hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06342804, orgStudyIdInfo id: GIB-01-02-2023, briefTitle: Food Effect on the Bioavailability of 4-MUST, Tablets, 128 mg, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Primary objective of the study: evaluation of the effect of food intake on the bioavailability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets).Additional aim of the study: evaluation of pharmacokinetic parameters, safety and tolerability of 4-MUST, tablets, 128 mg (Valenta Pharm JSC) in healthy volunteers after a single oral administration on an empty stomach and after a meal, at a dose of 256 mg (two tablets)., conditionsModule conditions: Cholecystitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: 4-MUST, 2 tablets, fasted, interventions name: 4-MUST, 2 tablets, after meals, outcomesModule primaryOutcomes measure: Pharmacokinetics - Cmax, primaryOutcomes measure: Pharmacokinetics - tmax, primaryOutcomes measure: Pharmacokinetics - AUC0-t, primaryOutcomes measure: Pharmacokinetics - AUC0-inf, primaryOutcomes measure: Pharmacokinetics - AUC ratio, primaryOutcomes measure: Pharmacokinetics - t1/2, primaryOutcomes measure: Pharmacokinetics - kel, primaryOutcomes measure: Pharmacokinetics - MRT, primaryOutcomes measure: Pharmacokinetics - Vd, primaryOutcomes measure: Pharmacokinetics - Cmax/AUC0-t, primaryOutcomes measure: Pharmacokinetics - f', primaryOutcomes measure: Pharmacokinetics - f'', primaryOutcomes measure: Bioavailability - ratio of Cmax, primaryOutcomes measure: Bioavailability - ratio of AUC0-t, primaryOutcomes measure: Bioavailability - ratio of AUC0-inf, secondaryOutcomes measure: Adverse event type, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severety, secondaryOutcomes measure: Drop-outs associated with adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Federal Budgetary Institution of Science "North-Western Scientific Center for Hygiene and Public Health", status: RECRUITING, city: Saint Petersburg, zip: 191036, country: Russian Federation, contacts name: Elena S Shalukho, MD, role: CONTACT, phone: +7 (903) 099 57 86, email: elena.shalukho@yandex.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False
protocolSection identificationModule nctId: NCT06342791, orgStudyIdInfo id: 004349, briefTitle: Effect of Laser Acupuncture on Menstrual Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: effect of laser acupuncture on menstrual back pain, conditionsModule conditions: Laser Acupuncture, conditions: Low Back Pain, conditions: Menstruation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: laser acupuncture, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: laser acupuncture, outcomesModule primaryOutcomes measure: back Pain intensity during menstruation, primaryOutcomes measure: pain threshold, primaryOutcomes measure: Ability to perform daily activities, secondaryOutcomes measure: back Pain intensity during menstruation, secondaryOutcomes measure: pain threshold, secondaryOutcomes measure: Ability to perform daily activities, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy cairo university, status: RECRUITING, city: Cairo, zip: 37617692, country: Egypt, contacts name: Mai Ali Galal El sayed, role: CONTACT, phone: 01152457470, email: Princessmai828@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06342778, orgStudyIdInfo id: DIP-05-02-2023, briefTitle: Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals, conditionsModule conditions: Nausea, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Doxylamine + Pyridoxine, interventions name: Diclectin, outcomesModule primaryOutcomes measure: Pharmacokinetics - Cmax, primaryOutcomes measure: Pharmacokinetics - tmax, primaryOutcomes measure: Pharmacokinetics - AUC0-t, primaryOutcomes measure: Pharmacokinetics - AUC0-inf, primaryOutcomes measure: Pharmacokinetics - AUCextr, primaryOutcomes measure: Pharmacokinetics - t1/2, primaryOutcomes measure: Pharmacokinetics - kel, primaryOutcomes measure: Pharmacokinetics - MRT, primaryOutcomes measure: Bioequivalence - ratio of Cmax, primaryOutcomes measure: Bioequivalence - ratio of AUC0-t, primaryOutcomes measure: Bioequivalence - ratio of AUC0-inf, secondaryOutcomes measure: Adverse event type, secondaryOutcomes measure: Adverse event frequency, secondaryOutcomes measure: Adverse event severety, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: GBOU VPO "Yaroslavl State Medical University" of Ministry of Health of Russian Federation, status: RECRUITING, city: Yaroslavl, zip: 150000, country: Russian Federation, contacts name: Sergey M Noskov, Prof., role: CONTACT, phone: +7-4852-242332, email: Noskov-SM@mail.ru, geoPoint lat: 57.62987, lon: 39.87368, hasResults: False
protocolSection identificationModule nctId: NCT06342765, orgStudyIdInfo id: SV009, briefTitle: Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment, acronym: FixedD3, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-22, primaryCompletionDateStruct date: 2028-05-30, completionDateStruct date: 2028-05-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: SpineVision, class: INDUSTRY, collaborators name: Slb Pharma, descriptionModule briefSummary: The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis®, in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery., conditionsModule conditions: Intervertebral Disc Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Pedicle fixation surgery, outcomesModule primaryOutcomes measure: Incidence of serious and non-serious device- and/or procedure-related adverse events, primaryOutcomes measure: Change of the Oswestry Disability Index (ODI), secondaryOutcomes measure: Fusion success, secondaryOutcomes measure: Change of the Oswestry Disability Index (ODI), secondaryOutcomes measure: Change of the back and leg Visual Analogue Score (VAS), secondaryOutcomes measure: Incidence of revision surgery at implant site, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: DOSCEA Pôle Rachis, status: RECRUITING, city: Bayonne, zip: 64100, country: France, contacts name: Jean Bernard, role: CONTACT, email: secretariatdoscea@outlook.fr, geoPoint lat: 43.48333, lon: -1.48333, locations facility: Clinique du dos Bordeaux-Terrefort, status: RECRUITING, city: Bruges, zip: 33520, country: France, contacts name: Louis Boissière, Doctor, role: CONTACT, email: boissierelouis@gmail.com, geoPoint lat: 44.87981, lon: -0.61219, locations facility: Orthéo Neurochirurgie, status: RECRUITING, city: Saint-Étienne, zip: 42199, country: France, contacts name: Benjamin Pommier, Doctor, role: CONTACT, email: benjamin.pommier@neurochirurgie.fr, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
