bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Seniors' Health With Home Care Aides
Condition: Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      This study aims to test whether a safe physical activity program with a built-in motivational
      enhancement component, performed in a seated position, preserves the function and well-being
      of older home care clients.
    

Detailed description: 
      Regular physical activity benefits older adults physically and mentally. However, the
      availability and the evidence for physical activity programs that are safe and appropriate
      for home-bound older adults at risk for nursing home admission are limited. The current
      project aims to examine the effectiveness of a safe physical activity program, led by home
      care aides who regularly help hard-to-reach older home care clients with housekeeping and
      routine personal care services in the home. The primary aim is to test whether the safe
      physical activity program with a built-in motivational enhancement component, performed in a
      seated position, preserves the function and well-being of home care clients. The secondary
      aim is to understand for whom the program is efficacious, the extent to which the program can
      reach the target population, the extent to which participants drop out of the program, the
      extent to which program participants maintain the behavioral change introduced by the
      intervention, and what the program's cost-effectiveness is. Building on a pilot project that
      demonstrated the program's feasibility in a large home care program funded by the state and
      Medicaid, this randomized controlled trial will inform future expansion of the physical
      activity program into real-world home care settings.
    

Intervention name(s): Healthy Moves for Aging Well (Healthy Moves); Active Mind for Aging Well (Active Mind)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients.; A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Home care aide-client pairs will be randomly assigned to one of two groups in parallel for the duration of the study. Home care aides will not be allowed to have multiple participating clients assigned to different groups to prevent group contamination.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Exercise; Frail Elderly; Homebound Persons; Activities of Daily Living; Mobility Limitation; Home Care Services; Long-Term Care; Dual MEDICAID MEDICARE Eligibility
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis
Condition: Alcoholic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Study type: Observational

Summary: 
      Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with
      alcoholic hepatitis. The liver might play an important role in this stress-catabolism by
      increasing the production of urea during the inflammatory process.

      The purpose of this study is to examine the regulation of urea synthesis in patients with
      alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and
      pentoxifylline on this regulation.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with alcoholic hepatitis admitted to hospital for treatment.
      
Biospecimen description: 
      Serum, plasma, urine
    
Keywords: Inflammation; Urea Synthesis; Catabolism; Nitrogen balance
Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)
Condition: Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional
Phase: Phase 1

Summary: 
      Neurofibromatosis type I (NF1) is a genetic disorder that affects approximately 1 in 3500
      individuals. Half of people with NF1 inherit the condition from a parent, and half have a new
      occurrence of the condition. The manifestation of NF1 is highly variable and multiple organ
      systems are typically affected. Some of the more common symptoms include benign
      neurofibromas, café au lait spots, Lisch nodules (tan spots on the iris of the eye). Some
      individuals with NF1 also exhibit more severe associated conditions, such as optic pathway
      tumors (gliomas) or bones bending or curving. Neurocognitive deficits and specific learning
      disabilities occur in approximately 30 to 50% of individuals with NF1 and are regarded by
      some observers and sufferers to be among the most troubling features of a disease. The most
      commonly reported findings are deficits in visuoperceptual ability, motor coordination,
      expressive and receptive language, and executive functioning, which requires intact
      short-term memory and attention. Patients with NF1 also show a slight depression in mean IQ
      scores compared to healthy adults without the disorder.

      While cognitive deficits are now a widely-recognized feature of Neurofibromatosis Type 1
      (NF1), the precise cause of these deficits still remain to be determined. Dr. Alcino Silva, a
      co- investigator on this study, has developed an animal model of NF1 in which mice have a
      specific mutation of the *NF1* gene. These mice are physically normal but show specific
      learning impairments. Dr. Silva's lab found that treatment with a medication called
      lovastatin, a drug typically used for high cholesterol, reversed some of the spatial deficits
      seen in these animals. Lovastatin is a medication commonly used to treat high cholesterol and
      has been proven to be relatively safe and tolerable in humans.

      The investigators are now conducting a randomized, double-blinded, placebo- controlled, trial
      of lovastatin in patients with NF1. Participants will be randomly assigned to lovastatin or
      placebo and treated for approximately 14 weeks with baseline and follow-up assessments to
      evaluate safety and any effects on neurocognitive test performance.
    


