hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06359080, orgStudyIdInfo id: 120200004OL, briefTitle: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL), statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-08, primaryCompletionDateStruct date: 2022-12-11, completionDateStruct date: 2022-12-11, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: JelikaLite LLC, class: INDUSTRY, descriptionModule briefSummary: The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open Label StudyThis will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Cognilum TM: Light Treatment Condition, outcomesModule primaryOutcomes measure: Change in Autism Symptoms, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Dr. Steingold Psychology PC, city: Brooklyn, state: New York, zip: 11229, country: United States, geoPoint lat: 40.6501, lon: -73.94958, locations facility: Dr. Steingold Psychology PC, city: New York, state: New York, zip: 10019, country: United States, geoPoint lat: 40.71427, lon: -74.00597, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-05-01, uploadDate: 2024-04-08T10:25, filename: Prot_000.pdf, size: 332012, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2022-05-01, uploadDate: 2024-04-08T10:25, filename: SAP_001.pdf, size: 134095, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-05-01, uploadDate: 2024-04-08T10:26, filename: ICF_002.pdf, size: 172416, hasResults: False
protocolSection identificationModule nctId: NCT06359067, orgStudyIdInfo id: APHP240295, briefTitle: A Real-World Study of Bispecific Antibodies in Multiple Myeloma, acronym: BISPEMM, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP)., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ACTUAL, armsInterventionsModule interventions name: Treated by bispecific antibodies, teclistamab or elranatamab in usual care, interventions name: Not treated by bispecific antibodies in usual care, outcomesModule primaryOutcomes measure: Infection rate, secondaryOutcomes measure: Global survival, secondaryOutcomes measure: Progression-free survivals, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assistance Publique - Hôpitaux de Paris (AP-HP), city: Paris, state: IDF, zip: 75004, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06359054, orgStudyIdInfo id: CelalBayarNRG, briefTitle: The Role of 68GA DOTATATE PET/CT In Breast Cancer Imaging, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-11, primaryCompletionDateStruct date: 2023-05-15, completionDateStruct date: 2023-09-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, descriptionModule briefSummary: Currently, F-18 FDG PET/CT is routinely used for breast cancer staging and treatment response assessment. Most breast cancers express Estrogen Receptor (ER) and Progesterone Receptor (PR) and this subtype shows lower activity on FDG imaging. 68Ga DOTATATE PET/CT is an effective imaging option for somatostatin receptor (SSTR) positive neuroendocrine tumors. There are case reports showing 68Ga DOTATATE uptake in non-Hodgkin lymphoma, meningioma, breast cancer, thyroid adenoma and papillary carcinoma. There are also histochemical studies showing that SSTR is a potential radiopharmaceutical target for ER+/PR+ breast cancer . Its hypothesized that 68Ga DOTATATE PET/CT may be superior to 18F FDG PET/CT primarily in hormone receptor (HR) positive breast cancer. In this study, its aimed to compare the uptake pattern of breast cancer lesions and HR status with 68Ga DOTATATE and 18F FDG uptake in lesions., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: 18F FDG PET/CT, interventions name: 68Ga DOTATATE PET/CT, outcomesModule primaryOutcomes measure: Comparative Diagnostic Accuracy of 68Ga DOTATATE and 18F FDG PET/CT, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manisa Celal Bayar University Faculty of Medicine, General Surgery Department, city: Manisa, zip: 45030, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, locations facility: Manisa Celal Bayar University Faculty of Medicine, Nuclear Medicine Department, city: Manisa, zip: 45030, country: Turkey, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
protocolSection identificationModule nctId: NCT06359041, orgStudyIdInfo id: CAB-201-004, briefTitle: RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2029-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cabaletta Bio, class: INDUSTRY, descriptionModule briefSummary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis, conditionsModule conditions: Generalized Myasthenia Gravis (gMG), designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: CABA-201, outcomesModule primaryOutcomes measure: To evaluate incidence and severity of adverse events (AEs), secondaryOutcomes measure: To evaluate the incidence and severity of adverse events (AEs), secondaryOutcomes measure: To characterize the pharmacodynamics (PD), secondaryOutcomes measure: To characterize the pharmacokinetics (PK), secondaryOutcomes measure: To evaluate disease-related biomarkers, secondaryOutcomes measure: To evaluate efficacy by change in Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over time., secondaryOutcomes measure: To evaluate efficacy by change in Quantitative Myasthenia Gravis (QMG) score over time., secondaryOutcomes measure: To evaluate efficacy by change in Myasthenia Gravis Composite (MGC) score over time., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359028, orgStudyIdInfo id: 300103, briefTitle: Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: HALEON, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste., conditionsModule conditions: Dentin Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: Stannous fluoride toothpaste, interventions name: Crest cavity protection toothpaste, outcomesModule primaryOutcomes measure: Change from Baseline in Schiff Sensitivity Score at Day 56, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 56, secondaryOutcomes measure: Change from Baseline in Schiff sensitivity score at Day 28, secondaryOutcomes measure: Change from Baseline in Tactile Threshold at Day 28, secondaryOutcomes measure: Change from Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56, secondaryOutcomes measure: Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Salus Research, city: Fort Wayne, state: Indiana, zip: 46825, country: United States, geoPoint lat: 41.1306, lon: -85.12886, hasResults: False
