hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06323837, orgStudyIdInfo id: 20383, briefTitle: Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment, acronym: MIRROM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Washington State University, class: OTHER, descriptionModule briefSummary: This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the treatment of methamphetamine (MA) use among medication for opioid use disorder (MOUD) patients, to significantly decrease MA use and related health-impairing behaviors. MZP has already successfully been used in the treatment of methamphetamine (detailed further below and in the Appendices).The investigators hypothesize that those assigned to the MZP plus treatment as usual (TAU) MZP+TAU arm will demonstrate significantly increased rates of biochemically verified abstinence from MA and other substances of abuse and experience improvements in health impairing behaviors relative to the placebo (PLO)+TAU arm across the 10-week treatment and follow-up periods., conditionsModule conditions: Stimulant Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mirtazapine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Urinanalysis Verified Increased Days of MA Abstinence, secondaryOutcomes measure: Actigraphy Verified Improved Sleep Patterns, otherOutcomes measure: Self Reported Quantity of Adverse Events, otherOutcomes measure: Urinanalysis Verified Increased Days of Abstinence from Other Substances, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323811, orgStudyIdInfo id: COPE CMR, briefTitle: Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics, acronym: COPE-CMR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, collaborators name: ETH Zurich, descriptionModule briefSummary: This clinical study examines patients presenting with acute myocardial infarction and no significant coronary artery disease on coronary angiography (MINOCA) and patients with MINOCA-mimics with advanced CMR.The present study aims to:* assess the microvascular function with a novel quantitative 3D myocardial perfusion imaging approach in the acute phase and post-convalescence* refine the role and diagnostic potential of advanced quantitative CMR imaging* assess the potential prognostic significance of microvascular dysfunction and epicardial adipose tissue on cardiovascular outcomesParticipants will undergo advanced CMR imaging in the acute setting (within 10 days after event) and post convalescence (after 3 months)., conditionsModule conditions: Myocardial Infarction With Non-Obstructive Coronary Artery, conditions: Myocarditis Acute, conditions: Takotsubo Cardiomyopathy, conditions: Spontaneous Coronary Artery Dissection, conditions: Non ST Elevation Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 5 groups of patients (MINOCA, myocarditis, Takotsubo cardiomyopathy, SCAD, NSTEMI) will undergo CMR with 3D perfusion in the acute setting (within 10 days after the event) and post convalescence (after 3 months), primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: CMR, outcomesModule primaryOutcomes measure: Myocardial perfusion reserve index, secondaryOutcomes measure: epicardial adipose tissue (EAT), secondaryOutcomes measure: cardiovascular events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Zurich, status: RECRUITING, city: Zürich, zip: 8091, country: Switzerland, contacts name: Robert Manka, role: CONTACT, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
protocolSection identificationModule nctId: NCT06323798, orgStudyIdInfo id: 2024PI035, briefTitle: Diffusion Weighted MRI Enables Differential Diagnosis Between Pyocele and Mucocele, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-07-28, completionDateStruct date: 2024-12-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Diffusion MRI should allow for differentation of pus and simple retention in the paranasal sinuses, but this remained to be determined, conditionsModule conditions: Pyocele; Sinus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: apparent diffusion coefficient, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323785, orgStudyIdInfo id: 2022-D0067, briefTitle: Whole-body Hyperthermia for Depression, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Zurich, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of whole-body hyperthermia in major depression. The main question it aims to answer is:• Does whole-body hyperthermia alleviate symptoms of depression?Participants will be randomised to sham or active whole-body hyperthermia. The study will last 6 weeks during which five visits will take place. Depression will be measured repeatedly and biological mechanisms will be investigated., conditionsModule conditions: Major Depressive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Active whole-body hyperthermia, interventions name: Sham whole-body hyperthermia, outcomesModule primaryOutcomes measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression), secondaryOutcomes measure: Beck Depression Inventory (BDI; minimum: 0, maximum: 63; higher scores indicate higher depression), secondaryOutcomes measure: Medical Outcomes Study 36-item short-form health survey (MOS-SF; minimum: 0, maximum: 100, higher scores indicate better health status), secondaryOutcomes measure: Hamilton Rating Scale for Depression (HAMD-17; minimum: 0, maximum: 68, higher scores indicate higher depression), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zurich, Institute of Psychology, status: RECRUITING, city: Zurich, zip: 8050, country: Switzerland, contacts name: Susanne Fischer, PhD, role: CONTACT, phone: +41446357460, email: s.fischer@psychologie.uzh.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