Intervention name(s): Lovastatin; Lovastatin; placebo pill
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lovastatin capsules daily for 14 weeks (titrated up from 10 mg to 40 mg)
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurofibromatosis Type 1; NF1; Lovastatin; statin
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral
      antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2
      diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized
      to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and
      efficacy parameters will be assessed at intervals during the treatment period. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): Actos; aleglitazar
Intervention type(s): Drug; Drug
Intervention description(s): 45mg po daily; 0.6mg po daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Aldafermin (NGM282) for Chronic Diarrhea Due to Bile Acid Malabsorption (BAM)
Condition: Chronic Diarrhea; Irritable Bowel Syndrome With Diarrhea; Bile Acid Malabsorption; Bile Acid Diarrhea; Bile Acid Malabsorption Syndrome Type II; Functional Diarrhea
MeSH terms: Irritable Bowel Syndrome; Malabsorption Syndromes; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-center, randomized, double-blind, placebo-controlled study is designed to compare
      effects of aldafermin, (NGM282), 1 mg, and placebo given daily by subcutaneous injection on
      bowel functions and hepatic synthesis and fecal excretion of bile acids in patients with
      diarrhea associated with bile acid malabsorption (BAM).
    

Detailed description: 
      This single-center, randomized, double-blind, placebo-controlled study is designed to compare
      effects of aldafermin, NGM282, 1 mg, and placebo given daily by subcutaneous injection on
      bowel functions and hepatic synthesis and fecal excretion of bile acids in patients with
      diarrhea associated with bile acid malabsorption (BAM). Thirty patients will receive either
      aldafermin (NGM282) or placebo, not both. The study includes a 7 to 28-day long prescreen
      period and a 28-day long treatment period for a maximum study duration of 56 days. Bowel
      pattern will be assessed by patient-recorded daily bowel pattern diaries. Serum 7-alpha C4
      (C4) and fibroblast growth factor 19 (FGF-19) and fecal bile acids will be measured at
      baseline and Day 14 and Day 28 of treatment. Safety will be assessed through regular
      monitoring of adverse events, clinical laboratory results, 12-lead ECGs, physical
      examinations, and vital signs.
    

Intervention name(s): Aldafermin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg solution; Aldafermin placebo solution
Other intervention name(s): NGM282
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan
Condition: Advanced Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171
      following single and multiple oral doses in patients in Japan with advanced solid
      malignancies. In addition there will be an expanded cohort multi-centre study phase with
      NSCLC patient and CRC patients
    


Intervention name(s): AZD2171
Intervention type(s): Drug
Intervention description(s): oral tablet
Other intervention name(s): cediranib; RECENTIN™
Intervention MeSH terms: Cediranib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japan; Phase I; solid tumor; AZD2171
Inspiratory Muscle Training in Patients With End-stage Renal Disease
Condition: Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion
      capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the
      respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy.
      The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory
      muscle strength, with positive effects on functional capacity and quality of life of kidney
      patients, however, the effects of IMT were not addressed in the specific variables of the
      respiratory system and to date there are no studies on the use of daily training in this
      population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on
      respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage
      renal disease patients. Methods: A randomized controlled clinical trial to be developed in
      Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE)
      during the period from November 2015 to December 2016. The sample is composed of 24
      individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months
      and provide inspiratory muscle weakness. Patients will be divided into two groups, the
      training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of
      30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham
      group will be subjected to the same procedure (duration and frequency), but without load.
      Participants will be assessed before and after intervention through a global assessment form,
      questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic
      ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.
    


Intervention name(s): POWERbreathe® Classic Light
Intervention type(s): Device
Intervention description(s): Inspiratory Muscle Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions
Condition: Stroke
Study type: Interventional

Summary: 
      This study evaulates the addition to the standard theraphy of enriched sensorimotor training
      by means of robotic glove therapy, or functional electrical stimulation in the treatment of
      chronic stroke patients with upper limb motor impairments. All the patients receive the
      conventional physiotherapic treatment. Supplemental to the conventional treatment, patients
      are evenly split in four groups to provide different treatments for an equivalent amount of
      time. Patient in the first group receive supplemental conventional therapy; patients in the
      second group receive robotic glove therapy; patients in the third group receive functional
      electrical stimulation; patients in the fourth group receive robotic glove treatment and
      functional electrical stimulation in different sessions.
    

