hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06336603, orgStudyIdInfo id: WIN2022, briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sun Pharmaceutical Industries Limited, class: INDUSTRY, descriptionModule briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice., conditionsModule conditions: Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Winlevi (clascoterone) 1% & Adapalene 0.3% gel, outcomesModule primaryOutcomes measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16., secondaryOutcomes measure: Percent of total lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Tolerability measures of erythema based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of dryness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of peeling based on 5-point severity scale, secondaryOutcomes measure: Assessment of skin oiliness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of burning/stinging based on 6-point severity scale, secondaryOutcomes measure: Tolerability measures of pruritus based on 6-point severity scale, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skin Sciences, PLLC, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
protocolSection identificationModule nctId: NCT06336577, orgStudyIdInfo id: 2024/0003, briefTitle: Infectious and Non-infectious Lower Respiratory Diseases in Children With Down Syndrome Followed in Pediatric Pulmonology Consultations in Ile-de-France, acronym: ARBT21, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Sud Francilien, class: OTHER, descriptionModule briefSummary: The purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with Down syndrome followed in pediatric pulmonology consultations in Ile de France., conditionsModule conditions: Down Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: lower respiratory tract disease, outcomesModule primaryOutcomes measure: distribution of lower respiratory tract diseases, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Sud Francilien, city: Corbeil-Essonnes, zip: 91106, country: France, contacts name: Yousra MESBAHI, role: CONTACT, phone: 0161697760, email: yousra.mesbahi@chsf.fr, geoPoint lat: 48.60603, lon: 2.48757, hasResults: False
protocolSection identificationModule nctId: NCT06336538, orgStudyIdInfo id: CASE1124, briefTitle: Abbreviated MBCT for Depression in Older African American/Black Breast Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to develop and test an intervention designed to improve mood and reduce symptoms of depression., conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Female, conditions: Breast Cancer Stage I, conditions: Breast Cancer Stage II, conditions: Breast Cancer Stage III, conditions: Mild Depression, conditions: Moderate Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Investigator will first conduct focus groups with older (≥65 years old) African American/Black (AA/B) breast cancer survivors (BCS) with elevated depressive symptoms. They will collect participant perspectives on barriers and facilitators to participation in MBI clinical trials, as well as how to adapt this intervention, called Mindfulness-Based Cognitive Therapy-Brief (MBCT-Brief), to increase cultural relevancy for older AA/B BCS with elevated depressive symptoms. They will then conduct a single arm clinical trial that incorporates the results of the qualitative data analysis to establish feasibility and acceptability of MBCT-Brief., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: MBCT, outcomesModule primaryOutcomes measure: Mean participant attendance rate, secondaryOutcomes measure: Acceptability rate using CSQ(Client Satisfaction Questionnaire-8), otherOutcomes measure: Change in fear of recurrence as assessed using FCRI(Fear of Cancer Recurrence Inventory) scores, otherOutcomes measure: Change in trait mindfulness as assessed using FFMQ-15(Five Facet of Mindfulness Scale Short Form) scores, otherOutcomes measure: Change in Quality of life as assessed using ICS-2(Impact of Cancer Scale version 2) scores, otherOutcomes measure: Change in depressive symptoms as assessed using PROMIS-D(Patient Reported Outcomes Measurement Information System-Depression) scores, eligibilityModule sex: FEMALE, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Department of Wellness and Preventive Medicine, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Jacob Hill, ND, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
protocolSection identificationModule nctId: NCT06336512, orgStudyIdInfo id: RC.28.1.2024, briefTitle: Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics., conditionsModule conditions: Gestational Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Newly Pregnant Women with singleton fetus, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: ELISA, outcomesModule primaryOutcomes measure: Estimation of Gestational DM, eligibilityModule sex: FEMALE, minimumAge: 22 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Benha university, city: Banhā, state: El- Qalyobia, zip: 13511, country: Egypt, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False
protocolSection identificationModule nctId: NCT06336499, orgStudyIdInfo id: TREC2023-KY107, briefTitle: Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology., conditionsModule conditions: Orbital Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ACTUAL, armsInterventionsModule interventions name: Multi-parametric MRI and image analysis by deep learning or machine learning algorithms, outcomesModule primaryOutcomes measure: The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones., secondaryOutcomes measure: The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., secondaryOutcomes measure: Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06336486, orgStudyIdInfo id: BalikesirU-FTR-BG-01, briefTitle: the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-04, primaryCompletionDateStruct date: 2020-02-01, completionDateStruct date: 2020-02-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Busra Gunes, class: OTHER, descriptionModule briefSummary: In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated, conditionsModule conditions: Diabetic Neuropathic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two groups with a conventional therapy control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: intermittent pneumatic compression +pregabalin group, interventions name: pregabalin group, outcomesModule primaryOutcomes measure: The Leeds assessment of neuropathic symptoms and signs(LANSS), primaryOutcomes measure: Pain quality rating scale(PQAS), primaryOutcomes measure: Visual Analog Scale(VAS), secondaryOutcomes measure: 36-Item Short Form Health Survey(SF-36), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Balıkesir University, city: Balıkesir, state: Merkez, zip: 10050, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False
