hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06364046, orgStudyIdInfo id: ZJLS-KLDMIR-22006, briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Central Hospital of Lishui City, class: OTHER, descriptionModule briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice., conditionsModule conditions: Carcinoma, conditions: Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Drug-eluting beads bronchial arterial chemoembolization, interventions name: Serplulimab, interventions name: Intravenous chemotherapy, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Time to tumor untreatable progression, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Overall Response, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Eastern Cooperative Oncology Group Score, secondaryOutcomes measure: Recurrence rate of hemoptysis, secondaryOutcomes measure: Quality of life Questionare-Core score, secondaryOutcomes measure: The incidence of adverse events and serious adverse events, secondaryOutcomes measure: Pain assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lishui central hospital, city: Lishui, state: Zhejiang, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, hasResults: False
protocolSection identificationModule nctId: NCT06364033, orgStudyIdInfo id: CLL2624, briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Gruppo Italiano Malattie EMatologiche dell'Adulto, class: OTHER, descriptionModule briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, conditions: CLL-like MBL, conditions: Varicella-zoster Virus Reactivation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: serologic response evaluation, outcomesModule primaryOutcomes measure: Serologic response evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC Ematologia ASST dei Sette Laghi, city: Varese, country: Italy, contacts name: Marta Coscia, role: CONTACT, geoPoint lat: 45.82058, lon: 8.82511, hasResults: False
protocolSection identificationModule nctId: NCT06364020, orgStudyIdInfo id: APHP230067, briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions, acronym: LACIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies., conditionsModule conditions: Anxiety, conditions: Stress, conditions: Non-carious Cervical Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To investigate the association between anxiety/stress and the presence of NCCL., secondaryOutcomes measure: To investigate the association between bruxism and the presence of NCCL., secondaryOutcomes measure: To investigate the association between eating disorders and the presence of NCCL., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Rothschild - Service Odontologie, city: Paris, zip: 75012, country: France, contacts name: Caroline Mocquot, MCU-PH, role: CONTACT, phone: +33622971627, email: caroline.mocquot@aphp.fr, contacts name: Maria Clotilde Carra, Professor, role: CONTACT, phone: +33630746555, email: mariaclotilde.carra@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06364007, orgStudyIdInfo id: SLiu0401, briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sulai Liu, class: OTHER, descriptionModule briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: HAIC+STRIDE+Len, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: DCR, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University), status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Chuang Peng, PhD, role: CONTACT, phone: 15200850489, email: pengchuangcn@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06363994, orgStudyIdInfo id: ICP-CL-00128, briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2034-12-25, completionDateStruct date: 2035-12-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: InnoCare Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL), conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 490, type: ESTIMATED, armsInterventionsModule interventions name: Orelabrutinib, interventions name: Bendamustine Injection, interventions name: Rituximab, interventions name: Orelabrutinib Placebo, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Progression-free Survival (PFS) for Arm A vs. Arm C, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06363981, orgStudyIdInfo id: JagiellonianU72, briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Jakub Antczak, class: OTHER, collaborators name: Andrzej Frycz Modrzewski Krakow University, descriptionModule briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression., conditionsModule conditions: Unipolar Depression, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Active rTMS over the left DLPFC and over the left DMPFC, interventions name: Active rTMS over the left DLPFC, interventions name: Sham rTMS, outcomesModule primaryOutcomes measure: Beck Depression Inventory 2, primaryOutcomes measure: Froward digit span, primaryOutcomes measure: Language part of Addenbrooke's Cognitive Examination, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale, secondaryOutcomes measure: Athens Insomnia Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Epworth Sleepiness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Education of Research and Development Center, Babinski Clinical Hospital, city: Cracovia, zip: 30393, country: Poland, contacts name: Wojciech Korzeniowski, MD, role: CONTACT, phone: +48 12 652 42 00, email: wojciech.korzen@gmail.com, contacts name: Jakub Antczak, MD, role: CONTACT, phone: +48 12 25 50, email: jakub.antczak@uj.edu.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
