bioihbjkbjnl/mcl2 huggingface dataset:
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
Condition: Stroke; Cerebrovascular Accident; CVA; Acute Stroke; Acute Cerebrovascular Accident; Apoplexy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a non-painful, non-invasive,
      brain-stimulation technique called transcranial direct current stimulation (tDCS) combined
      with traditional physical-occupational therapy (OT) will improve motor function in patients
      with chronic stroke. The aim is to determine the effect of applying real (anodal and/or
      cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on
      both hemispheres - in a dual configuration - to improve motor function in chronic stroke
      patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS
      is applied to the brain's motor region during motor learning. The effects after a single
      session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per
      day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in
      stroke patients have shown that improvements in motor functions can be seen and that effects
      may last for at least 30 minutes. Patients enrolled in this trial will be randomized to
      receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days.
      Assessments will be done about 3 days and 7 days after the end of the experimental treatment
      by investigators who are blinded to the intervention. Patients are also blinded as to whether
      they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor
      regions in combination with PT-OT results in a subsequent improvement in motor function of
      the recovering hand over sham tDCS in combination with PT-OT.
    


Intervention name(s): Real Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation
Intervention type(s): Device; Device
Intervention description(s): A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue; A sham current runs between two electrode positions and might affect the underlying brain tissue.
Other intervention name(s): Non-invasive brain stimulation; Brain stimulation; Enhancing stroke recovery; Non-invasive brain stimulation; Brain stimulation; Enhancing stroke recovery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Ischemia; Infarction; Cerebrovascular Disorder; Central Nervous System Diseases; Brain Infarction; Brain Ischemia; Rehabilitation; Recovery; Neurorehabilitation; Plasticity
Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis
Condition: Cerebrovascular Disease
MeSH terms: Cerebrovascular Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus
      cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200
      chronic stroke patients with 50-99% stenosis, to be followed up for 2 years
    

Detailed description: 
      Intracraial arterial stenosis (IAS) is more common in Asia, including Japanese, than in
      Cocasian. Also, stroke recurrence rate is high in patients with such lesions, despite medical
      treatment. Accoding to the result of WASID (N Engl J Med 2005;352:1305-16), warfarin is not
      recommended because of the concern of safety (higher risk of intracranial hemorrhage and
      death when compared with aspirin), wheras the efficacy of aspirin is not enough in
      symptomatic IAS patients. Under these conditions, we planned to conduct a nationwide
      multi-center, open labelled, randomized controlled trial to compare the effect of aspirin
      plus cilostazol (phosphodiestrase type 3 inhibitor) and aspirin alone on the progression of
      IAS in 200 IAS patients with ischemic stroke after 2 weeks to 6 months of onset. Patients are
      randomly allocated to either of two groups. Aspirin 100mg/day plus cilostazol 200 mg/day is
      given to the 100 patients in one group, and aspirin 100 mg/day alone is given to 100 patients
      in another group.

      Follow-up period is at least two years. The primary endpoint is progression of IAS on MRA at
      two years after randomization. The secondary endpoints are cardiovascular events (ischemic
      stroke, myocardial infarct, and other vascular events), death, serious adverse events, new
      silent brain infarcts, and activity of daily life. The purpose of this study is to establish
      the best medical treatment in symptomatic IAS patients. This study will also provide
      important information for the future randomized controlled study to compare medical treatment
      alone and intravascular intervetnion (PTA and/or stenting) in these patients.
    

Intervention name(s): Asprin, Cilostazol
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracranial arteriosclerosis; cilostazol; Platelete aggrigation inhibitors dual antiplatelet therapy; Drug therapy, combination; Clinical trials
Make up for the Epinephrine Autoinjector
Condition: Anaphylaxis
MeSH terms: Anaphylaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      Part of the problems related with proper use of epinephrine autoinjector may be related with
      the design of the autoinjector itself.The aim of the study is to investigate whether minor
      modifications in the design of currently available epinephrine autoinjector ease its use and
      abrogate common use errors.
    

Detailed description: 
      All interns except the ones who previously worked in allergy department in a medical school
      were invited to the study. Two identical epinephrine autoinjector trainers (Epipen trainer®)
      were used, one of which was modified by changing gray safety cap to red and placing a yellow
      arrow pointing to the black injection tip. Written and visual instruction sheet for each
      trainer was provided. Participants were asked to demonstrate the use of Epipen trainer either
      with the original or the modified one. They were scored and timed for demonstration. Primary
      study parameter was the rate of participants correctly demonstrating the use of epinephrine
      autoinjector. Secondary study parameters were the mean total score, mean time required to
      administer autoinjector and unintentional self injection of autoinjector into thumb.
    

