hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06341608, orgStudyIdInfo id: K23DA057528, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DA057528, briefTitle: Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-08, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies.The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment.The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Telehealth for opioid use disorder treatment delivery, outcomesModule primaryOutcomes measure: Treatment Engagement, secondaryOutcomes measure: Days of medication for OUD, secondaryOutcomes measure: Opioid and non-opioid substance use, secondaryOutcomes measure: Feasibility of intervention, secondaryOutcomes measure: Acceptability, secondaryOutcomes measure: Fidelity, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Shoshana Aronowitz, PhD, role: CONTACT, phone: 781-266-8571, email: visho@nursing.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
protocolSection identificationModule nctId: NCT06341556, orgStudyIdInfo id: iNHL-03, briefTitle: A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy, conditionsModule conditions: Mantle Cell Lymphoma, conditions: Maintenance Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Zanubrutinib, outcomesModule primaryOutcomes measure: 2-year progression-free survival (PFS), secondaryOutcomes measure: 2-year event-free survival (EFS), secondaryOutcomes measure: overall survival, secondaryOutcomes measure: Hematology and non hematology toxicity, secondaryOutcomes measure: Quality of life questionnaire, otherOutcomes measure: Exploratory biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Yizhen Liu, role: CONTACT, phone: 021-64175590, phoneExt: 85100, email: aliuyz@126.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Yizhen Liu, role: CONTACT, phone: 021-64175590, phoneExt: 85100, email: aliuyz@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06341530, orgStudyIdInfo id: SURPASS-1, briefTitle: Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Zhengzhou University, class: OTHER, descriptionModule briefSummary: In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: anlotinib combined with penpulimab, outcomesModule primaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhe Cheng, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Zhe Cheng, role: CONTACT, phone: 18638027777, email: cz711010@163.com, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
protocolSection identificationModule nctId: NCT06341517, orgStudyIdInfo id: IRB_in_progress, briefTitle: Brain Circuitry Therapeutics for Schizophrenia, acronym: ATHENA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-05, primaryCompletionDateStruct date: 2026-01-05, completionDateStruct date: 2027-12-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Indrit Begue, class: OTHER, descriptionModule briefSummary: This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia, conditionsModule conditions: Schizophrenia; Psychosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: iTBS, outcomesModule primaryOutcomes measure: Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indrit Bègue, city: Geneva, zip: 1202, country: Switzerland, contacts name: Indrit Bègue, MD, PhD, role: CONTACT, phone: +41589440300, email: indrit.begue@unige.ch, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False
protocolSection identificationModule nctId: NCT06341491, orgStudyIdInfo id: obs. Delay Discounting, briefTitle: The Study of Delay Discounting Among Beneficiaries of the Pé-de-Meia Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Federal Institute of Education, Science and Technology of the State of Mato Grosso, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to explore how the "Pé-de-Meia" Program, a policy of the Brazilian Federal Government designed to encourage the retention and completion of studies by students from low-income families, affects both the students' tendency towards delay discounting and their academic performance. The study seeks to answer the following questions:How does the "Pé-de-Meia" Program affect the students' propensity for delay discounting? Is there a relationship between the level of delay discounting among students, their academic performance, and school attendance? Participants in the study, high school students enrolled in the "Pé-de-Meia" Program, will undergo assessments to measure their level of delay discounting. The academic performance and school attendance of the participants will be monitored and analyzed in relation to their propensity for delay discounting, conditionsModule conditions: Delay Discounting, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Pé-de-Meia Program, outcomesModule primaryOutcomes measure: Delay discounting, primaryOutcomes measure: Academic performance - grades, primaryOutcomes measure: School attendance, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341465, orgStudyIdInfo id: HÜ- FTR- BD- 3, briefTitle: Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-07-04, completionDateStruct date: 2024-07-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images., conditionsModule