hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06326190, orgStudyIdInfo id: EORTC-2334-BTG, briefTitle: 177Lu-DOTATATE for Recurrent Meningioma, acronym: LUMEN-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-06, primaryCompletionDateStruct date: 2027-04-14, completionDateStruct date: 2028-12-22, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: European Organisation for Research and Treatment of Cancer - EORTC, class: NETWORK, collaborators name: Novartis, descriptionModule briefSummary: Novel treatments are urgently needed for meningiomas progressing after local therapies (surgery, radiotherapy). So far, no effective systemic therapies are known in this situation. The LUMEN-1 trial will investigate in a prospective randomized trial the efficacy of the precision medicine "theranostic" concept of combining diagnostic patient selection using PET-based molecular imaging and target-specific therapeutic intervention using a systemically administered radioligand.The rationale for the LUMEN-1 trial is based on the following: (a) high somatostatin receptor (SSTR) expression in meningiomas, (b) wide-spread availability of clinically established SSTR-PET imaging, (c) proven efficacy of SSTR-targeting radioligand therapy using \[177Lu\]Lu-DOTATATE in another tumor type (neuroendocrine tumors), and (d) promising experiences with \[177Lu\]Lu-DOTATATE therapy in compassionate use applications and retrospective case series and interim results from one ongoing uncontrolled prospective trial in meningiomas. LUMEN-1 is the first randomized clinical trial to investigate \[177Lu\]Lu-DOTATATE therapy in refractory meningioma and may open new avenues for treatment and research in this area., conditionsModule conditions: Recurrent Meningioma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Local standard of Care, interventions name: 177Lu-DOTATATE, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Radiological response rate, secondaryOutcomes measure: Radiological response rate, secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: The magnitude of change in Health-related quality of life (HRQoL), secondaryOutcomes measure: Neurological function (NANO scale), secondaryOutcomes measure: Toxicity According to CTCAE Version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06326177, orgStudyIdInfo id: Yeditepe U - Poyraz Tuncer, briefTitle: Investigating Association Between Spine, Scapular, Shoulder and Core in Swimmers, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Yeditepe University, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to investigate relationship between cervical, thoracic, lumbar and thoracolumbar spine posture, spine movement, isometric and eccentric shoulder strength, scapular dyskinesis and core muscle endurance in healthy competitive young swimmers in comparison with healthy recreational swimmers. The main question is whether spine posture affects spine movement, shoulder strength, scapular dyskinesia and core endurance. Participants will asked to complete a warm up period, after that spine posture, spine movement, scapular dyskinesia, shoulder strength and core endurance will be assessed by examiner. Researchers will compare competitive swimmer group and recreational swimmer group. Additionally correlation between spine posture, spine movement, scapular dyskinesia, shoulder strength and core muscle endurance will be investigated in competitive swimmer group. Aim of the study is to determine whether posture have any effect upon these parameters., conditionsModule conditions: Postural Kyphosis, conditions: Postural Lordosis, conditions: Movement, Abnormal, conditions: Spine Injury, conditions: Cervical Lordosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Spine Posture Assessment, interventions name: Spine Movement Assessment, interventions name: Core Muscle Endurance Assessment, interventions name: Scapular Dyskinesia, interventions name: Shoulder Strength, outcomesModule primaryOutcomes measure: Spinal Posture, primaryOutcomes measure: Cervical Movement, primaryOutcomes measure: Thoracic Movement, primaryOutcomes measure: Lumbar Movement, primaryOutcomes measure: Thoracolumbar Movement, secondaryOutcomes measure: Anterior Core Musculature Assessment, secondaryOutcomes measure: Lateral Core Musculature Assessment, secondaryOutcomes measure: Posterior Core Musculature Assessment, secondaryOutcomes measure: Core Musculature Ratio Assessment, secondaryOutcomes measure: Shoulder Strength Assessment, secondaryOutcomes measure: Shoulder Strength Ratio Assessment, secondaryOutcomes measure: Scapular Dyskinesia, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: PT Academy, city: Istanbul, state: Kadıköy, zip: 