Intervention name(s): Epinephrine autoinjector
Intervention type(s): Device
Intervention description(s): We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.
Other intervention name(s): Epipen trainer®, Meridian Medical Technologies, Inc. Columbia, USA
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Anaphylaxis, autoinjector, design, epinephrine
Psychological Effects of Tai Chi Training
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The general purpose of this study is to examine the effect of tai chi training on cognitive
      function in young adults. The investigators will test subjects enrolled in a semester-long
      tai chi course along with control subjects. The specific aims are to measure duration of
      practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder
      (ADHD) indicators. The investigators primary hypotheses are that, compared to controls,
      subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b)
      response inhibition. The investigators secondary hypotheses are that, among the subjects
      participating in the tai chi course, these cognitive improvements will correlate with (2a)
      improvements in balance and (2b) duration of tai chi practice, and that, among all
      participants, (2c) ADHD indications will correlate with cognitive measures.
    


Intervention name(s): Tai Chi training
Intervention type(s): Behavioral
Intervention description(s): 24 form Yang style Tai Chi. 50 minute sessions, twice weekly.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
Condition: PreDiabetes; Obesity, Childhood
MeSH terms: Insulin Resistance; Prediabetic State; Glucose Intolerance; Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the longitudinal test performance of an array of
      conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic
      biomarkers for identifying progression of glucose tolerance (normal to prediabetes or
      prediabetes to diabetes) in an overweight and obese pediatric cohort.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of normal weight, overweight or obese individuals aged 8
        to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and
        #4. Participants will be recruited from a variety of sites including University Michigan
        clinical sites, non-University of Michigan clinical sites, schools in the local area, and
        the University Michigan medical school campus. Participants from Group 2 (visits #3-4)
        completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study
        purposes.
Blood Flow and Bone Density in Healthy Adult Women
Condition: Bone Loss; Hypotensive; Lower Limb Fluid Pooling
Study type: Interventional

Summary: 
      This project will test the efficacy of using a non-invasive neuromuscular stimulation on the
      plantar surface of the feet to prevent and/ or reverse bone loss in a sample of healthy adult
      women.
    

Detailed description: 
      Women between the ages of 30 and 60 years of age who work in positions that require them to
      be seated at desks for a large portion of each day, are capable of following the protocol for
      one year, have a t-score >- 2.5 (do not have osteoporosis), and respond to plantar
      stimulation will be asked to participate. Women will be excluded who are receiving
      medications for osteoporosis, taking hormone replacement therapy, taking steroids (either
      oral or inhaled), have metal implants in the tibia, hip and spine that interfere with DEXA
      (bone density) scanning, are professional or semi-professional athletes, have
      hyperparathyroidism, have a history of pulmonary embolism, deep vein thrombosis, peripheral
      vascular disease or varicose veins, have a Body Mass Index greater than 40 Kg/m2, have any
      type of neuromuscular disease, or are pregnant . Once the inclusion and exclusion criteria
      are met, 45 subjects will be randomized into 3 groups including 1) a group of 15 subjects who
      will use the device (stimulation) for up to 4 hours a day, 2) a group of 15 subjects that
      will use the device for up to 8 hours a day, and 3) a control group who will not use the
      device. Subjects in the two treatment groups will be asked to place their feet on a
      mechanical device that will deliver a slight vibration while they are seated at work.
      Vibrations between 30-60 Hz has been shown to stimulate the Meissner's corpuscles which in
      turn stimulate contraction of the deep muscles of the calves. This contraction has been shown
      to increase venous and lymphatic return from the lower extremities thus improve bone
      metabolism. Bone density readings and venous circulation will be measured at the onset of
      this research and will be repeated after 12 months of using the device.
    

Intervention name(s): calf muscle pump stimulation
Intervention type(s): Device
Intervention description(s): Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoporosis; Sarcopenia; Calf muscle pump; Venous insufficiency; DEXA; Soleus muscle; APG
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis
      who are inadequately treated by glucocorticoid.
    


Intervention name(s): Tacrolimus capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Prograf; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prograf; immunosuppressant
Urodynamics and Music
Condition: Incontinence, Urinary
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several
      trials have confirmed its potential administration and benefits in urology practice. We aimed
      to assess the influence of music therapy on perceived anxiety and pain during outpatient
      urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety
      Inventory (STAI) in a prospective, randomized fashion
    

Detailed description: 
      Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder
      and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis,
      the process itself can be accompanied by discomfort and pain as it includes the positioning
      the catheters urethral and rectally, and the bladder filling. Reports of having such invasive
      outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete
      examinations and patient noncompliance2,3.

      Various pharmacologic options including lidocaine gel and catheter tip lubrication for
      urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are
      some non-pharmalogical methods such as patient education, heating pad, music, distraction and
      relaxation4-6.

