bioihbjkbjnl/mcl2 huggingface dataset:
Development of Training Programs for Nursing Competency Reinforcement to Spread Trauma Intervention
Condition: Nurses Who Work at the Community Mental Health Welfare Center
Study type: Interventional

Summary: 
      This study aims to improve the trauma intervention competency of nurses through online-based
      training of the nursing intervention program for trauma-experienced subjects. The specific
      goals are as follows.

        1. Based on Swanson's Caring Theory, develop an online training program for nurses to
           spread trauma nursing intervention and improve competency.

        2. Evaluate the effects of the developed program's workbook and online training on nurses'
           trauma-related knowledge and attitude, self-efficacy, and professional quality of life.

      Of the 42 subjects who enrolled in the study, 1 dropped out before intervention, resulting in
      41 participants who completed all interventions and surveys.
    


Intervention name(s): Nursing Competency Enhancement Training Program in PTSD Intervention
Intervention type(s): Other
Intervention description(s): This program was for nurses who work at the Mental Health Welfare Center and consisted of a workbook, self-learning online education, and workshop. It included a spoken audio track that was accompanied by visual prompts to provide knowledge on traumatic stress and introduce trauma recovery methods. Its online format made it convenient and widely accessible, and allowed for a low-intensity, cost-effective educational program. The program focused on providing self-learning guidelines for nurses to develop their capacity for PTSD intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and
      change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple
      sclerosis patients.
    

Detailed description: 
      This is an observational pilot study in patients with definitive relapsing-remitting multiple
      sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric
      oxide levels during a clinically observed increase in disease activity. Each subject will
      followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a
      week.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        USF Medical Clinic Tampa, Flrida
      
Keywords: MS; Serum Leptin Levels during relapse; Multiple sclerosis; relapse
Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
Condition: Antibiotics; Subcutaneous Injection; Daptomycin
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Multidrug-resistant bacteria are a major public health problem worldwide, notably due to
      excess mortality and an increase in the length of hospital stay. Antibiotics that can be used
      to treat these infections are limited. Daptomycin is one of the most widely used antibiotics
      for the treatment of infections with gram-positive bacteria, such as methicillin-resistant
      Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is
      therefore interesting to find new routes of administration in order to widen the
      possibilities of using daptomycin, especially in people who have difficulties with the venous
      approach.

      Methods/design:

      In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the
      investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous
      and the intravenous route of daptomycin in healthy volunteers. They will conclude the
      bioequivalence if the confidence interval of the area under the curve obtained is entirely
      within the interval [80% - 125%].

      Discussion:

      This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a
      clinical trial in infected patients in order to assess the efficacy and safety of daptomycin
      by the subcutaneous route.
    


Intervention name(s): Daptomycin; Daptomycin
Intervention type(s): Drug; Drug
Intervention description(s): Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.; Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
Intervention MeSH terms: Daptomycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of CKD-330
      (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the
      two separate drugs in healthy male volunteers.
    


Intervention name(s): CKD-330 8/5mg; Candesartan 8mg and Amlodipine 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Measurement of Optic Nerve Sheath Diameter
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      It is reported that optic nerve sheath diameter increases when higher volume of medication is
      injected during epidural anesthesia.

      This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline
      of different speed (3cc/sec vs. 1cc/sec).
    

Detailed description: 
      It is known that insufficient intraoperative or postoperative management can lengthen the
      hospital stay with unwanted complications. Therefore, active and proper management using
      continuous thoracic epidural catheterization is suggested good option to prevent such
      potential complication.

      According to previous study, injection of different volume of local anesthetics (1.0 ml/kg
      vs. 1.5 ml/kg) during caudal anesthesia, high volume of local anesthetics resulted in
      significant increase of intracranial pressure (ICP). Increase of ICP can reduce regional
      cerebral flow and oxygen saturation causing the safety of patients. In addition, increase of
      ICP can result in headache, syncope, and transient loss of visual acuity.

      Although it is very invasive method, ICP can be measured directly at the brain parenchyme.
      Among methods to measure the ICP indirectly, measurement of optic nerve sheath diameter using
      ultrasound is known to reflect the degree of ICP. It is reported that optic nerve sheath
      diameter increases when higher volume of medication is injected during epidural anesthesia.

      This study is designed to compare the optic nerve sheath diameter using 10cc of nomal saline
      of different speed (3cc/sec vs. 1cc/sec).
    

