hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06388980, orgStudyIdInfo id: UFCIN1_2022, briefTitle: Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Corporacion Parc Tauli, class: OTHER, descriptionModule briefSummary: Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv, conditionsModule conditions: Nurse's Role, conditions: Knowledge, Attitudes, Practice, conditions: Wound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Validated questionnaires and ad hoc questions, outcomesModule primaryOutcomes measure: "What not to do in chronic wounds?", primaryOutcomes measure: ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test), secondaryOutcomes measure: Ad hoc open questions, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Corporació Sanitària Parc Taulí, city: Sabadell, state: Barcelona, zip: 08208, country: Spain, geoPoint lat: 41.54329, lon: 2.10942, hasResults: False
protocolSection identificationModule nctId: NCT06388941, orgStudyIdInfo id: CLNP023R12201, briefTitle: Iptacopan in Patients With ANCA Associated Vasculitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-28, primaryCompletionDateStruct date: 2027-08-27, completionDateStruct date: 2027-09-22, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL., conditionsModule conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Iptacopan, interventions name: Placebo, interventions name: Rituximab, outcomesModule primaryOutcomes measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48., secondaryOutcomes measure: B cell counts, secondaryOutcomes measure: Total IgG levels, secondaryOutcomes measure: Complete remission at week 24, secondaryOutcomes measure: Time to reach BVAS=0, secondaryOutcomes measure: Time to major relapse, secondaryOutcomes measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks, secondaryOutcomes measure: Cumulative dose of glucocorticoid (GC), secondaryOutcomes measure: Glucocorticoid toxicity index over 48 weeks, secondaryOutcomes measure: 36-Item short form survey (SF-36), secondaryOutcomes measure: Patient's Global Assessment (PtGA), secondaryOutcomes measure: Physician's global assessment (PhGA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06388928, orgStudyIdInfo id: P.T.REC/012/004596, briefTitle: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-09, primaryCompletionDateStruct date: 2023-12-26, completionDateStruct date: 2023-12-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.This study was conducted to answer the following question:- Is there any effect of the menstrual cycle on the manual dexterity of female dentists?, conditionsModule conditions: Menstrual Cycle, conditions: Manual Dexterity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Manual dexterity assessment, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Horus University, city: Damietta, country: Egypt, geoPoint lat: 31.41648, lon: 31.81332, hasResults: False
protocolSection identificationModule nctId: NCT06388915, orgStudyIdInfo id: K2202403004, briefTitle: A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-03-23, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Weikang Chen, class: OTHER, descriptionModule briefSummary: Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries., conditionsModule conditions: Pelvic Fracture, conditions: Morel-Lavallee Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, outcomesModule primaryOutcomes measure: Site of MLL, primaryOutcomes measure: Site of injury and Classification of pelvic fracture, secondaryOutcomes measure: Time to treatment, secondaryOutcomes measure: Drainage volume, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Provincial Hospital, city: Fuzhou, state: Fujian, zip: 350000, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
protocolSection identificationModule nctId: NCT06388902, orgStudyIdInfo id: BR115-101, briefTitle: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: BioRay Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study., conditionsModule conditions: Advanced Solid Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: BR115 for injection, outcomesModule primaryOutcomes measure: Treatment-emergent Adverse Events Following Treatment With BR115, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR)., secondaryOutcomes measure: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC), secondaryOutcomes measure: The anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Rui Xu, MD, role: CONTACT, phone: 86-20-87343468, email: ruihxu@163.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06388889, orgStudyIdInfo id: AR-DEX-22-04, briefTitle: Phase III Long-Term Extension Study With Dexpramipexole, acronym: EXHALE-5, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Areteia Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3., conditionsModule conditions: Eosinophilic Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: Dexpramipexole Dihydrochloride, outcomesModule primaryOutcomes measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event, primaryOutcomes measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations, primaryOutcomes measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight, primaryOutcomes measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters, secondaryOutcomes measure: Severe Asthma Exacerbations, secondaryOutcomes measure: Change in Asthma Control Questionnaire-6 (ACQ-6), secondaryOutcomes measure: Change in absolute eosinophil counts (AEC), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site 20001-004, city: Tampa, state: Florida, zip: 33607, country: United States, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