Detailed description: 
      Stroke very frequently impacts on patients' motor function, and particularly on upper limb
      movements. Limited hand functionality is a major negative outcome after stroke, negatively
      affecting patients' recovery and independence, with major impact on rehabilitation.However,
      standard motor rehabilitation outcome is often suboptimal, because insufficient or
      non-specific treatment is provided. Robotic hand mobilization and functiona electrical
      stimulation grasp rehabilitation each improve motor capabilities in grasp impaired patients,
      but they do so by different mechanisms.

      Robotic hand mobilization achieves grasp rehabilitation by providing passive mobilization of
      the affected limb if the subject does not react to the designed task.

      Functional electrical stimulation achieves grasp rehabilitation by inducing localized muscle
      contraction, that is by providing an electrical field able to stimulate both sensory afferent
      pathways and lower motor neurons in the targeted volume.
    

Intervention name(s): Conventional Therapy; Robotic Glove; Electrical Stimulation
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Conventional treatment allocated to patients in all arms. Supplemental dose matched treatment to each of the four arms (9 weeks, 3 treatments a week) as follows:
conventional treatment (27 treatments)
functional electrical stimulation (27 treatments)
robotic glove ( 27 treatments )
robotic glove and electrical stimulation ( each session uses one device, half of the sessions uses the robotic glove, half the functional electrical stimulation )
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; functional electrical stimulation; electrode array; upper limb; chronic; motor relearning
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation
      of osteoarthritis of the knee.
    


Intervention name(s): honeybee venom (Apitoxin (Korea) Apitox (USA))
Intervention type(s): Drug
Intervention description(s): multiple intradermal injections of 100 ug pure honeybee venom
Other intervention name(s): Apitoxin (Korea) Apitox (USA)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: honeybee venom; osteoarthritis; pain; knees
A Study of Insulin Peglispro in Healthy Male Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how the body processes the study drug known as
      insulin peglispro and how the study drug affects blood sugar in healthy male Japanese
      participants. This study will also evaluate safety of the study drug. The study will last up
      to 46 days for each participant, not including screening.
    


Intervention name(s): Insulin Peglispro
Intervention type(s): Drug
Other intervention name(s): LY2605541
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis
Condition: Juvenile Osteochondrosis of Spine
MeSH terms: Osteochondrosis; Spinal Osteochondrosis; Scheuermann Disease
Study type: Interventional

Summary: 
      This study compares effect of swiss ball exercises with sling suspension exercises in the
      treatment of juvenile osteochondrosis in adolescent-girls
    

Detailed description: 
      One of the main tasks in the treatment of osteochondrosis related back pain is training trunk
      stabilizing muscles. This might be achieved by using a sling suspension exercise systems.
      Redcord is a trademark for Sling Exercise Therapy. Suspension exercise training has been
      shown to improves functional movement patterns more effectively than traditional exercise by
      creating a challenging and pain free environment for movement re-training. Another commonly
      used option in the treatment of juvenile osteochondrosis is Gymball, also known as Swissball
      core training programmes that are popular trends in physiotherapy and strength and
      conditioning programs. Benefits of Gymball core training exercises that facilitate spinal
      stability and balance have often been emphasized by researchers in development of strength
      and endurance, flexibility, and neuromuscular control as a cost effective and enjoyable way
      to treat and prevent back pain. Both exercises modes are used in treatment of back pain and
      muscle training in young people with juvenile osteochondrosis, what is why this study aims to
      compare Sling Suspension therapy with Gymball exercise in this population.
    

Intervention name(s): Sling suspension using red cord; Gym ball exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): 3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.; 3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.
Other intervention name(s): SST; GBT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were recruited from an inpatient rehabilitation department, specializing in the treatment of children and adolescents with degenerative disorders. The research population consisted of 40 adolescents-girls, who were diagnosed with juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42.0). All subjects were randomly divided into two groups: Sling Suspension Therapy, and Gymball therapy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: back pain; suspension therapy; Gymball; standing posture; muscle endurance
Efficacy and Safety of Red Ginseng on Decrement of Body Fat
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The
      investigators measured decrement of body fat parameters , including Body Fat Mass, Percent
      Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
    


Intervention name(s): Red Ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Red Ginseng (1.4g/day); Placebo (1.4g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention