hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06261541, orgStudyIdInfo id: ABLEexoMS, briefTitle: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: ABLE Human Motion S.L., class: INDUSTRY, collaborators name: Fundación Esclerosis Múltiple Madrid (FEMM), descriptionModule briefSummary: The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: ABLE Exoskeleton, outcomesModule primaryOutcomes measure: Number and type of device-related Adverse Events, primaryOutcomes measure: Level of Assistance (LoA) to don/doff the device, primaryOutcomes measure: Time taken to don/doff the device, primaryOutcomes measure: Level of Assistance (LoA) to complete therapy activity tasks, primaryOutcomes measure: Time spent upright and time spent walking, primaryOutcomes measure: Number of steps walked, primaryOutcomes measure: Distance walked, secondaryOutcomes measure: Timed 25-Feet Walk test (T25FW), secondaryOutcomes measure: Ambulation Index (AI), secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Timed Up-and-Go test (TUG), secondaryOutcomes measure: Trunk Impairment Scale (TIS), secondaryOutcomes measure: Lower extremity muscle strenght, secondaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: Borg Rating of Perceived Exertion, secondaryOutcomes measure: Barthel Index (BI) score, secondaryOutcomes measure: Modified Fatigue Impact Scale (MFIS) score, secondaryOutcomes measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54), secondaryOutcomes measure: Psychosocial Impact of Assistive Devices Scale (PIADS) score, secondaryOutcomes measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Esclerosis Múltiple Madrid (FEMM), status: RECRUITING, city: Madrid, country: Spain, contacts name: Almudena Chao, role: CONTACT, phone: 913993245, email: achao@femmadrid.org, contacts name: Kenneth Malpartida, role: CONTACT, email: kmalpartida@femmadrid.org, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
protocolSection identificationModule nctId: NCT06261528, orgStudyIdInfo id: STU-2023-1289, briefTitle: Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis, acronym: NO-FATIGUE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: National Multiple Sclerosis Society, collaborators name: International Progressive Multiple Sclerosis Alliance, descriptionModule briefSummary: The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team., conditionsModule conditions: Progressive Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This will be an open label, single arm, single center phase 1 research study designed to generate safety data, biomarker data, and preliminary efficacy data to reduce fatigue in patients with progressive MS, to include PPMS and SPMS, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Light therapy, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UT Southwestern Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75247, country: United States, contacts name: Ana Raicu, role: CONTACT, phone: 214-645-0292, email: ana.raicu@utsouthwestern.edu, contacts name: Ana Raicu, role: CONTACT, phone: 214-645-0292, contacts name: Peter Sguigna, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Benjamin Greenberg, MD, role: SUB_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
protocolSection identificationModule nctId: NCT06261515, orgStudyIdInfo id: Perio-gut PRIN, briefTitle: Multi-omics Analysis of Oral-gut Microbial Profiles, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2026-02-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Active periodontal treatment, outcomesModule primaryOutcomes measure: Changes in gut microbial profile measured in stool samples, primaryOutcomes measure: Changes in oral microbial profile measured in saliva samples, primaryOutcomes measure: Changes in oral microbial profile measured in subgingival plaque samples, secondaryOutcomes measure: Changes in oral-gut metabolome measured in stool samples, secondaryOutcomes measure: Changes in oral-gut miRNAome measured in stool samples, secondaryOutcomes measure: Metabolic plasma changes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06261489, orgStudyIdInfo id: REB23-1128, briefTitle: Cannabis (THC vs. CBD) in Multiple Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Multiple Sclerosis Society of Canada, descriptionModule briefSummary: The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks., conditionsModule conditions: Multiple Sclerosis, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: THC, interventions name: CBD, outcomesModule primaryOutcomes measure: Cognitive outcome: The Differential Effect, if any, of THC and CBD in MS Cognition will be measured by Symbol Digit Modality Test (SDMT)., primaryOutcomes measure: NLUTD outcome: The Differential Effect, if any, of THC and CBD on Neurogenic lower urinary tract dysfunction (NLUTD) symptoms will be measured by Neurogenic Bladder Symptom Score (NBSS)., secondaryOutcomes measure: Blinding feasibility: The ability to blind the administration of THC vs CBD in PwMS will be evaluated based on participants and investigators report., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06261476, orgStudyIdInfo id: DYP-Pharm-RP-23, briefTitle: Safety of Ashwagandha (Withania Somnifera) Root Extract, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: SF Research Institute, Inc., class: NETWORK, descriptionModule briefSummary: The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Ashwagandha (Withnia somnifera), outcomesModule primaryOutcomes measure: Hemoglobin Test, primaryOutcomes measure: Total Erythrocyte Count, primaryOutcomes measure: Total Leukocyte Count, primaryOutcomes measure: Platelet Count, primaryOutcomes measure: Hematocrit Test, primaryOutcomes measure: Total Cholesterol Test, primaryOutcomes measure: LDL Test, primaryOutcomes measure: HDL Test, primaryOutcomes measure: Triglycerides Test, primaryOutcomes measure: Serum Alkaline Transaminase Test, primaryOutcomes measure: Aspartate Transaminase Test, primaryOutcomes measure: Alkaline Phosphatase Test, primaryOutcomes measure: Bilirubin Test, primaryOutcomes measure: Serum Creatinine Test, primaryOutcomes measure: Blood Urea Nitrogen Test, primaryOutcomes measure: T4, primaryOutcomes measure: T3, primaryOutcomes measure: Serum TSH, primaryOutcomes measure: Fasting Blood Sugar, primaryOutcomes measure: HbA1c, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Quality of Life (SF-36 QoL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SF Research Institute, status: RECRUITING, city: San Francisco, state: California, zip: 94127, country: United States, contacts name: John Ademola, PhD, role: CONTACT, phone: 415-549-9362, email: studyrecruitment@sfinstitute.com, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
