hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06304051, orgStudyIdInfo id: Naochuxue-IOE, briefTitle: Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-17, primaryCompletionDateStruct date: 2023-05-10, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.Participants will be divided into two groups randomly, with different nutritional support respectively., conditionsModule conditions: Intracerebral Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 118, type: ACTUAL, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: Number of cases of successful extubation, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Serum albumin level, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Clinical Pulmonary Infection Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hongkong central Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06304038, orgStudyIdInfo id: 2018, briefTitle: Cost-consequence Analysis of Influenza Vaccination in a Teaching Hospital in Rome, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-16, primaryCompletionDateStruct date: 2018-04-29, completionDateStruct date: 2019-11-14, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Flu vaccination, as well as being effective to prevent seasonal influenza, decreases staff illness and absenteeism and reduces costs resulting from loss of productivity. Despite the effectiveness of flu vaccination, the seasonal coverage among healthcare workers is usually low. The aim of this retrospective observational study is to analyze the vaccination coverage rate among all employees (healthcare workers and administrative staff) of a large teaching hospital in Rome during the 2017-2018 influenza season, to perform a cost-consequence analysis of influenza vaccination (by evaluating the absenteeism due to illness in the epidemic period), and to assess the impact of vaccination in terms of both costs and sick days., conditionsModule conditions: Influenza Vaccine, conditions: Cost-Benefit Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5483, type: ACTUAL, armsInterventionsModule interventions name: Flu Vaccine, outcomesModule primaryOutcomes measure: Effectiveness of the quadrivalent vaccine, primaryOutcomes measure: Economic impact of the quadrivalent vaccine, secondaryOutcomes measure: Expected economic savings for each one percentage point increase in vaccination coverage, secondaryOutcomes measure: Non-economic incentives for healthcare personnel who decide to vaccinate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario "A.Gemelli" IRCCS, city: Rome, zip: 00168, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
protocolSection identificationModule nctId: NCT06304025, orgStudyIdInfo id: GvHD 01, briefTitle: Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment, acronym: GvHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, class: OTHER, collaborators name: Instituto Distrital de Ciencia, Biotecnología e Innovación en Salud - IDCBIS, descriptionModule briefSummary: Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs).The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib., conditionsModule conditions: Graft Versus Host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental (pilot clinical study), randomized, blind, and parallel., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Wharton's jelly mesenchymal stem cells (WJ-MSCs), outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events: safety and tolerability, primaryOutcomes measure: Efficacy clinic profile: response of acute GVDH, primaryOutcomes measure: Efficacy clinic profile : duration of response, primaryOutcomes measure: Efficacy clinic profile: decrease in treatments, primaryOutcomes measure: Efficacy biological profile: secretion pattern of soluble factors, primaryOutcomes measure: Efficacy biological profile: cell populations, primaryOutcomes measure: Efficacy biological profile: ocrrelation of the biological markers with the clinical response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06304012, orgStudyIdInfo id: IOE-TBI lao, briefTitle: Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2023-05-17, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ACTUAL, armsInterventionsModule interventions name: Nasogastric tube feeding, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Rehabilitation therapy, outcomesModule primaryOutcomes measure: Concentration of hemoglobin, primaryOutcomes measure: Concentration of albumin, primaryOutcomes measure: Concentration of prealbumin, primaryOutcomes measure: Nutritional status-body mass index, secondaryOutcomes measure: Complications-Pulmonary Infections, secondaryOutcomes measure: Complications-Gastroesophageal Reflux, secondaryOutcomes measure: Complications- Gastrointestinal Bleeding, secondaryOutcomes measure: Complications-Gastric Retention, secondaryOutcomes measure: Complications-Diarrhea, secondaryOutcomes measure: Complications-Constipation, secondaryOutcomes measure: Decannulation of tracheostomy tube-placement duration, secondaryOutcomes measure: Level of consciousness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jiansheng Hos., city: Yilan, country: Taiwan, geoPoint lat: 24.757, lon: 121.753, hasResults: False
