hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06372288, orgStudyIdInfo id: 22-1754, briefTitle: Theta Burst TMS for Treatment of Methamphetamine Use Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Carilion Clinic, class: OTHER, collaborators name: Virginia Polytechnic Institute and State University, descriptionModule briefSummary: This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm., conditionsModule conditions: Methamphetamine Abuse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation, interventions name: Sham Transcranial Magnetic Stimulation, outcomesModule primaryOutcomes measure: Stimulant Craving Questionnaire (STCQ), primaryOutcomes measure: Urine Drug Screen (UDS), secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q), secondaryOutcomes measure: Hamilton Anxiety Scale (HAM-A), secondaryOutcomes measure: Montgomery Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Clinical Global Impression - Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression - Improvement (CGI-I), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Carilion Clinic, status: RECRUITING, city: Roanoke, state: Virginia, zip: 24014, country: United States, contacts name: Sooraj John, M.D., role: CONTACT, contacts name: Maryann Hollen, B.S., role: CONTACT, phone: 540-566-8081, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False
protocolSection identificationModule nctId: NCT06372262, orgStudyIdInfo id: Rowers2022, briefTitle: Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase, acronym: Rowers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study., conditionsModule conditions: Endothelial Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: ergometer test, outcomesModule primaryOutcomes measure: I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury, primaryOutcomes measure: zonulin to measure tight junction leakage, primaryOutcomes measure: LBP (lipopolysaccharide binding protein) to measure endotoxin, primaryOutcomes measure: LPS (lipopolysaccharide) to measure endotoxin, primaryOutcomes measure: Lactic acid to measure fatigue after the race, secondaryOutcomes measure: energy, secondaryOutcomes measure: fiber intake, secondaryOutcomes measure: protein, secondaryOutcomes measure: carbohydrate, secondaryOutcomes measure: body mass, secondaryOutcomes measure: Body composition - water, secondaryOutcomes measure: Body composition - fat, secondaryOutcomes measure: Lean body mass, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 23 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Physical Education, city: Poznań, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
protocolSection identificationModule nctId: NCT06372249, orgStudyIdInfo id: 22-249, secondaryIdInfos id: 2U54MD012388-06, type: NIH, link: https://reporter.nih.gov/quickSearch/2U54MD012388-06, briefTitle: A Clinical Trial of Soluble Fiber for Asthma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Phoenix Children's Hospital, class: OTHER, collaborators name: Northern Arizona University, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet., conditionsModule conditions: Asthma in Children, 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: 105, type: ESTIMATED, armsInterventionsModule interventions name: NOVELOSETM 3490, outcomesModule primaryOutcomes measure: Alpha diversity., secondaryOutcomes measure: Asthma control., secondaryOutcomes measure: Gut microbiome composition., secondaryOutcomes measure: Nasal inflammatory response., secondaryOutcomes measure: Quantification of circulating short chain fatty acids., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Phoenix Children's, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85016, country: United States, contacts name: Destiny Ogbeama, role: CONTACT, geoPoint lat: 33.44838, lon: -112.07404, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-17, uploadDate: 2024-04-02T16:19, filename: Prot_SAP_000.pdf, size: 285020, hasResults: False
protocolSection identificationModule nctId: NCT06372223, orgStudyIdInfo id: SPH5030-102, briefTitle: A Food Effect Study of SPH5030 Tablets., statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-03-25, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Shanghai Pharmaceuticals Holding Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: SPH5030, interventions name: SPH5030, outcomesModule primaryOutcomes measure: Peak Plasma Concentration (Cmax), primaryOutcomes measure: Peak time（Tmax）, primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Second Hospital ,Sichuan University, city: Chengdu, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06372210, orgStudyIdInfo id: 031-201-00521, briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2023-07-19, completionDateStruct date: 2023-07-19, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Otsuka Pharmaceutical Development & Commercialization, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch., conditionsModule conditions: Mental Disorder, conditions: Schizophrenia, conditions: Major Depressive Disorder, conditions: Bipolar I Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Placebo IEM tablet, interventions name: Abilify MyCite®, interventions name: D-Tect Patch, outcomesModule primaryOutcomes measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch, primaryOutcomes measure: Cohort 1 and 2: Patch Detection Latency Period, primaryOutcomes measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period, primaryOutcomes measure: Cohort 1 and 2: Total Detection Latency Period, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research site, city: Garden Grove, state: California, zip: 92845, country: United States, geoPoint lat: 33.77391, lon: -117.94145, hasResults: False
