hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06332092, orgStudyIdInfo id: FID-007-003, briefTitle: FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma, acronym: HNSCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fulgent Pharma LLC., class: INDUSTRY, descriptionModule briefSummary: The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Two different dosing regimens of FID-007 in combination with fixed-dose Cetuximab, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: FID007, outcomesModule primaryOutcomes measure: ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST), secondaryOutcomes measure: BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST), secondaryOutcomes measure: Duration of Response (DoR) measurement, secondaryOutcomes measure: Progression-free Survival (PFS) measurement, secondaryOutcomes measure: Overall Survival (OS) measurement, secondaryOutcomes measure: Disease Control Rate (DCR) analysis, secondaryOutcomes measure: Adverse Events (AEs) graded according to the CTCAE version 5.0, secondaryOutcomes measure: Vital Signs safety assessments, secondaryOutcomes measure: Clinical Laboratory safety assessments, secondaryOutcomes measure: ECGs safety assessment, secondaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Terminal/elimination half-life (t1/2), secondaryOutcomes measure: Clearance (CL), secondaryOutcomes measure: Volume of Distribution (Vd), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gabrail Cancer Center Research, status: RECRUITING, city: Canton, state: Ohio, zip: 44718, country: United States, contacts name: Nashat Gabrail, MD, role: CONTACT, geoPoint lat: 40.79895, lon: -81.37845, hasResults: False
protocolSection identificationModule nctId: NCT06332079, orgStudyIdInfo id: HAITI 2023-505356-22-00, briefTitle: Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients, acronym: HAITI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Gruppo Oncologico del Nord-Ovest, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).A total of 23 patients will be enrolled in each cohort., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: 166Holmium TARE, interventions name: Cetuximab, interventions name: Panitumumab, interventions name: 5-Fluorouracil, interventions name: Bevacizumab, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) Rate, secondaryOutcomes measure: Overall Toxicity rate, secondaryOutcomes measure: Grade 3/ Grade 4 Toxicity rate, secondaryOutcomes measure: Post-treatment Disease Control Rate (DCR), secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Dose-response relationships, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire, secondaryOutcomes measure: Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Pisana, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Beatrice Borelli, MD, PhD, role: CONTACT, phone: +39050992192, email: b.borelli89@gmail.com, contacts name: Gianluca Masi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Beatrice Borelli, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
protocolSection identificationModule nctId: NCT06332053, orgStudyIdInfo id: SY-5007-I-03, briefTitle: A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Shouyao Holdings (Beijing) Co. LTD, class: OTHER, descriptionModule briefSummary: This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin)., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: SY-5007, interventions name: Itraconazole, interventions name: SY-5007, interventions name: Rifampin, outcomesModule primaryOutcomes measure: Cmax for SY-5007, primaryOutcomes measure: Tmax for SY-5007, primaryOutcomes measure: AUC0-t for SY-5007, primaryOutcomes measure: AUC0-∞ for SY-5007, primaryOutcomes measure: t½ for SY-5007, primaryOutcomes measure: CL/F for SY-5007, primaryOutcomes measure: Vz/F for SY-5007, secondaryOutcomes measure: Safety of SY-5007, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Li Zheng, role: CONTACT, phone: 86-28-85423655, email: zhengli@wchscu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06332040, orgStudyIdInfo id: 22-500-243-50-35, briefTitle: Gentamicin Bladder Instillation on CAUTI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-09, primaryCompletionDateStruct date: 2026-10-08, completionDateStruct date: 2026-10-08, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: St. Joseph's Hospital and Medical Center, Phoenix, class: OTHER, descriptionModule briefSummary: Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs., conditionsModule conditions: Catheter Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, outcomesModule primaryOutcomes measure: CAUTI as primary outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Jpseph's Hospital and Medical Center, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85013, country: United States, contacts name: Kristina Kupanoff, PhD, role: CONTACT, phone: 602-406-5192, email: Kristina.Kupanoff@Commonspirit.org, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
protocolSection identificationModule nctId: NCT06332014, orgStudyIdInfo id: 20210123, briefTitle: Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-07-29, completionDateStruct date: 2026-07-29, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Prolia, outcomesModule primaryOutcomes measure: Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12, secondaryOutcomes measure: Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12, secondaryOutcomes measure: Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12, secondaryOutcomes measure: Percent change from baseline in total hip and femoral neck BMD at month 6 and 12, secondaryOutcomes measure: Percent change from baseline in lumbar spine BMD at month 6, secondaryOutcomes measure: Number of participants with adverse events (AE), eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06332001, orgStudyIdInfo id: IEO 1403, briefTitle: Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition., conditionsModule conditions: Neoplasm Malignant, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, interventions name: Control Group, outcomesModule primaryOutcomes measure: Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition., secondaryOutcomes measure: Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020), eligibilityModule sex: ALL, stdAges: CHILD, 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: NCT06331988, orgStudyIdInfo id: IEO 1341, briefTitle: Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer, acronym: MITICO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-21, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2029-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Relapse free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Davide Ciardiello, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06331975, orgStudyIdInfo id: IEO 0836, briefTitle: Radiomics and Radiogenomics of Non-small Cell Lung Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-06-12, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-09-14, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up, conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule interventions name: Radiomic signature, outcomesModule primaryOutcomes measure: Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status, primaryOutcomes measure: Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS), primaryOutcomes measure: Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06331962, orgStudyIdInfo id: B-ER-112-010, briefTitle: Digestive Tract Cancer and CIPN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-19, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, collaborators name: National Cheng Kung University, descriptionModule briefSummary: According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy., conditionsModule conditions: Digestive Tract Cancer, conditions: Chemotherapy-induced Peripheral Neuropathy, conditions: Remote Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: remote home-based exercise therapy group, interventions name: supervised exercise therapy group, interventions name: regular care group, outcomesModule primaryOutcomes measure: Basic information, primaryOutcomes measure: gene, primaryOutcomes measure: body height, primaryOutcomes measure: body weight, primaryOutcomes measure: body mass index, primaryOutcomes measure: blood data, primaryOutcomes measure: Questionnaire of Quality of Life, primaryOutcomes measure: Questionnaire of Chemotherapy-Induced Peripheral Neuropathy, secondaryOutcomes measure: Muscle Strength, secondaryOutcomes measure: Dynamic Balance, secondaryOutcomes measure: Sensation Test, secondaryOutcomes measure: Cardiovascular Endurance, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Physical Therapy, National Cheng-Kung University, status: RECRUITING, city: Tainan, zip: 701, country: Taiwan, contacts name: Cheng-Feng Lin, Ph.D, role: CONTACT, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False
protocolSection identificationModule nctId: NCT06331949, orgStudyIdInfo id: TR TOKAT02, briefTitle: Video Supported Training on Non-Stress Test Application to Pregnant Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hilal Özbek, class: OTHER, descriptionModule briefSummary: Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided, conditionsModule conditions: First Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: video assisted training, outcomesModule primaryOutcomes measure: State-Trait Anxiety Scale, primaryOutcomes measure: Prenatal Attachment Inventory (PAI), secondaryOutcomes measure: State-Trait Anxiety Scale, secondaryOutcomes measure: Prenatal Attachment Inventory (PAI), otherOutcomes measure: State-Trait Anxiety Scale, otherOutcomes measure: Prenatal Attachment Inventory (PAI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False