hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06302621, orgStudyIdInfo id: 21-725, briefTitle: Pemigatinib + Afatinib in Advanced Refractory Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Boehringer Ingelheim, collaborators name: Incyte Corporation, descriptionModule briefSummary: This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors.The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects.This research study involves the study drugs Afatinib and Pemigatinib., conditionsModule conditions: Advanced Solid Tumor, conditions: Unresectable Solid Tumor, conditions: Metastatic Solid Tumor, conditions: Cholangiocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Afatinib, interventions name: Pemigatinib, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Best Overall Response, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Treatment Related Adverse Events, secondaryOutcomes measure: Maximum Plasma Concentration [Cmax]) and C trough of pemigatinib and afatinib, secondaryOutcomes measure: Molecular correlates of response, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Massachusetts General Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Andreas Varkaris, MD, role: CONTACT, phone: 617-724-4000, email: AVARKARIS@MGH.HARVARD.EDU, contacts name: Andreas Varkaris, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06302608, orgStudyIdInfo id: NGGT-BCD-P-2203, briefTitle: Safety and Efficacy Study of NGGT001 in Bietti Crystalline Corneoretinal Dystrophy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-08, primaryCompletionDateStruct date: 2024-05-29, completionDateStruct date: 2028-05-29, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Xiamen Ophthalmology Center Affiliated to Xiamen University, class: OTHER, descriptionModule briefSummary: Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD), conditionsModule conditions: Bietti's Crystalline Dystrophy, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: NGGT001, outcomesModule primaryOutcomes measure: BCVA, primaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiuju Chen, city: Xiamen, state: Fujian, zip: 361000, country: China, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False
protocolSection identificationModule nctId: NCT06302595, orgStudyIdInfo id: 2022P001093, secondaryIdInfos id: 5R44CA224853, type: NIH, link: https://reporter.nih.gov/quickSearch/5R44CA224853, briefTitle: MRI Guided Prostate Biopsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-24, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: Physical Sciences Inc., descriptionModule briefSummary: This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template., conditionsModule conditions: Suspected Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: MRI-guided prostate biopsy using the needle holder frame., outcomesModule primaryOutcomes measure: Accuracy of needle placement, eligibilityModule sex: MALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Kemal Tuncali, MD, role: CONTACT, phone: 617-732-7631, email: ktuncali@bwh.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06302582, orgStudyIdInfo id: stress injury, briefTitle: Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11-25, completionDateStruct date: 2024-11-25, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Liaocheng People's Hospital, class: OTHER, descriptionModule briefSummary: This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury., conditionsModule conditions: Pressure Injuries - Stage 3, conditions: Pressure Injuries - Stage 4, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Platelet-rich plasma (PRP) combined with human umbilical cord mesenchymal stem cells (huMSCs), interventions name: Control group, outcomesModule primaryOutcomes measure: Change From Baseline in Pressure Ulcer Scale for Healing (PUSH), primaryOutcomes measure: Change from baseline in Determination of growth factor content, secondaryOutcomes measure: Wound healing time, secondaryOutcomes measure: Positive rate of bacterial culture, otherOutcomes measure: Safety evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central laboratory, status: RECRUITING, city: Liaocheng, state: Shandong, zip: 252000, country: China, contacts name: changhui Zhou, postgraduate, role: CONTACT, phone: 13562078772, email: zhouchanghui008@163.com, geoPoint lat: 36.45596, lon: 115.97766, hasResults: False
protocolSection identificationModule nctId: NCT06302569, orgStudyIdInfo id: Bellini INT 2024-511587-93-00, briefTitle: Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma, acronym: REPRINT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Giuseppe Procopio, class: OTHER, descriptionModule briefSummary: This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin.Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice.Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin.The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes., conditionsModule conditions: Bellini Carcinoma, conditions: Collecting Duct Carcinoma, conditions: Renal Medullary Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Pembrolizumab + Enfortumab Vedotin, outcomesModule primaryOutcomes measure: ORR in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Progression-free survival (PFS) in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Overall-survival (OS) in patients treated with Pembrolizumab plus Enfortumab Vedotin, secondaryOutcomes measure: Number of Participants treated with Pembrolizumab + Enfortumab Vedotin who experience AEs/SAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Irccs Istituto Dei Tumori Di Milano, city: Milan, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06302543, orgStudyIdInfo id: POI bone marrow, briefTitle: Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells, acronym: alfarah, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-10, completionDateStruct date: 2024-10-24, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: abdulmajeed hammadi, class: INDUSTRY, descriptionModule briefSummary: investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program., conditionsModule conditions: Premature Ovarian Insufficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single armed interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: autologous bone marrow cells injection, outcomesModule primaryOutcomes measure: change in gonadotropin levels, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ministry of Health, status: RECRUITING, city: Baghdad, zip: 964, country: Iraq, contacts name: abdulmajeed Hammadi, MD, role: CONTACT, phone: +9647902268105, email: alzaitounhospital@gmail.com, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
protocolSection identificationModule nctId: NCT06302517, orgStudyIdInfo id: K2020097, briefTitle: Bis Monitoring Effect on Delirium Occurrence and Nursing Quality Improvement Recovering From General Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-05-31, completionDateStruct date: 2022-08-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: ①Effects of BIS Index (BIS) monitoring on delirium incidence in Post-anesthesia care unit (PACU) in patients undergoing general anesthesia②Effects of BIS BIS Index (BIS) monitoring on the quality of nursing care in the Post-anesthesia care unit (PACU), conditionsModule conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 134, type: ACTUAL, armsInterventionsModule interventions name: BIS-guided, outcomesModule primaryOutcomes measure: Ricker sedation-agitation scale, primaryOutcomes measure: The nursing activity score (NAS), primaryOutcomes measure: vital signs （Mean arterial pressure, heart rate, pulse oxygen saturation ）, primaryOutcomes measure: Comparison of complications during the PACU period, primaryOutcomes measure: The comprehensive satisfaction score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital, School of Medicine, Zhejiang University, city: Jinhua, state: Zhejiang, zip: 322000, country: China, geoPoint lat: 29.10678, lon: 119.64421, hasResults: False
protocolSection identificationModule nctId: NCT06302504, orgStudyIdInfo id: Nature, briefTitle: Nature-based Mindfulness Intervention Program for Family Carers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-15, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nature-based mindfulness program, outcomesModule primaryOutcomes measure: depression, primaryOutcomes measure: anxiety, primaryOutcomes measure: stress, primaryOutcomes measure: family functioning, primaryOutcomes measure: family conflict, primaryOutcomes measure: well-being, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, zip: 852, country: Hong Kong, contacts name: Hay-ming Herman Lo, PhD, role: CONTACT, phone: +852-27665769, email: herman.lo@polyu.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06302478, orgStudyIdInfo id: KhonKaenU001, briefTitle: 5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:* Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?* Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?* Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?Participants in the intervention group will receive the 5E program, including* Education: health education regarding venous thromboembolism prevention* Elevation: leg elevation of 10-20 degrees* Exercise: ankle exercises* Enough fluid: adequate fluid uptake* Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission, conditionsModule conditions: Venous Thromboembolism, conditions: Spinal Cord Diseases, conditions: Spinal Cord Injuries, conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A quasi-experimental research (two group pretest-posttest design), primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: 5E program, outcomesModule primaryOutcomes measure: The rate of venous thromboembolism, secondaryOutcomes measure: Signs and symptoms of deep venous thrombosis and pulmonary embolism, secondaryOutcomes measure: Thigh and calf circumference, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chaiyaphum Hospital, status: RECRUITING, city: Chaiyaphum, zip: 36000, country: Thailand, contacts name: Suchada Chindamart, BNS, role: CONTACT, phone: +66619411828, email: suchada.chi@kkumail.com, geoPoint lat: 15.81047, lon: 102.02881, hasResults: False
protocolSection identificationModule nctId: NCT06302465, orgStudyIdInfo id: PKUPH-sarcoma 18, briefTitle: Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis., conditionsModule conditions: Malignant Bone Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: narlumosbartmab plus doxorubicin、cisplatin、methotrexate、ifosfamide, interventions name: doxorubicin、cisplatin、methotrexate、ifosfamide, outcomesModule primaryOutcomes measure: local recurrence rate, secondaryOutcomes measure: tumor necrosis rate, secondaryOutcomes measure: R0 removal rate, secondaryOutcomes measure: Event-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100044, country: China, contacts name: Lu Xie, M.D., role: CONTACT, phone: +8613401044719, email: xie.lu@hotmail.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False