hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06346275, orgStudyIdInfo id: 3rdZhejiangCMU-11, briefTitle: Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, outcomesModule primaryOutcomes measure: Three-dimensional gait analysis, primaryOutcomes measure: Cerebral hemodynamics, secondaryOutcomes measure: Mini-Mental State Examination, secondaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Barthel Index, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06346249, orgStudyIdInfo id: 49/2024, briefTitle: Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Universidad de Extremadura, class: OTHER, descriptionModule briefSummary: The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Electrical Stimulation Therapy, interventions name: Manual Therapy, interventions name: Exercise Therapeutic, outcomesModule primaryOutcomes measure: Changes in Pain, primaryOutcomes measure: Changes Pressure Pain, primaryOutcomes measure: Changes in Disability, secondaryOutcomes measure: Changes in Range of Motion, secondaryOutcomes measure: General Health., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: María de los Ángeles Cardero Durán, status: RECRUITING, city: Badajoz, zip: 06006, country: Spain, contacts name: María de los Ángeles Cardero Durán, Doctor, role: CONTACT, email: mcarderod@unex.es, geoPoint lat: 38.87789, lon: -6.97061, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-27, uploadDate: 2024-04-01T16:35, filename: ICF_000.pdf, size: 253582, hasResults: False
protocolSection identificationModule nctId: NCT06346236, orgStudyIdInfo id: 69HCL21_0843, secondaryIdInfos id: 401, type: OTHER, domain: AGORA HCL, briefTitle: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity., acronym: NEO-TYR, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-01, primaryCompletionDateStruct date: 2021-07-01, completionDateStruct date: 2022-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis., conditionsModule conditions: Transient Hypothyroxinemia of Prematurity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 373, type: ACTUAL, armsInterventionsModule interventions name: L-thyroxine at a dose of 7.5 µg/kg/d for THOP, interventions name: THOP without treatment, interventions name: NoTHOP, outcomesModule primaryOutcomes measure: Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation., eligibilityModule sex: ALL, maximumAge: 2 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: HFME, city: Bron, zip: 69300, country: France, geoPoint lat: 45.73333, lon: 4.91667, locations facility: CHU Grenoble, city: Grenoble, zip: 38100, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: CHU Saint EtienneHopital, city: Saint-Étienne, zip: 42000, country: France, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
protocolSection identificationModule nctId: NCT06346223, orgStudyIdInfo id: HSEARS20230928006, briefTitle: Mindfulness-Based Intervention for Family Caregivers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: Health and Medical Research Fund, descriptionModule briefSummary: The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points., conditionsModule conditions: Caregiving Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A single-blinded, parallel-group, randomized-controlled trial (RCT) design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness and psychoeducation, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Perceived Caregiving Stress in the Family Caregiver, secondaryOutcomes measure: Depressive Symptoms in the Family Caregiver, secondaryOutcomes measure: Positive Aspect of Caregiving in the Family Caregiver, secondaryOutcomes measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient, secondaryOutcomes measure: Trait Mindfulness in the Family Caregiver, secondaryOutcomes measure: Neuropsychiatric Syndromes in the Care Recipient, secondaryOutcomes measure: Feasibility of Eligibility and Enrollment, secondaryOutcomes measure: Feasibility of Attendance Rate, secondaryOutcomes measure: Feasibility of Adherence to Self-Practice, secondaryOutcomes measure: Feasibility of Retention Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06346210, orgStudyIdInfo id: UNT: U1111-1288-2037, briefTitle: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Healthcare Region Dalarna, descriptionModule briefSummary: Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4000, type: ACTUAL, armsInterventionsModule interventions name: Tracheostomy, outcomesModule primaryOutcomes measure: Ventilator free days alive, secondaryOutcomes measure: 60 day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala University, city: Uppsala, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
protocolSection identificationModule nctId: NCT06346197, orgStudyIdInfo id: ET23-185, briefTitle: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas, acronym: CIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2028-05-15, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre Leon Berard, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm)., conditionsModule conditions: Gastric Cancer, conditions: MSI-H, conditions: Metastatic Cancer, conditions: Advanced Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: Balstilimab, interventions name: Botensilimab, interventions name: Folfox Protocol, interventions name: XELOX, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Survival of patients, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Adverse Event description as assessed by CTCAE V5.0, secondaryOutcomes measure: EORTC QLQ C30, otherOutcomes measure: Gene expression and genomic profile description, otherOutcomes measure: Gene expression and genomic profile description, otherOutcomes measure: Number of tumor samples with modification of tumor microenvironment under study treatments, otherOutcomes measure: Value of Tumor mutational Burden (Mutation/ Megabase) on tumor and blood (circulating tumor DNA) during treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Clélia COUTZAC, MD, role: CONTACT, email: clelia.coutzac@lyon.unicancer.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