protocolSection identificationModule nctId: NCT06336473, orgStudyIdInfo id: 2023-A02097-38, briefTitle: Evaluation of the Effects of Cross Linking on the Biomechanical Characteristics of Skin Samples From Patients With Classic or Hypermobile Ehlers-Danlos Syndrome, acronym: SEDSKIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: GCS Ramsay Santé pour l'Enseignement et la Recherche, class: OTHER, descriptionModule briefSummary: The main aim of this study is to evaluate the effect of cross linking on the elasticity of skin samples from patients with non-vascular Ehlers-Danlos Syndrome (hEDS or cEDS)., conditionsModule conditions: Ehlers-Danlos Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-center study performed on biopsied skin samples, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: skin biopsy, outcomesModule primaryOutcomes measure: Young's modulus quantification, secondaryOutcomes measure: Collagen fibril diameter measurement, secondaryOutcomes measure: Collagen fibril D-period length measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Maussins-Nollet, city: Paris, zip: 75019, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06336460, orgStudyIdInfo id: 2023-537, briefTitle: PENG vs. FIC Blocks in Hip Fractures in the ED, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Orange Park Medical Center, class: OTHER, descriptionModule briefSummary: This study is a prospective, randomized clinical trial assessing the efficacy of physician-performed ultrasound-guided pericapsular nerve group (PENG) block vs fascia iliaca compartment (FIC) block for pain control in acute hip fracture., conditionsModule conditions: Hip Fractures, conditions: Nerve Block, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The research associate/outcome assessor will not have access to group assignment and will therefore be blinded to the type of block. Although the patient, their caregiver(s), and the clinician caring for the patient will not be directly informed of the group assignment, a note will be logged in the clinical record by the physician placing the block indicating the details of the block after this procedure has been completed., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pericapsular Nerve Group (PENG) Block, interventions name: Fascia Iliaca Compartment (FIC) Block for Patients with Isolated Hip Fractures, outcomesModule primaryOutcomes measure: Numeric pain score at 30 minutes, primaryOutcomes measure: Numeric pain score at 60 minutes, secondaryOutcomes measure: Cumulative Morphine Milligram Equivalents in 24 hours after enrollment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06336447, orgStudyIdInfo id: STU00220295, briefTitle: VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain.The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures., conditionsModule conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trail., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessor will be blinded to study randomization, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Group #1: Virtual Reality Headset, interventions name: Group 2 No Virtual Reality Headset, outcomesModule primaryOutcomes measure: Procedural related pain, secondaryOutcomes measure: Procedure related satisfaction, secondaryOutcomes measure: Post procedure anxiety, secondaryOutcomes measure: Mean reduction in pain 1 month after procedure, secondaryOutcomes measure: Midazolam administered, secondaryOutcomes measure: Fentanyl administered, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Medicine Pain Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Paul Fitzgerald, role: CONTACT, phone: 312-695-1064, email: p-fitzgerald2@northwestern.edu, contacts name: Jason Ross, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06336421, orgStudyIdInfo id: Şuletuvanç, briefTitle: The Effect of Virtual Reality Application on Perceived Anxiety and Vital Signs in Primiparous, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Purpose: To determine the effect of virtual reality application on anxiety and vital signs perceived by primiparous women during cesarean section.The research was conducted in a randomized controlled experimental design.The population of the research consisted of primiparous pregnant women with a caesarean section indication in the Ataturk University Health Research and Application Center Gynecology Clinic Operating Room., conditionsModule conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: statistics expert, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Personal Information Form, primaryOutcomes measure: State Anxiety Scale, primaryOutcomes measure: Pregnant follow-up form, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ayse Aydin, city: Yakutiye, state: Erzurum, zip: 25000, country: Turkey, geoPoint lat: 39.89821, lon: 41.26916, hasResults: False
protocolSection identificationModule nctId: NCT06336408, orgStudyIdInfo id: B2023-370R, briefTitle: The SLEEP-CARE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Sleep disorder is common in ICU patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. In 2023, American Thoracic Society released a research statement on sleep and circadian disruption(SCD) in ICU, which considered SCD is an important potential target for improving critical illness outcomes. Although polysomnography(PSG) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in ICU. This makes the sleep quality of ICU patients overestimated and difficult to reflect their true sleep conditions. And the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored., conditionsModule conditions: Sleep Disturbance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Compound outcome index, secondaryOutcomes measure: LOS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Jingjing Li, Master, role: CONTACT, phone: 13512106878, email: li.jingjing@zs-hospital.sh.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False