hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06369480, orgStudyIdInfo id: Journal-nr.: R-23057752, briefTitle: Prognostic Factors for Survival in Patients With Cholangiocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field., conditionsModule conditions: Cholangiocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Resection/Ablation of tumor, interventions name: Palliative chemotherapy, interventions name: Neoadjuvant chemotherapy, interventions name: Stereotatic radiotherapy, interventions name: Best supportive care, outcomesModule primaryOutcomes measure: Aim I, primaryOutcomes measure: Aim II, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Hans-Christian Pommergaard, MD DMSc PhD, role: CONTACT, email: hans-christian.pommergaard@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06369441, orgStudyIdInfo id: Ovation-23-001, briefTitle: Collection of Biological Specimens and Associated Health Information, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ovation.io, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease., conditionsModule conditions: Cancer, conditions: Other Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Biorepository, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ovation.io, city: Portland, state: Maine, zip: 04101, country: United States, contacts name: Stephanie Balcaitis, role: CONTACT, phone: 617-795-4947, phoneExt: 2, email: ClinicalAffairs@ovation.io, contacts name: Ed Stepanski, PhD, role: CONTACT, email: ClinicalAffairs@ovation.io, contacts name: Pauline Gee, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.66147, lon: -70.25533, hasResults: False
protocolSection identificationModule nctId: NCT06369415, orgStudyIdInfo id: 04/24/DD-BVMD, briefTitle: Health of Babies Born From IVF Versus IVM at 5 Years Old, acronym: FM-BABIES-5Y, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mỹ Đức Hospital, class: OTHER, descriptionModule briefSummary: The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count., conditionsModule conditions: Infertility, conditions: IVF, conditions: IVM, conditions: Development, Child, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 231, type: ESTIMATED, armsInterventionsModule interventions name: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's), outcomesModule primaryOutcomes measure: Normal ASQ-3 score rate., primaryOutcomes measure: Normal SDQ score rate., primaryOutcomes measure: Normal weight rate, secondaryOutcomes measure: Thinness rate, secondaryOutcomes measure: Overweight rate, secondaryOutcomes measure: Obesity rate, secondaryOutcomes measure: Score of Communication (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Gross motor (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Fine motor (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Problem solving (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Personal-Social (ASQ-3 questionnaire), secondaryOutcomes measure: Score of Emotional symptoms (SDQ questionnaire), secondaryOutcomes measure: Score of Conduct problems (SDQ questionnaire), secondaryOutcomes measure: Score of hyperactivity/inattention (SDQ questionnaire), secondaryOutcomes measure: Score of peer relationship problems (SDQ questionnaire), secondaryOutcomes measure: Score of prosocial behavior (SDQ questionnaire), secondaryOutcomes measure: The total difficulties score., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mỹ Đức Hospital, status: RECRUITING, city: Ho Chi Minh City, state: Tan Binh, country: Vietnam, contacts name: Tuong M Ho, MD, MCE, role: CONTACT, phone: +84903633377, email: tuongho.ivfmd@gmail.com, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False
protocolSection identificationModule nctId: NCT06369376, orgStudyIdInfo id: ONZ-2022-0072, briefTitle: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2023-11-29, completionDateStruct date: 2024-04-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Hospital, Ghent, class: OTHER, descriptionModule briefSummary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences., conditionsModule conditions: New Nerve Conduction Protocol for Pectoral Nerve, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: New nerve conduction protocol, outcomesModule primaryOutcomes measure: Latency, primaryOutcomes measure: Amplitude, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Gent, city: Gent, state: Oost-Vlaanderen, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
