hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06356623, orgStudyIdInfo id: SHDC2202020401, briefTitle: A Risk Prediction Model of Postoperative Nausea and Vomiting in Patients With Liver Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2024-08-05, completionDateStruct date: 2024-08-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: PONV management has been recommended as a necessary part of enhanced recovery protocols during the perioperative period, and PONV risk assessment is, therefore, a necessary first step in determining the number of medications or strategies for prophylaxis and treatment by considering the number of modifiable and non-modifiable risk factors. However, the external validity of two commonly-used PONV prediction models for patients undergoing liver surgery is unsatisfied, and need to be updated for liver cancer populations to better inform personalized perioperative care regime and individualized decision-making in clinical practice., conditionsModule conditions: Nausea and Vomiting, Postoperative, conditions: Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 476, type: ESTIMATED, armsInterventionsModule interventions name: 1, outcomesModule primaryOutcomes measure: Postoperative nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06356597, orgStudyIdInfo id: KY2024-004-A, briefTitle: Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-12, completionDateStruct date: 2027-12-12, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Jing-yuan Fang, MD, Ph. D, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab with Fruquintinib, Metronidazole, outcomesModule primaryOutcomes measure: objective response rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai First People's Hospital, status: RECRUITING, city: Shanghai, country: China, contacts name: Qi Li, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Ninth People's Hospital, status: NOT_YET_RECRUITING, city: Shanghai, country: China, contacts name: Yanjie Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06356571, orgStudyIdInfo id: LPS18183, secondaryIdInfos id: U1111-1298-7348, type: OTHER, domain: WHO ICTRP, briefTitle: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma, acronym: SubQSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-11, primaryCompletionDateStruct date: 2027-01-08, completionDateStruct date: 2027-07-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy., conditionsModule conditions: Plasma Cell Myeloma Refractory, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Isatuximab SC-OBDS, interventions name: Montelukast, interventions name: Dexamethasone, interventions name: Acetaminophen, interventions name: Diphenhydramine, interventions name: Methylprednisolone, interventions name: Carfilzomib, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Number of participants with infusion reactions (IRs), secondaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable), secondaryOutcomes measure: Number of participants with injection site reactions (ISRs), secondaryOutcomes measure: CR or better, secondaryOutcomes measure: VGPR or better, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Time to first response (TT1R), secondaryOutcomes measure: Time to best response (TTBR), secondaryOutcomes measure: Patient experience and Satisfaction Questionnaire v2 (PESQ v2), secondaryOutcomes measure: Positivity titer of anti-drug antibodies (ADA) in a subset of 15 participants, secondaryOutcomes measure: Maximum observed concentration (Cmax) of isatuximab in a subset of 15 participants, secondaryOutcomes measure: Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of 15 participants, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06356545, orgStudyIdInfo id: OMICS_CODE_01, briefTitle: Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Fudan University, class: OTHER, descriptionModule briefSummary: This study will establish a clinical cohort of children with congenital diarrhea and enteropathy (CODE), mine biomarkers of CODE through multi-omics technology and construct a clinical risk prediction model., conditionsModule conditions: Diarrhea Infantile, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Clinical phenotype of congenital diarrhea and enteropathy in China, secondaryOutcomes measure: Biomarkers of congenital diarrhea and enteropathy with diagnostic value through microbiome, metabolome and proteome features, secondaryOutcomes measure: Cinical risk prediction model for congenital diarrhea and enteropathy built by artificial intelligence and machine learning, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 3 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06356519, orgStudyIdInfo id: YOUNGBC-29, briefTitle: Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Sacituzumab Govitecan, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: OS, secondaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Biyun Wang, role: CONTACT, phone: 18017312387, email: pro_wangbiyun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06356506, orgStudyIdInfo id: 2022-P2-338-01, briefTitle: A Study on Factors of Biochemical Response in Autoimmune Hepatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2034-05-01, completionDateStruct date: 2034-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up., conditionsModule conditions: Autoimmune Hepatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 630, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Alanine aminotransferase (ALT) recovery, primaryOutcomes measure: Aspartate transaminase (AST) recovery, primaryOutcomes measure: Immunoglobulin G (IgG) recovery, primaryOutcomes measure: Death, primaryOutcomes measure: Liver transplantaiton, primaryOutcomes measure: Progression to hepatocellular carcinoma (HCC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06356493, orgStudyIdInfo id: OBIIA CMNT, briefTitle: Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-02, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Tunis University, class: OTHER, descriptionModule briefSummary: The placenta