hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06299904, orgStudyIdInfo id: stroke, briefTitle: Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Second Affiliated Hospital of Dalian Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Modified Air-pulse Stimulation, interventions name: Conventional air-pulse stimulation, outcomesModule primaryOutcomes measure: the score of Fiberoptic endoscopic examination of swallowing (FEES), primaryOutcomes measure: the score of Murray's secretion scale (MSS), primaryOutcomes measure: the score of penetration-aspiration scale (PAS), secondaryOutcomes measure: the score of Clinical Pulmonary Infection Score (CPIS), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Second Affiliated Hospital of Dalian Medical University, status: RECRUITING, city: Dalian, state: Liaoning, zip: 116024, country: China, contacts name: wuyao Pan, postgraduate, role: CONTACT, phone: +86-18186766836, email: 331189506@qq.com, geoPoint lat: 38.91222, lon: 121.60222, hasResults: False
protocolSection identificationModule nctId: NCT06299878, orgStudyIdInfo id: MelPRO-0322, briefTitle: MelPRO-0322 (CRISTINA Trial) [miCrobiome pRedIctS aPD1 effecTivnes In melaNoma pAtietns], acronym: CRISTINA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Russian Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-PD1 agents in patients with resectable stage IIIB-D melanoma. The main questions it aims to answer are:* radiological and pathological response rate to three doses of antiPD1 agents;* do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features Participants will receive three doses of aPD1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. Before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery.After sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years., conditionsModule conditions: Melanoma, Skin, conditions: Melanoma Stage Iii, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Gut microbiota analysis, outcomesModule primaryOutcomes measure: 2-year disease-free survival, secondaryOutcomes measure: pathological response rate, otherOutcomes measure: biomarker reproducibility, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: N.N. Blokhin Russian Cancer Research Center, skin tumor department, status: RECRUITING, city: Moscow, zip: 115478, country: Russian Federation, contacts name: Igor V Samoylenko, MD, PhD, role: CONTACT, phone: +7 (499) 444-24-24, email: i.samoylenko@ronc.ru, contacts name: Angelina O Kuzmenko, MD, role: CONTACT, phone: +74993249024, email: angelin.kuzmenko@gmail.com, contacts name: Igor V Samoylenko, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
protocolSection identificationModule nctId: NCT06299852, orgStudyIdInfo id: TK01, briefTitle: Stereotactic Radiation Therapy for HE2-positive Oligometastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: N.N. Petrov National Medical Research Center of Oncology, class: OTHER, descriptionModule briefSummary: This study involves two non-randomized groups of patients: the observation group and the comparison group. The comparison group will retrospectively include data on 29 patients with oligometastatic HER2-positive breast cancer who received treatment with trastuzumab-emtansine and had a history of SRT.The prospective part of this study aims to include 29 patients with oligometastatic HER2-positive breast cancer. These patients will undergo SRT followed by the administration of trastuzumab emtansine 24 hours after the SRT.The combined effect of stereotactic radiation therapy on a metastatic lesion followed by anti-HER2 therapy in the 2nd line - trastuzumab emtansine, remains unexplored. This study plans to evaluate the effectiveness of combining systemic therapy and local control methods (SRT) in patients with oligometastatic HER2-positive breast cancer. It will be the first time the efficacy and toxic profile of this new combined treatment method in this patient population will be studied. This basket trial evaluates trastuzumab emtansine for oligo-metastatic breast cancer with the aim of inducing deep responses, long-lasting disease remissions, and potentially cure., conditionsModule conditions: HER2-positive Metastatic Breast Cancer, conditions: Oligometastatic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Trastuzumab emtansine, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Toxicity profile, secondaryOutcomes measure: Second co-primary outcome measure is quality of life, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: N.N. Petrov National Medical Research Center of Oncology, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Tatiana Semiglazova, DSc Med., Prof., role: CONTACT, email: tsemiglazova@mail.ru, contacts name: Tatiana Kudryashova, role: CONTACT, phone: +79632165730, email: tatyana-kudryashova-98@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
protocolSection identificationModule nctId: NCT06299826, orgStudyIdInfo id: D9090C00008, briefTitle: A Phase IIb Study of AZD5462 in Patients With Chronic Heart Failure, acronym: LUMINARA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2025-11-24, completionDateStruct date: 2025-11-24, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the effect of AZD5462 on cardiac function in participants with chronic heart failure (HF)., conditionsModule conditions: Chronic Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: AZD5462, interventions name: Placebo, outcomesModule primaryOutcomes measure: Cohort A and B: Change from Baseline in Ejection Fraction, secondaryOutcomes measure: Cohort A and B: Change from Baseline in Ejection Fraction, secondaryOutcomes measure: Cohorts A and B: Change from Baseline in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS), secondaryOutcomes measure: Cohorts A and B: Change from Baseline in New York Heart Association Functional Class (NYHA FC), secondaryOutcomes measure: Cohorts A and B: Percentage