hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06296966, orgStudyIdInfo id: VP-VSJ-110-2201, briefTitle: A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Vanda Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye., conditionsModule conditions: Dry Eye, 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: 40, type: ESTIMATED, armsInterventionsModule interventions name: VSJ-110, interventions name: Placebo, outcomesModule primaryOutcomes measure: Schirmer's Tear Test, secondaryOutcomes measure: Ocular Staining, secondaryOutcomes measure: Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanda Investigational Site, status: RECRUITING, city: Andover, state: Massachusetts, zip: 01810, country: United States, contacts name: Vanda Pharmaceuticals Inc., role: CONTACT, phone: 202-734-3400, email: clinicaltrials@vandapharma.com, geoPoint lat: 42.65843, lon: -71.137, hasResults: False
protocolSection identificationModule nctId: NCT06296940, orgStudyIdInfo id: WEST 2.0, briefTitle: Written Exposure in Substance Treatment, acronym: WEST, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Potomac Health Foundations, class: OTHER, collaborators name: University of Maryland, Baltimore County, descriptionModule briefSummary: The purpose of this pilot randomized clinical trial is to test the feasibility and efficacy of written exposure therapy (WET) for posttraumatic stress disorder (PTSD) within the context of residential substance use disorder (SUD) treatment. All participants meet criteria for PTSD and are in a short term residential SUD treatment program (target residential treatment duration = 28 days) regardless of the research. The main questions the study aims to answer are: 1) Is the delivery of WET feasible in short term residential SUD treatment for individuals with severe SUD; 2) Do participants in the TAU+WET condition have greater reductions in PTSD symptoms pre/post treatment compared to participants in TAU alone?, conditionsModule conditions: Posttraumatic Stress Disorder, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: We are conducting a randomized controlled trial of approximately 50 randomized subjects (up to 100 total enrollments) who will be assigned 1:1 to treatment as usual (TAU) or TAU+WET., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Written Exposure Therapy, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Efficacy of WET, secondaryOutcomes measure: Feasibility of WET delivered in residential SUD treatment context, secondaryOutcomes measure: Acceptability of WET delivered in residential SUD treatment context, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maryland Treatment Centers, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21229, country: United States, contacts name: Kevin Wenzel, PhD, role: CONTACT, phone: 410-233-1400, email: kwenzel@marylandtreatment.org, contacts name: Marc Fishman, MD, role: CONTACT, phone: 410.233.1400, email: mfishman@marylandtreatment.org, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06296927, orgStudyIdInfo id: SumeyyeKose-E.138186, briefTitle: The Effect of the Emotional Freedom Technique on Perceived Pain, Situational Anxiety, Cortisol and Satisfaction Levels in Mammography Screening., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Saglik Bilimleri Universitesi, class: OTHER, descriptionModule briefSummary: This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxiety, salivary cortisol and satisfaction level during mammography screening., conditionsModule conditions: Mammography Screening, conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a randomized controlled two-group study., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Freedom Technique, outcomesModule primaryOutcomes measure: Anxiety, primaryOutcomes measure: Pain Level, secondaryOutcomes measure: Satisfaction Level, secondaryOutcomes measure: Cortisol Level, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center, city: Istanbul, country: Turkey, contacts name: SUMEYYE KOSE, role: CONTACT, phone: 2163961630, phoneExt: 6173, email: sumeyyekose28@gmail.com, contacts name: Sümeyye Köse, Phd Student, role: PRINCIPAL_INVESTIGATOR, contacts name: Handan Özcan, Assoc.Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Türkinaz Aşti, Prof.Dr., role: SUB_INVESTIGATOR, contacts name: Fatih Hacımustafaoğlu, Lecturer Dr., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06296901, orgStudyIdInfo id: 202310353, briefTitle: To Wipe or Not To Wipe?: That Is The Question, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Joanna A. Orzel, class: OTHER, descriptionModule briefSummary: The primary aim of this randomized control trial is to characterize whether a mid-stream clean catch sample using a cleansing wipe in the setting of symptomatic UTI in a female patient is associated with a lower rate of contamination. We hypothesize that using a perineal cleansing wipe at the time of a midstream urine sample will decrease rates of contamination for female patients with a symptomatic UTI., conditionsModule conditions: Urinary Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Perineal Wipe, outcomesModule primaryOutcomes measure: Rate of Contamination, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06296862, orgStudyIdInfo id: STUDY00005563, briefTitle: Effect of DASH on HF Outcomes Heart Failure Status in Older Adults (DASH HF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: Emory University, descriptionModule briefSummary: The purpose of this study is to examine the effect of the Dietary Approaches to Stop Hypertension (DASH) diet has on heart failure status in older adults. This study is important because it may provide a low-cost strategy to help reduce hospitalizations and deaths for heart failure patients. Participants will be adults age 65 and older with heart failure. They will have 4 study visits, each lasting about 2 hours, and will be in the study for 12 weeks. They will also be asked about their dietary consumption 6 times, each time lasting about 45 minutes. All in-person study visits will take place in the Emory GCRC. Participants will have physical exams, body measurements, blood tests, urinalysis, chart review, and answer surveys. They will be randomized to eat only the DASH diet provided to them for 4 weeks either at the beginning or end of their participation in the study. Participants will be recruited from heart failure patients at Emory University Hospital, Emory University Hospital Midtown, and Emory Outpatient Advanced Heart Failure Therapy Center. The total enrollment planned under Emory's oversight, accounting for screen failures and withdrawals, will be n=38 participants. The study team will obtain informed consent prior to the first study visit either in person, or, alternatively, over the phone, if requested by participants. Specimens and data obtained in this study will not be banked for future use., conditionsModule conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Dietary Approaches to Stop Hypertension Diet, outcomesModule primaryOutcomes measure: B-natriuretic peptide (BNP), secondaryOutcomes measure: N-terminal-proBNP (NT-proBNP), secondaryOutcomes measure: Systolic and Diastolic Pulmonary Artery Pressures, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 110 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory Clinical Cardiovascular Research Center (ECCRI), city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Arshed A Quyyumi, MD, PhD, role: CONTACT, phone: 404-727-6635, email: quyyum@emory.edu, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
