bioihbjkbjnl/mcl2 huggingface dataset:
Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
Condition: Bilateral Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Treatment: five intro-articular Hyaluronic Acid injection

      Assessment has two parts, that are as follow:

        1. Postural stability and risk of fall assessment using Biodex stability index and "Timed
           up and Go" test

        2. Gait and stair climbing assessment using Vicon motion capture system synchronized with
           four force plates.

      For knee OA subjects, assessment was done in week one or before injection; and for healthy
      controls one assessment was performed.
    

Detailed description: 
      This study aimed to assess the effect of hyaluronic acid injection on Postural stability,
      biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis
      (OA).

      Participants were individuals with knee OA (control and treatment) and healthy people.
    

Intervention name(s): Hyaluronic acid
Intervention type(s): Other
Intervention description(s): treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
Other intervention name(s): Hyalgan; Manufacturer: Fidia Pharmaceutici S.p.A, Italy
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Condition: Dientamoebiasis
MeSH terms: Dientamoebiasis
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Dientamoeba fragilis (DF) is a commonly occurring intestinal protozoan that is
      considered a possible cause of infectious gastrointestinal disease in adults and children. DF
      has a particular high prevalence in children, and it is suspected that children present more
      symptoms in infection than adults. However, evidence of causality is lacking, treatment
      regimens are largely untested in controlled trials, and the most commonly used antibiotic
      against DF in Denmark, metronidazole, has never been tested against placebo.

      Main objective: To determine the clinical effect of metronidazole in DF-infected children
      with gastrointestinal complaints, where no other aetiology is known and no other
      gastrointestinal pathogens could be shown.
    


Intervention name(s): Metronidazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metronidazole, oral suspension, 40mg/ml.
1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents.; Placebo.
1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents.
Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis.
Other intervention name(s): Flagyl® (Metronidazole), oral suspension. Sanofi-aventis; ATC-code: P01AB01
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; parasite; intestinal; treatment; RCT
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Chronic Renal Insufficiency; Chronic Renal Failure
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the levels of CTA018 in the body over time (pharmacokinetics, PK)
      in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT),
      undergoing regular hemodialysis. This study will also investigate the safety and effects of
      different strengths of CTA018, on parathyroid hormone (PTH) levels.
    


Intervention name(s): CTA018 Injection
Intervention type(s): Drug
Intervention description(s): Comparison of different dosages of drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure
Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the
      effect of inhaled corticosteroids.

      Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled
      methacholine in patients with mild to moderate persistent asthma treated with a stable dose
      of inhaled corticosteroids.
    


Intervention name(s): Montelukast (Singulair); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg tablet once daily; Oral placebo once daily
Other intervention name(s): Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Airway responsiveness; Dose-response plateau; Montelukast; Add-on to inhaled corticosteroids
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
Condition: Aging
Study type: Interventional
Phase: Phase 2

Summary: 
      This study addresses a "lifespan approach to healthy development and aging" with direct
      relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot
      study to: i) better estimate power for a larger trial, ii) establish the safety and potential
      beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the
      effects of acarbose on the microbiome likely play a role in its enhancement of longevity
      and/or healthy aging. These are essential initial steps for translating acarbose into an
      anti-aging human therapy.
    

Detailed description: 
      Treatment with acarbose, an α-glucosidase inhibitor, extends median lifespan by 22% in male
      mice. Acarbose is FDA-approved for use in humans and has been extensively employed for the
      management of diabetics; there have been few associated side effects reported. Acarbose is
      considered a very safe treatment. Thus, the investigators hypothesize that acarbose treatment
      could be used in elderly humans to elicit improvement in systems known to be negatively
      affected by aging. Since the outcomes of acarbose treatment may be differentially affected by
      age, it is imperative to test the drug directly in older subjects for its safety and
      efficacy. Towards this end, the investigators propose to perform a small pilot study
      assessing the effects of acarbose in ten elderly subjects, aged 75-95 years old. Briefly, a
      cohort of non-diabetics will be recruited; subjects will be in generally good health with all
      chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Trial
      participants will be studied before drug initiation (pre-treatment), during 3 months of
      acarbose (blood draws at 1 month and 3 months of treatment), and following termination of the
      drug (1 and 3 months post treatment) such that each subject will serve as his own control.
      Gut microbiome composition will be assessed.
    