protocolSection identificationModule nctId: NCT06363968, orgStudyIdInfo id: 1743326, briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments, acronym: BRIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2030-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: VA Puget Sound Health Care System, class: FED, descriptionModule briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot studyPosttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?Participants will be asked to:* Undergo ERG recordings before and after a single dose of sertraline.* Provide relevant clinical information related to PTSD symptoms and treatment history.Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording., conditionsModule conditions: PTSD, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: RETeval, outcomesModule primaryOutcomes measure: ERG b-wave amplitude response to SSRI, secondaryOutcomes measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score, secondaryOutcomes measure: Total PTSD Checklist for DSM-5 (PCL-5), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Puget Sound Health Care System, status: RECRUITING, city: Seattle, state: Washington, zip: 98108, country: United States, contacts name: Rebecca C Hendrickson, MD, PhD, role: CONTACT, phone: 206-277-5054, email: rebecca.hendrickson@va.gov, contacts name: Katharine J Liang, MD, PHD, role: SUB_INVESTIGATOR, contacts name: Rebecca C Hendrickson, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
protocolSection identificationModule nctId: NCT06363942, orgStudyIdInfo id: 2024-5973, briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not., conditionsModule conditions: Fall Injury, conditions: Frailty, conditions: Old Age; Atrophy, conditions: Age-Related Atrophy, conditions: Age-Related Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SAFE program (exercise intervention), outcomesModule primaryOutcomes measure: Objective 1, primaryOutcomes measure: Objective 2, secondaryOutcomes measure: Objective 4, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Victoria Hospital - Glen site, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06363929, orgStudyIdInfo id: 341-23, briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: MemorialCare Health System, class: OTHER, collaborators name: DexCom, Inc., descriptionModule briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly., conditionsModule conditions: Hyperinsulinism, conditions: Hypoglycemia Neonatal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G6 continuous glucose monitor, outcomesModule primaryOutcomes measure: Mean absolute relative difference (MARD), secondaryOutcomes measure: Mean absolute difference (MAD), eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Miller Children's Hospital, status: RECRUITING, city: Long Beach, state: California, zip: 90806, country: United States, contacts name: Erin Okawa, role: CONTACT, phone: 310-825-6244, email: eokawa@memorialcare.org, geoPoint lat: 33.76696, lon: -118.18923, hasResults: False
protocolSection identificationModule nctId: NCT06363903, orgStudyIdInfo id: 2022-MMC-051, briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-09, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Maxima Medical Center, class: OTHER, collaborators name: Amsterdam UMC, collaborators name: Maastricht University Medical Center, descriptionModule briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics., conditionsModule conditions: Autoimmunity, conditions: Inguinal Hernia, conditions: Stress Urinary Incontinence, conditions: Pelvic Organ Prolapse, conditions: Implant Complication, conditions: Systemic Autoimmune Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: mesh allergy test, interventions name: blood tests, interventions name: Mesh removal, outcomesModule primaryOutcomes measure: Positive diagnostic tests, secondaryOutcomes measure: Autoimmune complaints and objective findings in immunologic blood test, secondaryOutcomes measure: Autoimmune complaints and objective findings in mesh allergy test (MAT), secondaryOutcomes measure: Mesh removal and subjective complaints, secondaryOutcomes measure: Mesh histopathology, secondaryOutcomes measure: Patient demographics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Centre, status: ACTIVE_NOT_RECRUITING, city: Maastricht, state: Limburg, zip: 6229HX, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Maxima Medical Centre, status: RECRUITING, city: Veldhoven, state: Noord-Brabant, zip: 5504DB, country: Netherlands, contacts name: Willem AR Zwaans, MD PhD, role: CONTACT, phone: +31408888550, email: willem.zwaans@mmc.nl, contacts name: Maurits JC Gielen, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.41833, lon: 5.40278, locations facility: Amsterdam UMC, status: NOT_YET_RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: Prof. Dr. J.P. Roovers, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False