Intervention name(s): thoracic epidural catheterization
Intervention type(s): Other
Intervention description(s): thoracic epidural catheterization with different speed of injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Optic Nerve Sheath Diameter Injection Speed
Study to Investigate the Effect of Superba Boost on the Skin
Condition: Trans-epidermal Water Loss
Study type: Interventional

Summary: 
      Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to
      placebo on reduction in Trans-Epidermal Water-Loss (TEWL).
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, parallel group trial in 70
      healthy adult male and female subjects between 20 and 50 years. The primary objective is to
      assess whether Superba Boost krill oil administered at a dose of 1 g per day for 12 weeks (84
      days) has a positive effect on the TEWL, skin hydration and elasticity. At screening, the
      subjects must have TEWL values of >10 g/m2/h and <24.9 g/m2/h when measured by a TWEAmeter,
      i.e. within the range defined as normal and healthy skin. The change in omega-3 index,
      defined as EPA and DHA as percentage of total fatty acids in red blood cells, will be
      measured and correlated to the changes in the skin parameters. The study consists of 4
      visits: the screening visit (V1), baseline visit / week 0 / Start of treatment (V2), Interim
      / Week 6 (V3) and week 12 / end of treatment (V4) . In this study, subjects must have a low
      habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or
      less will be recruited.

      Each subject must fulfill all inclusion criteria and will not be allowed to meet any of the
      exclusion criteria.
    

Intervention name(s): Superba Boost
Intervention type(s): Dietary Supplement
Intervention description(s): To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of intervention using a TEWAMetre.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who successfully meet the eligibility criteria will be randomized on a 1:1 basis, to receive Superba Boost or Placebo.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Functionality of an 8-Channel Paddle Coil for Use With MRI
Condition: Prostate in Healthy Males
Study type: Interventional

Summary: 
      The objective of this study is to determine the functionality of an eight-channel paddle coil
      system which is to be used in future MRI studies.
    

Detailed description: 
      Prostate cancer is the most common malignancy among men and the second leading cause of
      cancer death in men. Currently, MRI is the best imaging modality for both detecting prostate
      cancer and determining the presence of extra-prostatic extension. Multiparametric Magnetic
      Resonance, combining T2-weighted, diffusion-weighted and dynamic contrast enhanced imaging
      (DCE-MRI) is recommended as the minimum acceptable standard for prostate MRI examination.
      However, MPMRI still lacks diagnostic accuracy in the transition zone, where distinguishing
      cancer from proliferative nodules has proven difficult. DCE-MRI techniques evaluate the time
      course of signal intensities after administration of a contrast medium and have been used to
      successfully differentiate benign from malignant tumours, particularly in breast and prostate
      cancer. Unfortunately, current DCE approaches have high false-positive rates and are limited
      in distinguishing prostatitis and vascularized BPH nodules from cancer in active surveillance
      studies. Future studies that employ spectroscopic MR imaging of the prostate after
      administration of Hyperpolarized (13C) Pyruvate Injection, are expected to provide a robust,
      non-invasive method to assist in detecting and characterizing prostate cancer. The objective
      of this study is to determine the functionality of an eight-channel paddle coil system which
      is to be used in future Hyperpolarized (13C) Pyruvate Injection studies.
    

Intervention name(s): 8-channel paddle coil
Intervention type(s): Device
Intervention description(s): MRI Coil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Eight; Channel; Paddle; Coil; MRI; Prostate; Healthy Male
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
Condition: Amputation
Study type: Interventional
Phase: Phase 1

Summary: 
      Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a
      socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb.
      VAS may improve stability, weight bearing, comfort, proprioception, limb health, and
      function. To date, there is no evidence to support whether VAS alters balance, kinematics,
      and kinetics when walking for TF amputees as compared to conventional socket suspension
      technology. Further, there is question regarding what the optimal height of the socket should
      be to maintain stability and function. So long as stability is not sacrificed, it may be
      advantageous to lower the height of the socket to allow full hip motion and improve sitting
      comfort. The purpose of this investigation is to assess if the socket height alters the
      motion of the leg and changes the way one walks when using VAS compared to conventional
      socket suspension technology. In this study, TF amputees will be fitted with a VAS socket
      that will be attached to their current prosthesis using similar alignment. Individuals will
      be assessed while walking on a level floor and during stair negotiation while wearing the
      prosthesis with the VAS socket at various socket heights as well as their current socket.
      Additionally, balance and socket standing and sitting comfort will be investigated.
    


Intervention name(s): Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
Intervention type(s): Device
Intervention description(s): The brim height of the socket will be systematically reduced
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lower limb loss; Leg amputation; walking study; socket technology
Study of a Pneumococcal Conjugate Vaccine in Adults Aged 50 to 84 Years.
Condition: Pneumoccocal Immunisation
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

        -  To assess the immune response of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
           30 days after the administration of the single dose vaccination

        -  To assess the safety profile of the 3 SP0202 formulations, Prevnar 13 and Pneumovax 23
    

Detailed description: 
      The duration of each participant's participation will be approximately 6 months.
    