protocolSection identificationModule nctId: NCT06388876, orgStudyIdInfo id: AnkaraYBUbk, briefTitle: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, collaborators name: TÜBİTAK, descriptionModule briefSummary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye., conditionsModule conditions: Earthquake, conditions: Stress Disorders, Post-Traumatic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: there are 2 groups; exercise and control, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Exercise, interventions name: lifestyle advice, outcomesModule primaryOutcomes measure: Post-traumatic Stress Disorder Short Scale, primaryOutcomes measure: Pittsburgh Sleep Quality Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Yildirim Beyazıt University, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06388863, orgStudyIdInfo id: B2024-002, briefTitle: Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Healthy donor-derived FMT capsule, interventions name: Placebo capsule, outcomesModule primaryOutcomes measure: Response rate of constipation in Parkinson's Disease (PD), secondaryOutcomes measure: Change from baseline PD symptoms at week 5, week 13 and week 24, secondaryOutcomes measure: Change from baseline anxiety at week 5, week 13 and week 24, secondaryOutcomes measure: Change from baseline depression at week 5, week 13 and week 24, secondaryOutcomes measure: Change from baseline quality of life at week 5, week 13 and week 24, secondaryOutcomes measure: Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24, secondaryOutcomes measure: Change from baseline fecal microbiota at week 5, week 13 and week 24, secondaryOutcomes measure: Change from baseline fecal metabolites at week 5, week 13 and week 24, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 180 Fenglin Road, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Shengdi Wu, role: CONTACT, phone: (86)13817923359, email: wu.shengdi@zs-hospital.sh.cn, contacts name: Shengdi Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06388850, orgStudyIdInfo id: 5U01CE003393-03, type: NIH, link: https://reporter.nih.gov/quickSearch/5U01CE003393-03, briefTitle: Evaluation of HRP Among Pre-K Through 5th Grade, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-03-23, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Northeastern University, class: OTHER, descriptionModule briefSummary: This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data., conditionsModule conditions: Child Sexual Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Healthy Relationships Project, outcomesModule primaryOutcomes measure: Reports of child sexual abuse, secondaryOutcomes measure: The Parental Knowledge Scale (PKS), secondaryOutcomes measure: The Parental Discussions about Sex Abuse Scale (PDSAS), secondaryOutcomes measure: The adapted Parenting Self Agency (PSAM), secondaryOutcomes measure: The Parent Knowledge Questionnaire (PKQ), secondaryOutcomes measure: HRP evaluation, secondaryOutcomes measure: The CSA Myths Scale, secondaryOutcomes measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Safe Shores, city: Washington, state: District of Columbia, zip: 20001, country: United States, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False
protocolSection identificationModule nctId: NCT06388837, orgStudyIdInfo id: RECO6U/20- 2021, briefTitle: Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-20, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2023-03-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft, conditionsModule conditions: Symphysis Onlay Bone Graft, conditions: Platelet Rich Fibrin, conditions: Xenograft, conditions: Horizontal Alveolar Ridge Augmentation, conditions: Esthetic Zone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: Injectable Platelet Rich Fibrin, interventions name: Xenograft, outcomesModule primaryOutcomes measure: Alveolar ridge width, secondaryOutcomes measure: Bone density, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 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: NCT06388824, orgStudyIdInfo id: GWang028, briefTitle: The Effect of Esketamine on Sleep Disturbance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University General Hospital, class: OTHER, descriptionModule briefSummary: To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance, conditionsModule conditions: Sleep Disturbance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: normal saline, interventions name: Esketamine, outcomesModule primaryOutcomes measure: The incidence of sleep disturbance on the first night after surgery, secondaryOutcomes measure: The incidence of sleep disturbance on the second and third postoperative nights, secondaryOutcomes measure: The incidence of sleep disturbance on the seventh postoperative nights, secondaryOutcomes measure: Postoperative anxiety, secondaryOutcomes measure: Postoperative depression, secondaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Adverse event, secondaryOutcomes measure: preoperative hemoglobin concentration, secondaryOutcomes measure: Human Chorionic Gonadotropin level, secondaryOutcomes measure: The incidence of sleep disturbance on the day before surgery, secondaryOutcomes measure: The incidence of sleep disturbance before surgery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University General Hospital, city: Tianjin, zip: 300052, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False