hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06321692, orgStudyIdInfo id: IEO 1003, briefTitle: Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-10-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome., conditionsModule conditions: Neuroendocrine Tumors, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of blood levels of biomarkers of cardiac damage, outcomesModule primaryOutcomes measure: blood levels of biomarkers of cardiac damage, primaryOutcomes measure: blood levels of biomarkers of hemodynamic impairment, primaryOutcomes measure: blood levels of biomarkers of cardiac fibrosis, secondaryOutcomes measure: Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Daniela Cardinale, MD, role: CONTACT, email: daniela.cardinale@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06321679, orgStudyIdInfo id: IEO 1269, briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone, acronym: RESPECT, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-07-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.This is a monocentric, prospective observational study., conditionsModule conditions: Castration-resistant Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Imaging evaluation, outcomesModule primaryOutcomes measure: Time to disease progression in bone metastasis identify by WB-MRI, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IEO Istituto Europeo di Oncologia, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Giuseppe Petralia, role: CONTACT, email: giuseppe.petralia@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06321666, orgStudyIdInfo id: IEO 0986, briefTitle: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone, acronym: RESPECT-MI, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-09-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ACTUAL, armsInterventionsModule interventions name: WB-MRI, outcomesModule primaryOutcomes measure: Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IEO Istituto Europeo di Oncologia, city: Milan, zip: 20141, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06321653, orgStudyIdInfo id: IEO 0953, briefTitle: Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes, acronym: AXILL-ART, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-04-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections., conditionsModule conditions: Arm Lymphedema, conditions: Breast Cancer, conditions: Radiotherapy Side Effect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hypofractionated radiotherapy scheme, outcomesModule primaryOutcomes measure: Percentage of patients with arm lymphedema, secondaryOutcomes measure: Evaluation of cute locoregional toxicity at breast and axilla, secondaryOutcomes measure: Evaluation of chronic toxicity at breast and axilla, secondaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Quality of life (QoL) in order to evaluate pain, itching and burning at breast or axilla, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Maria Cristina Leonardi, role: CONTACT, phone: +39 02 94372156, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06321627, orgStudyIdInfo id: IEO 1811, briefTitle: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach, acronym: ICARUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-14, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body., conditionsModule conditions: HPV-Related Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Radiation therapy as curative treatment, outcomesModule primaryOutcomes measure: Disease free survival, secondaryOutcomes measure: Genetic patterns of radiosensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Daniela Alterio, MD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06321614, orgStudyIdInfo id: 2022098, briefTitle: Deep Learning in Classifying Bowel Obstruction Radiographs, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-12-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples.Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation., conditionsModule conditions: Digestive System Disease, conditions: Polyp of Colon, conditions: Bowel Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnostic and classification performance, secondaryOutcomes measure: Visualized interpretation of the self-supervised model, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TheFirst Affiliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215006, country: China, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
protocolSection identificationModule nctId: NCT06321601, orgStudyIdInfo id: 20230070, briefTitle: Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2030-04-28, completionDateStruct date: 2030-04-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV., conditionsModule conditions: Vasculitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Avacopan, outcomesModule primaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Pediatric Vasculitis Activities Score (PVAS), primaryOutcomes measure: Proportion of Participants With Sustained Disease Remission at Week 52 According to the PVAS, secondaryOutcomes measure: Plasma Concentrations of Avacopan, secondaryOutcomes measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAE), secondaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 26 According to the Birmingham Vasculitis Activity Score (BVAS), secondaryOutcomes measure: Proportion of Participants Achieving Disease Remission at Week 52 According to the BVAS, secondaryOutcomes measure: Proportion of Participants With PVAS of 0 Over Time Through Week 52, secondaryOutcomes measure: Proportion of Participants With BVAS of 0 Over Time Through Week 52, secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Urinary Albumin-Creatinine Ratio (UACR), secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Estimated Glomerular Filtration Rate (eGFR), secondaryOutcomes measure: Change From Baseline Over 52 Weeks In Physician Global Assessment (PGA) of Disease Activity, secondaryOutcomes measure: Change From Baseline Over 52 Weeks in Pediatric Vasculitis Damage Index (PVDI), secondaryOutcomes measure: Number of Glucocorticoid Dosages Administered, secondaryOutcomes measure: Proportion of Participants Across the Taste Score Categories of the TASTY Faces Scale, secondaryOutcomes measure: Taste and Acceptability Score of Avacopan per TASTY Faces Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06321575, orgStudyIdInfo id: AVA-CL-5000, briefTitle: The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial), acronym: GREAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Avantec Vascular, class: INDUSTRY, collaborators name: Bright Research Partners, collaborators name: Yale Cardiovascular Research Group, descriptionModule briefSummary: The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 15 investigational sites in the U.S., conditionsModule conditions: Peripheral Arterial Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The investigation is a prospective, multicenter, non-randomized, single-arm, open-label pivotal clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 159, type: ESTIMATED, armsInterventionsModule interventions name: Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS), outcomesModule primaryOutcomes measure: Freedom from major adverse events (MAE), primaryOutcomes measure: Technical success, secondaryOutcomes measure: Change in % stenosis in target lesion after treatment with Golazo Peripheral AS, secondaryOutcomes measure: Procedural Success Rate, secondaryOutcomes measure: Clinical Success Rate, secondaryOutcomes measure: Rates of all adverse events classified as MAEs, secondaryOutcomes measure: Incidence of minor target limb amputation, secondaryOutcomes measure: Incidence of myocardial infarction, secondaryOutcomes measure: Incidence of target vessel revascularization (TVR) in the target limb, secondaryOutcomes measure: Incidence of angiographic procedural distal embolization in the target limb, secondaryOutcomes measure: Time to primary patency of the target vessels, secondaryOutcomes measure: Time to assisted primary patency of the target vessels, secondaryOutcomes measure: Time to secondary patency of the target vessels, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06321549, orgStudyIdInfo id: 202201562B0, briefTitle: New Era of DIEP With Minimally Invasive Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-03, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2023-10-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue. To restore appropriate symmetry, a larger flap inset ratio must be transferred. Supercharging of the second vein or inclusion of bilateral pedicle is commonly required. Current paradigm shifts in mastectomy has also resulted in more minimally invasive surgeries (MIS) espousing smaller lateral incisions, leading to a significant change in available recipient vessels. This study aimed to demonstrate our experience in changing strategies of DIEP flaps following the evolution of mastectomy techniques.Between October 2008 and March 2022, retrospective data was gathered for 278 patients who underwent breast reconstruction surgery utilizing DIEP flaps by a single plastic surgeon. These patients were divided into two distinct groups based on their operation dates, with November 2018 marking a pivotal moment when the first MIS was introduced., conditionsModule conditions: Breast Reconstruction, conditions: Mastectomy; Lymphedema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 278, type: ACTUAL, armsInterventionsModule interventions name: The reference point of minimally invasive mastectomy procedure conducted, outcomesModule primaryOutcomes measure: Endoscopy mastectomy, primaryOutcomes measure: Robotic mastectomy, primaryOutcomes measure: Incision, primaryOutcomes measure: Usage of SIEV, primaryOutcomes measure: Inclusion of bipedicle, primaryOutcomes measure: Location of recipient artery/vein, primaryOutcomes measure: Recipient artery/vein selection, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung Memorial Hospital, city: Taoyuan, zip: 33305, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
protocolSection identificationModule nctId: NCT06321536, orgStudyIdInfo id: STUDY00007230, secondaryIdInfos id: U54CK000601, type: NIH, link: https://reporter.nih.gov/quickSearch/U54CK000601, briefTitle: Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: Centers for Disease Control and Prevention, descriptionModule briefSummary: REACT is a phase two, open-label, cluster randomized, crossover study of microbiota therapy (MT) to reduce colonization with multi-drug resistant organisms (MDRO). REACT is designed to assess the safety and efficacy of MT administered to subjects colonized with a MDRO. The overarching hypothesis is that MT can reduce MDRO colonization with safety that is comparable to observation., conditionsModule conditions: Multi-Drug Resistant Organism Colonization, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Allogeneic Microbiota in Glycerol (9%) (AMG), outcomesModule primaryOutcomes measure: Difference in number of solicited Adverse Events (AEs), primaryOutcomes measure: Difference in severity of solicited AEs, primaryOutcomes measure: Difference in number of unsolicited AEs, primaryOutcomes measure: Difference in severity of unsolicited AEs, primaryOutcomes measure: Difference in proportion of participant stool positive cultures for any target MDRO among AMG-treated compared to Observation participants, secondaryOutcomes measure: Count of serious AEs (SAEs), secondaryOutcomes measure: Count of AEs of Special Interest (AESIs), secondaryOutcomes measure: Proportion of stool cultures at Day 28 positive for category-specific MDROs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emory University Hospital, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Michael Woodworth, MD, role: CONTACT, phone: 404-778-1691, geoPoint lat: 33.749, lon: -84.38798, hasResults: False