bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Auditory Cues on Gait Mechanics in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine how using auditory cues of a metronome and music at
      various frequencies impacts the gait mechanics in people with Parkinson's disease when
      walking over ground and on a treadmill.

      The investigators will enroll a total of 40 participants: 30 subjects with a diagnosis of
      Parkinson's disease (10 in Stage 1, 10 in Stage 2, and 10 in Stage 3) and 10 unimpaired
      subjects.

      Participants will complete 7 different treadmill walking conditions and overground walking
      conditions while the investigators measure step length, cadence, gait speed, and variability
      of movement.
    


Intervention name(s): Metronome Normal; Metronome Slow; Metronome Fast; Music Normal; Music Slow; Music Fast; No Auditory cueing
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Steps are timed with the beat of the metronome set to the subject's cadence; Steps are timed with the beat of the metronome set to 85% of the subject's cadence; Steps are timed with the beat of the metronome set to 115% of the subject's cadence; Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence; Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence; Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence; Steps are not timed with any auditory cue.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Axial Spondyloarthritis; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the benefits and risks of etanercept withdrawal in
      patients who have achieved a significant clinical response.
    

Detailed description: 
      This multcenter, open-label, three period study will evaluate withdrawal and retreatment of
      etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of
      treatment.
    

Intervention name(s): Etanercept
Intervention type(s): Biological
Intervention description(s): 50 mg subcutaneous, once weekly, 24 weeks
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-radiographic axial spondyloarthritis
Intraocular Lens-shell Technique in Phacoemulsification
Condition: Cataract; Pseudoaphakia
MeSH terms: Cataract
Study type: Interventional

Summary: 
      In this study, the investigators introduce a surgical procedure called "IOL-shell technique"
      in the purpose of reduce complications of surgeries for dense cataract, and report a
      prospective randomized controlled study aiming at assessing efficacy and safety of the
      IOL-shell technique, which showed that the new procedure offered a safer way for hard
      cataract surgery over the conventional phacoemulsification procedure without compromise in
      efficacy.
    

Detailed description: 
      A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled.
      Patients were assigned to two groups: Group I: IOL was traditionally implanted after all
      nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted
      in the bag before last residual nuclear fragment was removed. This novel adjusted surgical
      procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not
      just as a refractive alternative, was conceptual different from the traditional step-by-step
      procedure. Clinical examinations including uncorrected visual acuity, central corneal
      thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density
      were carried out.
    

Intervention name(s): IOL-shell technique; Conventional procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.; In this procedure, a IOL was not implanted until all the nuclear fragments were removed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dense cataract; phacoemulsification; lens-shell technique; intraocular lens
Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating
      gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical
      effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg.
      This pilot study aims to compare the one-week clinical effects of single doses of the two
      drugs in treating GERD patients.
    

Detailed description: 
      A comparative study to different PPIs in pharmacokinetic change showing that after 12-24
      hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for
      dexlansoprazole than esomeprazole . However, the study did not report the clinical effect
      after tablets used. There was no report on the short-term clinical effects and timing to
      symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and
      esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to
      compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole
      40 mg in for GERD.
    

Intervention name(s): Esomeprazole group; Dexlansoprazole group
Intervention type(s): Drug; Drug
Intervention description(s): Esomeprazole 40mg qd; Dexlansoprazole 60mg qd
Other intervention name(s): Nexium; Dexilant
Intervention MeSH terms: Esomeprazole; Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cerebral Hemodynamics in Sleep Disorders
Condition: Sleep Disorders, Intrinsic
MeSH terms: Sleep Wake Disorders; Parasomnias; Sleep Disorders, Intrinsic
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine the relationship between sleep disorders and
      cerebral hemodynamics.
    

Detailed description: 
      Sleep disorders continue to be the most unrecognized modifiable risk factor for stroke. The
      relationship between sleep disorders and vascular risk factors and stroke has been
      well-documented but not fully understood. The investigators hypothesize hemodynamics
      impairment to be its potential mechanism. It has been reported that sleep-related breathing
      disorder, a type of sleep disorders, contributed as a risk factor for stroke through
      hemodynamic and hematologic changes. The purpose of this study is to determine the
      relationship between different kind of sleep disorders and cerebral hemodynamics, including
      OSHAS, RLS, RBD, narcolepsy, etc. The dynamic cerebral auto-regulation (dCA) and Transcranial
      Doppler (TCD) will be used to evaluate cerebral hemodynamics.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators conducted a prospective study of consecutive patients with sleep
        disorders treated at the Department of Neurology, First Hospital of Jilin University,
        China, from March 2016 to March 2017. Each patient was diagnosed with intrinsic sleep
        disorders by two neurologists according to the Diagnostic Criteria for Sleep Dyssomnias.
      