protocolSection identificationModule nctId: NCT06323772, orgStudyIdInfo id: RDC-RP-01, briefTitle: Natural History Study in Patients With PDE6A-, PDE6B- and RHO-linked Retinitis Pigmentosa, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, descriptionModule briefSummary: The aim of the study is to apply a novel clinical investigation protocol in patients with Phosphodiesterase 6A (PDE6A), PDE6B and Rhodopsin (RHO)-based retinitis pigmentosa. This novel, multimodal clinical examination protocol describes and correlates structural, functional and metabolic aspects during natural disease development.Test-retest variability of new measurements as well as correlations of the structural, functional, and metabolic changes will be defined to be able to define well-suited readouts for safety and efficacy of future treatment developments before they reach the clinical phase., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Optical coherence tomography (OCT), primaryOutcomes measure: Fundus autofluorescence imaging, primaryOutcomes measure: Wide-field fundus photography, primaryOutcomes measure: Adaptive optics imaging, primaryOutcomes measure: V1 morphology (MRI), primaryOutcomes measure: Diffusion Tensor Imaging (DTI), primaryOutcomes measure: flavoprotein fluorescence (FPF), primaryOutcomes measure: Retinal oxymetry, primaryOutcomes measure: Local dark adapted adaptation curves, primaryOutcomes measure: best corrected visual acuity (BCVA), primaryOutcomes measure: Static cone perimetry and dark adapted perimetry, primaryOutcomes measure: chromatic pupil campimetry (CPC), primaryOutcomes measure: electroretinogram (ERG), primaryOutcomes measure: Virtual reality (VR) functional test, eligibilityModule sex: ALL, minimumAge: 5 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Ophthalmic Research, University Tübingen, status: RECRUITING, city: Tübingen, state: Baden-Württemberg, zip: 72076, country: Germany, contacts name: Katarina Stingl, Prof, role: CONTACT, phone: 070712988088, email: katarina.stingl@med.uni-tuebingen.de, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
protocolSection identificationModule nctId: NCT06323746, orgStudyIdInfo id: HR-EEG-CSAR, briefTitle: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Sharjah, class: OTHER, descriptionModule briefSummary: The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination., conditionsModule conditions: Cervical Lordosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Denneroll cervical traction orthodontic, outcomesModule primaryOutcomes measure: Cervical Sagittal Alignment Radiographs, primaryOutcomes measure: Cervical Sagittal Alignment Radiographs, secondaryOutcomes measure: Heart rate Variability (HRV) physiological parameter, secondaryOutcomes measure: Corticomuscular Coherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Sharjah, city: Sharjah, zip: 0000, country: United Arab Emirates, contacts name: Ibrahim Mostafa Abuamr, professor, role: CONTACT, email: iabuamr@sharjah.ac.ae, contacts name: Shima Zadeh, Research Assistant, role: SUB_INVESTIGATOR, contacts name: Ibrahim Mostafa Abuamr, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.33737, lon: 55.41206, hasResults: False
protocolSection identificationModule nctId: NCT06323720, orgStudyIdInfo id: ONZ-2023-0442, briefTitle: Signs of Central Sensitization in Tension-type Headache, acronym: CSTTH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:- Are signs of central sensitization present in tension-type headache?Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group., conditionsModule conditions: Tension-Type Headache, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Quantitative Sensory Testing, outcomesModule primaryOutcomes measure: Pain sensitivity for heat stimuli, primaryOutcomes measure: Pain sensitivity for cold stimuli, primaryOutcomes measure: Pain sensitivity for electrical stimuli, primaryOutcomes measure: Pain sensitivity for pressure, primaryOutcomes measure: Function of the pain facilitating pathways, primaryOutcomes measure: Function of the pain inhibiting pathways, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent University, status: RECRUITING, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Jessica Van Oosterwijck, Prof., role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
protocolSection identificationModule nctId: NCT06323694, orgStudyIdInfo id: Attesa chirurgia-1, briefTitle: Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery, acronym: chirurgia-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-15, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, collaborators name: University of Bologna, descriptionModule briefSummary: The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.Hypothesis:Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority., conditionsModule conditions: Spinal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: quality of life, outcomesModule primaryOutcomes measure: Descriptive survey for vertebroplasty patients, primaryOutcomes measure: Descriptive survey for spinal arthrodeses patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, city: Bologna, zip: 40136, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
protocolSection identificationModule nctId: NCT06323668, orgStudyIdInfo id: H-23067693, briefTitle: Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment, acronym: CIEDOUT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2038-01-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection., conditionsModule conditions: Cardiac Implantable Electronic Device Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized open label trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None (Open Label), enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac implantable electronic device extraction, interventions name: Empirical antibiotic therapy, outcomesModule primaryOutcomes measure: Rate of death or relapse bacteremia, secondaryOutcomes measure: Days alive and out-of-hospital, secondaryOutcomes measure: Rate of death, secondaryOutcomes measure: Rate of readmission for any cause, secondaryOutcomes measure: Rate of cardiac implantable electronic device extraction, secondaryOutcomes measure: Rate of relapse bacteremia (the same microorganism), secondaryOutcomes measure: Rate of bacteremia (all species), secondaryOutcomes measure: Rate of definite CIED infection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323655, orgStudyIdInfo id: VP-VEC-162-1201, briefTitle: Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-19, primaryCompletionDateStruct date: 2018-08-28, completionDateStruct date: 2018-08-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Vanda Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Tasimelteon, interventions name: Active Control Placebo, interventions name: Tasimelteon Placebo, interventions name: Active Control, outcomesModule primaryOutcomes measure: Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Vanda Investigational Site, city: Laval, state: Quebec, country: Canada, geoPoint lat: 45.56995, lon: -73.692, hasResults: False