hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06297642, orgStudyIdInfo id: TQB2928-AK105-Ib-01, briefTitle: TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the safety and efficiency of TQB2928 injection combined with Penpulimab in the treatment of patients with advanced malignant tumors., conditionsModule conditions: Advanced Malignant Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: TQB2928 injection, interventions name: Penpulimab, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Adverse event rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of Anti-Drug antibody, secondaryOutcomes measure: Incidence of neutralizing antibodies, secondaryOutcomes measure: Peak time (Tmax), secondaryOutcomes measure: Peak concentration (Cmax), secondaryOutcomes measure: The area under the plasma concentration time curve from zero to after 24h (AUC0-24h), secondaryOutcomes measure: Steady-state apparent volume of distribution (Vz/F), secondaryOutcomes measure: Minimum plasma concentration at steady state (Cmin,ss), secondaryOutcomes measure: Receptor Occupancy (RO%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Science, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Ning Li, Doctor, role: CONTACT, phone: 15601395554, email: lining@cicams.ac.cn, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Gansu Provincial Cancer Hospital, city: Lanzhou, state: Gansu, zip: 730000, country: China, contacts name: Junfeng Jiang, Master, role: CONTACT, phone: 13893332604, email: 13893332604@163.com, contacts name: Yuhua Liu, Bachelor, role: CONTACT, phone: 15682892029, email: tianlujyx@163.com, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qingqing Cai, Doctor, role: CONTACT, phone: 18376665396, email: caiqq@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06297629, orgStudyIdInfo id: 2021-0636, secondaryIdInfos id: NCI-2024-01689, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Astex Pharmaceuticals, Inc., descriptionModule briefSummary: To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant., conditionsModule conditions: Allogeneic Stem Cell Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: ASTX727, interventions name: Donor Lymphocyte Infusion, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Betul Oran, MD, role: CONTACT, phone: 713-745-2820, email: boran@mdanderson.org, contacts name: Betul Oran, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06297616, orgStudyIdInfo id: 18814, secondaryIdInfos id: J3R-JE-YDAB, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of LY3841136 in Japanese Participants With Obesity or Overweight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-10-12, completionDateStruct date: 2025-10-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to learn about the side effects of LY3841136 when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last about 28 weeks and may include up to 17 visits., conditionsModule conditions: Obesity, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: LY3841136, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration, secondaryOutcomes measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136, secondaryOutcomes measure: PK: Maximum Observed Concentration (Cmax) of LY3841136, secondaryOutcomes measure: Pharmacodynamics (PD): Change From Baseline in Body Weight, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sumida Hospital, status: RECRUITING, city: Sumida-ku, state: Tokyo, zip: 130-0004, country: Japan, contacts role: CONTACT, phone: 81356087276, contacts name: Takuma Yonemura, role: PRINCIPAL_INVESTIGATOR, locations facility: Hakata Clinic, status: RECRUITING, city: Fukuoka, zip: 812-0025, country: Japan, contacts role: CONTACT, phone: 81922837701, contacts name: Takashi Eto, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6, lon: 130.41667, hasResults: False
protocolSection identificationModule nctId: NCT06297577, orgStudyIdInfo id: MASH2024, briefTitle: Clinical Evaluation of Injectable Alb-PRF in the Management of Intrabony Defect in Stage-III Periodontitis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients.The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are:will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST., conditionsModule conditions: Intrabony Periodontal Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the type of intervention, only the outcome assessor and the statistician will be blinded, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Albumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST), interventions name: Platelet Rich Fibrin (PRF) combined with minimally invasive surgical technique (MIST), outcomesModule primaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Probing Depth (PD), secondaryOutcomes measure: Radiographic Linear Defect Depth (RLDD), secondaryOutcomes