Keywords: Sleep Disorders; Cerebral Hemodynamics; Dynamic Cerebral Auto-Regulation; Stroke
Evaluation of Systemic Microvascular Endothelial Function in Metabolically Healthy Obesity
Condition: Obesity; Dyslipidemias
MeSH terms: Obesity; Dyslipidemias; Obesity, Metabolically Benign
Study type: Interventional

Summary: 
      Obesity is known to be a risk factor for cardiovascular disease (CVD), type 2 diabetes
      mellitus, gastrointestinal tract disease, respiratory problems (such as obstructive sleep
      apnea), joint and muscle problems, reproductive disorders, depression and cancer.

      However, recently a new classification has emerged about obesity, the metabolically healthy
      obesity (MHO). According to the definition of the term, MHO represents obesity that occurs
      segregated from the metabolic syndrome criteria defined by the International Diabetes
      Federation (IDF). However, as there is still disagreement about the definition of MHO, the
      cardiovascular risk of these individuals is also uncertain. This phenotype may present as an
      intermediate risk between metabolically healthy normal-weight individuals and metabolically
      unhealthy obese individuals (MUO) or as a transition stage of the disease; when evolving to
      MUO, represents a higher risk of developing CVDs.

      The hypothesis of the present study is that obese individuals classified as metabolically
      healthy have worse vascular endothelial function when compared to non-obese individuals,
      demonstrating increased cardiovascular risk even in this subgroup considered "low risk". The
      detection of endothelial dysfunction in metabolically healthy obese may help in the
      prevention, treatment and follow-up of these individuals, aiming to reduce the development
      and morbidity and mortality of CVD.

      In the present study, the investigators will use a laser-based method for evaluating
      non-invasive, operator-independent systemic microvascular function that detects microvascular
      flow in the skin for the evaluation of systemic vascular endothelial function.
    


Intervention name(s): Evaluation of systemic skin microvascular endothelial function
Intervention type(s): Diagnostic Test
Intervention description(s): Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: laser speckle contrast imaging
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
Condition: Pain; Premature Infant; Human Milk; Breastfeeding
MeSH terms: Pain, Procedural
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the non-inferiority of non- pharmacological breast milk
      expressed versus oral sucrose in relief procedural pain of venipuncture in preterm neonates.

      This is an experimental comparative study of non-inferiority randomized crossover, to be
      performed in Neonatal units of hospitals in the Community of Madrid.

      The 54 pair of preterm that after the selection criteria are included in the study, they
      performed the randomization of the sequence and breast milk expressed receive oral or 24%
      sucrose.

      The doses administered are: 0.1ml preterm less than 27 weeks corrected gestational age (CGA),
      0.25 ml for infants 27 to 31 weeks CGA and 0.5 ml for infants of 32-37 weeks. Both groups
      will be accompanied by non-nutritive sucking and swaddling and administered two minutes prior
      to venipuncture.

      The outcome variable, pain, will be determined by the scale Premature Infant Pain Profile
      (PIPP) and by percent of cry.

      Data for the primary objective was analysed per intention to treat. This study was approved
      by local ethical committee.
    


Intervention name(s): expressed breast milk; sucrose 24% oral
Intervention type(s): Other; Behavioral
Intervention description(s): The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.; The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; premature infant; sucrose; breastfeeding; expressed breast milk; PIPP
Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Dietary modification is of great essential for the prevention and treatment of type 2
      diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential
      benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat
      (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of
      organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.

      After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial
      of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes.
      Participants would be randomly assigned to one of the four following groups: usual care group
      (only basic health advice, no other interventions), diet group (systematic education,
      structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus
      replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years
      would be carried out to predict the long-term effects of ONOG plus diet intervention on
      patients with type 2 diabetes.

      The investigators hypothesized that ONOG combined with diet would have better effects on
      glycaemia and insulin resistance control in addition to those yielded by diet or usual care.
    


