hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06280885, orgStudyIdInfo id: FIERCE, briefTitle: A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy, acronym: FIERCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, collaborators name: St. James's Hospital, Ireland, descriptionModule briefSummary: The primary aim of this study is to measure the feasibility of delivering a co-designed exercise programme for patients with cancer receiving chemotherapy treatment., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility randomised controlled trial using a 2:1 randomisation, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Not indicated for this feasibility study., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Health Behaviour Change (Pedometer), outcomesModule primaryOutcomes measure: Feasibility: Recruitment rates, primaryOutcomes measure: Feasibility: Adherence rates, primaryOutcomes measure: Feasibility: Attendance rates, primaryOutcomes measure: Feasibility: Retention Rates, primaryOutcomes measure: Feasibility: Reason for drop0out, secondaryOutcomes measure: Cardiorespiratory Fitness, secondaryOutcomes measure: Muscular Strength, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Mid-arm circumference, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Bioimpedance Analysis, secondaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Fatigue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St James's Hospital, city: Dublin, zip: 8, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
protocolSection identificationModule nctId: NCT06280846, orgStudyIdInfo id: P.T.REC/012/004878, briefTitle: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, collaborators name: King Khalid University, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP)., conditionsModule conditions: Chronic Nonspecific Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: random generator, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: high-intensity laser acupuncture and Exercise therapy program, interventions name: low-intensity laser acupuncture and Exercise therapy program, interventions name: Sham laser acupuncture, outcomesModule primaryOutcomes measure: peak torque, primaryOutcomes measure: peak torque, primaryOutcomes measure: Fatigue, primaryOutcomes measure: Fatigue, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: lumbar flexion ROM assessment, secondaryOutcomes measure: lumbar flexion ROM assessment, secondaryOutcomes measure: Disability, secondaryOutcomes measure: Disability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Doaa Ayoub Elimy, status: RECRUITING, city: Giza, zip: 11251, country: Egypt, contacts name: Doaa A Elimy, lecturer, role: CONTACT, phone: 00201066474654, email: do3aayoub25@gmail.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
protocolSection identificationModule nctId: NCT06280833, orgStudyIdInfo id: 10001884, secondaryIdInfos id: 001884-HG, briefTitle: Care Choreographies and the Making of the Psychosocial in Genetic Counseling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Human Genome Research Institute (NHGRI), class: NIH, descriptionModule briefSummary: Background:Genetic counselors play a new and evolving role in medical care. Recent advances in genetic testing are changing many health care treatments, and genetic counselors play a key role in teaching people how their genes may affect both health and treatments. Genetic counselors may also help guide people through complex talks about their treatment risks; their chances for recovery; and their social and emotional health and wellbeing. Researchers want to learn more about the role genetic counselors play in health care.Objective:To observe how genetic counselors at NIH manage the social and psychological aspects of patient care.Eligibility:Genetic counselors who work at NIH. People aged 18 years or older who are scheduled to meet with one of these counselors are also needed.Design:An investigator will sit in on the session between the counselor and the participant. The investigator will take notes. The session will not be recorded. The investigator will leave at any point if asked.The investigator will focus on talk about social and psychological care. That person will also listen to talk about risk; diagnosis; odds of recovery; and hope, grief, and loss. That person will note strategies that help the participant manage their emotions and how they perceive their risks.Counselors may later have a 1-hour interview with the investigator. They will answer questions about their experiences as a care provider at NIH.Participants will have only 1 session with the investigator. Counselors may have 4 to 10 sessions with an investigator over 8 months., conditionsModule conditions: Genetic Counselor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Care, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 115 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Human Genome Research Institute (NHGRI), status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Sara Hull, Ph.D., role: CONTACT, phone: 301-435-8712, email: shull@nhgri.nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
