hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06389344, orgStudyIdInfo id: lk20240401, briefTitle: Effect of Esketamine on Conscious State in Patients With pDoC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia.Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated., conditionsModule conditions: Esketamine, conditions: Consciousness Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine, interventions name: normal saline, outcomesModule primaryOutcomes measure: Coma recovery scale-revised(CRS-R), secondaryOutcomes measure: Coma recovery scale-revised(CRS-R), secondaryOutcomes measure: Full Outline of UnResponsiveness(FOUR), secondaryOutcomes measure: Glasgow coma scale(GCS), secondaryOutcomes measure: Original EEG, secondaryOutcomes measure: Patient state index(PSI), secondaryOutcomes measure: Power spectral density, secondaryOutcomes measure: Burst-suppression ratio, secondaryOutcomes measure: Spectral edge frequency, secondaryOutcomes measure: The incidence of perioperative adverse events, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06389331, orgStudyIdInfo id: IRC/1971/020, briefTitle: Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2021-06-30, completionDateStruct date: 2021-08-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: B.P. Koirala Institute of Health Sciences, class: OTHER, descriptionModule briefSummary: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested., conditionsModule conditions: Hernia, conditions: Direct Inguinal Hernia, conditions: Seroma Following Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: closed the defect with barbed suture, outcomesModule primaryOutcomes measure: seroma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vijay Pratap Sah, city: Malangwa, state: Madhesh Pradesh, country: Nepal, geoPoint lat: 26.85679, lon: 85.55811, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2020-09-01, uploadDate: 2024-04-24T12:06, filename: Prot_ICF_000.pdf, size: 190465, hasResults: False
protocolSection identificationModule nctId: NCT06389318, orgStudyIdInfo id: RC 29-11-2023, briefTitle: Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-26, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients, conditionsModule conditions: Inguinal Hernia Repair, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture), primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Both participant and the care-provider in this trial were blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: buccal midazolam +oral placebo syrup, interventions name: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline, outcomesModule primaryOutcomes measure: Ramsay sedation score, secondaryOutcomes measure: Parental separation anxiety scale, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Benha University, city: Banha, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False
protocolSection identificationModule nctId: NCT06389305, orgStudyIdInfo id: BJGBYY-IIT-LCYJ-2024-012, briefTitle: CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Beijing GoBroad Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, double-blind, randomized trial. Patients with r/r B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the mRNA-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled., conditionsModule conditions: B-cell Acute Lymphoblastic Leukemia, conditions: Acute Lymphoblastic Leukemia, in Relapse, conditions: Refractory Acute Lymphoid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective cohort study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 213, type: ESTIMATED, armsInterventionsModule interventions name: peripheral blood lymphocytes, interventions name: CIK cell, outcomesModule primaryOutcomes measure: EFS in CIK infusion group, secondaryOutcomes measure: PFS in CIK infusion group, secondaryOutcomes measure: DOR in CIK infusion group, secondaryOutcomes measure: OS in CIK infusion group, secondaryOutcomes measure: EFS in mRNA-CIK infusion group, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Beijing GoBroad Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 102206, country: China, contacts name: Tengyu Wang, role: CONTACT, phone: 86+18333186020, email: tengyu.wang@gohealtharo.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06389292, orgStudyIdInfo id: APG2575AG301, briefTitle: A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05-25, completionDateStruct date: 2029-03-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ascentage Pharma Group Inc., class: INDUSTRY, descriptionModule briefSummary: An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: Lisaftoclax (APG-2575), interventions name: Placebo, interventions name: Azacitidine Injection, outcomesModule primaryOutcomes measure: Overall Survival（OS）, secondaryOutcomes measure: Percentage of Participants with Objective Response Rate (ORR), secondaryOutcomes measure: Safety evaluation based on the adverse event concurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Hui Wei, M.D., role: CONTACT, phone: 022-23909120, email: weihui@ihcams.ac.cn, contacts name: Hui Wei, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Jie Jin, M.D., role: CONTACT, email: jiej0503@163.com, contacts role: CONTACT, phone: 0571-87236896, contacts name: Jie Jin, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06389279, orgStudyIdInfo id: 2023-18/11, briefTitle: The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-09-24, completionDateStruct date: 2024-10-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Antalya Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia., conditionsModule conditions: Hip Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PENG block group, interventions name: FIC block group, interventions name: Femoral block group, interventions name: Control group, outcomesModule primaryOutcomes measure: recovery quality, secondaryOutcomes measure: postoperative Numeric Rating Scale (NRS) pain score, secondaryOutcomes measure: postoperative opioid consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, Antalya Training and Researh Hospital, city: Antalya, country: Turkey, contacts name: Antalya Training and Research Hospital, role: CONTACT, geoPoint lat: 36.90812, lon: 30.69556, hasResults: False
protocolSection identificationModule nctId: NCT06389253, orgStudyIdInfo id: HTSW1, briefTitle: Subtalar Extra-articular Screw Arthroereisis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Università Vita-Salute San Raffaele, class: OTHER, descriptionModule briefSummary: The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi., conditionsModule conditions: Flatfoot, Flexible, conditions: Ankle Proprioception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Histological Analysis, outcomesModule primaryOutcomes measure: Primary Endpoint (%), secondaryOutcomes measure: Secondary Endpoint, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ircss Ospedale San Raffaele, city: Milan, state: Lombardy, zip: 20149, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Università Vita-Salute San Raffaele, city: Milan, zip: 20132, country: Italy, contacts name: Francesco Pezone, role: CONTACT, contacts role: CONTACT, email: f.pezone@studenti.unisr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06389240, orgStudyIdInfo id: 160848, briefTitle: Early Weight Bearing in Unicondylar Tibial Plateau Fractures, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-21, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, descriptionModule briefSummary: The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome, conditionsModule conditions: Early Mobilization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 6 weeks post-operatively early weight bearing, interventions name: 10 weeks post-operatively weight bearing (standard of care), outcomesModule primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), primaryOutcomes measure: Average peak load (Newtons (N)), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah Orthopedics, city: Salt Lake City, state: Utah, zip: 84108, country: United States, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
protocolSection identificationModule nctId: NCT06389227, orgStudyIdInfo id: 0433611, briefTitle: Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-15, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination., conditionsModule conditions: Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: dynamic ecological approach (DEA), interventions name: traditional training group, outcomesModule primaryOutcomes measure: Number of participants evaluated on physical efficiency, eligibilityModule sex: MALE, minimumAge: 12 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cit Turin LDE, city: Turin, zip: 10100, country: Italy, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False
protocolSection identificationModule nctId: NCT06389214, orgStudyIdInfo id: ADX-102-DED-030, briefTitle: A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Aldeyra Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease, conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Reproxalap Ophthalmic Solution (0.25%), interventions name: Vehicle Ophthalmic Solution, outcomesModule primaryOutcomes measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cliantha Research, status: RECRUITING, city: Mississauga, state: Ontario, country: Canada, contacts name: Patricia Couroux, MD, role: CONTACT, phone: (888) 989-1808, email: pcouroux@cliantha.com, geoPoint lat: 43.5789, lon: -79.6583, hasResults: False
protocolSection identificationModule nctId: NCT06389201, orgStudyIdInfo id: 2024HCQ, briefTitle: Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Affiliated Hospital of Nantong University, class: OTHER, descriptionModule briefSummary: Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: HCQ, interventions name: Placebo, outcomesModule primaryOutcomes measure: Recurrence and metastasis, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bo You, city: Nantong, state: Jiangsu, zip: 226000, country: China, geoPoint lat: 32.03028, lon: 120.87472, hasResults: False