measure: Recession Depth (RD), secondaryOutcomes measure: Post-operative Pain, secondaryOutcomes measure: Radiographic defect fill (RDF), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297564, orgStudyIdInfo id: 07/3/9-2023/4, briefTitle: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: New Valley University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments., conditionsModule conditions: Progesterone Primed Endometrial Protocol, conditions: Gonadotropin Releasing Hormone Antagonist Protocol, conditions: Assisted Reproductive Treatments, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Progesterone primed endometrial protocol, interventions name: Gonadotropin-releasing hormone antagonist protocol, outcomesModule primaryOutcomes measure: The number of retrieved oocytes, secondaryOutcomes measure: Pregnancy rate, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: New Valley University, city: New Valley, zip: 72511, country: Egypt, hasResults: False
protocolSection identificationModule nctId: NCT06297538, orgStudyIdInfo id: GR-2021-12372323, briefTitle: Parkinson's Disease and Gamma-transcranial Alternating Current Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-29, primaryCompletionDateStruct date: 2024-10-29, completionDateStruct date: 2026-04-29, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Neuromed IRCCS, class: OTHER, collaborators name: Fondazione Policlinico Universitario Campus Bio-Medico, collaborators name: I.R.C.C.S. Fondazione Santa Lucia, descriptionModule briefSummary: Cortical-basal ganglia gamma oscillations are pathologically reduced in Parkinson's disease (PD) and the plasticity of the primary motor cortex (M1) is impaired. Enhancing gamma oscillations through transcranial alternating current stimulation (tACS), a non-invasive neurophysiological tool that modulates cortical rhythms, can restore this alteration. However, whether tACS-related normalization of M1 plasticity results in positive clinical effects is unknown. Motor learning is also impaired in PD and gamma oscillations play a relevant role in different forms of learning in humans. Nevertheless, whether motor learning abnormalities relate to reduced gamma oscillations in PD is another unclear issue. It can be hypothesized that gamma oscillations impairment in M1 contributes to altered motor control, plasticity and learning in PD. Accordingly, in this project, the authors intend to test whether gamma-tACS on M1 in PD patients ameliorates motor performance and learning, as objectively assessed with kinematic techniques., conditionsModule conditions: Parkinson Disease, 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: 84, type: ESTIMATED, armsInterventionsModule interventions name: gamma transcranial alternating current stimulation (tACS), interventions name: sham transcranial alternating current stimulation (tACS), outcomesModule primaryOutcomes measure: Changes in bradykinesia features as objectively assessed by kinematic techniques, primaryOutcomes measure: Changes in motor learning performance as objectively assessed by kinematic techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Neuromed, status: RECRUITING, city: Pozzilli, country: Italy, contacts name: Giulia Paparella, role: CONTACT, phone: 3384780752, geoPoint lat: 41.51142, lon: 14.06252, hasResults: False
protocolSection identificationModule nctId: NCT06297525, orgStudyIdInfo id: STP938-201, briefTitle: Study of STP938 in Advanced Solid Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Step Pharma, SAS, class: INDUSTRY, descriptionModule briefSummary: The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: STP938, outcomesModule primaryOutcomes measure: Safety and Tolerability, secondaryOutcomes measure: Area under the curve (AUC) of STP938, secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to reach maximum concentration (TMax), secondaryOutcomes measure: Evaluation of preliminary clinical activity of STP938, secondaryOutcomes measure: Evaluation of best overall response of STP938, secondaryOutcomes measure: Evaluation of Duration of Response, secondaryOutcomes measure: Evaluation of Progression Free Survival, secondaryOutcomes measure: Change in serum CA125 (ovarian cancer only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297512, orgStudyIdInfo id: pGBM-WBRT/DOX2020, briefTitle: Evaluate the Role of Anthracycline After Radio Therapy in Patients With Glioblastoma (pGBM)., statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-09, primaryCompletionDateStruct date: 2027-11-09, completionDateStruct date: 2028-03-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Iacopo Sardi, class: OTHER, descriptionModule briefSummary: Glioblastoma (GBM) and diffuse intrinsic bridge gliomas (DIPG) only the most aggressive forms of