hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06374381, orgStudyIdInfo id: 854990, briefTitle: PEACE for ImPACT Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: Institute of Education Sciences, collaborators name: Michigan State University, descriptionModule briefSummary: Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors will be masked to randomization condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: PEACE Online Resources, interventions name: PEACE Weekly Group Facilitation, interventions name: PEACE Weekly Individual Facilitation, outcomesModule primaryOutcomes measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool, secondaryOutcomes measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO), secondaryOutcomes measure: Autism Impact Measure (AIM), secondaryOutcomes measure: Social Communication Checklist (SCC), secondaryOutcomes measure: Confusion, Hubbub, and Order Scale (CHAOS), secondaryOutcomes measure: Acceptability, Appropriateness, and Adoption measure, secondaryOutcomes measure: Qualitative Interview, eligibilityModule sex: ALL, minimumAge: 12 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Mental Health, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-30, uploadDate: 2024-04-12T13:20, filename: Prot_SAP_000.pdf, size: 508769, hasResults: False
protocolSection identificationModule nctId: NCT06374355, orgStudyIdInfo id: Semibranch_Retro, briefTitle: Semibranch Registry - Retrospective, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2030-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital Muenster, class: OTHER, descriptionModule briefSummary: The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair., conditionsModule conditions: Aortic Aneurysm, conditions: Endovascular Aortic Repair, conditions: Stent-Graft Endoleak, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Semibranch CMD branched aortic stentgraft, outcomesModule primaryOutcomes measure: Freedom from target vessel instability, primaryOutcomes measure: Mortality, primaryOutcomes measure: Technical success, secondaryOutcomes measure: Morbidity, secondaryOutcomes measure: Freedom of Endoleak type I and III, secondaryOutcomes measure: Long term mortality, secondaryOutcomes measure: Branch patency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Muenster University Hospital, city: Münster, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, hasResults: False
protocolSection identificationModule nctId: NCT06374290, orgStudyIdInfo id: HSC-MS-24-0024, briefTitle: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Naltrexone (Vivitrol), interventions name: Bupropion, outcomesModule primaryOutcomes measure: Feasibility as assessed by the percentage of participants that enroll in the study, primaryOutcomes measure: Percentage of participants that complete 3 weeks of treatment, primaryOutcomes measure: Safety as assessed by the percentage of participants that show no serious adverse events, secondaryOutcomes measure: Change in number of cigarettes smoked per day (CPD), secondaryOutcomes measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU), secondaryOutcomes measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT), secondaryOutcomes measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas health Science Center at Houston, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Jin H Yoon, PhD, role: CONTACT, phone: 713-486-2800, email: jin.ho.yoon@uth.tmc.edu, contacts name: Jessica Vincent, role: CONTACT, phone: (713) 486-2645, email: Jessica.N.Vincent@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06374264, orgStudyIdInfo id: NM100, briefTitle: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder, acronym: aNiMatO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: MedRhythms, Inc., class: INDUSTRY, collaborators name: Alexion Pharmaceuticals, Inc., descriptionModule briefSummary: The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit., conditionsModule conditions: Neuromyelitis Optica Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: MR-C-014, outcomesModule primaryOutcomes measure: Participant acceptability of MR-C-014, primaryOutcomes measure: Number of device-related adverse events (AEs), secondaryOutcomes measure: 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Number of walks per week, otherOutcomes measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors, otherOutcomes measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors, otherOutcomes measure: Stride length as measured by the MR-C-014 sensors, otherOutcomes measure: Falls Efficacy Scale-International (FES-I), otherOutcomes measure: Number of falls as recorded in Falls Diary, otherOutcomes measure: Multiple Sclerosis Walking Scale (MSWS-12), otherOutcomes measure: Visual Analogue Scale (VAS), otherOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), otherOutcomes measure: 9 Hole Peg Test (9-HPT), otherOutcomes measure: Symbol Digit Modalities Test (SDMT), otherOutcomes measure: Fatigue Scale for Motor and Cognitive Functions (FSMC), otherOutcomes measure: Expanded Disability Status Scale (EDSS) Ambulation Score, otherOutcomes measure: Activities-Specific Balance Confidence Scale (ABC), otherOutcomes measure: Patient Experience and Satisfaction Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Eric Klawiter, MD, role: CONTACT, email: EKLAWITER@mgh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06374251, orgStudyIdInfo id: 0S-23-2, secondaryIdInfos id: NCI-2023-08890, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 0S-23-2, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2025-03-27, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being., conditionsModule