bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Video Game Exercise on Dynamic Balance and Gait in Individuals With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional

Summary: 
      To examine the benefits of using a video-game, Dance, Dance, Revolution, as an exercise
      modality to improve gait and balance in individuals with Huntington's disease.
    

Detailed description: 
      The primary purpose of this study was to determine the effectiveness of a therapist-guided
      Video-game Biofeedback Modulated Exercise (ViBE) program administered via Dance Dance
      Revolution to improve dynamic balance, gait and mobility in individuals with Huntington's
      Disease. Secondary aims were to explore whether the ViBE intervention would improve quality
      of life, fall risk, and neuropsychological functions. The investigators hypothesized that the
      video-game program would lead to greater improvements in walking, dynamic balance, quality of
      life, fall risk, and neuropsychological function than a control handheld video game program.
      Since motivation is essential to the long-term maintenance of an exercise program the
      investigators were also interested in finding out how successful people with Huntington's
      Disease were at playing Dance Dance Revolution, what their perceptions were of playing the
      game, and whether they thought that it was beneficial
    

Intervention name(s): Video game exercise using Dance Dance Revolution; hand-held video game
Intervention type(s): Other; Other
Intervention description(s): use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance; hand-held video games
Other intervention name(s): exercise; video-game based exercise
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants completed one arm of the study and then crossed over into the other arm of the study
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Huntington's Disease; gait; exercise; balance; video game
Propofol to Reduce the Incidence of Postanesthetic Emergence Agitation in Pediatric Patients Under General Anesthesia
Condition: Pediatric ALL
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      This study aimed to know the effectivity of 0.5 mg/kg propofol in the end of anesthesia to
      reduce the incidence of postanesthetic emergence agitation in pediatric patients under
      general inhalation anesthesia
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study
      and randomized into two groups; propofol and control. Non-invasive blood pressure monitor,
      electrocardiogram (ECG), pulse-oxymetry, and capnograph were set on the subjects in the
      operation room. Induction and maintenance of anesthesia will use sevoflurane. Mechanical
      ventilation will be given to maintaining end-tidal carbon dioxide 35 to 40 mmHg. After
      surgery, patient will be given intravenously 15mg/kg acetaminophen, 0.05mg/kg neostigmine,
      and 0.02 mg/kg atropine. Patient will also be given propofol 0.5 mg/kg on propofol group
      while no propofol will be given on control group. 30 minutes after patient was admitted to
      post-anesthesia care unit, patient will be evaluated for emergence agitation using Aono scale
      and Pediatric Anesthesia Emergence Delirium scale. The incidence of emergence agitation,
      hypotension, and desaturation will be treated accordingly.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Those who received intravenous propofol
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Emergence agitation; Propofol; General anesthesia
Metabolic Effects of Chemical Interactions in Toxicity
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      This pilot study tests the feasibility of using GSH redox state and high resolution proton
      NMR spectroscopy (1H-NMR) to detect metabolic changes due to acetominophen and sulfur amino
      acid deficiency. Our central hypothesis is that the a 2-day sulfur amino acid deficiency will
      alter acetominophen metabolism, acetominophen will affect sulfur amino acid homeostasis, and
      the treatments together will alter the global metabolic profile, as measured by 1H-NMR
      spectroscopy.
    

Detailed description: 
      Most occupational exposures to toxic chemicals occur in the context of complex mixtures,
      often in combination with varied diet, prescription drug use and disease. In principle,
      information-rich metabolic analyses provide an approach to study toxicologic consequences of
      such complex chemical interactions by revealing metabolic perturbations before irreversible
      injury occurs. This pilot study tests the feasibility of using GSH redox state and high
      resolution proton NMR spectroscopy (1H-NMR) to detect metabolic changes due to chemical
      interactions. The proposed model involves interaction of chemical exposure (2 doses of
      acetaminophen, APAP, 15 mg/kg) and 2 days of sulfur amino acid- (SAA-) free diet. 30% of APAP
      metabolism occurs through pathways dependent upon SAA metabolites and up to 50% of the RDA
      for SAA is needed to metabolize 2 doses of APAP. Both treatments are without toxicity in
      humans and both affect GSH homeostasis, which will be assessed in vivo by plasma
      measurements. Inter-individual variation will be minimized with each individual being his/her
      own control. Environmental and dietary influences will be controlled in a clinical research
      unit. Aim 1 is to determine whether SAA-free diet and APAP independently perturb GSH redox
      homeostasis. Aim 2 is to determine whether APAP intake interacts with SAA-free diet in
      affecting GSH redox state. Aim 3 is to use 1H-NMR spectroscopy to determine whether exposure
      to APAP and SAA-free diet interact in their effects on metabolic profile. The results will
      provide key data on the suitability and sensitivity of redox measurements and 1H-NMR
      spectroscopy for study of chemical interactions. This could provide a foundation for the use
      of perturbation of metabolic profile as a means to identify risks and consequences of complex
      chemical mixtures which would be especially relevant to occupational exposures in combination
      with therapeutic drugs and other health risk factors.
    

