bioihbjkbjnl/mcl2 huggingface dataset:
Wheel Assisted Running Training (WART) in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to
      a conventional mixed physical activity training (CT) program on walking and gross motor
      function in trained children with cerebral palsy (CP).

      Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age
      11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT
      groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM),
      self-selected and fast walking velocity (SSV and FV, respectively), and cadence are
      administered by a trained physical therapist. The intervention period is six months, with two
      sessions per week.
    


Intervention name(s): Wheel assisted running training
Intervention type(s): Device
Intervention description(s): 'Race-Runner' uses the principle of body weight reduction and wheel assisted running training. This is a three-wheel device specifically designed in the 1990s for athletic purposes. The participant is walking or running with the feet on the ground while using a triangular frame equipped with three large bicycle wheels. Support to the participant's body is provided by a regular cycle saddle, a frontal body support plate, and the steering handlebars. The vertical and horizontal distance of the saddle and frontal support from the steering handlebars are adaptable to the participant's body dimension and comfort. This equipment is commonly used in competition in Scandinavia and Central Europe
Other intervention name(s): also called 'Petra'
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: training exercise gait
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
Condition: Child Development; Child Development Disorder; Development Delay; Developmental Delay; Global Developmental Delay; Motor Delay; Speech Delay
MeSH terms: Language Development Disorders; Developmental Disabilities
Study type: Observational

Summary: 
      This study aimed to evaluate the concurrent validity information of the 24-, 30-, and
      36-month Indonesian ASQ-3 with the Bayley Scales of Infant and Toddler Development 3rd
      Edition (BSID-III) in Indonesian children. Children living in Tanah Tinggi subdistrict,
      Central Jakarta, were recruited conveniently from November to December 2019. Children within
      the 24-, 30-, or 36-month age group were assessed for Indonesian ASQ-3 concurrently with
      BSID-III as the reference standard according to their age groups. Screening test accuracy was
      measured in sensitivity, specificity, and predictive values for both overall dan specific
      domains.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Parents with children aged 23-38 months living in Central Jakarta.
      
Keywords: ASQ-3; BSID-III; child development; Indonesia; screening test; validity
Argatroban Stroke Treatment - A Pilot Safety Study
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Is the combination of low doses of argatroban in combination with rt-PA safe, and does it
      increase recanalization in patients with acute ischemic stroke.
    

Detailed description: 
      All patients with acute ischemic stroke who qualify for IV rt-PA under accepted guidelines,
      and who have an occluded middle cerebral artery documented on TCD, receive standard dose IV
      rt-PA and a bolus and 48 hour infusion of argatroban aimed at prolonging the aPTT 1.75 X
      baseline. Follow up CT scanning and TCD every 30 minutes for 2 hours and then daily will
      determine the incidence of hemorrhage, recanalization and reocclusion, and serial
      neurological exam will determine the clinical outcome. For patients without temporal windows,
      a baseline CT-Angiogram (CTA) demonstrating arterial occlusion can also be enrolled. In those
      patients, a follow-up CTA (24-36 hours) will be performed.
    

Intervention name(s): argatroban
Intervention type(s): Drug
Intervention description(s): Argatroban IV Infusion at 1mcg/kg/min for 48 hours.
Intervention MeSH terms: Argatroban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; thrombin inhibition; thrombolysis; bleeding; outcome
The Effect of Lower Body Positive Pressure Treadmill Training on Individuals With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is neurological disease characterized by chronic major disability which will cause
      permanent changes in individuals life. In Saudi Arabia stroke considered as the main leading
      of disability and death. It is estimated to be 0.67% in Saudi Arabia compared to 2.5% of the
      population in the United States (US). Most of individuals have mobility deficit such as walk
      speed and postural maintenance which lead to increase the risk of fall and decrease activity
      of daily living (ADL).

      Stroke rehabilitation should starts as early as possible to avoid post-stroke complications.
      Several interventions for stroke rehabilitation to improve mobility deficit and posture
      control continuously being evaluated. One of the ways of stroke rehabilitation is a using of
      body weight supported treadmill training (BWSTT). It is a useful tool to facilitate gait
      training and recovery after neurological injures.

      The lower body positive pressure (LBPP) is a treadmill that is enclosed in inflated bag.
      There is a chamber inside the treadmill that is produce air pressure which is aid in
      eliminate the uncomfortableness feeling produce by weight bearing during gait. The chamber is
      supplied with a system provide LBPP aiding in decrease patient weight while walking by giving
      the patient lifting force from below using air pressure. This helps the patient to walk
      affectively with minimum weight bearing on the lower extremity.

      Therefore, the purpose of the study is to evaluate the feasibility and effectiveness of LBPP
      on gait function, balance and quality of life in chronic stroke individuals.

      The investigators hypothesis that the LBPP will significantly improve gait function, balance,
      quality of life in chronic stroke patients.
    


