hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06373809, orgStudyIdInfo id: PDSC1970222, briefTitle: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy, acronym: PDSC, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-08, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Michael H Carstens, class: OTHER, collaborators name: Ministerio de Salud de Nicaragua, collaborators name: Wake Forest Institute for Regenerative Medicine, descriptionModule briefSummary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot., conditionsModule conditions: Diabetic Foot, conditions: Diabetic Neuropathies, conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective an open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Transplantation of Placenta Derived Stem Cells, outcomesModule primaryOutcomes measure: Foot Ulcer Healing, secondaryOutcomes measure: Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes., secondaryOutcomes measure: Vibration: Documenting diabetes-associated lower extremity pathophysiology changes., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), city: León, state: Leon, zip: 21000, country: Nicaragua, geoPoint lat: 12.43787, lon: -86.87804, locations facility: Hospital Escuela Cesar Amador Molina, city: Matagalpa, zip: 61000, country: Nicaragua, geoPoint lat: 12.92559, lon: -85.91747, hasResults: False
protocolSection identificationModule nctId: NCT06373796, orgStudyIdInfo id: 2024-A00523-44, briefTitle: Ultrasound Index Fat Fraction, acronym: FAT-PLUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: SuperSonic Imagine, class: INDUSTRY, descriptionModule briefSummary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis., conditionsModule conditions: Steatosis of Liver, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Echographic scan, outcomesModule primaryOutcomes measure: FAT PLUS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06373770, orgStudyIdInfo id: MSRSW/Batch-Fall22/700, briefTitle: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum, conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Ayres sensory integration therapy, interventions name: Behaviour Therapy, outcomesModule primaryOutcomes measure: sensory profile by winnie dunn, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: RICCER Institute, city: Faisalabad, state: Punjab, country: Pakistan, geoPoint lat: 31.41554, lon: 73.08969, hasResults: False
protocolSection identificationModule nctId: NCT06373757, orgStudyIdInfo id: RECO6U/5-2023, briefTitle: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects., conditionsModule conditions: Chitosan, conditions: Nano-hydroxyapatite Hydrogel, conditions: Intrabony Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Nano-HAP/Chitosan hydrogel, outcomesModule primaryOutcomes measure: Gingival index, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Clinical attachment level, secondaryOutcomes measure: Periodontal probing depth, secondaryOutcomes measure: Acrylic stent for pocket assessment, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: October 6 University, city: Giza, zip: 12511, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06373744, orgStudyIdInfo id: SYSU-022, briefTitle: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 597, type: ACTUAL, armsInterventionsModule interventions name: cyclophosphamide, methotrexate, vinorelbine ,capecitabine, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shusen Wang, city: Guangzhou, state: Gangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06373679, orgStudyIdInfo id: Pro00125514, secondaryIdInfos id: 1R01DA056445-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA056445-01A1, briefTitle: Switch or Quit R01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Medical University of South Carolina, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks., conditionsModule conditions: Cigarette Smoking, conditions: Smoking Behaviors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: Switching to E-Cigarette, interventions name: Switching using Medication, outcomesModule primaryOutcomes measure: Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback, secondaryOutcomes measure: Greater than 50% reduction in cigarette smoking, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Univeristy of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, hasResults: False
protocolSection identificationModule nctId: NCT06373666, orgStudyIdInfo id: SPZ4-02, briefTitle: A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4)., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Spatz FGIA, Inc, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Spatz4 Adjustable Balloon System, outcomesModule primaryOutcomes measure: Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06373653, orgStudyIdInfo id: SOPHMAN-0922/IV, briefTitle: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI)., conditionsModule conditions: Eye Strain, conditions: Eye Strain of Both Eyes, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open-label,, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Manzanilla Sophia®, interventions name: Meticel Ofteno®, outcomesModule primaryOutcomes measure: Analog visual eyestrain test score, secondaryOutcomes measure: Incidence of unexpected adverse events related to the interventions, secondaryOutcomes measure: Incidence of conjunctival hyperemia, secondaryOutcomes measure: Incidence of sensation of ocular dryness., secondaryOutcomes measure: Incidence of ocular irritation, secondaryOutcomes measure: Incidence of sensation of (sleep-crust), secondaryOutcomes measure: Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06373640, orgStudyIdInfo id: RHM NEU0458, briefTitle: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage, acronym: HAPTO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital Southampton NHS Foundation Trust, class: OTHER, descriptionModule briefSummary: The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration., conditionsModule conditions: Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: Insertion of drains, interventions name: Vancomycin, outcomesModule primaryOutcomes measure: CSF-haemoglobin concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06373627, orgStudyIdInfo id: 2024-A00534-43, briefTitle: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease, acronym: PEACE-HYPNO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-05-02, completionDateStruct date: 2025-05-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondation Hôpital Saint-Joseph, class: OTHER, descriptionModule briefSummary: The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects., conditionsModule conditions: Procedural Pain, conditions: Congenital Heart Disease, conditions: Heart Surgery, conditions: Hypnosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Hypnosis, interventions name: Conventional medications used for sedation-analgesia, interventions name: Medications used in addition to hypnosis, outcomesModule primaryOutcomes measure: Primary Outcome : Pain evaluation by VAS self-assessment, secondaryOutcomes measure: Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal, secondaryOutcomes measure: Maximum heart rate, secondaryOutcomes measure: Cumulative doses of intravenous analgesics, secondaryOutcomes measure: Respiratory depression, secondaryOutcomes measure: Parental satisfaction using Visual Analogic Scale (VAS), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06373614, orgStudyIdInfo id: 2023/18, briefTitle: The Effect of Foot Massage and Bed Bath on Individuals With Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer., conditionsModule conditions: Patients, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: foot massage (intervention group) bed bath (intervention group) control (control group), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: foot massage, interventions name: bed bath, outcomesModule primaryOutcomes measure: sleep quality, primaryOutcomes measure: fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences, status: RECRUITING, city: Istanbul, state: Uskudar, country: Turkey, contacts name: Ayşe Kabuk, Dr, role: CONTACT, phone: 05469596616, email: ayse.kabuk@beun.edu.tr, contacts name: Ayşe Kabuk, PhD, role: CONTACT, phone: +905469596616, email: ayseyalili@gmail.com, contacts name: Ayşe Kabuk, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06373601, orgStudyIdInfo id: SPAGO, briefTitle: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective, acronym: SPAGO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS, class: OTHER, descriptionModule briefSummary: The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up., conditionsModule conditions: Coronary Artery Disease, conditions: Stenosis Coronary, conditions: Coronary Artery Lesion, conditions: Percutaneous Coronary Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A subject is randomized at a 1:1 ratio either to drug-coated balloon (DCB) angioplasty with a sirolimus-eluting Selution balloon (n=60 subjects) or DCB angioplasty with a paclitaxel-eluting Sequent Please Neo balloon (n=60 subjects)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: sirolimus-eluting balloon (Selution), interventions name: paclitaxel-eluting balloon (SeQuent Please Neo), outcomesModule primaryOutcomes measure: In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure, secondaryOutcomes measure: Device success (lesion based), secondaryOutcomes measure: Procedure success, secondaryOutcomes measure: Angiographic outcomes 1, secondaryOutcomes measure: Angiographic outcomes 2, secondaryOutcomes measure: Angiographic outcomes 3, secondaryOutcomes measure: Angiographic outcomes 4, secondaryOutcomes measure: Device oriented Composite Endpoint (DoCE/ TLF), secondaryOutcomes measure: Acute/subacute/early/late vessel thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False