hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06380309, orgStudyIdInfo id: LY001-I001, briefTitle: A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2027-10-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages., conditionsModule conditions: Advanced Malignant Solid Tumor of Digestive System, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: IDOV-SAFE, outcomesModule primaryOutcomes measure: Occurrence of dose-limiting toxicity (DLT), primaryOutcomes measure: Incidence of adverse events (AE), secondaryOutcomes measure: The level of (non-essential) viral DNA in tumor tissue, secondaryOutcomes measure: Tumor markers, secondaryOutcomes measure: Anti-vaccinia virus neutralizing antibody test(VV-Nab), secondaryOutcomes measure: Levels of viral DNA in blood, secondaryOutcomes measure: Levels of viral DNA in saliva, secondaryOutcomes measure: T cell subsets, secondaryOutcomes measure: Cytokines, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Lin Shen, role: CONTACT, phone: +86 10 8819 6561, email: doctorshenlin@sina.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06380296, orgStudyIdInfo id: 2024-10240, briefTitle: Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications., conditionsModule conditions: Pulp Disease, Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Primary molars pulpotomies with NeoMTA, interventions name: Primary molar pulpotomies with NeoPUTTY, outcomesModule primaryOutcomes measure: Success rate of a primary molar pulpotomy, primaryOutcomes measure: Radiographic success of a primary molar pulpotomy, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, hasResults: False
protocolSection identificationModule nctId: NCT06380283, orgStudyIdInfo id: 2024-10221, briefTitle: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment., conditionsModule conditions: Children, Only, conditions: Dental Anxiety, conditions: Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality headset, outcomesModule primaryOutcomes measure: Children's pain perception during dental treatment, primaryOutcomes measure: Children's fear during dental treatment, secondaryOutcomes measure: Children's acceptability of virtual reality intervention during dental care, secondaryOutcomes measure: Oral health care provider's acceptability of virtual reality during dental care, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre, status: RECRUITING, city: Montreal, state: Quebec, country: Canada, contacts name: Beatriz Ferraz dos Santos, DDS, MSc, role: CONTACT, phone: +1 (514) 412-4400, phoneExt: 23357, email: beatriz.ferrazdossantos@muhc.mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06380270, orgStudyIdInfo id: LUMHS/B12/Temp/14.04.2024, briefTitle: Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Liaquat University of Medical & Health Sciences, class: OTHER, descriptionModule briefSummary: Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene., conditionsModule conditions: Strep Throat, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Oral probiotic Streptococcus salivarius K12 sachet, outcomesModule primaryOutcomes measure: Effect on oral health physical condition, primaryOutcomes measure: Effect on other physical features, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on vital signs, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood biochemistry, primaryOutcomes measure: Effect on blood electrolytes balance, primaryOutcomes measure: Effect on hematology, primaryOutcomes measure: Incidence of inflammation, primaryOutcomes measure: Incidence of gastrointestinal side effects, primaryOutcomes measure: Incidence of Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Liaquat University of Medical and Health Sciences, city: Jāmshoro, zip: 76090, country: Pakistan, contacts name: Dr. Amjad Khan, DPhil, role: CONTACT, phone: 03000506955, email: amjadkhan@lumhs.edu.pk, geoPoint lat: 25.43773, lon: 68.28522, hasResults: False
protocolSection identificationModule nctId: NCT06380257, orgStudyIdInfo id: ANBA, briefTitle: Anorexia Nervosa and Brain in Adolescence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2030-08, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Kuopio University Hospital, class: OTHER, descriptionModule briefSummary: Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence., conditionsModule conditions: Anorexia Nervosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Observational study methods, outcomesModule primaryOutcomes measure: Neuroimaging, secondaryOutcomes measure: Neuroimaging, otherOutcomes measure: Psychiatric evaluation, otherOutcomes measure: Body composition measurement, otherOutcomes measure: Laboratory tests, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380244, orgStudyIdInfo id: 1072.6120.136.2023, briefTitle: Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV)., conditionsModule conditions: Analgesics, Opioid, conditions: Anesthesia, Endotracheal, conditions: Anesthesia, General, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: anesthesia without opioids, outcomesModule primaryOutcomes measure: Pain level, secondaryOutcomes measure: Total long acting opioid consumption in oxycodone equivalents, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jagiellonian University, status: RECRUITING, city: Kraków, state: Malopolskie, zip: 31501, country: Poland, contacts name: Tomasz Skladzien, phd md, role: CONTACT, phone: 506602250, phoneExt: 48, email: t.skladzien@interia.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
protocolSection identificationModule nctId: NCT06380231, orgStudyIdInfo id: IRU-YAZILE-001, briefTitle: Skin-to-skin Contact Between Premature Infant and Mother, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2019-12-01, completionDateStruct date: 2020-12-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Istanbul Rumeli University, class: OTHER, descriptionModule briefSummary: Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days., conditionsModule conditions: Kangaroo-mother Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: kangaroo mother care (KMC), outcomesModule primaryOutcomes measure: power analysis, secondaryOutcomes measure: The effect of kangaroo mother care, eligibilityModule sex: ALL, minimumAge: 24 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: TC Istanbul Rumeli University, city: Istanbul, state: Haliç, zip: 34445, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06380205, orgStudyIdInfo id: INCB54707-111, briefTitle: A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2024-06-07, completionDateStruct date: 2024-06-07, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Povorcitinib, interventions name: Levonorgestrel/Ethinyl estradiol, outcomesModule primaryOutcomes measure: Levonorgestrel (LNG) concentration in plasma, primaryOutcomes measure: Ethinyl estradiol (EE) concentration in plasma, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Additional LNG/EE PK parameters in plasma, secondaryOutcomes measure: Povorcitinib concentration in plasma, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion Clinical Research Unit, status: RECRUITING, city: Tempe, state: Arizona, zip: 85283, country: United States, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
protocolSection identificationModule nctId: NCT06380192, orgStudyIdInfo id: HJ22-DEE-RETRO, briefTitle: Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data, acronym: DEE-RETRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Imagine Institute, class: OTHER, descriptionModule briefSummary: Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent., conditionsModule conditions: Developmental and Epileptic Encephalopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies, primaryOutcomes measure: Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies, secondaryOutcomes measure: Identification of patient subgroups presenting the identified biomarkers, secondaryOutcomes measure: Assessment of patients' quality of life, secondaryOutcomes measure: Assessment of age-related adaptive behavior, secondaryOutcomes measure: Assessment of behavioral disorders, secondaryOutcomes measure: Assessment of autism spectrum disorders, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380166, orgStudyIdInfo id: A23-356, briefTitle: Hepatitis C Lab Testing Comparison Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories., conditionsModule conditions: Hepatitis C, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Hepatitis C core antigen, outcomesModule primaryOutcomes measure: Serum on the clot stability, primaryOutcomes measure: Serum off the clot stability, primaryOutcomes measure: Plasma on the gel stability, primaryOutcomes measure: Plasma off the gel stability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False