34744, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06326164, orgStudyIdInfo id: sample, briefTitle: Effect of Kinesio-taping of Lower Limbs, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-07-18, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trail is to test if kinesio-taping on lower limbs has an effect on balance and gait in children with diplegic cerebral palsy. Children in study group will have designed physiotherapy for gait and balance, the control group will have designed physiotherapy in addition to kinesio-taping on both lower limbs., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: kinesio-taping., interventions name: A designed physiotherapy program., outcomesModule primaryOutcomes measure: Change in gait., primaryOutcomes measure: Change in balance., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Asmaa Mohamed Khalil Sedeek, status: RECRUITING, city: Kafr Ash Shaykh, country: Egypt, contacts name: asmaa M khalil, role: CONTACT, phone: 01101011588, email: asmaakhalil011010@gmail.com, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
protocolSection identificationModule nctId: NCT06326138, orgStudyIdInfo id: 22121, briefTitle: Pharmacokinetics and Pharmacodynamics of Edoxaban Before and After Bariatric Surgery, acronym: EXPOSE, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-03-11, completionDateStruct date: 2024-03-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, class: OTHER, descriptionModule briefSummary: The study will be conducted at a single site in the Canada, Quebec. Participants will be recruited from the bariatric surgery clinic and will be required to be either, waiting for sleeve gastrectomy surgery (n=12, restrictive bariatric surgery, Group 1) or Roux-en-Y gastric bypass (n=12, mixed bariatric surgery, Group 1), or had underwent Roux-en-Y gastric bypass 12 ± 3 months ago (n=12, Group 2).Participants in Group 1, edoxaban pharmacokinetic and pharmacodynamics will be evaluated before and 48 ± 5 hours after bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass). Participants in Group 2, edoxaban pharmacokinetic and pharmacodynamics will be evaluated only once, at 12 ± 3 months following their Roux-en-Y gastric bypass.All participants will be received single oral doses of 60 mg edoxaban at each pharmacokinetic and pharmacodynamics evaluation., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1: 12 patients waiting for a sleeve gastrectomy surgery and 12 patients waiting for a Roux-en-Y gastric bypass surgery.Group 2: 12 patients 12 months after Roux-en-Y gastric bypass surgery., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Edoxaban Pharmacokinetics and Pharmacodynamics, outcomesModule primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, primaryOutcomes measure: Pharmacokinetics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, secondaryOutcomes measure: Pharmacodynamics edoxaban parameter, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06326125, orgStudyIdInfo id: SherzadSH, briefTitle: Pharmacology and Non-pharmacology Approaches in Reducing Children's Pain and Fear During Painful Procedures, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, descriptionModule briefSummary: This study Will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture, conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: TICK-B, interventions name: TKTX-Cream, interventions name: TICK-B and TKTX-C, outcomesModule primaryOutcomes measure: severity of Pain, secondaryOutcomes measure: Fear, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sherzad Khudeida Suleman, city: Duhok, state: Erbil, zip: 42012, country: Iraq, geoPoint lat: 36.86709, lon: 42.98845, hasResults: False
protocolSection identificationModule nctId: NCT06326112, orgStudyIdInfo id: 4588, briefTitle: Role of Active Deresuscitation After Resuscitation:, acronym: RADAR-Canada, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU)., conditionsModule conditions: Fluid Overload, conditions: Critical Illness, conditions: Sepsis, conditions: ARDS, conditions: Trauma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Masking of the health care team will not be feasible as they must administer the intervention, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Furosemide Injection, interventions name: Metolazone Tablets, outcomesModule primaryOutcomes measure: Efficacy: Mean cumulative fluid balance, primaryOutcomes measure: Compliance with deresuscitation protocol, primaryOutcomes measure: Acceptability of protocol, secondaryOutcomes measure: All cause mortality, secondaryOutcomes measure: New onset organ dysfunction, secondaryOutcomes measure: Organ support-free days, otherOutcomes measure: Inflammatory and renal biomarkers - change from baseline values, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unity Health Toronto, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: John C Marshall, MD, role: CONTACT, phone: 4168645225, email: john.marshall@unityhealth.to, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06326099, orgStudyIdInfo id: R34AA030655, type: NIH, link: https://reporter.nih.gov/quickSearch/R34AA030655, briefTitle: Brief Binge Eating and Drinking Online Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, descriptionModule briefSummary: This pilot project targets both binge drinking and binge eating behavior in college students through a mobile-based online program that provides students with evidence-based intervention material designed to reduce the incidence of both behaviors and encourage students to seek more formal in-person counseling., conditionsModule conditions: Binge Eating, conditions: Binge Drinking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Brief Online Binge Eating and Drinking Intervention, outcomesModule primaryOutcomes measure: Frequency of past 28-day binge drinking, primaryOutcomes measure: Frequency of past 28-day binge eating, primaryOutcomes measure: Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ), secondaryOutcomes measure: Mental Health/Substance Use Disorder Treatment History Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06326086, orgStudyIdInfo id: REC.65-080-7-1, briefTitle: Differences in Rate of Decline in CT-defined Skeletal Muscle Mass and Physical Performance in Patients With Advanced Non-small Cell Lung Cancer Receiving Chemotherapy and Targeted Therapy/Immunotherapy, Before and After Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: Lung cancer is a common disease leading to 18 % of cancer deaths worldwide. Despite various improvement in treatment, there still remains low 5-year survival rate of 10-20 % in advanced lung cancer patients. Skeletal muscle mass and physical performance have been shown to effect overall survival and prognosis in lung cancer. This research focuses on effects of different treatment of lung cancer such as chemotherapy, targeted therapy and immunotherapy on skeletal muscle mass and physical performance., conditionsModule conditions: Advanced Lung Cancer, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Chemotherapy drug, interventions name: Targeted Agent, interventions name: Immunotherapy, outcomesModule primaryOutcomes measure: To determine the differences in the rate of decline in CT defined skeletal muscle index at L3 vertebra and physical performance in advanced NSCLC patients receiving chemotherapy and targeted therapy/ immunotherapy, before and after treatment., secondaryOutcomes measure: To determine validity of gender based cut off for CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) based on recommendation of JSH/AWGS in Thai population., otherOutcomes measure: 2. To determine baseline association between CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) and physical performance using SPPB in advanced NSCLC patients., otherOutcomes measure: 4. To determine differences in rate decline in skeletal muscle mass using CT-defined skeletal muscle index at L3 lumbar vertebra (L3SMI) in patients receiving first line chemotherapy (CMT) and other line chemotherapy (OCMT)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince of Songkla University, status: RECRUITING, city: Hat Yai, state: Songkla, zip: 90110, country: Thailand, geoPoint lat: 7.00836, lon: 100.47668, hasResults: False
protocolSection identificationModule nctId: NCT06326073, orgStudyIdInfo id: OMUKAEK2019/324, briefTitle: Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-01, primaryCompletionDateStruct date: 2021-02-01, completionDateStruct date: 2021-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically., conditionsModule conditions: Periodontitis, conditions: Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SH)(n:11) and non-smokers(H)(n:11) with periodontal healthy individuals, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ACTUAL, armsInterventionsModule interventions name: Non Surgical Periodontal Treatment, outcomesModule primaryOutcomes measure: Evaluation of Periostin levels, primaryOutcomes measure: Evaluation of IL-17A levels, primaryOutcomes measure: Evaluation of IL-17E levels, secondaryOutcomes measure: Interaction Between Smoking and GCF Periostin, IL17A, IL17E levels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ondokuz Mayıs University Faculty of Dentistry Department of Periodontology, city: Samsun, zip: 55270, country: Turkey, geoPoint lat: 41.27976, lon: 36.3361, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-16, uploadDate: 2024-03-16T11:54, filename: Prot_SAP_000.pdf, size: 206405, hasResults: False