protocolSection identificationModule nctId: NCT06359015, orgStudyIdInfo id: 41138, secondaryIdInfos id: 605095, type: OTHER, domain: DDD, briefTitle: Metformin and Esomeprazole in Preterm Pre-eclampsia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-02-11, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Christiana Care Health Services, class: OTHER, descriptionModule briefSummary: The purpose of this study is to better understand diagnosis and treatment of preterm preeclampsia. Currently, there are limited laboratory tests that can be used to diagnosis preeclampsia. Additionally, there are few treatments for this condition. This clinical trial will explore treatment options, Metformin and Esomeprazole, as well as serum markers that could improve the diagnosis and treatment of preterm preeclampsia., conditionsModule conditions: Preeclampsia Severe, conditions: Pre-Eclampsia, conditions: Preeclampsia, conditions: Preeclampsia Second Trimester, conditions: Preeclampsia Complicating Childbirth, conditions: Preeclampsia Puerperium, conditions: Preterm, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups: experimental and control. The control group receives expectant management. The experimental group receives expectant management and medication treatment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ACTUAL, armsInterventionsModule interventions name: Metformin, interventions name: Esomeprazole, outcomesModule primaryOutcomes measure: Mean plasma difference in sFlt-1, secondaryOutcomes measure: Mean plasma difference in vascular endothelial growth factor (VEGF), secondaryOutcomes measure: Mean plasma difference in placental growth factor (PIGF), secondaryOutcomes measure: Mean plasma difference in soluble endoglin (sEng), secondaryOutcomes measure: sFlt-1:PIGF ratio, secondaryOutcomes measure: Prolongation of gestation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Christianacare Health System, city: Newark, state: Delaware, zip: 19718, country: United States, geoPoint lat: 39.68372, lon: -75.74966, hasResults: False
protocolSection identificationModule nctId: NCT06359002, orgStudyIdInfo id: BYON4413.001, secondaryIdInfos id: 2023-507781-13-00, type: CTIS, briefTitle: Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Byondis B.V., class: INDUSTRY, descriptionModule briefSummary: This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS., conditionsModule conditions: Relapsed / Refractory AML, conditions: Relapsed / Refractory MDS, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: BYON4413, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (dose escalation), primaryOutcomes measure: Composite Complete Remission Rate (expansion), secondaryOutcomes measure: Incidence and severity of adverse events, secondaryOutcomes measure: Number of patients with dose modifications, secondaryOutcomes measure: Rate of early death, secondaryOutcomes measure: Maximum Plasma Concentration (Cmax) BYON4413, secondaryOutcomes measure: Time to Cmax (Tmax) BYON4413, secondaryOutcomes measure: Area under the curve (AUC) BYON4413, secondaryOutcomes measure: Percentage of patients with confirmed anti-BYON4413 antibodies, secondaryOutcomes measure: Composite Complete Remission Rate (dose escalation), secondaryOutcomes measure: Percentage of blasts in bone marrow change from baseline, secondaryOutcomes measure: Percentage of blasts in peripheral blood change from baseline, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Relapse-free survival, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358989, orgStudyIdInfo id: Insulin resistance, briefTitle: Association Between Triglycerides Glucose Ratio With HOMA -IR as Indicators of Insulin Resistance in Obese Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of the present study was to investigate the correlation between the triglyceride/glucose index (TyG index) and homeostasic model assessment of insulin resistance (HOMA-IR) to predict insulin resistance (IR) in obese adults, conditionsModule conditions: Insulin Resistance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: HOMA IR, outcomesModule primaryOutcomes measure: Association between triglycerides glucose ratio with HOMA -IR as indicators of insulin resistance in obese adults, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358963, orgStudyIdInfo id: 131, briefTitle: CoQ10 and Omega-3 as Adjuncts to Periodontal Therapy, TAC of Saliva., statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-05-10, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Amirhossein Farahmand, class: OTHER, descriptionModule briefSummary: Comparative evaluation of CoQ10 and Omega-3 as adjuncts to periodontal therapy and total antioxidant capacity of saliva (randomized Double-Blind Clinicalials), conditionsModule conditions: Periodontal Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-blind, Controlled design., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The research was conducted using a double-blind methodology. To ensure impartiality, both the omega-3, Coq10, and control groups were given medications that had identical appearance, packaging, and color. To further eliminate bias, a clinician who had no involvement in the study labeled teh medications as A, B, and C (empty) based on their content, and distributed them among teh patients., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Receive 30 mg of Coq10, interventions name: Non-Medicare Drugs, outcomesModule primaryOutcomes measure: reduction of bleeding on probing, secondaryOutcomes measure: total Antioxidant capacity of saliva, eligibilityModule sex: ALL, minimumAge: 28 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amirhossein Farahmand, city: Tehran, zip: 1947833113, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
protocolSection identificationModule nctId: NCT06358950, orgStudyIdInfo id: ALKS 2860-201, briefTitle: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1, acronym: Vibrance-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Alkermes, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone., conditionsModule conditions: Narcolepsy Type 1, 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: 80, type: ESTIMATED, armsInterventionsModule interventions name: ALKS 2680, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6, secondaryOutcomes measure: Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6, secondaryOutcomes measure: Mean weekly cataplexy rate (WCR) as derived by subject cataplexy, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alkermes Investigational Site, status: RECRUITING, city: Huntersville, state: North Carolina, zip: 28708, country: United States, geoPoint lat: 35.41069, lon: -80.84285, hasResults: False