hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06281964, orgStudyIdInfo id: PLB1004-III-01, briefTitle: Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Avistone Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Efficacy and safety evaluation of PLB1004 in patients with locally advanced/metastatic non-squamous NSCLCharboring EGFR exon 20 insertion., conditionsModule conditions: Non-Small-Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 327, type: ESTIMATED, armsInterventionsModule interventions name: PLB1004, interventions name: Pemetrexed+（carboplatin or Cisplatin）with or without Sintilimab, outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS) by BICR, secondaryOutcomes measure: Progression-Free Survival (PFS) by the investigator, secondaryOutcomes measure: Intracranial Overall Response Rate（ORR）, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Plasma concentrations of PLB1004 and metabolites may be combined with data from other clinical studies, otherOutcomes measure: intracranial Progression-Free Survival（PFS）, otherOutcomes measure: second progression-free survival (PFS2), otherOutcomes measure: Assess the Quality of Healthy Living About Patients, otherOutcomes measure: EGFR Ex20ins status in tumor tissues and its relevance to the clinical efficacy of drugs, otherOutcomes measure: Gene mutation status in plasma ctDNA before and after medication, and its correlation with clinical efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06281951, orgStudyIdInfo id: 2022/0271/HP, briefTitle: Nebulized Fentanyl in Healthy Volunteers, acronym: AEROfen, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study, conditionsModule conditions: Analgesia, conditions: Emergencies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Fentanyl - Inhalation by facial nebulization, interventions name: Fentanyl - Nebulisation, outcomesModule primaryOutcomes measure: Measurement of [F] bioavailability via facial nebulization and intranasal inhalation., secondaryOutcomes measure: Measurement of maximum decrease in PUAL (pupillary under ambient light) between facial nebulization and intranasal inhalation., secondaryOutcomes measure: Measurement of the difference between observed and predicted PUAL values by a PK/PD model., secondaryOutcomes measure: Time required to achieve >30% decrease in PUAL compared to baseline., secondaryOutcomes measure: Measurement of dose required to achieve >30% decrease in PUAL compared to baseline., secondaryOutcomes measure: Measurement of administration comfort score using a visual analog scale ranging from 0 (maximum discomfort) to 10 (optimal comfort) (unitless)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, Rouen, city: Rouen, zip: 76031, country: France, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False
protocolSection identificationModule nctId: NCT06281938, orgStudyIdInfo id: 1617209, briefTitle: Machine Learning and 3D Image-based Modeling for Body Weight Estimation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Florida Atlantic University, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled clinical trial is to \[learn about, test, compare etc.\] in critically ill or injured cohorts of patients presenting to the Emergency Department. The main question\[s\] it aims to answer are:* Are weight estimates from a 3D camera system more accurate than standard methods of weight estimation?* Do patients who receive weight estimates with a 3D camera system have fewer drug dosing errors than patients receiving standard care?Participants will either receive a weight estimate using a 3D camera system, or standard methods of care.Researchers will compare the 3D camera group to those with standard care to see if the weight estimates are more accurate, to see if drug dosing is more accurate, and to compare the incidence of adverse events related to medications in each group., conditionsModule conditions: No Specific Conditions, conditions: Weight, Body, conditions: Drug Dose, conditions: Weight-Estimation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention cohort and control cohort will be used, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Investigators and outcomes assessors will be blinded to the arm. Coded data will be used for masking., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Weight estimation using 3D camera, interventions name: Standard care weight estimation, outcomesModule primaryOutcomes measure: Weight estimation accuracy, primaryOutcomes measure: Time to obtain weight estimate, primaryOutcomes measure: Drug dosing accuracy, primaryOutcomes measure: Correct dosing scalar used, secondaryOutcomes measure: Accuracy of in-bed scales, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06281925, orgStudyIdInfo id: 22-01363, briefTitle: Cryotherapy & Oxaliplatin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy., conditionsModule conditions: Colon Cancer, conditions: Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cryotherapy Gloves, outcomesModule primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 2, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 3, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 4, primaryOutcomes measure: Proportion of Participants with Peripheral Neuropathy at Visit 5, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: Mineola, state: New York, zip: 11501, country: United States, geoPoint lat: 40.74927, lon: -73.64068, locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06281912, orgStudyIdInfo id: 4504/23, briefTitle: Impact of Anti PD-1 Therapy in Children, Adolescents and Young Adults (CAYA) Melanoma Patients, acronym: MELCAYA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera di Perugia, class: OTHER, descriptionModule briefSummary: This is a retrospective observational cohort study, the primary objective is investigate the activity and efficacy of anti PD-1 antibodies in children, adolescents and young adult melanoma patients, with radically resected or metastatic disease, conditionsModule conditions: Early Melanoma, conditions: Advanced Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: rate of objective response, secondaryOutcomes measure: adverse event incidence, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 30 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Aix-Marseille Universite, city: Marseille, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Institut Curie, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Ospedale universitario della Charité, city: Berlino, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: German Cancer Research Center (Deutsches Krebsforschungszentrum (DKFZ), city: Heidelberg, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: University Children's Hospital Tuebingen, city: Tuebingen, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, locations facility: Universita Degli Studi Di Firenze, city: Firenze, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Fondazione Irccs Istituto Nazionale Dei Tumori, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Universita Cattolica Del Sacro Cuore, city: Roma, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Princess Máxima Center for Pediatric Oncology (Prinses Máxima Centrum voor kinderoncologie), city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, city: Warsaw, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Institut Catala D'Oncologia, city: Barcellona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Instituto de Investigaciones Biomédicas August Pi i Sunyer, city: Barcellona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, city: Stockholm, country: Sweden, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