Intervention name(s): acarbose
Intervention type(s): Drug
Intervention description(s): acarbose treatment with meals
Intervention MeSH terms: Acarbose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Upside Down, Give me the Handle
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      In schizophrenia, dislocation of psychic functions involving a loss of contact with reality
      is frequently found. A fragmentation of motor and sensory perceptions could be held
      responsible (Fuchs, 2005). However, automatic integration between perception and action is
      the necessary condition to be in "relationship with the world." Affordance is the
      experimental link between object perception and actions potentially associated (Gibson (1977,
      1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual
      motor neurons leads us to postulate that the affordance effect can be assisted by a
      visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor
      compatibility task, we study the capacity of affordance in schizophrenia, as well as the
      impact of perceptual motor priming on these affordance effects.
    

Detailed description: 
      All participants will perform cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm,
      2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960),
      and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987). Controls will only
      have the first three tasks (cognitive spots Alert and laterality). Then all will perform all
      tasks in successive order (task 1 and task 2). For both tasks, photographs of 20 objects of
      everyday life typical grip with one hand are presented in 4 orientations. The instruction is
      to say if the object is presented upright or inverted; The second task differs from the first
      only by the introduction of a prime: presenting a hand in position "catching" before the
      picture of an object
    

Intervention name(s): cognitive tasks + PANSS+ IQ; cognitive tasks
Intervention type(s): Other; Other
Intervention description(s): Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987; Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971),
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Schizophrenia; motor and sensory perceptions
A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the effect of lanabecestat on how the body absorbs and
      processes 3 other medications, midazolam, simvastatin and donepezil and how these 3
      medications affect lanabecestat when they are taken together. This study is in 2 cohorts,
      Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit
      is required within 30 days prior to the start on the study
    

Detailed description: 
      Astra Zeneca (AZ) registered this trial as sponsor. In July, 2015, sponsorship changed to Eli
      Lilly and Company (Lilly). In August, 2015, AZ transferred this trial to Lilly's
      ClinicalTrials.gov account and Lilly updated the record. This trial is not an applicable
      trial under the Food and Drug Administration Amendments Act of 2007 (FDAAA).
    

Intervention name(s): Lanabecestat; Simvastatin; Midazolam; Midazolam; Donepezil; Lanabecestat
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet; 20 mg simvastatin will be administered orally as 1 × 20-mg tablet; 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup; 250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution; 5 mg donepezil will be administered orally as 1 × 5-mg tablet; 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
Other intervention name(s): LY3314814; AZD3293; LY3314814; AZD3293
Intervention MeSH terms: Midazolam; Donepezil; Simvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      At present clinicians have no way to reverse anesthesia. Patients wake when their bodies
      clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and
      other cognitive problems after waking from anesthesia. In studies on animals, the
      investigators observed that caffeine caused rats to wake much more rapidly from propofol
      anesthesia. This was true for all the animals tested. The investigators would like to see if
      this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse
      the cognitive deficits associated with anesthesia, after waking?

      The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer
      will be anesthetized twice. Each volunteer will be anesthetized one time and receive an
      infusion of saline (placebo control), without the aid of any other drugs and the other time
      the volunteer will receive an infusion of a relatively low dose of caffeine. The order of
      saline versus caffeine will be randomized and the study will be done in a double blind
      manner. We will determine whether emergence from propofol anesthesia will be significantly
      accelerated by the caffeine infusion. And whether any adverse events are observed.
    


Intervention name(s): Placebo; Caffeine
Intervention type(s): Drug; Drug
Intervention description(s): Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
Saline; Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
Caffeine citrate
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      Aging is associated with a loss of brain function and conditions such as dementia and
      Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the
      progression of age related degenerative diseases. Aerobic exercise training can increase
      brain volumes and is associated with decreased risk for degenerative brain conditions.
      However, little is know about the changes that occur to brain metabolism with aerobic
      training and aging.
    