Intervention name(s): organic naked oat with whole germ (ONOG)
Intervention type(s): Dietary Supplement
Intervention description(s): The experimental product was ONOG (Inner Mongolia Sanzhuliang Natural Oats Industry Corporation), which was produced in the northwest part of China, applying with the organic standards. Participants in the 50g and 100g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 50g or 100g ONOG.
Other intervention name(s): organic naked oat with whole germ (ONOG),
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: naked oat (Avena nuda L.); diabetes mellitus; RCT
Simulator Based Powered Mobility Training of Children With Special Needs
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study compared conventional powered mobility practice to simulator based practice of
      children with special needs aged 6-18 years.
    

Detailed description: 
      This study compared conventional powered mobility practice to simulator based practice of
      children with special needs aged 6-18 years.

      The study has 3 stages: 1) Simulator validity study 2) Powered mobility outcome measures
      reliability and validity for children 6-18 years 3) Intervention study to compare simulator
      based practice and powered mobility practice.

        1. Simulator validity study included 30 children aged 6-18 years, proficient powered
           mobility drivers. All participants had physical disabilities- CP or Neuromuscular
           conditions.

        2. This stage included the first 30 children from the intervention study. Data for the
           study was based on the first evaluation out of the two evaluations in the study.

        3. This stage included 36 children aged 6-18 years in need of powered mobility practice to
           become a proficient driver. The particpants were divided into two groups- experimental
           (simulator based practice) and control group (standard powered wheelchair practice).
    

Intervention name(s): Powered Mobility Training Simulator; Training with Powered Wheel Chair
Intervention type(s): Procedure; Other
Intervention description(s): Two groups of participants- 18 in each- were provided with either a simulator or powered wheelchair. Both groups were tested at baseline for powered mobility level. Both groups the practiced at home or school for 12 weeks, 4 times a week for at least 20 minutes. Both groups returned and underwent another evaluation to assess powered mobility level after 12 weeks of practice.; Training with Powered Wheel Chair
Other intervention name(s): Powered Mobility Training with Wheel Chair
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups that practiced powered mobility via different modes.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Powered mobility; Simulator; Powered Mobility Outcome Measures
Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis
Condition: Vaginitis
MeSH terms: Vaginitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Open prospective multicenter phase IV study in patients presenting with symptoms of bacterial
      and/or mycotic (mushroom) vaginitis for 12 days as specified in the product information.

      Investigators/centers: 20 gynacologists are previewed to do the study in ambulatory
      treatment.

      Objectifs of the study:

      Principal objectif:

      Evaluation of the efficacy of the treatment on the clinical symptoms of bacterial and/or
      mycotic vaginitis

      Secondary objectif:

      Evaluation of the efficacy of the treatment on eradication of the diagnosed germs Evaluation
      of the correspondence of the efficacy on the symptoms and on the eradication of the germs.

      Numbers of patients previewed: 100 patients for evaluation of the efficacy

      Criteria of evaluation

      Principal criteria:

      Clinical efficacy as judged by the investigator Secondary criteria:evaluation of clinical
      symptoms judged by the patient reduction or emlimination of bacteria and other germs the
      relationship between clinical and bacterial results

      Evaluation of tolerance

      Used Study Drug:

      Polygynax, vaginal capsule consisting of Polymyxin 35000 UI, Neomycin 35000UI and Nystatin
      100000UI Application: vaginal application once daily in the evening for 12 days

      Study design:

      Visit 1:

      All patients presenting with the clinical symptoms, presenting all inclusion criteria and
      none of the exclusion criteria are included in the study at visit 1 and receive Polygynax
      treatment (one vaginal capsule once daily in the evening).

      A vaginal smear is obtained. Visit 2 (optional) If the results of the bacteriological
      examination confirms an infection with germs sensible to the treatment with Polygynax the
      treatment is continued. If other germs not sensible to Polygynax are present, the patients is
      contacted to stop the treatment, to come back to a second visit to her gynacologist who will
      change the treatment. The other patients continue the treatment.

      Visit 3:

      After the treatment the patients come back to the last visit. A clinical evaluation and a
      vaginal smear for control is obtained.
    


Intervention name(s): Polygynax combinaison of polymyxin, Neomycin and Nystatin
Intervention type(s): Drug
Intervention MeSH terms: Polymyxins; Neomycin; Nystatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mycotic Vaginitis