cancer, and their prognosis remains bleak. Currently, the standard of treatment is TMZ concomitant with radiotherapy, and, at the end of combined treatment, as adjuvant therapy. In vitro and in vivo experimental studies have suggested that anthracyclines are effective antineoplastics for the treatment of gliomas. In patients with solid tumors treated with anthracyclines, continuous infusion administration compared with bolus administration has been shown to provide a better safety profile especially with regard to cardiotoxicity. Based on this evidence, this study aims to evaluate the safety and antitumor activity of combined treatment with Dox, WBRT (whole body radiotherapy), and TMZ in pediatric and young adult patients affected by GMB, conditionsModule conditions: Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, Temozolomide, Doxorubicin, outcomesModule primaryOutcomes measure: Evaluation prolonged Dox, primaryOutcomes measure: Percentage of Withdrawal from the study rate, primaryOutcomes measure: Percentage of SAEs, primaryOutcomes measure: Mortality rate, primaryOutcomes measure: Early discontinuation of dox treatment rate, secondaryOutcomes measure: Event-free survival (EFS), disease progression (PFS), and overall survival (OS), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Iacopo Sardi, role: CONTACT, email: iacopo.sardi@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
protocolSection identificationModule nctId: NCT06297473, orgStudyIdInfo id: SJ-1050, briefTitle: Physical Attendance Versus Telephone or Video Follow-up in Patients With Non-functioning Pituitary Tumors., acronym: PITCARE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Zealand University Hospital, class: OTHER, descriptionModule briefSummary: The primary purpose of this study is to compare the safety of routine telephone assessment versus in-person assessment during a two-year period for patients with non-functioning pituitary adenomas. Secondly, to compare the quality of pituitary care in persons having biochemical assessment once versus twice a year. Thirdly, to assess the rationale of repeated assessment of pituitary function and imaging in patients with small pituitary tumors (microadenomas)., conditionsModule conditions: Non-Functional Pituitary Adenoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized to either intervention or control, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Adverse events (primary outcome) will be established by a blinded adjudication committee.A committé of external endocrinologist/ophthalmologist will blinded to participant ID/allocation assess all the participants admissions to hospital and assess wether it qualifies as an event, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 812, type: ESTIMATED, armsInterventionsModule interventions name: Telephone-/video follow-up, interventions name: In-person follow-up, outcomesModule primaryOutcomes measure: Composite outcome of adverse events, secondaryOutcomes measure: Thyroid replacement therapy, secondaryOutcomes measure: Growth hormone replacement therapy, secondaryOutcomes measure: Desmopressin replacement therapy, secondaryOutcomes measure: Hormonal replacement therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06297460, orgStudyIdInfo id: STEPPSPENITENTIARY, briefTitle: Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Universitat Jaume I, class: OTHER, collaborators name: Centre d'Estudis i Formació Especialtzada Generalitat de Catalunya, descriptionModule briefSummary: The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study., conditionsModule conditions: Self Harm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Systems Training for Emotional Predictability & Problem Solving (STEPPS), outcomesModule primaryOutcomes measure: Level of emotional and behavioral disregulation of patients, secondaryOutcomes measure: Type and levels of impulsivity of patients, secondaryOutcomes measure: Suicide risk of patients, secondaryOutcomes measure: Self-injury frequency, typology and funcionality of patients, secondaryOutcomes measure: Degree of hopeless of patients, secondaryOutcomes measure: Perceived level of feasibility by professionals, secondaryOutcomes measure: Perceived level of acceptability of the intervention by professionals, secondaryOutcomes measure: Satisfaction of the intervention by patients, secondaryOutcomes measure: Perceived level of adequacy by professionals, secondaryOutcomes measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information, secondaryOutcomes measure: Level of burnout of professionals, otherOutcomes measure: Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rosa, city: Castellón De La Plana, state: Castellón, zip: 12071, country: Spain, geoPoint lat: 39.98567, lon: -0.04935, hasResults: False