conditions: Malignant Digestive System Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Discussion, interventions name: Interview, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Number of participants who complete the narrative medicine sessions, primaryOutcomes measure: Change in well-being scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USC / Norris Comprehensive Cancer Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Eve L. Makoff, role: CONTACT, phone: 323-865-3000, email: makoff@usc.edu, contacts name: Eve L. Makoff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06374225, orgStudyIdInfo id: 23-0866, briefTitle: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention, acronym: SAVE-O2 AI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: United States Department of Defense, collaborators name: O2matic ApS, collaborators name: IDTS Medical, Inc., descriptionModule briefSummary: This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%)., conditionsModule conditions: Critical Illness, conditions: Wounds and Injury, conditions: Disease Attributes, conditions: Pathologic Processes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Automated Titration (O2matic), outcomesModule primaryOutcomes measure: Proportion of time spent within the targeted normoxemia range, secondaryOutcomes measure: Amount of supplemental oxygen administered, secondaryOutcomes measure: Proportion of time spent in hypoxemia (SpO2<88%), secondaryOutcomes measure: Proportion of time spent in hyperoxemia (SpO2 >96%), secondaryOutcomes measure: Time to Room Air, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Oregon Health and Sciences University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Vanderbilt University Medical Center, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
protocolSection identificationModule nctId: NCT06374212, orgStudyIdInfo id: 24-0191, briefTitle: Anifrolumab for Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: AstraZeneca, descriptionModule briefSummary: This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.* Receive related medical evaluation* Receive the study drug intravenously* Stay 20 minutes after the infusion for monitoring, conditionsModule conditions: Hidradenitis Suppurativa, conditions: Acne Inversa, conditions: Hidradenitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All study participants, if eligible, will receive the study drug (anifrolumab)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Anifrolumab, outcomesModule primaryOutcomes measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks, secondaryOutcomes measure: Percentage of participants achieving a HiSCR 50 at 24 weeks, secondaryOutcomes measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks, secondaryOutcomes measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UNC Dermatology and Skin Cancer Center, city: Chapel Hill, state: North Carolina, zip: 27516, country: United States, contacts name: Erika Hanami, role: CONTACT, phone: 984-974-3682, email: erika_hanami@med.unc.edu, contacts name: Christopher Sayed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06374199, orgStudyIdInfo id: 24-0181, briefTitle: Med-South Lifestyle Program for Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, descriptionModule briefSummary: Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program.The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups, conditionsModule conditions: Pregnancy Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Standard 2 group parallel randomized trial study design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Med-South Lifestyle Intervention for Pregnancy--Arm 1, interventions name: Med-South Lifestyle Intervention for Pregnancy--Arm 2, outcomesModule primaryOutcomes measure: Percent that would recommend this program to others who are pregnancy, primaryOutcomes measure: Percent of participants who take part in the 10 study counseling sessions, secondaryOutcomes measure: Maternal diet quality, otherOutcomes measure: skin carotenoids, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
protocolSection identificationModule nctId: NCT06374186, orgStudyIdInfo id: 2095072, secondaryIdInfos id: 2095072, type: OTHER, domain: UMKC IRB, briefTitle: Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City, acronym: COMMITTED2-KC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-08, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Missouri, Kansas City, class: OTHER, descriptionModule briefSummary: This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition., whoMasked: CARE_PROVIDER, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Behavioral Intervention with financial rewards and coaching, interventions name: Control, outcomesModule primaryOutcomes measure: Time in target blood glucose range per CGM, primaryOutcomes measure: Hemoglobin A1C, secondaryOutcomes measure: Diabetes Quality of Life Brief Inventory, secondaryOutcomes measure: Diabetes Distress Scale, secondaryOutcomes measure: PROMIS Medication Adherence Scale, secondaryOutcomes measure: Perceived Dietary Adherence Questionnaire, secondaryOutcomes measure: Motivation and Confidence Ruler, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Missouri - Kansas City School of Medicine, city: Kansas City, state: Missouri, zip: 64108, country: United States, contacts name: Carrie R Kriz, role: CONTACT, phone: 816-512-7473, email: mckinleycr@umkc.edu, contacts name: Jared M Bruce, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False