protocolSection identificationModule nctId: NCT06280820, orgStudyIdInfo id: 10001889, secondaryIdInfos id: 001889-H, briefTitle: Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-04-30, completionDateStruct date: 2034-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Heart, Lung, and Blood Institute (NHLBI), class: NIH, descriptionModule briefSummary: Background:More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF.Objective:To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time.Eligibility:People aged 18 years and older with heart failure.Design:Participants will be asked to join the study based on a review of their medical records.They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein.Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA.Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation.Researchers will follow the participants health by monitoring their medical records for up to 5 years., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To study the association between multi-omics signatures with all-cause mortality, secondaryOutcomes measure: Clinical phenotypes defined by:Ejection Fraction (>=50 vs. < 50)NYHA (3-4 vs. 1-2), secondaryOutcomes measure: To study the cross-sectional association between multi-omics signatures with clinical sub-phenotypes of heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Heart, Lung and Blood Institute (NHLBI), city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Veronique Roger, M.D., role: CONTACT, phone: 301-402-1715, email: veronique.roger@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
protocolSection identificationModule nctId: NCT06280794, orgStudyIdInfo id: Laser-Bell-2024, briefTitle: Efficacy of Laser Acupuncture for Idiopathic Bell's Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Beijing Tongren Hospital, class: OTHER, descriptionModule briefSummary: Objective:Bell's palsy is characterized by acute, unilateral onset that compromises function and esthetics, exerting a considerable impact on the social, professional, and psychological aspects of the lives of affected individuals. The objective of this study was to determine whether laser acupuncture therapy could relieve symptoms in patients with Bell's palsy in 8 weeks.Methods:This study was randomized controlled trial including 360 patients that undergoing Bell's palsy. All the patients received oral Betahistine Mesylate tablet, Vitamin B1 tablet and Prednisolone.Patients were assigned to the laser acupuncture (LA) group, Sham LA group and control group, with 120 patients in each group. LA group and Sham LA group were received 4 weeks of Laser treatment (3 times per week).Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), Facial Disability Index (FDI) and Facial Clinimetric Evaluation Scale (FaCE Scale) All the measurements were collected at the baseline, weeks 2, 4, 6, 8, 12 and 24., conditionsModule conditions: Bell's Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 336, type: ACTUAL, armsInterventionsModule interventions name: Laser acupuncture, interventions name: Steroids, outcomesModule primaryOutcomes measure: House Brackmann Grading System (HB), secondaryOutcomes measure: Sunnybrook Facial Grading Scale (SB Grading), secondaryOutcomes measure: Facial Disability Index (FDI), secondaryOutcomes measure: Facial Clinimetric Evaluation Scale (FaCE Scale), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing TongRen Hospital, Capital Medical University, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06280768, orgStudyIdInfo id: SHR-2004-102, briefTitle: Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Beijing Suncadia Pharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: SHR-2004 injection, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (including bleeding events), secondaryOutcomes measure: Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of Dupilumab: Elimination half life (t1/2), secondaryOutcomes measure: PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity, secondaryOutcomes measure: PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT), secondaryOutcomes measure: Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06280729, orgStudyIdInfo id: AI-TRYDIA, briefTitle: AI-Predicted Disease Trajectories in Diabetes: A Retrospective Study, acronym: AI-TRYDIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The study explores the utilization of artificial intelligence (AI) to predict disease progression trajectories in patients with diabetes. By analyzing historical data from a retrospective cohort, we aim to identify patterns and predictors of disease evolution. The approach seeks to enhance personalized treatment strategies and improve outcomes by foreseeing potential complications and disease milestones. The findings could pave the way for