bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      A tele-health treatment study for individuals with early stage ALS with the aim to improve
      communication, cough response, and respiratory strength. All participants complete a
      respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150)
      device from the comfort of their homes for 6 weeks.
    

Detailed description: 
      The investigators are looking for people with early stage ALS to participate in a completely
      tele-health (no in-person visits required) treatment study examining the effects of an
      Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and
      respiratory strength. Participants will be required to attend 2 virtual baseline assessment
      sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks).
      Participants should plan to be actively enrolled in the study for ~10 weeks (3 weeks of
      baseline monitoring followed by 6 weeks of training). Participants will also be required to
      fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.
    

Intervention name(s): Expiratory Muscle Strength Training (EMST-150)
Intervention type(s): Device
Intervention description(s): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).
Intervention model: Single Group Assignment
Intervention model description: All participants enrolled will receive the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Horizant (Gabapentin Enacarbil) on Augmentation
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Restless Legs Syndrome (RLS) is a common neurological disorder. Augmentation is the main
      complication during long-term DA treatment of RLS. This study aims to examine effect of
      Horizant (Gabapentin Enacarbil) on Augmentation in RLS patients.
    

Detailed description: 
      This is an Open label single arm study. The purpose of the study is to demonstrate the
      efficacy of Horizant in patients with RLS who exhibit augmentation while on Dopaminergic
      therapy. Adult patients (age 18-85 years) with diagnosis of primary RLS (diagnosed by study
      investigators) with augmentation on dopaminergic therapy will be screened for participation
      in the study. RLS diagnosis will be made by the study investigators using International RLS
      study group criteria. Patients with augmentation on dopaminergic therapy as defined by NIH
      2007 with ASRS of 5 to 15 will be offered to participate in the study. Inclusion and
      exclusion criteria are listed below. The study will be performed after approval of the
      Institutional Review Board of the University of Missouri.

      A total of 50 subjects will be entered into the study over a period of 1 year. Written
      consent will be obtained from all patients. After pre-participation evaluation for
      eligibility, subjects will be selected and enrolled in the study and followed for a total of
      6 follow up visits (Days 0, 30, 90, 120, 180, 360). Subjects Enrollment period will last up
      to 12 months. The total duration of study will be 24 months.
    

Intervention name(s): Horizant
Intervention type(s): Drug
Intervention description(s): Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.
Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360).
Other intervention name(s): Gabapentin enacarbil
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Clinical Safety/Tolerability and Exploratory Efficacy of EHT 0202 as Adjunctive Therapy to Acetylcholinesterase Inhibitor in Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this 3-month study is to assess the safety and efficacy of EHT 0202 in
      addition to acetylcholinesterase inhibitor in patients suffering from Alzheimer's Disease.
    

Detailed description: 
      The aim of this pilot study is to assess the safety and tolerability profile of 2 doses of
      EHT 0202 (40 mg and 80 mg b.i.d) versus placebo in addition to a treatment with
      acetylcholinesterase inhibitor and its exploratory efficacy on cognition, behavior,
      activities of daily living, caregiver's burden and patient's global assessment, during a
      3-month treatment period.
    

Intervention name(s): EHT 0202 etazolate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.; In each arm, 2 capsules of study treatment (capsules of EHT0202 40mg and/or placebo) are taken twice a day during breakfast and dinner over a 3-month treatment period. There is non treatment adjustment.
Other intervention name(s): EHT 0202; etazolate
Intervention MeSH terms: Etazolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; efficacy; Alzheimer's disease; treatment; phase II; study; cholinesterase inhibitor
Ultrasonographic Evaluation of Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in
      people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with
      clinical and demographic data.
    

Detailed description: 
      Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group
      (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves.
      Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the
      nerves were recorded, and the associations between pain intensity (measured with a visual
      analog scale [VAS]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain
      scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.
    

Intervention name(s): Ultrasonographic evaluation of nerves in diabetic patients; Ultrasonographic evaluation of nerves of healthy volunteers
Intervention type(s): Other; Other
Intervention description(s): Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy; evaluation of peripheral nerves and correlated with group I
Other intervention name(s): ultasonographic evaluation
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Outpatients in a University Hospital
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study was to determine the safety and effectiveness of
      an experimental drug called rilonacept in participants with gout who are beginning
      allopurinol treatment for gout. Participants will participate in this study for approximately
      22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.
    


Intervention name(s): Placebo; Rilonacept; Rilonacept
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks.; Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks.; Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intercritical Gout; Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout
Cognitive Impact of Pomegranate Polyphenols Following Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether pomegranate supplements improve cognitive
      functioning following stroke.
    