protocolSection identificationModule nctId: NCT06342739, orgStudyIdInfo id: IEO 1595, briefTitle: Verbal Synchrony, Satisfaction and Decision-making in Face-to-face Consultations, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-23, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Eligible participants will be: benign thyroid nodules patients, to be involved in a consultation with their endocrinologist and/or surgeon and/or radiologist, in order to discuss treatment options related to benign thyroid nodules., conditionsModule conditions: Thyroid Nodule, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Evaluation of predictive power of verbal synchrony established between patient and physician during the consultation on patients' satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06342726, orgStudyIdInfo id: 2024/714469, briefTitle: The Effect of Active External Rewarming on Rewarming Rate in Simulated Prehospital Accidental Hypothermia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2024-06-02, completionDateStruct date: 2024-06-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: In this study, we aim to compare the effect of active external rewarming to passive rewarming in healthy research participants on core temperature.The participants will be cooled to a core temperature of 35 degress C, the rewarmed using 2 different scenarios. Scenario 1 will be with passive rewarming, scenario 2 with active rewarming. Shivering will be pharmacologically inhibited using Buspirone and Meperidine., conditionsModule conditions: Accidental Hypothermia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. The research participants will be healthy volunteers providing both oral and written consent.Before the start of experiment, the research participant will be cooled in an ice cave wearing wet clothing and with 2-3 m/s wind to a core temperature of 35.0 °C using the established protocol for inhibition of shivering. The maximum cooling time will be 2 hours (120 minutes). The order of interventions will be randomized.When the research subjects reach the target temperature of 35.0°C or the maximum cooling time of 2 hours, they will be subjected to one of the two scenarios listed below, with a rewarming phase of maximum 60 minutes., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: PAX Warming Blanket, interventions name: Passive insulation, outcomesModule primaryOutcomes measure: Core body temperature, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Haukeland University Hospital, status: RECRUITING, city: Bergen, zip: 5021, country: Norway, contacts name: Sigurd Mydske, MD, role: CONTACT, phone: 90659586, email: sigurd.mydske@norskluftambulanse.no, contacts name: Øyvind Thomassen, MD, PhD, role: CONTACT, phone: 977 18 721, email: oyvind.thomassen1@helse-bergen.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
protocolSection identificationModule nctId: NCT06342713, orgStudyIdInfo id: BGB-45035-101, briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: BeiGene, class: INDUSTRY, descriptionModule briefSummary: This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.Study details include:* The study duration will be up to 16 months.* The treatment duration will be up to 14 days.* Safety follow-up 30 days after last dose of study drug., conditionsModule conditions: Healthy Participants, conditions: Healthy Subjects, conditions: Healthy Volunteers, conditions: Autoimmune Diseases, conditions: Healthy Adult Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The cohorts in Part A, B, and C will be double-blinded, while the food effect study in Part D will be open-label, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: BGB-45035, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Adverse Events (AEs), primaryOutcomes measure: Number of participants with clinically significant changes from baseline in clinical laboratory values, primaryOutcomes measure: Number of participants with clinically significant changes from baseline in vital signs, primaryOutcomes measure: Number of participants with clinically significant changes from baseline in cardiac conduction intervals, secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast), secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to infinite time (AUCinf), secondaryOutcomes measure: Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau), secondaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Time to maximum plasma concentration (Tmax), secondaryOutcomes measure: Trough plasma concentration (Ctrough), secondaryOutcomes measure: Half life (t½), secondaryOutcomes measure: Apparent systemic clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (Vz/F), secondaryOutcomes measure: Accumulation Ratios, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06342687, orgStudyIdInfo id: JagiellonianU 1, briefTitle: Compliance With ERAS and Five Year Survival After Colorectal Cancer Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection., conditionsModule conditions: Colorectal Cancer, conditions: ERAS, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 468, type: ACTUAL, armsInterventionsModule interventions name: High compliance with ERAS protocol, outcomesModule primaryOutcomes measure: Post operative 5 year survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University Medical College, city: Kraków, state: Małopolskie, zip: 31-008, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
protocolSection identificationModule nctId: NCT06342661, orgStudyIdInfo id: 2022IIT205, briefTitle: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Harbin Medical University, class: OTHER, descriptionModule briefSummary: 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years., conditionsModule conditions: Cerebrovascular Disease Small Vessel, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological testing, outcomesModule primaryOutcomes measure: Patient characteristics, primaryOutcomes measure: VISTA expression in PBMCs in the VCI and control groups, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150010, country: China, contacts name: LiJun Chi, role: CONTACT, phone: 13895783757, email: clj3757@163.com, geoPoint lat: 45.75, lon: 126.65, hasResults: False
protocolSection identificationModule nctId: NCT06342648, orgStudyIdInfo id: Cutaneous water in renal colic, briefTitle: Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Suez Canal University, class: OTHER, descriptionModule briefSummary: Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared., conditionsModule conditions: Renal Colic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 570, type: ESTIMATED, armsInterventionsModule interventions name: Sterile Water Injection, interventions name: Diclofenac Sodium injection, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False