hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06388239, orgStudyIdInfo id: BE24-006, briefTitle: Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-26, primaryCompletionDateStruct date: 2024-09-14, completionDateStruct date: 2024-09-23, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Apixaban 5MG, interventions name: ELIQUIS, outcomesModule primaryOutcomes measure: Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Apixaban, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388226, orgStudyIdInfo id: IRB # 16143, briefTitle: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Purdue University, descriptionModule briefSummary: The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Leg heat therapy, interventions name: Leg sham therapy, outcomesModule primaryOutcomes measure: Change in time to exhaustion during treadmill exercise, secondaryOutcomes measure: Change in maximal pulmonary oxygen uptake during treadmill exercise, secondaryOutcomes measure: Change in triceps surae microvascular oxygenation during treadmill exercise, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, secondaryOutcomes measure: Change in triceps surae microvascular oxygenation during reactive hyperemia, secondaryOutcomes measure: Change in triceps surae volume, secondaryOutcomes measure: Change in triceps surae intramuscular fat content, secondaryOutcomes measure: Change in the time constant for phosphocreatine recovery after dynamic exercise, secondaryOutcomes measure: Change in maximal plantar flexor strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388174, orgStudyIdInfo id: S2022-0336, briefTitle: Idiopathic Generalized Epilepsy Syndromes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis., conditionsModule conditions: Epilepsy, conditions: Epilepsy, Idiopathic Generalized, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: The proportion of drug-resistent epilepsy, primaryOutcomes measure: The proportion of seizure freedom, secondaryOutcomes measure: The proportion of psychiatric comorbidity, secondaryOutcomes measure: The proportion of psychosocial outcome, secondaryOutcomes measure: The proportion of seizure relapse after antiseizure medication withdrawn, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Chunhong Shen, role: CONTACT, phone: +86 0571 87783872, email: shen_neurology@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06388161, orgStudyIdInfo id: Yan2022-0336, briefTitle: Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Sir Run Run Shaw Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Shaoxing People's Hospital, descriptionModule briefSummary: Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage.It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing., conditionsModule conditions: Epilepsy, conditions: Encephalitis Autoimmune, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Detectable serum neural autoantibodies, primaryOutcomes measure: Neuronal surface antibodies-mediated autoimmune- encephalitis, secondaryOutcomes measure: The proportion of seizure freedom, secondaryOutcomes measure: The proportion of drug-resistent epilepsy, secondaryOutcomes measure: Clinical severity and recovery, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Chun-Hong Shen, role: CONTACT, phone: +86 0571 87783872, email: shen_neurology@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06388148, orgStudyIdInfo id: XL STROKE-2, briefTitle: Endovascular Treatment for eXtra-Large Ischemic Stroke, acronym: XL STROKE-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Zhongming Qiu, class: OTHER, collaborators name: The First Affiliated Hospital, University of South China, collaborators name: Xiangtan Central Hospital, collaborators name: Zhejiang University, collaborators name: Longyan First Affiliated Hospital of Fujian Medical University, descriptionModule briefSummary: The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion., conditionsModule conditions: Stroke, Acute Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 286, type: ESTIMATED, armsInterventionsModule interventions name: Medical management, interventions name: Endovascular thrombectomy, outcomesModule primaryOutcomes measure: Modified Rankin Scale score, secondaryOutcomes measure: Rate of successful reperfusion, secondaryOutcomes measure: Rate of excellent outcome, secondaryOutcomes measure: Rate of functional independence, secondaryOutcomes measure: Rate of independent ambulation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangtan Central Hospital, city: Xiangtan, state: Hunan, zip: 421001, country: China, geoPoint lat: 27.85, lon: 112.9, locations facility: Xingguo County People's Hospital, city: Ganzhou, state: Jiangxi, country: China, hasResults: False
protocolSection identificationModule nctId: NCT06388135, orgStudyIdInfo id: SNC-01, briefTitle: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Yang Jianjun, PhD, class: OTHER, descriptionModule briefSummary: Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1)., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab Combined With Nab-paclitaxel and Cisplatin, interventions name: nab-paclitaxel，Cisplatin, outcomesModule primaryOutcomes measure: pCR, secondaryOutcomes measure: MPR, secondaryOutcomes measure: DFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388122, orgStudyIdInfo id: 23-009689, secondaryIdInfos id: NCI-2024-03405, type: REGISTRY, domain: CTRP (Clinical Trials Reporting Program), secondaryIdInfos id: MC240301, type: OTHER, domain: Mayo Clinic, briefTitle: DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2026-06-15, completionDateStruct date: 2026-06-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor., conditionsModule conditions: HER2-negative Breast Cancer, conditions: Hormone-receptor-positive Breast Cancer, conditions: Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, outcomesModule primaryOutcomes measure: DiviTum®TKa assay as an early predictor of primary treatment resistance, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Pooja Advani, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False
protocolSection identificationModule nctId: NCT06388096, orgStudyIdInfo id: PERGCLAD001, briefTitle: CLAD Deconvolved PERG Responses in Glaucoma Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Jorvec Corp., class: INDUSTRY, collaborators name: University of Miami, descriptionModule briefSummary: Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls., conditionsModule conditions: Glaucoma, Suspect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention Provided, outcomesModule primaryOutcomes measure: PERG Amplitude, primaryOutcomes measure: PERG Latency, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Vittorio Porciatti, MD/PhD, role: CONTACT, email: vporciatti@med.miami.edu, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
protocolSection identificationModule nctId: NCT06388083, orgStudyIdInfo id: LBS-008-CT07, briefTitle: A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease, acronym: DRAGON II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Belite Bio, Inc, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease, conditionsModule conditions: STGD1, conditions: Stargardt Disease 1, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tinlarebant, interventions name: Placebo, outcomesModule primaryOutcomes measure: To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy, secondaryOutcomes measure: To measure the annualized rate of change in total area of atrophy, secondaryOutcomes measure: Change in BCVA measured by the ETDRS method, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Belite Study Site, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
protocolSection identificationModule nctId: NCT06388070, orgStudyIdInfo id: HUC3-053, briefTitle: To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Huons Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: HUC3-053, interventions name: Hyalein Mini Drops, outcomesModule primaryOutcomes measure: Change from Baseline in Corneal staining score, secondaryOutcomes measure: Change from Baseline in Corneal staining score, secondaryOutcomes measure: Change from Baseline in Conjunctival staining score, secondaryOutcomes measure: Change from Baseline in Schirmer test, secondaryOutcomes measure: Change from Baseline in Tear film break-up time, secondaryOutcomes measure: Change from Baseline in Ocular surface disease index, secondaryOutcomes measure: Change from Baseline in Soreness after eye drop assessed by NRS, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388057, orgStudyIdInfo id: 5836, briefTitle: Intraoperative Ultrasound in Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients with Crohn's disease with an indication for surgery, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative Small Bowel Ultrasonography, outcomesModule primaryOutcomes measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False