protocolSection identificationModule nctId: NCT06296836, orgStudyIdInfo id: 2024-001, briefTitle: Effect of Continuing Versus Holding Metformin During Hospitalizations., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, collaborators name: Emily Hanners, collaborators name: Dulal Bhaumik, collaborators name: Avisek Datta, collaborators name: Peggy Choye, collaborators name: Hailey Soni, collaborators name: Annesti Elmasri, collaborators name: Julie Jun, collaborators name: Colin Goodman, descriptionModule briefSummary: A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, parallel, prospective trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: Mean glucose levels, secondaryOutcomes measure: Incidence of hyperglycemia greater than 300 mg/dl., secondaryOutcomes measure: Incidence of hypoglycemia (Glu = 54 - 70)., secondaryOutcomes measure: Incidence of moderate hypoglycemia (Glu < 54), secondaryOutcomes measure: Incidence of severe hypoglycemia (Glu < 54 with symptoms), secondaryOutcomes measure: Mean lactic acid levels., secondaryOutcomes measure: Incidence of lactic acid levels greater than 2.0., secondaryOutcomes measure: Mean anion gap., secondaryOutcomes measure: Incidence of anion gap > 11, secondaryOutcomes measure: Incidence of elevated lactic acid level or anion gap., secondaryOutcomes measure: Incidence of inadvertently not continuing metformin on discharge, secondaryOutcomes measure: GI adverse effects, secondaryOutcomes measure: Mortality, otherOutcomes measure: Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, city: Chicago, state: Illinois, zip: 60612, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06296810, orgStudyIdInfo id: 23-0847, briefTitle: Adaptive DBS to Offset STN Dysregulation During Exercise in PD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: aDBS, outcomesModule primaryOutcomes measure: identification of L-beta frequency peak power, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06296784, orgStudyIdInfo id: PG/2021/8551, briefTitle: An E-health Psychoeducation for People With Bipolar Disorders, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-26, primaryCompletionDateStruct date: 2021-11-15, completionDateStruct date: 2021-11-15, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Cagliari, class: OTHER, collaborators name: Alessandra Perra, descriptionModule briefSummary: This study aims to present data on the improvement of Quality of life (QoL), biological rhythms, anxiety, depressive symptoms and the correlations between QoL and biorhythms following an e-health psychoeducational intervention for Bipolar Disoirder (BD) during Covid-19 pandemic, conditionsModule conditions: Bipolar Disorder, conditions: Psychoeducation, conditions: COVID-19 Pandemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Open-label cross-over randomized controlled trial (two arms), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: e-health psychoeducation, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), primaryOutcomes measure: Hamilton Depression Rating Scale (HDRS21), primaryOutcomes measure: Short Form Health Survey (SF-12), primaryOutcomes measure: Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Giovanni di Dio Hospital, city: Cagliari, state: CA, zip: 09100, country: Italy, geoPoint lat: 39.23054, lon: 9.11917, hasResults: False
protocolSection identificationModule nctId: NCT06296758, orgStudyIdInfo id: SiFi_HIP FRACTURE, briefTitle: SiFi vs FNB Local Anesthesia for Hip Fracture Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare two commonly used local/regional anesthesia techniques in adults patients undergoing hip fracture surgery. The main question\[s\] it aims to answer are: • the impact of both interventions on patient level of pain. • impact on postoperative analgesics administered Participants will be randomly assigned to one of two local/regional anesthesia techniques, either femoral nerve block (FNB) or suprainguinal fascia iliaca block (SiFi). Both techniques are the usual practice at the hospital, and we are NOT aiming to experiment on new anesthesia technique in this study., conditionsModule conditions: Hip Fractures, conditions: Surgery, conditions: Anesthesia, Local, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A concealed-allocation parallel-group blinded randomized controlled clinical, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization will be conducted through blocked randomization with blocks of 4 according to a schedule not known to the investigators using a computerized algorithm. The attending surgeon, anesthetist, and nursing team will be blinded to the randomization assignment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Regional anesthesia, outcomesModule primaryOutcomes measure: Postoperative pain, primaryOutcomes measure: Postoperative analgesics administered, secondaryOutcomes measure: Mobilization, secondaryOutcomes measure: Time to readiness for discharge, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alberta Hospital, city: Edmonton, state: Alberta, zip: t6g2b7, country: Canada, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False
protocolSection identificationModule nctId: NCT06296745, orgStudyIdInfo id: 2024-KY-008-01, briefTitle: Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-01-20, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Guangzhou Medical University, class: OTHER, descriptionModule briefSummary: Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in treating non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. An international multi-center clinical study published in 2019 confirmed that double dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, the choice of treatment after resistance to targeted therapy is a hot topic in clinical practice, with 78% of patients in the study above who responded to double-dose osimertinib still showing progression at the time of follow-up. The purpose of this study was to observe the safety and efficacy of intrathecal pemetrexed for leptomeningeal metastasis from lung adenocarcinoma that progressed after a double dose of a third-generation TKI such as osimertinib., conditionsModule conditions: Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Pemetrexed, outcomesModule primaryOutcomes measure: Clinical response rate, primaryOutcomes measure: Neurological progression-free survival (NPFS), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False