Intervention name(s): Pneumococcal Conjugate Vaccine - formulation 1; Pneumococcal Conjugate Vaccine - formulation 2; Pneumococcal Conjugate Vaccine - formulation 3; Pneumococcal 13 - valent conjugate vaccine; Pneumococcal Vaccine Polyvalent
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form:Suspension for injection Route of administration: intramuscular; Pharmaceutical form:Suspension for injection Route of administration: intramuscular; Pharmaceutical form:Suspension for injection Route of administration: intramuscular; Pharmaceutical form:Suspension for injection Route of administration: intramuscular; Pharmaceutical form:Solution for injection Route of administration: intramuscular
Other intervention name(s): SP0202-IIb; SP0202-VI; SP0202-VII; Prevnar 13; Pneumovax 23
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of PUR0200. In addition,
      the study will look at the blood levels of different doses of PUR0200 and their affect on
      lung function in COPD patients.
    

Detailed description: 
      This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and
      tolerability study of single doses of PUR0200.
    

Intervention name(s): PUR0200; PUR0200 Placebo; Active comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator; Randomized, single dose of inhaled placebo matched to PUR0200; Randomized single dose of inhaled active comparator product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Chronic Obstructive Pulmonary Disease
Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in Manikin by Novice
Condition: Intubation
Study type: Interventional

Summary: 
      The purpose of this study is to compare the intubation time and success rate between
      videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh
      laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice
      airway managers.
    


Intervention name(s): McGrath videolaryngoscopy; Pentax videolaryngoscopy; Macintosh laryngoscopy
Intervention type(s): Other; Other; Other
Intervention description(s): Participants perform three intubation attempts using McGrath videolaryngoscope in the normal and cervical immobilized manikin by novice; Participants perform three intubation attempts using Pentax Airway Scope in the normal and cervical immobilized manikin by novice; Participants perform three intubation attempts using Macintosh laryngoscope in the normal and cervical immobilized manikin by novice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: videolaryngoscope, novice
Effect of Betaine, Serine and Folic Acid on Vascular Function in Healthy Volunteers
Condition: Healthy; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether reducing the increase in plasma
      homocysteine concentrations following an oral methionine load affects vascular function in
      healthy volunteers, irrespective of the homocysteine-lowering agent.
    

Detailed description: 
      A high plasma homocysteine is a potential risk factor for cardiovascular disease and death.
      However, it remains uncertain whether homocysteine per se, low status of folate, or other
      factors related to methionine metabolism are involved in the pathogenesis of cardiovascular
      disease. Previous studies have shown that a high concentration of homocysteine in blood is
      related to an impaired vascular function in the arteries, an indicator of cardiovascular
      disease risk. Virtually all intervention trials used folic acid as a homocysteine-lowering
      agent, which may however affect vascular function through mechanisms not related to
      homocysteine. The researchers investigated whether reduction in homocysteine concentrations
      following a methionine load, via supplementation with serine, betaine or folic acid improves
      vascular function in healthy volunteers, in order to distinguish between effects of folic
      acid and of homocysteine-lowering per se.

      Comparison: The effects of supplementation with serine, folic acid and betaine (all together
      with an oral methionine load) were compared to the effects of a placebo (together with a
      methionine load) on plasma homocysteine concentrations and on vascular function following
      methionine loading in healthy volunteers.
    

Intervention name(s): supplementation with betaine, serine, and folic acid
Intervention type(s): Procedure
Intervention MeSH terms: Folic Acid; Betaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: betaine; serine; folic acid; methionine load; homocysteine; cardiovascular health; vascular function; human
The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients
Condition: Disorders Associated With Peritoneal Dialysis; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Observational

Summary: 
      The purpose of this study is to determine whether Febuxostat could protect cardiovascular
      function of peritoneal dialysis patients by lowering serum uric acid.
    

Detailed description: 
      Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use
      Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events
      of patients, and compare and evaluate the changes of heart function, heart construction,
      serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat
      treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Peritoneal dialysis patients with hyperuricemia
      
Keywords: peritoneal dialysis; hyperuricemia; cardiovascular; Febuxostat
Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve
      stimulation (NUEYNE-T30, NUEYNE-T100) and sound fusion stimulation on tinnitus.
    

Detailed description: 
      Duration of study period (per participant): Screening period (-7~0 days), Intervention period
      (30 days) Patient needs to visit site at least 3 times (Screening, V1, V2). V1 can be done
      with screening visit. Tele-visit should be done on day 15.
    

Intervention name(s): A transcutaneous trigeminal nerve stimulator: High Frequency; A transcutaneous trigeminal nerve stimulator: Low Frequency; A transcutaneous trigeminal nerve stimulator: Sham; Sound Therapy
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 30min/day, at least 5 to 7 times a week; 30min/day, at least 5 to 7 times a week; 30min/day, at least 5 to 7 times a week; Notch Therapy at least 30min/day, at least 5 to 7 times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Diet and Activity in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      This study aims to fill a gap in the literature, identify relevant clinical measures, and
      provide insight into the independent modifiable risk factors of obesity in the CP population
      with the long-term goal of improving screening, management and prevention of obesity in this
      at-risk and underserved population.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents (16-17) and adults with cerebral palsy
      
Keywords: Cerebral palsy; Adolescents; Adults; Diet; Activity; Metabolic Syndrome