protocolSection identificationModule nctId: NCT06369363, orgStudyIdInfo id: STUDY000024245, briefTitle: Estrogen Deficiency on Cardiovascular Risk, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-09, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor., conditionsModule conditions: Postmenopausal Symptoms, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Estradiol, outcomesModule primaryOutcomes measure: Red blood cell flux, primaryOutcomes measure: Mean arterial pressure (mmHg), primaryOutcomes measure: baseline plasma TNF-α concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma TNF-α concentration (pg/ml), primaryOutcomes measure: baseline plasma IL-1β concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma IL-1β concentration (pg/ml), primaryOutcomes measure: baseline plasma IL-6 concentration (pg/ml), primaryOutcomes measure: One week post-intervention plasma IL-6 concentration (pg/ml), secondaryOutcomes measure: baseline plasma estrogen (pg/ml), secondaryOutcomes measure: One week post-intervention plasma estrogen (pg/ml), eligibilityModule sex: FEMALE, minimumAge: 54 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06369350, orgStudyIdInfo id: STUDY000020217, secondaryIdInfos id: 940567, type: OTHER_GRANT, domain: American Heart Association, briefTitle: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients., conditionsModule conditions: Ischemia Reperfusion Injury, conditions: Peripheral Artery Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin B6 25 MG, interventions name: Vitamin B6 50 MG, interventions name: Vitamin B6 100 MG, interventions name: Placebo, outcomesModule primaryOutcomes measure: baseline blood pressure in mmHg, primaryOutcomes measure: Second visit blood pressure in mmHg, primaryOutcomes measure: baseline heart Rate in beats per minute, primaryOutcomes measure: Second visit heart Rate in beats per minute, primaryOutcomes measure: baseline muscle sympathetic nerve activity in burst/min, primaryOutcomes measure: Second visit muscle sympathetic nerve activity in burst/min, primaryOutcomes measure: baseline walking time in minutes, primaryOutcomes measure: Second visit walking time in minutes, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06369337, orgStudyIdInfo id: 014-24, briefTitle: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, collaborators name: Hospital Universitario Ramon y Cajal, descriptionModule briefSummary: Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics, conditionsModule conditions: Dysphagia, Oropharyngeal, conditions: Deglutition Disorders, conditions: Mechanical Ventilation Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Thickness of the submental muscles, primaryOutcomes measure: Hyolaryngeal displacement, secondaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Functional Status, secondaryOutcomes measure: Swallowing function, secondaryOutcomes measure: Swallowing function, secondaryOutcomes measure: Swallowing function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06369311, orgStudyIdInfo id: 2000037345, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06369285, orgStudyIdInfo id: PUMA-ALI-1201, secondaryIdInfos id: 2024-511497-79-00, type: CTIS, briefTitle: A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer, acronym: ALISCA-Breast1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Puma Biotechnology, Inc., class: INDUSTRY, descriptionModule briefSummary: PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy., conditionsModule conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer, conditions: Metastatic Breast Cancer, conditions: Recurrent Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Alisertib, interventions name: Endocrine therapy, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR) Within Dose Subgroup, primaryOutcomes measure: Duration of Response (DOR) Within Dose Subgroup, primaryOutcomes measure: Disease Control Rate (DCR) Within Dose Subgroup, primaryOutcomes measure: Progression Free Survival (PFS) Within Dose Subgroup, primaryOutcomes measure: Overall Survival (OS) Within Dose Subgroup, primaryOutcomes measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population, secondaryOutcomes measure: Objective Response Rate (ORR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Duration of Response (DOR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Disease Control Rate (DCR) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Progression Free Survival (PFS) Within Biomarker-Defined Subgroup, secondaryOutcomes measure: Overall Survival (OS) Within Biomarker-Defined Subgroup, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06369259, orgStudyIdInfo id: 2023-0997, secondaryIdInfos id: NCI-2024-03302, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2028-02-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer., conditionsModule conditions: Advanced Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Defactinib, interventions name: Cetuximab, interventions name: Avutometinib, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77807, country: United States, contacts name: Christine Parseghian, MD, role: CONTACT, contacts name: Christine Parseghian, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06369246, orgStudyIdInfo id: 2023-0893, secondaryIdInfos id: NCI-2024-03308, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer., conditionsModule conditions: Advanced Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Body Radiation Therapy, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Comron Hassanzadeh, MD, role: CONTACT, phone: 713-657-9802, email: cjhassanzadeh@mdanderson.org, contacts name: Comron Hassanzadeh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False