Detailed description: 
      Research suggests that antioxidants (substances that may slow or prevent cell damage) found
      in many fruits and vegetables may help improve brain functioning (for example, memory and
      attention) in healthy individuals and prevent cognitive decline in individuals who have
      suffered a stroke. The purpose of this research study is to examine whether dietary
      supplementation with an antioxidant extract can help promote healthy cognitive functioning as
      a component of recovery after stroke. The procedures include: Administering polyphenols via 2
      POMx pills, each of which contains polyphenols derived from pomegranates equivalent to the
      content of approximately 8 ounces of pomegranate juice, or placebo pills (capsules containing
      no polyphenol ingredients), every day for one week to inpatients who are in the acute
      post-stroke phase. Neuropsychological testing pre- and post-treatment will determine whether
      cognitive functioning changes. Subjects will be randomized into either a placebo or
      polyphenol group.
    

Intervention name(s): POMx; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Pomegranate supplement (1g) by mouth twice per day for 7 days; Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pomegranate; Stroke; Neuropsychology
Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      It has been suggested that a low dietary intake of antioxidant vitamins and minerals
      increases the incidence rate of cardiovascular disease and cancer. To date, however, the
      published results of randomized, placebo-controlled trials of supplements containing
      antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the
      efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins
      and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the
      general population.
    

Detailed description: 
      From experimental studies it is known that free radicals may induce numerous pathological
      processes, and it has been suggested that, because of their antioxidant capacity, nutrients
      such as beta-carotene, vitamin C, vitamin E, selenium and zinc may prevent such harmful
      effects. Epidemiological data from cross-sectional, case-control, and prospective studies
      have indeed shown a strong relationship between the intake of antioxidant vitamins and
      minerals, or foods rich in these nutrients, and the risk of cancer and ischaemic
      cardiovascular diseases (CVD). However, randomised placebo-controlled primary prevention
      trials, in which antioxidant micronutrients alone or in pairs were given at high doses over
      long periods, have not been able to prove this potential beneficial effect, and two of these
      even suggested harmful effects. The seemingly contradictory results between the observational
      studies and these randomised trials can be explained by the fact that the doses used in
      clinical trials were much higher than the highest levels reachable by usual dietary intake
      which have been found to be associated in observational studies with the lowest risk of
      cancer and CVD. In fact, the only trial which did observe a beneficial effect on total
      mortality and cancer incidence used nutritional doses of a combination of several vitamins
      and minerals and was performed on Chinese population with very low baseline micronutrient
      status, due to poor life conditions in this region (9).

      The objective of the "SUpplementation en VItamines et Minéraux AntioXydants" (SU.VI.MAX)
      study, was to test in a randomised, placebo-controlled trial, if an adequate and well
      balanced intake of antioxidant nutrients reduces the incidence of cancers and ischaemic
      cardiovascular diseases in a middle-age general population.
    

Intervention name(s): ascorbic acid, vitamin E, beta carotene, selenium, zinc
Intervention type(s): Behavioral
Intervention MeSH terms: Ascorbic Acid; Vitamin E; Beta Carotene; Selenium; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Prevention trial; Antioxydant vitamins and minerals; Cancer; Ischemic disease; Mortality; Health related quality of life
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
Condition: Lymphoma, Non-Hodgkin; Hodgkin Disease
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard
      G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for
      lymphoma.

      The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100, a
      significantly higher proportion of lymphoma patients will collect ≥ 2 x 10E6 CD34+ cells/kg.
    

Detailed description: 
      Autologous stem cell transplantation (ASCT) is indicated for patients with non-Hodgkin
      lymphoma (NHL) or Hodgkin lymphoma (HL) who have primary progressive disease or who relapse
      after a chemotherapy-induced complete remission. For these patients, as for other patients
      undergoing autologous transplantation, the number of CD34+ cells collected is a reliable
      predictor of neutrophil and platelet (PLT) engraftment after transplantation.

      AMD3100 (plerixafor) is a promising new mobilizing agent that has demonstrated efficacy in
      patients with NHL, HL, and multiple myeloma (MM). Although efficacious, the subcutaneous
      dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis,
      which can present logistical problems. Intravenous dosing of AMD3100 may result in a faster
      rise in peripheral CD34+ cell count, so that the drug can be administered the same day as
      apheresis. Intravenous dosing may also increase the peak CD34+ cell count, improving the
      number of CD34+ cells collected via apheresis.