Intervention name(s): acetominophen, sulfer amino acids; cysteine and methionine
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: sulfer amino acids; redox status
Development of a Head Cooling Device
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      This study is testing a head-cooling device on volunteers to assess temperature reduction.
    


Intervention name(s): University of Edinburgh head cooling device
Intervention type(s): Device
Intervention description(s): head cooling
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label study to be conducted in healthy adult male participants.
      This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480
      and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of
      [14C]-CC-92480.
    


Intervention name(s): [14C]-CC-92480
Intervention type(s): Drug
Intervention description(s): Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteers; CC-92480; Healthy male
Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000
      births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery,
      intensive care, and cardiac catheterization have reduced morbidity and early mortality in
      this population. Nowadays, health-related quality of life (HRQoL) assessment of this
      population is in the foreground. Our team is a tertiary care center for management of
      patients with CHD, from the fetal period to adulthood. The investigators have been conducting
      a clinical research program on HRQoL in pediatric and CHD. The investigators thus
      demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8
      to 18 years, the correlation between functional class and HRQoL in adults with CHD, the
      impact of therapeutic education on HRQoL in children under anticoagulants and the lack of
      difference between the HRQoL of children CHD aged 5 to 7 years old and that of control
      children. Currently, no controlled cross-sectional quality of life study assessment has been
      leded in the youngest children with CHD. This present study therefore extends our work in
      younger children aged 2 to 4 years.
    

Detailed description: 
      248 patients will be enrolled in this study (124 children in each group).

      Patients from group 1 will be included during their annual medical check-up. HRQoL
      questionnaire, neurodevelopmental status scale and clinical status will be assessed during
      this site visit. No supplementary visit, directly related to the research, will be necessary.
      Three sites will participate to the study, members of he French national network for complex
      congenital heart diseases (M3C) .

      Participants (healthy children) from group 2 will be included from kindergartens and schools.
      The prior agreement of the Ministry of National Education will be obtained before any
      procedure related to this study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Groupe 1 : Children with congenital heart disease aged 2 to 4 years Groupe 2 : Healthy
        children aged 2 to 4 years
      
Keywords: health related quality of life; pediatrics; cardiology
Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home
      situations. Patients must use insulin lispro injection [rDNA origin] Low Mix twice daily
      during the trial.
    


Intervention name(s): insulin lispro injection [rDNA origin] Low Mix
Intervention type(s): Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Exposure-Based Treatment for Perfectionism
Condition: Perfectionism
Study type: Interventional

Summary: 
      This study is examining the efficacy of a computerized, exposure-based, intervention for
      perfectionism.
    

Detailed description: 
      The primary aim of this study is to evaluate the effects of a two-week computerized
      exposure-based treatment for perfectionism (ETP). Individuals with elevated perfectionism
      will be randomly assigned to ETP or a waitlist (WL) control condition. ETP will consist of
      three tasks in which they will repeatedly make mistakes, repeated for five sessions over a
      two-week period (one session every 3 days).
    

Intervention name(s): Exposure-based Treatment for Perfectionism (ETP)
Intervention type(s): Behavioral
Intervention description(s): Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ARISCAT and LAS VEGUS Risk Scores for Predicting Postoperative Pulmonary Complications After Cardiac Surgery
Condition: Pulmonary Complication; Postoperative Complications; Postoperative Pulmonary Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The goal of this observational study is to compare the, ARISCAT and LAS VEGUS scales, for
      predicting postoperative pulmonary complications in patients undergoing cardiac surgery. The
      study aims to compare the diagnostic accuracies of the two risk prediction scores in
      predicting postoperative pulmonary complications.
    