conditions: Scoliosis, conditions: Scoliosis Idiopathic, conditions: Musculoskeletal Deformity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3 groups. Schroth exercise group (n=19), schroth exercise and kinesiological taping group (n=19), healthy people (n=19)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: Just Exercise, interventions name: Exercise, interventions name: Taping, outcomesModule primaryOutcomes measure: Trunk rotation, primaryOutcomes measure: Cobb angles, primaryOutcomes measure: Serum markers, secondaryOutcomes measure: Quality of life with scoliosis people, secondaryOutcomes measure: Body image assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 21 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341452, orgStudyIdInfo id: HD-NaM-01-EU, briefTitle: Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis, acronym: SODIAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Fresenius Medical Care Deutschland GmbH, class: INDUSTRY, descriptionModule briefSummary: The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing., conditionsModule conditions: End Stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, open, controlled, parallel, randomized, interventional, multi-center, explorative, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control, outcomesModule primaryOutcomes measure: Interdialytic weight gain, primaryOutcomes measure: Intradialytic hemodynamic stability, primaryOutcomes measure: Intradialytic hemodynamic stability, primaryOutcomes measure: Intradialytic morbid events, primaryOutcomes measure: Fluid status, primaryOutcomes measure: Fluid status, secondaryOutcomes measure: PRO: Thirst feeling, secondaryOutcomes measure: PRO: Thirst feeling, secondaryOutcomes measure: PRO: Fatigue, secondaryOutcomes measure: PRO: Hypotensive episodes, secondaryOutcomes measure: PRO: HRQOL, secondaryOutcomes measure: PRO: Health status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341439, orgStudyIdInfo id: Prot. 001_2023, briefTitle: Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX®, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-18, primaryCompletionDateStruct date: 2024-01-18, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of L'Aquila, class: OTHER, descriptionModule briefSummary: The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:* Is the response to periodontal therapy better if mouthwash containing Citrox is used?* What is the patients' perception?Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Mouthwash with chlorhexidine 0,12% and CITROX, interventions name: Mouthwash with chlorhexidine 0,12%, outcomesModule primaryOutcomes measure: Probing Depth (PD), primaryOutcomes measure: Gingival Index (GI), primaryOutcomes measure: Plaque Index (PI), primaryOutcomes measure: Full mouth plaque score (FMPS), primaryOutcomes measure: Full mouth bleeding score (FMBS), secondaryOutcomes measure: Patient Reported Outcome Measure (PROMS), eligibilityModule sex: ALL, minimumAge: 25 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of L'Aquila, division of periodontology, city: L'Aquila, zip: 67100, country: Italy, geoPoint lat: 42.35055, lon: 13.39954, hasResults: False
protocolSection identificationModule nctId: NCT06341413, orgStudyIdInfo id: 2023-1281, secondaryIdInfos id: A539500, type: OTHER, domain: UW- Madison, secondaryIdInfos id: SMPH/SLEEP CENTER/SLEEP CTR, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol version 1/17/2024, type: OTHER, domain: UW- Madison, secondaryIdInfos id: 1R01MH132221, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01MH132221, briefTitle: Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.Participants will attend 4 study visits:* A clinical and trauma assessment visit* A testing day that may include cognitive testing, surveys, and an MRI.* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition, conditionsModule conditions: Post Traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: SmartSleep device, outcomesModule primaryOutcomes measure: Change in Emotional Regulation - arousal, primaryOutcomes measure: Change in Emotional Regulation - recall, primaryOutcomes measure: Change in Slow-wave Activity (SWA), secondaryOutcomes measure: Change in Positive and Negative Affect Schedule (PANAS), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Sara Heyn, JD, PhD, role: CONTACT, phone: 303-296-2116, email: sheyn@wisc.edu, contacts name: Stephanie Jones, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06341400, orgStudyIdInfo id: 2024-KY-030-01, briefTitle: RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Zhujiang Hospital, class: OTHER, descriptionModule briefSummary: A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy., conditionsModule conditions: Bladder Cancer, conditions: Muscle-Invasive Bladder Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: DisitamabVedotinForIicction Toripalimab, outcomesModule primaryOutcomes measure: PcR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Peng Xu, doctor, role: CONTACT, phone: 18665073650, geoPoint lat: 23.11667, lon: 113.25, hasResults: False