protocolSection identificationModule nctId: NCT06261450, orgStudyIdInfo id: 2020-3424, secondaryIdInfos id: 236114, type: OTHER, domain: Health Canada, secondaryIdInfos id: 202010PJT-451514, type: OTHER_GRANT, domain: Canadian Institutes of Health Research, briefTitle: Effect of CBD on the Brain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-08-15, completionDateStruct date: 2027-08-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Université de Sherbrooke, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Jazz Pharmaceuticals, collaborators name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke, descriptionModule briefSummary: This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients., conditionsModule conditions: Fragile X Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This study is a double-blind-crossover placebo control comparing the acute effect of oral CBD in patients with FXS to controls., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Randomization and dispensing of active and control will be conducted by the research center pharmacy., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: CBD Oral Solution (eCBD system Target), interventions name: Placebo, outcomesModule primaryOutcomes measure: Short Intracortical Inhibition, secondaryOutcomes measure: Intracortical Facilitation, secondaryOutcomes measure: Gaba concentration levels, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06261411, orgStudyIdInfo id: 999430, secondaryIdInfos id: FOU2024-00038, type: REGISTRY, domain: Forskning och Utveckling (Region Uppsala), briefTitle: Lung Ultrasound as Alternative to Radiation in Thoracic Surgery, acronym: LUS-ART, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Uppsala University Hospital, class: OTHER, descriptionModule briefSummary: This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs., conditionsModule conditions: Thoracic Surgery, conditions: Ultrasonography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Case-Control, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: Inter-rater variability will be masked., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Lung Ultrasound, outcomesModule primaryOutcomes measure: Reduction in chest x-ray, secondaryOutcomes measure: Re-insertion of chest tube, secondaryOutcomes measure: Delayed removal of chest tube, secondaryOutcomes measure: Time to chest tube removal, secondaryOutcomes measure: Patient Satisfaction, otherOutcomes measure: Missed Care, otherOutcomes measure: Inter-rater variability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala Akademiska sjukhuset, city: Uppsala, state: Uppland, zip: 751 85, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-02, uploadDate: 2024-02-07T05:12, filename: Prot_000.pdf, size: 806384, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-02, uploadDate: 2024-02-07T05:12, filename: ICF_001.pdf, size: 350352, hasResults: False
protocolSection identificationModule nctId: NCT06261372, orgStudyIdInfo id: KY2023PJ204, briefTitle: Mindfulness Meditation Combined With Progressive Muscle Relaxation Training for Uremic Sarcopenia, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2023-11-15, completionDateStruct date: 2023-11-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Ningbo Medical Center Lihuili Hospital, class: OTHER_GOV, descriptionModule briefSummary: To study the effect of mindfulness meditation combined with progressive muscle relaxation training on clinical efficacy and quality of life in maintenance hemodialysis (MHD) patients with sarcopenia. Eligible sarcopenic patients in our hospital were randomly assigned to a control group (n = 24) and an intervention group (n = 25). The control group received conventional dialysis treatment, while the intervention group received mindfulness meditation combined with progressive muscle relaxation training during the interdialysis period in addition to conventional dialysis treatment. The effect of the intervention was evaluated after 12 weeks.To observe whether the combined intervention training can improve the motor ability and quality of life of patients with sarcopenia in a short period of time., conditionsModule conditions: Hemodialysis Patients With Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: The mindfulness meditation combined with progressive muscle relaxation training ., outcomesModule primaryOutcomes measure: 10 sit-to-stand test in seconds, primaryOutcomes measure: Grip strength in kilograms, primaryOutcomes measure: 6-meter walk test in metre per second, primaryOutcomes measure: KDQOLTM(Kidney Disease Quality of Life short Form) score, primaryOutcomes measure: interleukin-6 (IL-6), primaryOutcomes measure: high-sensitivity C-reactive protein (hsCRP), primaryOutcomes measure: albumin(ALB), primaryOutcomes measure: prealbumin (PA）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Li Huili Hospital, Ningbo Medical Center, city: Ningbo, state: Zhejiang, zip: 315046, country: China, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False
protocolSection identificationModule nctId: NCT06261359, orgStudyIdInfo id: CEND1-202, briefTitle: A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Qilu Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma (PDAC), 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: 120, type: ESTIMATED, armsInterventionsModule interventions name: CEND-1, interventions name: Gemcitabine, interventions name: Nab paclitaxel, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival(PFS), secondaryOutcomes measure: 6-month PFS rate, secondaryOutcomes measure: Duration Of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Incidence of AEs, SAEs and treatment-emergent adverse events (TEAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese People's Liberation Army (PLA) General Hospital, city: Beijing, state: Beijing, zip: 100000, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False