hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06385418, orgStudyIdInfo id: WST-CRC-202404, briefTitle: Fluorouracil Treatment Via Colon for Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Colonic local administration of fluorouracil with enhanced adhesion, outcomesModule primaryOutcomes measure: Objective response rate (according to RECIST1.1, investigator assessment), secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease control rate (according to RECIST1.1, investigator assessment), secondaryOutcomes measure: Drop period to ensure operation resection, secondaryOutcomes measure: Converted resection rate, secondaryOutcomes measure: Actual R0 resection rate, secondaryOutcomes measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, contacts name: Faming Zhang, MD, PhD, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06385405, orgStudyIdInfo id: 2024y0423, briefTitle: Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Shanghai Mental Health Center, class: OTHER, collaborators name: National Natural Science Foundation of China, collaborators name: Shanghai Municipal Science and Technology Commission, collaborators name: Shanghai Jiao Tong University School of Medicine, descriptionModule briefSummary: This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD)., conditionsModule conditions: Major Depressive Disorder (MDD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC)., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment, interventions name: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC), outcomesModule primaryOutcomes measure: the effective rate, secondaryOutcomes measure: complete remission rate, secondaryOutcomes measure: alpha band spectral connectivity in electroencephalogram (EEG) parameters, secondaryOutcomes measure: Evaluation of therapeutic effect, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, state: Shanghai, zip: 200030, country: China, contacts name: TianHong Zhang, Doctor, role: CONTACT, phone: 13127577024, email: zhang_tianhong@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06385392, orgStudyIdInfo id: A23-354, briefTitle: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Haptic module and insole device, outcomesModule primaryOutcomes measure: To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Struthers Parkinson's Center, city: Golden Valley, state: Minnesota, zip: 55427, country: United States, contacts name: Research Coordinator, role: CONTACT, phone: 651-495-6363, email: ClinicalTrials@HealthPartners.com, geoPoint lat: 45.00969, lon: -93.34912, locations facility: HealthPartners Neuroscience Center, city: Saint Paul, state: Minnesota, zip: 55130, country: United States, contacts name: Clinical Trial Coordinator, role: CONTACT, phone: 651-495-6363, email: ClinicalTrials@HealthPartners.com, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False
protocolSection identificationModule nctId: NCT06385366, orgStudyIdInfo id: GS_NP1, briefTitle: Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-05-06, completionDateStruct date: 2025-06-06, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Gene Solutions, class: INDUSTRY, collaborators name: Medical Genetics Institute (MGI), descriptionModule briefSummary: This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam., conditionsModule conditions: Pregnant With Complication, conditions: Preeclampsia, conditions: Preterm Birth, conditions: Gestational Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1105, type: ESTIMATED, outcomesModule primaryOutcomes measure: Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation), primaryOutcomes measure: Characteristics of pregnant women at recruitment, primaryOutcomes measure: Define the significant differences between cases and controls, primaryOutcomes measure: The development of learning machine models, primaryOutcomes measure: Evaluation of the developed models, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385340, orgStudyIdInfo id: CentroDerm_LRP22003, briefTitle: Investigation of the Effect of Lipikar Baume AP+M, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: CentroDerm GmbH, class: NETWORK, descriptionModule briefSummary: Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.A total of 20 subjects will be enrolled.The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application))., conditionsModule conditions: Actinic Keratoses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Lipikar Baume AP+M, outcomesModule primaryOutcomes measure: Skin hydration measured by Corneometrie, primaryOutcomes measure: Transepidermal water loss measured by Tewameter®, primaryOutcomes measure: Aktinic keratosis area and severity index (AKASI), primaryOutcomes measure: S. aureus colonization and S. epidermidis colonization (application area), primaryOutcomes measure: Subjects's skin aspect, secondaryOutcomes measure: Absolute lesion count by application site, secondaryOutcomes measure: Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site, secondaryOutcomes measure: Number of new lesions on application area over the study period by application site, secondaryOutcomes measure: Symptom severity score: percentage across individual scores at each visit by application site, secondaryOutcomes measure: modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9), secondaryOutcomes measure: Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days), secondaryOutcomes measure: Pictures at all time points, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06385314, orgStudyIdInfo id: Degirmenci1499, briefTitle: A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-05, primaryCompletionDateStruct date: 2023-11-25, completionDateStruct date: 2023-12-29, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered., conditionsModule conditions: Dental Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Collecting data with oral health related quality of life, dental anxiety and state anxiety, outcomesModule primaryOutcomes measure: United Kingdom Oral Health-Related Quality-of-Life Measure, primaryOutcomes measure: Modified Dental Anxiety Scale, primaryOutcomes measure: Spielberger State Anxiety Inventory, primaryOutcomes measure: Spielberger Trait Anxiety Inventory, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kubra Degirmenci, city: Bolu, country: Turkey, geoPoint lat: 40.73583, lon: 31.60611, hasResults: False
protocolSection identificationModule nctId: NCT06385301, orgStudyIdInfo id: Lung_disease_6MWD_SOT, briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise., conditionsModule conditions: Lung Disease Chronic, conditions: Lung Diseases, Interstitial, conditions: Lung Diseases, Obstructive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant is its own control, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: 6-minute walk distance (6MWD) test on ambient air, interventions name: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal), outcomesModule primaryOutcomes measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air, secondaryOutcomes measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air, secondaryOutcomes measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zürich, city: Zurich, zip: 8091, country: Switzerland, contacts name: Silvia Ulrich, Prof. Dr., role: CONTACT, phone: 0041 44 255 22 20, email: silvia.ulrich@usz.ch, contacts name: Mona Lichtblau, Dr., role: CONTACT, phone: +41442552220, email: mona.lichtblau@usz.ch, contacts name: Silvia Ulrich, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
protocolSection identificationModule nctId: NCT06385288, orgStudyIdInfo id: 268/2021BO2, briefTitle: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-21, primaryCompletionDateStruct date: 2026-07-21, completionDateStruct date: 2031-07-21, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging., conditionsModule conditions: Soft Tissue Sarcoma Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Open Label, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Blood and tissue collection for immunological studies, advanced imaging., interventions name: neoadjuvant Therapy, outcomesModule primaryOutcomes measure: Description of the cellular immune status via flow-cytometrie from collected blood samples, primaryOutcomes measure: Description of the cellular immune status on tissue samples ussing komplex immunohistochemie, primaryOutcomes measure: Measurement of the cellular free DNA from collected blood samples, primaryOutcomes measure: Measurement of HMGB1 from collected blood samples, primaryOutcomes measure: Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Tuebingen, status: RECRUITING, city: Tübingen, state: Baden-Württemberg, zip: 72076, country: Germany, contacts name: Vlatko Potkrajcic, MD, role: CONTACT, phone: +49 7071 29, phoneExt: 82165, email: Vlatko.potkrajcic@med.uni-tuebingen.de, contacts name: Cihan Gani, MD, role: CONTACT, phone: +49 7071 29, phoneExt: 82165, email: cihan.gani@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
protocolSection identificationModule nctId: NCT06385262, orgStudyIdInfo id: Pro00114645, briefTitle: TOP 2301: Neoadjuvant Chemo for NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Alirocumab, interventions name: Cemiplimab, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab., secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR), secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS), secondaryOutcomes measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS), secondaryOutcomes measure: Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC), secondaryOutcomes measure: Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False