protocolSection identificationModule nctId: NCT06372184, orgStudyIdInfo id: WMT-AR-RCT, briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2029-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR., conditionsModule conditions: Rhinitis, Allergic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Washed Microbiota Transplantation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in the reflective total nasal symptom score (rTNSS), secondaryOutcomes measure: Changes in the combined symptoms and medication score (CSMS), secondaryOutcomes measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score, secondaryOutcomes measure: Changes in the single reflective nasal symptoms score, secondaryOutcomes measure: Specific IgE, secondaryOutcomes measure: Inflammatory factors, secondaryOutcomes measure: Flow cytometric analysis of lymphocyte clusters, secondaryOutcomes measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0, secondaryOutcomes measure: Changes in the Modified Lund-Kennedy endoscopic score, secondaryOutcomes measure: The changes in composition and metabolites of gut microbiota and nasal microbiota, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210011, country: China, contacts name: Faming Zhang, MD,PhD, role: CONTACT, phone: 086-25-58509883, email: fzhang@njmu.edu.cn, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06372158, orgStudyIdInfo id: NYCU112181AE, briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Stage 1, interventions name: Stage 2, outcomesModule primaryOutcomes measure: General examination, primaryOutcomes measure: Hematology Test, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, state: Beitou Dist., zip: 112, country: Taiwan, contacts name: Tze-Fang Wang, Ph.D., role: CONTACT, phone: +886-2-28267907, email: tzefang@nycu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, zip: 112, country: Taiwan, contacts name: ChienYu Huang, Bachelor, role: CONTACT, phone: +886-955-879163, email: chienyu.ns11@nycu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06372145, orgStudyIdInfo id: LTS17043, secondaryIdInfos id: 2023-503631-18, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1287-6797, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2029-04-30, completionDateStruct date: 2029-04-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).SUBSTUDY: ToleDYNAMIC substudy, conditionsModule conditions: Relapsing Multiple Sclerosis, conditions: Secondary Progressive Multiple Sclerosis, conditions: Progressive Relapsing Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: Tolebrutinib, interventions name: Placebo, interventions name: Teriflunomide, outcomesModule primaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation, primaryOutcomes measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs), secondaryOutcomes measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies, secondaryOutcomes measure: Annualized Relapse Rate (ARR) for RMS only, secondaryOutcomes measure: Number of new and/or enlarging T2-hyperintense lesions per year, secondaryOutcomes measure: Change from baseline in total volume of T2-hyperintense lesions, secondaryOutcomes measure: ToleDYNAMIC substudy Change from baseline in biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Investigational Site Number : 0560005, status: RECRUITING, city: Brugge, zip: 8000, country: Belgium, geoPoint lat: 51.20892, lon: 3.22424, hasResults: False
protocolSection identificationModule nctId: NCT06372132, orgStudyIdInfo id: NL85305.068.23, briefTitle: G-POEM vs PEG-J in Gastroparesis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM.Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point., conditionsModule conditions: Gastroparesis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: G-POEM, outcomesModule primaryOutcomes measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months., secondaryOutcomes measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months., secondaryOutcomes measure: Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention., secondaryOutcomes measure: Number and severity of (s)AEs in the treatment groups., secondaryOutcomes measure: Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score., secondaryOutcomes measure: Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Zuid-Limburg, zip: 6229 HX, country: Netherlands, contacts name: Kim Sweerts, MD, role: CONTACT, phone: 0883887298, email: kim.sweerts@maastrichtuniversity.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False