Change from Baseline in cardiac biomarkers, secondaryOutcomes measure: Cohorts A and B : Plasma Concentration of AZD5462, secondaryOutcomes measure: Cohorts A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06299787, orgStudyIdInfo id: 058-2021, briefTitle: Cognitive Dysfunction in the Addictions Study - Project 4 (P4), acronym: CDiA-P4, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-07, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder., conditionsModule conditions: Major Depressive Disorder, conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: intermittent theta burst stimulation, interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Executive Function Index - inhibition, primaryOutcomes measure: Executive Function Index - working memory, primaryOutcomes measure: Executive Function Index - set shifting, secondaryOutcomes measure: 17-Item Hamilton Depression Rating Scale (HRSD-17), otherOutcomes measure: Columbia-Suicide Severity Rating Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centre for Addiction and Mental Health, status: RECRUITING, city: Toronto, state: Ontario, zip: M6J 1H4, country: Canada, contacts name: Daphne Voineskos, MD, role: CONTACT, phone: 416-535-8501, phoneExt: 30176, email: daphne.voineskos@camh.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06299774, orgStudyIdInfo id: 2023P003383, briefTitle: Emergency Care at Home, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2025-02-02, completionDateStruct date: 2025-03-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: This study will assess the efficacy of receiving emergency care at home versus in the brick-and-mortar emergency department., conditionsModule conditions: Emergency Medical Services, conditions: Emergency Department Visits, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Emergency care at home, interventions name: Emergency care at a brick-and-mortar emergency department, outcomesModule primaryOutcomes measure: Participant with an emergency department presentation, observation, or hospitalization within 9 days, secondaryOutcomes measure: Time to care initiation, secondaryOutcomes measure: Time spent receiving care, secondaryOutcomes measure: Number of days at home within 9 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: David Levine, MD, MPH, MA, role: CONTACT, phone: 617-732-7063, email: dmlevine@bwh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06299761, orgStudyIdInfo id: BBI-825-101, briefTitle: Study of the RNR Inhibitor BBI-825 in Subjects With Tumors With Resistance Gene Amplifications, acronym: STARMAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Boundless Bio, class: INDUSTRY, descriptionModule briefSummary: BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: BBI-825 single agent dose escalation, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: BBI-825, outcomesModule primaryOutcomes measure: Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825, primaryOutcomes measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825, secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) of BBI-825, secondaryOutcomes measure: Trough observed plasma concentration (Ctrough) of BBI-825, secondaryOutcomes measure: Time to Cmax (Tmax) of BBI-825, secondaryOutcomes measure: Area under the concentration time curve (AUC) of BBI-825, secondaryOutcomes measure: Anti-tumor activity of BBI-825 as determined by RECISTv1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sarcoma Oncology Research Center, status: RECRUITING, city: Santa Monica, state: California, zip: 90403, country: United States, geoPoint lat: 34.01945, lon: -118.49119, locations facility: START Midwest, status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
protocolSection identificationModule nctId: NCT06299748, orgStudyIdInfo id: ARGX-113-PAC-2206, briefTitle: A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2033-12, completionDateStruct date: 2033-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: argenx, class: INDUSTRY, descriptionModule briefSummary: This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the VYVGART IV or SC-exposed pregnancies were reported., conditionsModule conditions: Myasthenia Gravis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 279, type: ESTIMATED, armsInterventionsModule interventions name: Efgartigimod, outcomesModule primaryOutcomes measure: Pregnancy outcomes, secondaryOutcomes measure: Congenital malformations, secondaryOutcomes measure: The number of observed other events of interest in the developing neonate and infant (such as hospitalizations for serious illness), secondaryOutcomes measure: Maternal complications of pregnancy, secondaryOutcomes measure: Maternal infections, secondaryOutcomes measure: The number of observed fetal growth deficiency, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06299709, orgStudyIdInfo id: VX23-121-012, briefTitle: A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: VNZ/TEZ/D-IVA, interventions name: VNZ/TEZ/D-IVA, outcomesModule primaryOutcomes measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA, primaryOutcomes measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VNZ, TEZ, and D-IVA, secondaryOutcomes measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, Inc., status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
protocolSection identificationModule nctId: NCT06299696, orgStudyIdInfo id: VX23-121-011, briefTitle: A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: VNZ/TEZ/D-IVA, outcomesModule primaryOutcomes measure: Flavor Assessment Based on Flavor Profile Method of Descriptive Sensory Analysis per American Society for Testing and Material (ASTM) Approved Sensory Evaluation Method, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 001, city: Woburn, state: Massachusetts, zip: 01801, country: United States, geoPoint lat: 42.47926, lon: -71.15228, hasResults: False