Intervention name(s): Anti-Gravity Treadmill
Intervention type(s): Device
Intervention description(s): Each participant will started with a 5 - 10 minute warm-up on a standard cycle ergometer, manual and therapeutic therapy for upper extremity, and gait training using LBPP. Manual and therapeutic therapy will consist of passive and active ROM, joint mobilization, passive and active stretch, manual resistance exercise, and activities of daily life (ADL). All participants will walk in Alter G one session a day (for 40 min), three days a week, for six weeks. On session one, the Alter G pressure chamber will be set to unload 50% of patient's body weight. On the following sessions, the percentage of unload patient's body weight will be decrease depends on the patient's comfort.
The physical therapist assistance and treadmill speed will be evaluated and altered based on the patient's capacity. The participants can take a rest whenever his/her need during walking. The rest time will be measured and documented.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia.
Condition: Hyperoxia; Complication
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target
      values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very
      common situation. Even though there are many side effects reported related to hyperoxemia and
      hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe
      hyperoxemia frequently.

      Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of
      hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating
      from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia
      in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing
      hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring
      management to prevent the harmful effects of hyperoxia.In this study, in patients who
      underwent major abdominal surgery; It was aimed to investigate the effectiveness of
      ORi-guided FiO2 titration in preventing hyperoxia.
    


Intervention name(s): Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation; SpO2 (oxygen saturation)
Intervention type(s): Procedure; Procedure
Intervention description(s): FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00.
FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98
FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg; Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98
Other intervention name(s): ORİ+SpO2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the
      comparative efficacy and safety between dapagliflozin and Placebo.
    

Detailed description: 
      A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28
      Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10
      mg in T2DM Patients aged 10-24 years
    

Intervention name(s): Dapagliflozin; Dapagliflozin placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.; matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.
Other intervention name(s): FORXIGA
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Dapagliflozin; Placebo; Insulin resistance; Metabolic Diseases
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
Condition: Anovulation
MeSH terms: Anovulation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant
      Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including
      polycystic ovarian syndrome [PCOS] subjects).
    


Intervention name(s): Gonal-F
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anger Control Training for Youth With Tourette Syndrome
Condition: Tourette Syndrome; Chronic Tic Disorder; Oppositional Defiant Disorder; ADHD
MeSH terms: Tourette Syndrome; Tic Disorders; Syndrome; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This is a clinical study of a cognitive-behavioral therapy known as anger control training in
      adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to
      treatment as usual (TAU) in a randomized clinical trial.
    

Detailed description: 
      This is a randomized controlled study of a cognitive-behavioral, anger control training (ACT)
      in adolescents with Tourette Syndrome (TS) complicated by disruptive behavior. Disruptive
      behaviors in TS may take numerous forms including noncompliance, anger outbursts, and
      physical aggression. Anger outbursts in TS have been described as rage attacks or rage storms
      due to their high intensity and unpredictability in response to minimal provocation. Whether
      these behaviors are part of TS, related to comorbid conditions, or due to the burden of
      chronic illness is not clear. Nevertheless, these disruptive behaviors can result in
      significant functional impairment and often require clinical attention. The purpose of the
      ACT intervention is to improve the explosive and noncompliant behavior in adolescents with TS
      by enhancing affect regulation and social problem-solving skills. The treatment is based on
      anger control training which has been empirically supported for reducing aggressive behaviors
      and improving social functioning in aggressive youths. The primary outcome measures include
      the parent-rated Oppositional Defiant Scale and the Clinicians Global Improvement Score
      assessed by a clinician blind to treatment assignment.
    

Intervention name(s): Anger control training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Anger control training; Cognitive behavioral therapy; Behavior therapy; Tourette Syndrome; Randomized trial; Anger; Aggression
The Role of Melatonin in the Effective Attainment of Sleep Electroencephalograms (EEG) in Children
Condition: Epilepsy; Electroencephalogram; Children; Sedation
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to determine the safety and effectiveness of oral melatonin as natural
      inducer of sleep to acquire useful EEGs in South African children following its introduction
      as the main agent used in the Neurophysiology department at Red Cross Children's Hospital.
      This is an observational retrospective study.
    


Intervention name(s): Melatonin; Chloral Hydrate
Intervention type(s): Dietary Supplement; Drug
Intervention MeSH terms: Melatonin; Chloral Hydrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Epilepsy; Electroencephalogram; children; sedation
Phase I Safety and Immunogenicity Trial of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (gp160; VaxSyn)
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if priming (giving the first vaccination) with a vaccinia recombinant (HIVAC-1e)
      provides a significant advantage in immunogenicity (production of antibodies) compared to
      priming with a soluble recombinant protein (gp160); to learn more about the safety of the
      combination use of the two HIV envelope vaccines utilized in the study.

      Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines,
      HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include:
      Does combination vaccination result in a synergistic (added) response not predicted by just
      the addition of a second vaccination, and does this synergism depend on the unique priming
      effect of a vaccinia recombinant, or will any combination do?
    

Detailed description: 
      Recent studies at the AIDS vaccine units have shown the safety of two candidate HIV vaccines,
      HIVAC-1e and gp160. Specific questions to be addressed in this part of the study include:
      Does combination vaccination result in a synergistic (added) response not predicted by just
      the addition of a second vaccination, and does this synergism depend on the unique priming
      effect of a vaccinia recombinant, or will any combination do?

      Volunteers will be randomized to one of four groups. Group A (20 volunteers) will receive
      gp160 (VaxSyn) followed two months later by a repeat dose. Group B (20 volunteers) will
      receive VaxSyn followed two months later by HIVAC-1e. Group C (20 volunteers) will receive
      HIVAC-1e followed two months later by VaxSyn. Group D (10 volunteers) will receive HIVAC-1e
      followed two months later by HIVAC-1e. For volunteers in Groups A, B, and C who do not react
      to the initial vaccination, a second attempt to obtain a reaction may be made 7 or more days
      following the initial inoculation. Per addendum, two additional booster inoculations are
      given: one at 6 months or later post initial inoculation (Groups A, C, and D receive VaxSyn
      and Group B receives HIVAC-1e) and another at 12 months or later (all Groups receive VaxSyn).
    

Intervention name(s): HIVAC-1e; gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological; Biological
Allocation: Randomized
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Envelope Proteins; Acquired Immunodeficiency Syndrome; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to determine the effects of methylphenidate versus
      placebo on driving ability of adult ADHD patients.
    

Detailed description: 
      This study was set-up to examine the controversial issue whether or not it is safe to drive a
      car or not when treated with methylphenidate.

      On-the-road driving tests during normal traffic are conducted to determine the effects of
      methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two
      laboratory tests are conducted to examine memory functioning and inhibitory control.
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: adult
Real-world Effectiveness of Adalimumab on Health Outcomes in Chinese Patients With Immune-Mediated Inflammatory Diseases
Condition: Ankylosing Spondylitis (AS); Psoriasis; Rheumatoid Arthritis (RA)
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis; Spondylitis, Ankylosing; Psoriasis
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effect of adalimumab on health outcomes in
      participants with rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chinese participants diagnosed with rheumatoid arthritis, ankylosing spondylitis or plaque
        psoriasis, for whom adalimumab (Humira®) treatment has already been decided as per local
        label, will be recruited from within the clinical setting of each rheumatologist or
        dermatologist participating in the study.
      
Keywords: rheumatoid arthritis; plaque psoriasis; ankylosing spondylitis; Immune-Mediated Inflammatory Diseases; Chinese Patients
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the
      new liquid growth hormone formulation, somatropin, in children with growth hormone
      deficiency.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebrovascular Reactivity in Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Observational

Summary: 
      It has been observed that patients with cirrhosis present a generalized state of
      vasoconstriction as an homeostatic response to splanchnic arteriolar vasodilatation. On
      progression of the disease, vascular regulation is mismatched, causing altered systemic blood
      flow and lose in the cerebrovascular reactivity.

      The investigators hypothesize that the altered cerebrovascular reactivity induces
      neurological disturbances related to hepatic encephalopathy and, therefore, the existence of
      a correlation between cerebrovascular reactivity and the stage of hepatic encephalopathy.
    

Detailed description: 
      There is no bibliography that evidenciates a correlation between cerebrovascular reactivity
      and the stage of hepatic encephalopathy. There are however, papers that reveal generalized
      systemic vasoconstriction in patients with cirrhosis and others that affirm the presence of
      vascular disregulation and altered reactivity in the Middle Cerebral Artery in cirrhotic
      patients. In the other hand, there is published data that correlates the neurological
      manifestations of diseases characterised by altered blood flow and cerebrovascular reactivity
      with the degree of the vascular disregulation itself, identified by US Doppler. However,
      there are no studies correlating transcranial US Doppler findings of cerebrovascular
      reactivity and hepatic encephalopathy in patients with cirrhosis. Giving its importance to
      the chance of revealing a new way of pathophysiology and therefore, early therapeutic
      management.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population from which the cohorts will be selected are from a hospital care population.

        Control group will be selected from the health personal by invitation to volunteer.
      
Biospecimen description: 
      1. Patients with cirrhosis without hepatic encephalopathy.

        2. Patients with cirrhosis and minimal hepatic encephalopathy.

        3. Patients with cirrhosis and hepatic encephalopathy stage 1.

        4. Healthy subjects willing to participate.
    
Keywords: Hepatic Encephalopathy; Psychometric Hepatic Encephalopathy Score; Critical Flicker Frequency; Cerebrovascular Reactivity; Endotoxemia; Transcranial Doppler; Liver Cirrhosis