      Music has been considered complementary treatment modality as cheap, safe and effective. In
      various urological procedures including cystoscopy, transrectal prostate biopsy and
      extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and
      anxiety levels 7-10. However, current literature presents limited and controversial data
      evaluating the influence of music on pain and anxiety perspective of the patient during UDS.
      We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and
      anxiolytic way during UDS.
    

Intervention name(s): Music Therapy
Intervention type(s): Other
Intervention description(s): Patients in the study group were exposed to flute music therapy (Sufi musical recital - Huseyni mode) at low tempo (60-80 rhythm / min) with weak beats and calm rhythms during the UDS.
This audition involves both vocal and instrumental music performed by a reed flute called 'Ney'. A competent lecturer who was specialized in music suggested all the musical compositions during the therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music
Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Background:

      The effect of existing treatment modalities of extensive disease small-cell lung cancer
      (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is
      wanted. Endostar® (Rh-endostatin Injection) may have anti-tumor activity by against vascular
      endothelial growth factor for initial treatment. This study was designed to evaluate the
      safety and efficacy of Endostar® combined with etoposide-carboplatin (EC) chemotherapy in
      patients with ED-SCLC seeking for more effective treatment.
    

Detailed description: 
      Methods:

      In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are
      planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June
      2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong
      University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC,
      with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or
      with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar®
      7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on
      day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on
      day 1.

      Primary endpoint: progress free survival (PFS).

      Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective
      response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP)
      and quality of life (QOL).
    

Intervention name(s): Endostar; Etoposide-Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Endostar® 7.5mg/m2 on day 1 to day 14; Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Intervention MeSH terms: Carboplatin; Etoposide; Endostar protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamic Interactions of Propofol and Dexmedetomidine on Intravenous Anesthesia
Condition: Pharmacodynamic Interaction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine pharmacodynamic interactions of propofol and
      dexmedetomidine,exploring the effect of dexmedetomidine on propofol unconsciousness median
      effective concentration (EC50).
    

Detailed description: 
      64 cases were randomly divided into four groups, In each group, dexmedetomidine target plasma
      concentration are 0, 0.4, 0.6, 0.8 ng/ml. Dexmedetomidine administered 15 min before target
      controlled infusion of propofol. The propofol infusion was started to provide a target
      effect-site concentration of 1.0ug/ml, and increased by 0.2ug/ml until loss of consciousness
      when the effect-site concentration and target concentration equilibrium.
    

Intervention name(s): 0.0ng/ml Dexmedetomidine; 0.4ng/ml Dexmedetomidine; 0.6ng/ml Dexmedetomidine; 0.8ng/ml Dexmedetomidine; Propofol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexmedetomidine target plasma concentration is 0.0ng/ml; Dexmedetomidine target plasma concentration is 0.4ng/ml; Dexmedetomidine target plasma concentration is 0.6ng/ml; Dexmedetomidine target plasma concentration is 0.8ng/ml
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacodynamic; Dexmedetomidine; Propofol; Target-controlled Infusion Intravenous Anesthesia
Efficacy, Safety and Pharmacodynamic/Pharmacokinetic Study of Fimasartan (BR-A-657•K)
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Study objective:

        1. To evaluate the antihypertensive efficacy, safety and tolerability of the drug after the
           oral administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential
           hypertension.

        2. To review the pharmacokinetic profile after the multiple administration and the
           pharmacodynamic profile regarding the renin-angiotensin system, after the oral
           administration of BR-A-657•K at 20~180mg for 4 weeks to patients with essential
           hypertension.

        3. To determine the dose for the clinical study at the next phase by analyzing the
           relationship between the antihypertensive efficacy and pharmacokinetic • pharmacodynamic
           results.
    

Detailed description: 
      Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
      potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan
      (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the
      Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan
      (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was
      safe and tolerable though one temporal adverse event was observed in high dose.

      A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be
      conducted to evaluate the antihypertensive efficacy and tolerability and to determine
      adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate
      essential hypertension.

      Approximately 60 patients will be enrolled over 12 months in Seoul National University
      Hospital.

      After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
      following 5 groups. Subjects will take test drug/placebo for 28 days of treatment period. If
      subjects take any antihypertensive medications before screening, the subjects will have 1
      week of wash-out period.

      Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV :
      Fimasartan 180 mg
    

Intervention name(s): Placebo; Fimasartan (BR-A-657•K) 20 mg; Fimasartan (BR-A-657•K) 60 mg; Fimasartan (BR-A-657•K) 180 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; Fimasartan 20 mg, 1 tablet + placebo, 2 tablets; Fimasartan 20 mg, 1 tablet + 40 mg, 1 tablet + placebo 1 tablet; Fimasartan 20 mg, 1 tablet + 80 mg, 1 tablet + 80 mg 1 tablet
Other intervention name(s): Fimasartan; Fimasartan; Fimasartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fimasartan; Essential Hypertension