protocolSection identificationModule nctId: NCT06346184, orgStudyIdInfo id: HM-EMMA-101, briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-06-08, completionDateStruct date: 2024-06-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Hanmi Pharmaceutical Company Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: HCP2303, interventions name: RLD2302, interventions name: RLD2102, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, secondaryOutcomes measure: AUCinf, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vd/F, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 54 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jeonbuk University Hospital, city: Jeonju, state: Jeollabuk-do, country: Korea, Republic of, contacts name: Jin A Lee, Researcher, role: CONTACT, phone: 063-259-3550, contacts name: Min-gul Kim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
protocolSection identificationModule nctId: NCT06346158, orgStudyIdInfo id: 2024-3615, briefTitle: Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia, acronym: PRESCOD-AI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, collaborators name: CIUSSS du Nord de l'Ile de Montréal, descriptionModule briefSummary: The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by* Electroencephalographic (EEG) features available prior to induction of anesthesia* Cognitive performance* Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded., conditionsModule conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive testing, interventions name: electroencephalogram, interventions name: High density electroencephalogram, interventions name: General anesthesia, outcomesModule primaryOutcomes measure: Concentration at the effect-site propofol associated with deep anesthesia (CeDA), secondaryOutcomes measure: Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia, secondaryOutcomes measure: Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia, secondaryOutcomes measure: Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia., otherOutcomes measure: Concentration at the effect-site propofol associated with loss of consciousness (CeLOC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06346132, orgStudyIdInfo id: 2024-00043 CE 4516, briefTitle: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Schlotterbeck Hervé, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia., conditionsModule conditions: Virtual Reality, conditions: Medical Device, conditions: Local Anesthesia, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality application, outcomesModule primaryOutcomes measure: Global pain intensity experienced during the procedure., secondaryOutcomes measure: Need for supplementary sedation and/or analgesia during the procedure., secondaryOutcomes measure: Global anxiety intensity experienced during the procedure., secondaryOutcomes measure: Patient's comfort during the procedure assessed by the surgeon and cardiologist., secondaryOutcomes measure: Incidence of motion sickness during the virtual reality experience., secondaryOutcomes measure: Patient's perceived procedure duration., secondaryOutcomes measure: Maximal systolic arterial blood pressure., secondaryOutcomes measure: Incidence of hypotensive or hypoxic events during procedure., secondaryOutcomes measure: Total dose of local anaesthetic used during the procedure., secondaryOutcomes measure: Change in anesthetic strategy during procedure., secondaryOutcomes measure: Interruption of virtual reality experience during the procedure., secondaryOutcomes measure: Intra- and post-procedure complications., secondaryOutcomes measure: Overall patient's comfort and satisfaction experienced during the procedure., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto CardioCentro, city: Lugano, state: Ticino, zip: 6900, country: Switzerland, contacts name: Herve Schlotterbeck, MD, role: CONTACT, phone: +41918115189, email: herve.schlotterbeck@eoc.ch, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
protocolSection identificationModule nctId: NCT06346119, orgStudyIdInfo id: PI-2023-01, briefTitle: Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital, acronym: ETDR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-27, primaryCompletionDateStruct date: 2024-01-05, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Niort, class: OTHER, descriptionModule briefSummary: This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation., conditionsModule conditions: Reaction Anxiety, conditions: Difficult or Failed Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the "touch" and the second group will not receive it will be the control arm., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day, outcomesModule primaryOutcomes measure: chemical restraint, secondaryOutcomes measure: self-extubations, secondaryOutcomes measure: patient discomfort, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: Ratio chemical restraint use, secondaryOutcomes measure: cardiac frequency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Niort, status: RECRUITING, city: Niort, zip: 79000, country: France, geoPoint lat: 46.32313, lon: -0.45877, hasResults: False