hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06332820, orgStudyIdInfo id: 202401226RINB, briefTitle: In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease., conditionsModule conditions: Obstructive Airway Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Inspiratory capacity during exercise, secondaryOutcomes measure: Change of FEV1 and symptoms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06332807, orgStudyIdInfo id: NGGT002-P-2301, briefTitle: AAV Gene Therapy Clinical Study in Adult Classic PKU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-22, primaryCompletionDateStruct date: 2030-12-30, completionDateStruct date: 2030-12-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: NGGT (Suzhou) Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years., conditionsModule conditions: Phenylketonurias, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: NGGT002, outcomesModule primaryOutcomes measure: Incidence and severity of Adverse Events (AEs), primaryOutcomes measure: Change from baseline in clinical laboratory values, primaryOutcomes measure: Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations, primaryOutcomes measure: Change from baseline in Plasma Phe Concentration, secondaryOutcomes measure: Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose, secondaryOutcomes measure: Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose, secondaryOutcomes measure: Change in PKU Profile of Mood States (POMS), secondaryOutcomes measure: Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06332781, orgStudyIdInfo id: 2126175, briefTitle: Intravesical Gentamicin to Prevent Recurrent UTI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Women and Infants Hospital of Rhode Island, class: OTHER, descriptionModule briefSummary: Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI), conditionsModule conditions: Recurrent Uti, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Gentamicin, interventions name: Nitrofurantoin, outcomesModule primaryOutcomes measure: UTIs, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, secondaryOutcomes measure: Patient reported outcome measures, otherOutcomes measure: urobiome analysis, otherOutcomes measure: urobiome analysis, eligibilityModule sex: FEMALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06332768, orgStudyIdInfo id: WEAN_2021, briefTitle: NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-09-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-03-01, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Northern State Medical University, class: OTHER, descriptionModule briefSummary: The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support., conditionsModule conditions: Mechanical Ventilation Complication, conditions: Weaning Failure, conditions: Acute Respiratory Distress Syndrome, conditions: High-flow Oxygenation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized assignment, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Respiratory support, outcomesModule primaryOutcomes measure: Weaning failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City hospital # 1, city: Arkhangelsk, state: Arkhangelsk Region, zip: 163000, country: Russian Federation, geoPoint lat: 64.5401, lon: 40.5433, hasResults: False
protocolSection identificationModule nctId: NCT06332755, orgStudyIdInfo id: LG-LRCL001, briefTitle: Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors, acronym: LB-LR1109, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: LG Chem, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options., conditionsModule conditions: Non-small Cell Lung Cancer(NSCLC), conditions: Head and Neck Squamous Cell Carcinoma(HNSCC), conditions: Renal Cell Carcinoma(RCC), conditions: Urothelial Carcinoma, conditions: Malignant Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: LB-LR1109, outcomesModule primaryOutcomes measure: MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events of LB-LR1109, secondaryOutcomes measure: Preliminary efficacy of LB-LR1109, secondaryOutcomes measure: Anti-tumor efficacy of LB-LR1109, secondaryOutcomes measure: Pharmacokinetic profile of LB-LR1109, secondaryOutcomes measure: Characterize PK of LB-LR1109, secondaryOutcomes measure: Immunogenicity of LB-LR1109, secondaryOutcomes measure: Quality of life of participants, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06332742, orgStudyIdInfo id: QXZS for DOR, briefTitle: Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Yun Chen, class: OTHER, descriptionModule briefSummary: A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction, conditionsModule conditions: Decreased Ovarian Reserve, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Traditional Chinese medicine syndrome score, primaryOutcomes measure: serum sex hormone levels, primaryOutcomes measure: serum AMH levels, primaryOutcomes measure: transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC), secondaryOutcomes measure: Seven items of thyroid function, secondaryOutcomes measure: natural pregnancy rate, eligibilityModule sex: FEMALE, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210023, country: China, contacts name: Chen Yun, role: CONTACT, phone: 8613675167221, email: 66teoyq@gmail.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06332716, orgStudyIdInfo id: KY20222234, briefTitle: Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-26, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Jianjun Yang,MD, class: OTHER, descriptionModule briefSummary: Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors., conditionsModule conditions: Gastrointestinal Tumors，3D Organoids，Drug Sensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time., outcomesModule primaryOutcomes measure: Progression-free survival（PFS）, secondaryOutcomes measure: Overall survival（OS）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: XijingH, status: RECRUITING, city: Xi'an, state: Shaanxi, country: China, contacts name: Jianjun Yang, role: CONTACT, phone: 13756154175, email: yangjj@fmmu.edu.cn, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
protocolSection identificationModule nctId: NCT06332703, orgStudyIdInfo id: IACA, briefTitle: Acanthamoeba and Artificial Intelligence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Ospedale San Raffaele, class: OTHER, descriptionModule briefSummary: Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model., conditionsModule conditions: Acanthamoeba Keratitis, conditions: Artificial Intelligence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 151, type: ESTIMATED, outcomesModule primaryOutcomes measure: Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images., secondaryOutcomes measure: Correlation assessment between IVCM images and laboratory results., eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06332690, orgStudyIdInfo id: 514.2021, briefTitle: OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: IRCCS Multimedica, class: OTHER, collaborators name: AbbVie, descriptionModule briefSummary: The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome., conditionsModule conditions: Diabetic Macular Edema, conditions: Macular Edema Due to Diabetes Mellitus, conditions: Retinal Vein Occlusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: dexamethasone implant, outcomesModule primaryOutcomes measure: Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure), secondaryOutcomes measure: Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MultiMedica IRCCS Multimedica, status: RECRUITING, city: Milan, zip: 20123, country: Italy, contacts name: Stela Vujosevic, MD, role: CONTACT, phone: +39 02 85 99 4601, email: stela.vujosevic@multimedica.it, contacts name: GAbriele Piccoli, role: CONTACT, phone: +39 02 85 99 4601, email: gabriele.piccoli@multimedica.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06332677, orgStudyIdInfo id: TERS, briefTitle: Target of Suv420h1/2 in Hepatocytes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids., conditionsModule conditions: NAFLD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: study the cellular and molecular mechanisms of correlation between the SUV420H1/H2 methyltransferase and the progression of liver damage in mice (San Raffaele Institute) and to confirm these findings in human samples and in vitro 3D liver models., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: the main genes and expression by comparing the transcriptomic lipidomic profile, outcomesModule primaryOutcomes measure: the main genes and expression by comparing the transcriptomic lipidomic profile, primaryOutcomes measure: the main genes and expression by comparing the transcriptomic lipidomic profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, status: RECRUITING, city: Milano, zip: 20122, country: Italy, contacts name: Luca Vittorio Carlo Valenti, role: CONTACT, phone: 02 5503 6595, email: luca.valenti@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-26, uploadDate: 2024-03-14T09:56, filename: Prot_SAP_000.pdf, size: 703523, hasResults: False