protocolSection identificationModule nctId: NCT06303999, orgStudyIdInfo id: IOE-Small lao, briefTitle: Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-02, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube, interventions name: Nasogastric tube, outcomesModule primaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Serum albumin, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Activities of daily living, secondaryOutcomes measure: World Health Organization Quality of Life Assessment Instrument Brief Version, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huimin Hos., city: Pengfu, country: Taiwan, geoPoint lat: 24.98333, lon: 121.41667, hasResults: False
protocolSection identificationModule nctId: NCT06303973, orgStudyIdInfo id: IOE-PRS, briefTitle: Effect of Oral Enteral Nutrition in Pierre Robin Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-10, primaryCompletionDateStruct date: 2023-06-02, completionDateStruct date: 2023-06-15, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared., conditionsModule conditions: Pierre Robin Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: IOE, interventions name: PNG, outcomesModule primaryOutcomes measure: Number of patients diagnosed as the pulmonary infection "Positive"., secondaryOutcomes measure: Nutritional status-total protein, secondaryOutcomes measure: Nutritional status-hemoglobin, secondaryOutcomes measure: Nutritional status-albumin, secondaryOutcomes measure: Nutritional status-prealbumin, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Swallowing function, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Renai Hospital, city: Yilan, country: Taiwan, geoPoint lat: 24.757, lon: 121.753, hasResults: False
protocolSection identificationModule nctId: NCT06303960, orgStudyIdInfo id: Cerebellar DBS for stroke, briefTitle: Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-07, completionDateStruct date: 2026-03-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral Cerebellar deep brain stimulation, interventions name: Unilateral Cerebellar deep brain stimulation, outcomesModule primaryOutcomes measure: safety and feasibility of bilateral cerebellar DBS, secondaryOutcomes measure: FM-UE scores between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS, secondaryOutcomes measure: nerve conduction velocity between bilateral and unilateral cerebellar DBS, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chao Zhang, status: RECRUITING, city: Jinan, state: Sichuan, zip: 250100, country: China, contacts name: chao zhang, role: CONTACT, phone: +8613969007232, email: chao_zhang@sdu.edu.cn, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06303947, orgStudyIdInfo id: IOE-PKS, briefTitle: Effect of Oral Enteral Nutrition Feeding in Parkinson Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube, interventions name: Nasogastric tube, interventions name: Comprehensive rehabilitation training, outcomesModule primaryOutcomes measure: Serum albumin level, primaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06303934, orgStudyIdInfo id: IOE-NT, briefTitle: Oral Enteral Nutrition in Infants With Cerebral Palsy and Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-06-15, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a randomized controlled study including 80 infants with cerebral palsy and dysphagia. The Participants were evenly divided into the observation group (with intermittent oro-esophageal tube feeding, n=40) and the control group (with persistent nasogastric tube feeding, n=40). Nutritional status and physical development, condition of dysphagia, and pneumonia before and after 3-month treatment were compared., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: systemic therapy, interventions name: Intermittent Oro-Esophageal Tube Feeding, interventions name: Persistent Nasogastric Tube Feeding, outcomesModule primaryOutcomes measure: The Oral Motor Assessment Scale, secondaryOutcomes measure: Pneumonia, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Total Protein, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: Prealbumin, secondaryOutcomes measure: body weight, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale for Infants, secondaryOutcomes measure: Feeding amount, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: River First Hos., city: Pingdong, country: Taiwan, geoPoint lat: 24.46667, lon: 118.41667, hasResults: False
protocolSection identificationModule nctId: NCT06303921, orgStudyIdInfo id: 854681, briefTitle: Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2029-02, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites., conditionsModule conditions: Tauopathies, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: 11C-M503 PET, interventions name: Brain MRI, interventions name: Amyloid PET, interventions name: Neurological assessments, outcomesModule primaryOutcomes measure: Organ Biodistribution or Dosimetry, primaryOutcomes measure: PET Uptake of Tracer, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Erin Schubert, role: CONTACT, phone: 215-662-3041, email: erinshu@pennmedicine.upenn.edu, contacts name: IIya Nasrallah, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False