more targeted and effective management of diabetes through AI-driven insights., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule interventions name: AI-Analyis, outcomesModule primaryOutcomes measure: Primary Endpoint, primaryOutcomes measure: Primary Endpoint, primaryOutcomes measure: Primary Endpoint, secondaryOutcomes measure: Exploratory Objectives, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Diabetes Research Institute-IRCCS Ospedale San Raffaele, city: Milan, state: Lombardy, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06280690, orgStudyIdInfo id: NL83765.058.23, briefTitle: SGM-101 Tumor Targeted Fluorescence Endoscopy in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia, acronym: SGM-T1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: This will be the first trial investigating whether tumor targeted fluorescence is able to discriminate invasive T1 carcinoma / High grade dysplasia from Low grade dysplasia/normal tissue during endoscopic intraluminal resection. This will be done using the CEA-targeted fluorescent probe SGM-101., conditionsModule conditions: Colorectal Cancer, conditions: Image, conditions: Low Grade Dysplasia of Colon, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a single center prospective, non-randomized phase 2 proof of concept study, on the performance of SGM-101 to discriminate T1RC/HGD from LGD in patients that will be scheduled for endoscopic local en-bloc resection in the Leiden University Medical Centre (LUMC)., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SGM-101, outcomesModule primaryOutcomes measure: The ex-vivo NIR-fluorescence tumour to dysplasia ratio (TDR, T1RC/HGD to LGD ratio) on bread loafs (macroscopic) and pathology slides (microscopic)., secondaryOutcomes measure: - Ex-vivo NIR-fluorescence tumour-to-background ratio (TBR) and dysplasia-to-background ratio (DBR) (ex-vivo TDR already encountered within main objective), secondaryOutcomes measure: - In-vivo TDR, TBR and DBR, as measured with the Quest spectrum laparoscope., secondaryOutcomes measure: - The accuracy of SGM-101 to discriminate T1RC/HGD from LGD ex-vivo, secondaryOutcomes measure: -The accuracy of SGM-101 to discriminate T1RC/HGD from LGD in-vivo, secondaryOutcomes measure: - The correlation between in-vivo TBR/TDR and Kudo level (SM1 vs SM2/3), secondaryOutcomes measure: - The agreement of resection margins status (R0 vs R1) assessed by fluorescence and histopathology. A resection margin is classified positive when there is a fluorescent hotspot visible in the wound bed or on the specimen., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University Medical Center, status: RECRUITING, city: Leiden, zip: 2333ZA, country: Netherlands, contacts name: Mats Warmerdam, Msc, role: CONTACT, phone: +31715298420, email: m.i.warmerdam@lumc.nl, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
protocolSection identificationModule nctId: NCT06280677, orgStudyIdInfo id: 2023.Aurora-Donor, briefTitle: Aurora Test for ART Donor Patients (AURORA-Donor), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fertiga, Belgium, class: INDUSTRY, collaborators name: Fertilab, collaborators name: Ferring Pharmaceuticals, descriptionModule briefSummary: This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger., conditionsModule conditions: Infertility, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: AURORA-Donor, outcomesModule primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: P4, primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: E2, primaryOutcomes measure: Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose, primaryOutcomes measure: Clinical evaluation: number of Follicles, primaryOutcomes measure: Clinical evaluation: number of cumulus-oocyte complex, primaryOutcomes measure: Clinical evaluation: Meiosis II oocytes, primaryOutcomes measure: Clinical evaluation: Abnormal fertilization, primaryOutcomes measure: Clinical evaluation: Normal Fertilization, primaryOutcomes measure: Clinical evaluation: Day 3 embryo evaluation, primaryOutcomes measure: Clinical evaluation: Day 5/6 embryo evaluation, primaryOutcomes measure: Clinical evaluation: Day5/6 good quality blastocyst rate, primaryOutcomes measure: Clinical evaluation: Embryo utilization, primaryOutcomes measure: Expression profile: blastocyst formation, secondaryOutcomes measure: Biochemical pregnancy, secondaryOutcomes measure: Clinical pregnancy with positive fetal heartbeat, secondaryOutcomes measure: Expression profile: pregnancy prediction, secondaryOutcomes measure: Normalized messenger ribonucleic acid (mRNA) expression, otherOutcomes measure: Ongoing pregnancy rate, otherOutcomes measure: Live birth, otherOutcomes measure: Cumulative pregnancy, otherOutcomes measure: Cumulative live birth, otherOutcomes measure: Miscarriage rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fertilab, status: RECRUITING, city: Barcelona, zip: 08017, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False