasi experimental study will be conducted in urban areas. Data will be collected in both qualitative and quantitative methods. Multi-cluster sampling method will be used to select study locations. Pharmacists or drug sellers and patients aged more than 18 years and located within selected intervention areas will be our target population. A baseline survey will be conducted among the pharmacy volunteers to evaluate their knowledge, perception, and practice of rational use of anti-microbials prior to any intervention. Additionally, a household survey will be conducted among community members applying systematic random sampling where one adult from every selected household will be approached maintaining gender equality. After collecting the baseline data, intervention will be given to the community people through awareness building campaign and distributing leaflets and posters on rational use of anti-microbials. After three months, a follow-up survey will be conducted among the same participants with the same questionnaire. For quantitative portion of the study, all the medicine shops in the selected study areas will be included in the study sample alongside a total of anticipated 6240 community dwellers. For qualitative part, the sample will be selected purposively until data saturation and a total of 20 experts will be interviewed. Two sets of questionnaires for pharmacy volunteers and the community dwellers will be prepared based on literature review that will include health literacy questions regarding anti-microbial use. The questionnaire for the follow-up data collection will include some additional questions regarding acceptability, adoption, feasibility, and cost of the intervention.
The study is expected to bring light upon a comprehensive understanding of the current level of knowledge, perception and practice of irrational use of anti-microbials among target population. Furthermore, a digital intervention design will be produced to reduce irrational use of anti-microbials after considering its effectiveness. The wide range of the study findings will aid in assessing the acceptability, adoption, feasibility and cost of the intervention to make recommendations on sustainability and scaling up of the intervention programs. conditions: Resistance Bacterial conditions: Increased Drug Resistance conditions: Drug Resistance, Microbial studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 39 type: ESTIMATED name: SmartAMR measure: Irrational usage of anti-microbials measure: Acceptance rate measure: Completion rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicine Shop status: RECRUITING city: Dhaka zip: 1212 country: Bangladesh name: Abid Hasan Khan, MPH role: CONTACT phone: +8801308634347 email: ahkriaz.ju@gmail.com lat: 23.7104 lon: 90.40744 hasResults: False
nctId: NCT06313606 id: 2047436 briefTitle: Sparking Gut Bacteria Production of Bioactive Xenolipids in Situ overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-31 date: 2024-05-31 date: 2024-03-15 date: 2024-03-26 name: University of California, Davis class: OTHER briefSummary: Long-chain cyclopropane fatty acids (CpFAs) are microbially-derived lipids (fats), some of which can be found in select foods and appear to be produced naturally in the gut from dietary fatty acid precursors. Some of these lipids appear to have signaling properties in the body's tissues, i.e., to help regulate cardiometabolic health. Thus, increasing the bioavailability of CpFAs in humans may have utility to improve management of blood sugar and blood lipids, or to mitigate or prevent non-alcoholic fatty liver disease (NAFLD). This study is a proof-of-principle experiment in 10 subjects, to feed dietary fats thought to enhance upper gut CpFA production. The latter will be monitored through post-meal blood and urine CpFA concentration measurements, as well as concentration in the stool. conditions: Dietary Fat Metabolism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Dietary fat positive control name: Dietary fat negative control measure: Cyclopropane fatty acid metabolite concentrations in blood, urine, and stool sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of California, Davis School of Medicine city: Sacramento state: California zip: 95817 country: United States name: Sean H. Adams, PhD role: CONTACT phone: 916-734-4868 email: shadams@ucdavis.edu lat: 38.58157 lon: -121.4944 hasResults: False
nctId: NCT06313593 id: INCB160058-101 briefTitle: A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms overallStatus: NOT_YET_RECRUITING date: 2024-06-14 date: 2027-06-06 date: 2027-09-04 date: 2024-03-15 date: 2024-03-15 name: Incyte Corporation class: INDUSTRY briefSummary: This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms. conditions: Myeloproliferative Neoplasms studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: INCB160058 measure: Number of participants with Dose Limiting Toxicities (DLTs) measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Number of participants with TEAEs leading to dose modification or discontinuation measure: INCB160058 pharmacokinetic (PK) in Plasma measure: Response using the revised IWG-MRT and ELN response criteria for MF measure: Percentage of participants achieving spleen volume reduction as defined in the protocol measure: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS) measure: Participants with MF with symptomatic anemia: Anemia Response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06313580 id: 22-1055 briefTitle: Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile overallStatus: RECRUITING date: 2023-01-01 date: 2024-12 date: 2025-06 date: 2024-03-15 date: 2024-03-20 name: University of Alabama, Tuscaloosa class: OTHER name: McCormick Science Institute briefSummary: Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites. conditions: Cardiometabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: In a single blind crossover design, participants are randomized to 4 weeks of yogurt intake twice daily with or without added spices with a two-week washout period between study arms. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded. whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Yogurt with added Spices name: Yogurt without added Spices measure: Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate measure: Concentration of serum leptin measure: Concentration of serum ghrelin (pg/mL) measure: Concentration of serum peptide tyrosine tyrosine (PYY) sex: FEMALE minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Alabama status: RECRUITING city: Tuscaloosa state: Alabama zip: 35487 country: United States name: Kristi M. Crowe-White, PhD, RD role: CONTACT phone: 205-348-6173 email: kcrowe@ches.ua.edu lat: 33.20984 lon: -87.56917 hasResults: False
nctId: NCT06313567 id: Meca-GC briefTitle: Metronomic Capecitabine in Stage III Gastric Cancer overallStatus: RECRUITING date: 2024-03-10 date: 2029-03-10 date: 2029-03-10 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: The purpose of this study is to find out whether treatment with metronomic capecitabine will improve the survival of gastric cancer patients with stage III who had received standard treatment. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 722 type: ESTIMATED name: Metronomic capecitabine name: Observation measure: Disease-free survival measure: Overall survival measure: Side effects sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai zip: 200000 country: China name: Dazhi Xu, MD,PHD role: CONTACT phone: 021-64175590 email: xudzh@shca.org.cn lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06313554 id: HMPL-012-SH-ICC101 briefTitle: Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-05-20 date: 2027-05-20 date: 2024-03-15 date: 2024-03-15 name: Fudan University class: OTHER briefSummary: This study is a single-arm, open-arm, single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma.
The study was divided into three stages: screening period, treatment period and follow-up period. During the treatment period, the tumor status was evaluated by imaging every 6 weeks (±7 days), and the efficacy was changed to every 8 weeks (±7 days) after 12 weeks until the disease progressed (RECIST 1.1) or death (during the treatment of the patient) or toxicity became intolerable. The tumor treatment status and survival status after the disease progression were recorded. Safety outcome measures included AE, changes in laboratory test values, vital signs and electrocardiogram changes. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 63 type: ESTIMATED name: Surufatinib、Toripalimab、Gemcitabine、Oxaliplatin measure: ORR objective response rate measure: Progression-Free Survival(PFS) measure: OS overall survival measure: DCR disease control rate measure: Adverse events as assessed by NCI CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False