      This Phase I/II study will evaluate the safety and efficacy of intravenous AMD3100 added to
      the standard G-CSF mobilization regimen of patients undergoing autologous stem cell
      transplantation for Hodgkin and non-Hodgkin lymphomas.
    

Intervention name(s): AMD3100; G-CSF; Apheresis
Intervention type(s): Drug; Drug; Procedure
Other intervention name(s): Plerixafor; Neupogen; Filgrastim; Leukopheresis
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plerixafor; Lymphoma; Hematopoietic Stem Cell Mobilization; Transplantation, Autologous; Receptors, CXCR4
Exercise and Severe Depression: Clinical and Biological Analysis
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The study aimed to evaluate the use of exercise as a complementary strategy to treat severe
      major depression in inpatients.

      Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe
      depressed inpatients.
    


Intervention name(s): Exercise
Intervention type(s): Other
Other intervention name(s): Aerobic Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Depression; Quality of life; Exercise; BDNF; TBARS
Effect of Rapamycin to Improve Cardiac Function in Frail Older Adults
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to see if the drug rapamycin will improve the heart's ability
      to pump by improving your oxygen consumption.
    

Detailed description: 
      This will be a pilot, proof-of-concept study. Patients 60 years or older with invasively
      proven HFpEF or have definite HFpEF as determined by the 2 established scores and frailty
      (positive screen for computable phenotype), will be approached for enrollment. Subjects
      meeting screening criteria following written informed consent will be randomized to receive
      rapamycin or matching placebo (study drug). Efficacy outcomes will be measured at baseline
      and at 6 months. Safety will be assessed by in person or remote video monitoring weekly for 1
      month, then monthly for 5 months till the end of the study. We will also measure trough
      rapamycin levels (≤4ng/mL) twice-a-month for the first month and then monthly for 5 months.
    

Intervention name(s): Rapamune
Intervention type(s): Drug
Intervention description(s): We will start the dose at 0.5mg capsule every other day for 2 weeks. If participants tolerate this dose and trough blood levels are (≤4ng/mL), the dose of rapamycin will be increased to 0.5mg daily for the duration of the study. If necessary, dose can remain at 0.5 mg every other day, depending on the trough level. To avoid immunosuppression, we will target lower dose of rapamycin, maintain lower trough serum levels (≤4ng/mL).
Other intervention name(s): Rapamycin
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Fitness on Brain and Cognition
Condition: Aging; Cognitive Ability, General
Study type: Observational

Summary: 
      The purpose of this study is to examine the effect of aerobic fitness training on human
      cognition, brain structure, and brain function of older adults.
    

Detailed description: 
      Recent studies have shown the encouraging effects of fitness training on human cognition, and
      brain structure and function. Such effects are of great interest both for what may they tell
      us about the nature of cognitive and brain aging and also for their public health
      implications. This study will test the hypotheses that: 1) improvements in aerobic fitness of
      older adults will lead to improved performance on a variety of cognitive processes, and
      especially those processes that are supported by frontal regions of the brain; 2)
      improvements in cognitive processes due to enhanced aerobic fitness will be visible on fMRI
      scans, and will be similar to those of young adults; 3) improvements in aerobic fitness, over
      the course of a 1 year intervention, will result in increases in gray and white matter
      volume.

      One hundred forty sedentary older adults will be recruited for this study. Participants will
      be randomized to an aerobic exercise intervention group, or to a stretching and toning
      control group. Aerobic exercise sessions will be conducted three times a week for one year,
      beginning at a light to moderate intensity level over the first two months and progressing to
      a moderate to high level for the remainder of the year. The control group will meet on the
      same basis as the intervention group, and will participate in an organized program of
      stretching, limbering, and toning for the whole body that is specially designed for
      individuals 60 years of age and older.

      During this time, participants will exercise, keep a daily exercise log detailing distance
      walked (routes will be measured and mapped for participants), time spent in aerobic activity,
      degree of intensity (rating of perceived exertion), general level of affect during exercise,
      resting and exercise heart rates. Participants will participate in the MRI/fMRI,
      physiological (cardiorespiratory) and psychosocial testing prior to the beginning of the
      fitness training intervention, following 6 months of fitness training, and at the conclusion
      of the 1 year of fitness training.
    

Intervention name(s): Aerobic Exercise; Stretching and toning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One hour per day three times a week for one year; One hour per day three times a week for one year
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults over 60
      
Keywords: Mild Cognitive Impairment; cognition disorders; brain health; psychological aspect of aging; exercise; physical fitness