accreta spectrum is a heterogeneous disorder due to abnormal placental invasion into the uterine wall putting at risk the lives of the patients by causing a massive hemorrhage. Its incidence is increasing due to the rise of the cesarean section. The management of this spectrum is multidisciplinary but not yet codified. Hysterectomy-caesarean, though hemostatic surgery, remains the standard Gold. Several adjuvant treatments have emerged in recent years to minimize the risk of bleeding and morbidity of these disorders including the internal-iliac prophylactic occlusion balloons.The aim of the study is to demonstrate the effect of prophylactic occlusion balloons in both uterine iliac arteries in the management of placental accreta spectrum disorders., conditionsModule conditions: Hemorrhage, conditions: Placenta Accreta Spectrum, conditions: Cesarean Section Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: caesarean hysterectomy with prior placement of prophylactic occlusion balloons of both internal iliac arteries, interventions name: caesarean hysterectomy without prior placement of prophylactic occlusion balloons of both internal iliac arteries, outcomesModule primaryOutcomes measure: calculated blood loss, primaryOutcomes measure: Transfusion peroperatively, primaryOutcomes measure: Duration of surgery, primaryOutcomes measure: Postoperative hospital stay, primaryOutcomes measure: Postoperative transfer to the intensive care unit, secondaryOutcomes measure: Morbidity, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Haithem Aloui, city: Manouba, state: Nabeul, zip: 2010, country: Tunisia, geoPoint lat: 36.80803, lon: 10.09721, locations facility: Haithem Aloui, city: Tunis, state: Nabeul, zip: 2010, country: Tunisia, geoPoint lat: 36.81897, lon: 10.16579, hasResults: False
protocolSection identificationModule nctId: NCT06356480, orgStudyIdInfo id: 266, briefTitle: 1% Acetic Acid vs Normal Saline Dressing inManagement of Diabetic Foot, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dr. Muhammad Naeem, class: OTHER, descriptionModule briefSummary: Chronic diabetic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic diabetic wounds, conditionsModule conditions: Granulation of Chronic Diabetic Wounds, conditions: Diabetic Wounds, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: 1% Acetic acid dressing, outcomesModule primaryOutcomes measure: Early epithelialization and granulation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pak Emirates military hospital, city: Rawalpindi, state: Punjab, country: Pakistan, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
protocolSection identificationModule nctId: NCT06356467, orgStudyIdInfo id: FARINET, briefTitle: Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs, acronym: FARINET, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated., conditionsModule conditions: Neuroendocrine Tumors, conditions: GEP-NET, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, outcomesModule primaryOutcomes measure: Global Progression Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS OSpedale San Raffaele, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06356454, orgStudyIdInfo id: KAPCON-CR, briefTitle: Knowledge, Attitudes and Practices of Paediatric Cardiologists About Cardiac Rehabilitation in Children With Congenital Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-02, primaryCompletionDateStruct date: 2025-06-02, completionDateStruct date: 2025-12-02, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Karamanoğlu Mehmetbey University, class: OTHER, descriptionModule briefSummary: Despite significant clinical benefits and recommendations of clinical practice guidelines to refer patients for exercise and physical activity counselling in the capacity of cardiac rehabilitation (CR), CR is largely underutilised and not implemented effectively. Studies have reported that the reasons for the low implementation of CR are multifactorial at the healthcare system, physician and patient levels. Therefore, the aim of this study was to investigate the knowledge, attitudes and practical applications of paediatric cardiologists regarding cardiac rehabilitation and specifically exercise and physical activity in children with congenital heart disease (CHD)., conditionsModule conditions: Physician's Role, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease, outcomesModule primaryOutcomes measure: The score of Questionnaire on knowledge, attitudes and practices of paediatric cardiologists about cardiac rehabilitation in children with congenital heart disease, eligibilityModule sex: ALL, minimumAge: 32 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06356441, orgStudyIdInfo id: B2024-039-01, briefTitle: Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation., conditionsModule conditions: Artificial Intelligence Supported Image Reviewing, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10400, type: ESTIMATED, armsInterventionsModule interventions name: AI, outcomesModule primaryOutcomes measure: sensitivity, secondaryOutcomes measure: specificity, secondaryOutcomes measure: positive predictive value, secondaryOutcomes measure: negative predictive value, secondaryOutcomes measure: total time of interpretation for all the MR images, secondaryOutcomes measure: the rate of discussion with a third radiologist, secondaryOutcomes measure: the detection rate of local recurrence in the AI-supported reading group, secondaryOutcomes measure: the sensitivity in the subgroups of different rT-stage, secondaryOutcomes measure: the incidence of cases whose recurrent risks and contours cannot be provided by the AI model, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-Sen University Cancer Center, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Fang-Yun Xie, role: CONTACT, phone: +8602087342926, email: xiefy@sysucc.org.cn, contacts name: Pu-Yun OuYang, role: CONTACT, phone: +8602087342926, email: ouyangpy@sysucc.org.cn, contacts name: Fang-Yun Xie, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False