Intervention name(s): High intensity aerobic training; Sedentary Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High intensity aerobic interval training will be performed 12-weeks. Exercise training will last 1 hour per day, 5 days per week and include high intensity interval cycling at ~70-95% maximum workload for 4 minutes followed by 3 minutes of rest.; Sedentary control participants will not perform any regular exercise for 12-weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: High intensity aerobic training
Treatment Efficacy for Developmental Motor Speech Disorders
Condition: Randomized Controlled Trial for Speech Disorders in Children
MeSH terms: Speech Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to carry out a high-level treatment efficacy study on children
      with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled
      Randomized Controlled Trial design.

      The intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets
      (PROMPT) approach, which has been effective in treating motor speech disorders in adults and
      in children with autism and cerebral palsy.
    

Detailed description: 
      The results of this study will allow us to determine if there is a causal relationship
      between PROMPT treatment and outcome measures and predict how much improvement can be
      expected from this therapy. This study is being conducted as a part of a multicenter clinical
      trial in the province of Ontario, Canada with three sites: The John McGivney Children's
      Centre in Windsor, The ErinoakKids Centre for Treatment and Development in Mississauga, and
      The Speech and Stuttering Institute in Toronto.

      The study integrity will be monitored by an arms-length, external agency, The Applied Health
      Research Centre (AHRC) at St. Michael's Hospital in Toronto. The study is coordinated by the
      Department of Speech-Language Pathology at the University of Toronto and funded by the PROMPT
      Institute in Santa Fe, New Mexico.
    

Intervention name(s): PROMPT
Intervention type(s): Behavioral
Intervention description(s): The PROMPT approach utilizes a motor-speech hierarchy (MSH) to guide speech language pathologists (SLP) in selecting speech movement goals for treatment. PROMPT treatment generally proceeds systematically in a bottom-up fashion starting with the lowest subsystem in the hierarchy where a child has control issues. Furthermore, in the PROMPT approach specific techniques are used to stimulate sensory input that are assumed to facilitate the formation of sensory-motor pathways required for the acquisition and accurate production of speech movement patterns. As the speech motor behaviors are established, the clinician reduces the number of cues and the frequency and immediacy of feedback and practices transfer and generalization activities.
Other intervention name(s): PROMPT therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Speech sound disorders; Randomized Controlled Trial; Speech intelligibility; PROMPT treatment; Developmental motor speech disorders; Children; Functional outcomes; Treatment efficacy
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
Condition: Parkinson Disease; Gait Disorders, Neurologic
MeSH terms: Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The aim of this study is to improve knowledge about mechanical gait assistance combined with
      virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that
      12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill
      rehabilitation combined with virtual reality treatment is effective for increase gait
      autonomy in patients with Parkinson's disease.
    


Intervention name(s): Virtual reality combined with anti-gravity treadmill
Intervention type(s): Other
Intervention description(s): The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.
The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson; Virtual reality; Anti-gravity treadmill; Rehabilitation; Gait disorders
Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

Summary: 
      RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help
      identify biomarkers related to cancer. It may also help doctors learn how patients respond to
      treatment.

      PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic
      lymphocytic leukemia who were treated on clinical trial ECOG-2997.
    

Detailed description: 
      OBJECTIVES:

        -  To analyze the expression of a variety of informative molecules using a unique
           high-resolution flow cytometric immunophenotyping technology in samples from patients
           with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997.

      OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70,
      phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1,
      phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker
      signals are amplified using enzymatic amplification staining to obtain high resolution
      detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured
      using fluorescence activated cell sorting analysis. Relationships between clinical outcomes,
      standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping
      will also be assessed.
    

Intervention name(s): cytogenetic analysis; flow cytometry; fluorescence activated cell sorting; immunoenzyme technique; laboratory biomarker analysis
Intervention type(s): Genetic; Other; Other; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E2997
      
Keywords: chronic lymphocytic leukemia
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of
      JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are
      receiving background non-biologic disease-modifying anti-rheumatic drug therapy.
    


Intervention name(s): JTE-051; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug tablets containing JTE-051; Placebo tablets identical in appearance to the active drug tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JTE-051; Active Rheumatoid Arthritis; Efficacy; Safety; Tolerability; Rheumatoid Arthritis