hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06341387, orgStudyIdInfo id: R178522-ieo1906, briefTitle: Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-05, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, collaborators name: University of Rome Tor Vergata, descriptionModule briefSummary: The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:* Which are the "omics" biomarkers that characterize the early stage of lung cancer?* How to Translate Laboratory Data into Clinical Data?For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile., conditionsModule conditions: Lung Cancer, conditions: Non-small Cell Lung Cancer Stage I, conditions: Non-small Cell Lung Cancer Stage II, conditions: Lung Cancer Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Breath, urine and blood analysis, outcomesModule primaryOutcomes measure: Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk., secondaryOutcomes measure: Omics-Data intagration., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Europen insitute of Oncology- Division of Thoracic Surgery, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Roberto Gasparri, MD, PhD, role: CONTACT, phone: 0257489499, email: roberto.gasparri@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06341374, orgStudyIdInfo id: 2023/5079, briefTitle: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Parc Taulí Hospital Universitari, class: OTHER, descriptionModule briefSummary: Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response., conditionsModule conditions: Apnea, Obstructive Sleep, conditions: SARS CoV 2 Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Influvac Tetra, outcomesModule primaryOutcomes measure: Immunological study: cytokines., secondaryOutcomes measure: Innate cells: monocytes, classical dendritic cells and Natural Killer cells., secondaryOutcomes measure: Epigenetic modification., secondaryOutcomes measure: Diagnostic of obstructive sleep apnea in selected cohort, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Parc Tauli, status: RECRUITING, city: Sabadell, state: Barcelona, zip: 08208, country: Spain, contacts name: Andrea F Grau, Medicine, role: CONTACT, phone: +34608151458, email: andreagrau94@gmail.com, contacts name: Miguel D Gallego, Medicine, role: CONTACT, phone: +34616315290, email: mgallego@tauli.cat, geoPoint lat: 41.54329, lon: 2.10942, hasResults: False
protocolSection identificationModule nctId: NCT06341361, orgStudyIdInfo id: OCT-FFR, briefTitle: OCT-based Machine Learning FFR for Predicting Post-PCI FFR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, collaborators name: Gangnam Severance Hospital, collaborators name: Severance Hospital, descriptionModule briefSummary: This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR., conditionsModule conditions: Tomography, Optical Coherence, conditions: Fractional Flow Reserve, Myocardial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: OCT-based machine learning FFR, outcomesModule primaryOutcomes measure: Correlation of OCT-based machine learning FFR compared to wire-based FFR, secondaryOutcomes measure: Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR, secondaryOutcomes measure: Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341348, orgStudyIdInfo id: Dalin Tzuchi Hospital, briefTitle: Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2018-06-30, completionDateStruct date: 2018-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Dalin Tzu Chi General Hospital, class: OTHER, descriptionModule briefSummary: Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them., conditionsModule conditions: Case Management, conditions: Rheumatoid Arthritis, conditions: Effectiveness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: A trained interviewer, who was blind with the study design and participants, was assigned to collect the participants' information on demographic and disease characteristics., enrollmentInfo count: 96, type: ACTUAL, armsInterventionsModule interventions name: Case management, outcomesModule primaryOutcomes measure: Depressive symptoms, primaryOutcomes measure: Self-efficacy level, primaryOutcomes measure: Sexual dysfunctionform-14, primaryOutcomes measure: DAS28, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06341335, orgStudyIdInfo id: AK109-301, briefTitle: A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Akeso, class: INDUSTRY, descriptionModule briefSummary: This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy., conditionsModule conditions: Gastric and Gastroesophageal Junction Adenocarcinoma, 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: 506, type: ESTIMATED, armsInterventionsModule interventions name: cadonilimab, interventions name: pulocimab, interventions name: paclitaxel, interventions name: placebo, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by blinded independent central review (BICR), primaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS) assessed by investigator, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease control rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341309, orgStudyIdInfo id: CSPC-DEY-CRC-K09, briefTitle: Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan Liposome, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Progression free survival -1, secondaryOutcomes measure: Progression free survival -2, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341296, orgStudyIdInfo id: CSPC-DEY-CRC-K07, briefTitle: Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Irinotecan Liposome, interventions name: 5-FU, interventions name: LV, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Percentage of patients undergoing surgery., secondaryOutcomes measure: R0 resection, secondaryOutcomes measure: Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341283, orgStudyIdInfo id: BCOOS2024, briefTitle: A Retrospective Real-world Study of Abemaciclib Tablets Based on HIS System in HR+ Breast Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Affiliated Hospital of Qingdao University, class: OTHER, descriptionModule briefSummary: The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer., conditionsModule conditions: Breast Cancer, conditions: Neoplasms, conditions: Breast Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Abemaciclib and Letrozole/Anastrozole, interventions name: Letrozole or Anastrozole, interventions name: Abemaciclib and Fulvestrant, interventions name: Fulvestrant, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Objective Remission Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Toxicity rate, secondaryOutcomes measure: Cost-utility analysis, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center, city: Qingdao, state: Shandong, country: China, geoPoint lat: 36.06488, lon: 120.38042, hasResults: False
protocolSection identificationModule nctId: NCT06341257, orgStudyIdInfo id: VGHTCCTC_SCART001, briefTitle: Efficacy and Toxicity of SCART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary., conditionsModule conditions: Tumor Size Greater Than or Equal to 5 cm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Central/Core Ablative Radiation Therapy (SCART), outcomesModule primaryOutcomes measure: Local Control (LC), primaryOutcomes measure: Progression-Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, status: RECRUITING, city: Taichung, zip: 407, country: Taiwan, contacts name: Hao-Shen Cheng, MD, role: CONTACT, phone: 886975871151, email: mark89050921@gmail.com, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06341244, orgStudyIdInfo id: UNIFESP, briefTitle: Air Stacking Technique Efficacy on Peak of Expiratory Flow and Cough Peak Flow in Non-cardiac Thoracic Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-08-20, primaryCompletionDateStruct date: 2020-11-05, completionDateStruct date: 2022-12-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Universidade Cidade de Sao Paulo, class: OTHER, collaborators name: Federal University of São Paulo, descriptionModule briefSummary: After thoracic surgical intervention, patients often feel intense pain with respiratory movements reduction making coughing less effective. The air stacking improves peak of expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives: To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure (MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and postoperatory., conditionsModule conditions: Postoperative Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Air Stacking Technique, outcomesModule primaryOutcomes measure: Peak of expiratory flow (PEF), primaryOutcomes measure: Cough peak flow (CPF), secondaryOutcomes measure: Maximum Inspiratory Pressure ( MIP), secondaryOutcomes measure: Maximun Expiratory Pressure (MEP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Luciana Chiavegato, city: São Paulo, zip: 04115000, country: Brazil, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
protocolSection identificationModule nctId: NCT06341231, orgStudyIdInfo id: 202400248, briefTitle: Personalized Anticoagulant Therapy for Pulmonary Thromboembolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are:* To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors).* Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy., conditionsModule conditions: Pulmonary Thromboembolisms, conditions: Anticoagulants; Increased, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 4700, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Major bleeding, primaryOutcomes measure: Clinically relevant non-major bleeding, primaryOutcomes measure: Recurrent VTE, secondaryOutcomes measure: All-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangya Hospital, status: RECRUITING, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Juan Jiang, MD, role: CONTACT, phone: +8615388078713, email: juanjiang@csu.eud.cn, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False