protocolSection identificationModule nctId: NCT06281886, orgStudyIdInfo id: GASTO-10107, briefTitle: Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma, conditionsModule conditions: Esophageal Squamous Cell Carcinoma, conditions: Efficacy, conditions: Toxicity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Induction Immunotherapy-Toripalimab, interventions name: Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin, interventions name: Radiotherapy, interventions name: Apatinib, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Local-regional progression-free survival, secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, secondaryOutcomes measure: Score of Quality of Life Questionnare-Core 30 (The European Organization for Reasearch and Treatment of Cancer), secondaryOutcomes measure: Distant metastasis-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Bo Qiu, Professor, role: CONTACT, phone: +86-020-87343031, email: qiubo@sysucc.org.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06281873, orgStudyIdInfo id: 0645, briefTitle: Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-27, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2024-02-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis., conditionsModule conditions: Oroantral Fistula, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ACTUAL, armsInterventionsModule interventions name: closure by PRF membrane, outcomesModule primaryOutcomes measure: Evaluation of the soft tissue wound's healing, secondaryOutcomes measure: Secondary radiographic outcomes, assessment of bone formation, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Alexandria, zip: 562589, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
protocolSection identificationModule nctId: NCT06281860, orgStudyIdInfo id: PITHAC, secondaryIdInfos id: 2023-00099, type: REGISTRY, domain: BASEC, briefTitle: Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration, acronym: PITHAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-24, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dr Jean Yannis PERENTES, class: OTHER, descriptionModule briefSummary: Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD)., conditionsModule conditions: Mesothelioma, Malignant, conditions: Carcinoma, Non-Small-Cell Lung, conditions: Carcinoma Breast Stage IV, conditions: Ovarian Cancer, conditions: Esophageal Cancer, conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatine Teva®, outcomesModule primaryOutcomes measure: Dose Escalation and Maximum Tolerated Dose determination (Part A):, primaryOutcomes measure: Expansion phase (Part B):, secondaryOutcomes measure: Dose Escalation and MTD determination (Part A):, secondaryOutcomes measure: Expansion phase (Part B):, otherOutcomes measure: Dose Escalation and MTD determination (Part A):Exploratory outcomes, otherOutcomes measure: Expansion phase (Part B):Exploratory outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier Universitaire Vaudois, status: RECRUITING, city: Lausanne, country: Switzerland, contacts name: Jean-Yannis PERENTES, role: CONTACT, contacts name: Jean Yannis PERENTES, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
protocolSection identificationModule nctId: NCT06281834, orgStudyIdInfo id: 2024P000306, briefTitle: Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: APIN Public Health Initiatives, collaborators name: University of Cape Town, descriptionModule briefSummary: Tuberculosis (TB) is the leading cause of death among children living with HIV, yet insufficient data are available on the pharmacokinetics of newer TB prevention strategies in children. Short-course TB prevention/latent TB infection (LTBI) treatment regimens increase completion rates but have not been adequately studied among children living with HIV. Our prospective, open-label PK study will examine and extend use of weekly rifapentine and isoniazid (3HP) among children receiving dolutegravir. This will address gaps in knowledge by examining two-way PK of short-course LTBI treatment in a vulnerable pediatric population., conditionsModule conditions: Pediatric HIV Infection, conditions: Latent Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective single-arm, open-label, pharmacokinetic and safety study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Rifapentine, interventions name: Dolutegravir, outcomesModule primaryOutcomes measure: Dolutegravir AUC during weekly rifapentine/isoniazid, secondaryOutcomes measure: Rifapentine AUC, secondaryOutcomes measure: Proportion of participants experiencing severe (grade 3 or 4) clinical or laboratory adverse events, eligibilityModule sex: ALL, minimumAge: 4 Weeks, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06281821, orgStudyIdInfo id: 4947 [Study 2], briefTitle: Mobile App-based Approach for Reducing Pain and Hazardous Drinking: a Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Boston University Charles River Campus, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: Chronic pain and heavy drinking are common co-occurring conditions among patients presenting to primary care settings. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce alcohol use and pain that can be readily incorporated into the health care settings. The objective of this study is to test a modified version of a smartphone-based intervention for reducing pain and alcohol use among individuals experiencing chronic pain who engage in heavy drinking. The primary goal is to test the feasibility and acceptability of implementing this intervention in a sample that includes participants from rural areas and providing initial data on the utility of the intervention., conditionsModule conditions: Alcohol Drinking, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Compare an intervention to an assessment only control condition, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes assessor at follow-up timepoint is masked to condition. Baseline assessment occurs prior to randomization, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: mhealth-pc, outcomesModule primaryOutcomes measure: Pain (average weekly), Enjoyment of Life, General Activity (PEG) Scale, primaryOutcomes measure: Time Line Follow-Back-30 Day Weekly Drinking, secondaryOutcomes measure: Time Line Follow-Back 30-Day Heavy Episodic Drinking, secondaryOutcomes measure: Perceptions of Treatment Questionnaire, secondaryOutcomes measure: Systems Usability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Boston University, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Maya Kratzer, BA, role: CONTACT, phone: 857-225-8843, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False