Intervention name(s): Detection/screening
Intervention type(s): Diagnostic Test
Intervention description(s): Using ARISCAT and LAS VEGUS risk scores for predicting PPCs
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of either gender, aged between 18-65 years, undergoing elective heart surgery.
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
Condition: HIV Infections
MeSH terms: Infections
Study type: Observational

Summary: 
      Taking anti-HIV medication consistently and properly is a critical issue for patients with
      HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become
      resistant to the drugs. Taking anti-HIV medication properly leads to improved health.
      Children and adolescents with HIV face unique challenges to taking HIV medication properly.
      This study will look at the relationship between how children cope with the responsibility
      for taking medication and the child's language, memory, attention, behavior, and academic
      skills. This study is open to children and adolescents who are currently enrolled in the
      PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).
    

Detailed description: 
      Medication adherence is a critical issue for HIV infected children and adolescents because of
      drug resistance and the increased complexity of treatment regimens. Children and adolescents
      with HIV face depression, anxiety, denial, and rebellion that may interfere with their
      motivation to take medication. Depression and self-perceived social support have been found
      to predict regimen adherence in adults with HIV. Children with other chronic diseases are
      less likely to adhere to their medication regimens if they also have behavioral or emotional
      problems; assessing emotional and behavioral function in children and adolescents with HIV
      may help in predicting adherence and explaining adherence failure. This study will correlate
      cognitive, behavioral, and psychosocial functioning with measures of virologic suppression
      and immunological status, and it will compare self-report and pill count measures of
      adherence in a randomly selected subset of perinatally infected HIV participants of PACTG
      219C.

      Children and adolescents currently enrolled in PACTG 219C will be randomly selected for this
      study, which will last for 48 weeks. At entry, participants will undergo neuropsychological
      evaluation, including academic achievement, attention, memory, language comprehension, and
      behavior assessments, and complete a health beliefs questionnaire. Both the participants and
      their parents or primary caregivers will complete questionnaires at study entry and Weeks 24
      and 48. Adherence will be evaluated from self-reported and pill count measures (Weeks 4 and
      24) and the PACTG 219C Adherence Module (Weeks 24 and 48).
    

Time perspective: Prospective
Keywords: Treatment Experienced
Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men
Condition: Physical Activity; Metabolic Syndrome; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main purpose of this study is to examine the feasibility of an exercise intervention on
      metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men
      with MetS who are at increased risk of prostate cancer.
    

Detailed description: 
      The specific aim for the proposed study is to examine the feasibility and impact of a 6-month
      two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to
      prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate
      cancer, this proposal will focus on the impact of an aerobic and resistance exercise
      intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically,
      our proposed clinical trial compares an aerobic and resistance exercise intervention to an
      attention control group among Black men.
    

Intervention name(s): Exercise; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.; We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prostate cancer; African-American; Metabolic Syndrome; Exercise; Men's Health
A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of
      AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose
      PK of AB521 tablet in healthy adult volunteers.
    


Intervention name(s): AB521
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AB521
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Condition: Agitation in Patients With Dementia of the Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
      probable Alzheimer's disease (AD) was to be based on the "2011 Diagnostic Guidelines for
      Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
      (AA) workgroups.
    

Detailed description: 
      Eligible participants for this study must have had a diagnosis of probable AD and must have
      had clinically meaningful agitation secondary to AD.

      This was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of
      treatment.

      Approximately 380 participants were to be enrolled at approximately 60 centers in North
      America.

      Study medication was to be administered orally twice-daily from Day 1 through Day 85.
      Screening was to occur within approximately 4 weeks prior to randomization. Following
      screening procedures for assessment of inclusion and exclusion criteria, eligible
      participants were to be randomized into the study.
    

Intervention name(s): AVP-786; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sequential parallel comparison design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation; Dementia; Alzheimer's disease
Pediatric Difficult Airway Prediction Using Ultrasonography
Condition: Difficult Intubation; Difficult Mask Ventilation
Study type: Observational

Summary: 
      Recognition of difficult airway is purported to be the most important factor in successful
      management of difficult airway. The incidence of difficult airway in pediatrics is much less
      than in adults; however, airway related complications can lead to hypoxic brain damage or
      even death especially in younger age groups as neonates and infants.The aim of this work is
      to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances,
      tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone,
      thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and
      difficult mask ventilation in pediatric patients undergoing elective surgery under general
      anesthesia.
    


Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): The following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 584 consecutive pediatric patients, aged one month-10 years scheduled for
        elective surgery under general anesthesia will be included in the study.
      
Keywords: Difficult airway; pediatric; Airway ultrasound