bioihbjkbjnl/mcl2 huggingface dataset:
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
Condition: Hearing Loss, Sensorineural; Cognitive Impairment
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The objectives of the current project aim to determine whether a more controlled
      amplification method or a visual administration has an effect on hearing impaired older
      individuals' cognitive test scores.
    

Detailed description: 
      Aim 1 is to create a visually administered condition of a cognitive test and to validate this
      condition in comparison to the auditory administration. Data will be collected from younger
      individuals with normal hearing. Each younger individual is tested using both visual and
      auditory condition and the scores are compared across the two conditions. It is anticipated
      that the scores will not be significantly different between the two conditions.

      Aim 2 is to examine the test condition effect on cognitive testing results in older
      individuals with hearing loss. The three test conditions include auditory unamplified,
      auditory amplified, and visual. Each older individual will be tested using two different test
      conditions. It is predicted the auditory amplified and visual administrations will alleviate
      the cognitive load associated with hearing difficulty and lead to improved performance on the
      test.
    

Intervention name(s): Auditory amplified; Visual; Auditory unamplified
Intervention type(s): Other; Other; Other
Intervention description(s): The cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds.; The cognitive test will be administered visually by using timed computer slides.; The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Study Evaluating TMI-005 in Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this clinical research study is to compare the efficacy and the
      safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active
      Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).
    


Intervention name(s): TMI-005
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and
      young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042).

      Partial funding for this study was provided by the Office of Orphan Product Development
      (OOPD).
    

Detailed description: 
      Asfotase Alfa was formerly referred to as ENB-0040

      Hypophosphatasia (HPP) is a life-threatening, genetic, and ultra-rare metabolic disease
      characterized by defective bone mineralization and impaired phosphate and calcium regulation
      that can lead to progressive damage to multiple vital organs, including destruction and
      deformity of bones, profound muscle weakness, seizures, impaired renal function, and
      respiratory failure. There are limited data available on the natural course of this disease
      over time, particularly in patients with the juvenile-onset form.
    

Intervention name(s): asfotase alfa
Intervention type(s): Biological
Other intervention name(s): ENB-0040
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypophosphatasia; HPP; Bone disease; Soft bones; Low alkaline phosphatase; Genetic metabolic disorder; Alkaline phosphatase; Tissue non-specific alkaline phosphatase; Rickets; Osteomalacia
Addition of the Interferential Current to the Pilates Method in the Treatment of Chronic Nonspecific Low Back Pain
Condition: Chronic Nonspecific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of the addition of the interferential current
      to Pilates method exercises in the treatment of 148 patients with chronic nonspecific low
      back pain.
    


Intervention name(s): Electrotherapy; Pilates
Intervention type(s): Device; Device
Intervention description(s): Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).; Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilates-based exercises; Electrotherapy; Interferencial current
Leucine Supplementation in Young Subjects Undergoing Resistance Training
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Leucine supplementation could be useful to support muscle anabolism. This study aims to
      investigate the effects of leucine supplementation on muscle mass and muscle strength in
      young subjects undergoing resistance training.
    


Intervention name(s): Leucine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effects of High Dietary Fiber Supplementation in Diabetic Chronic Kidney Disease
Condition: Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Loss of kidney function results in accumulation in the blood of molecules that are either
      excreted or metabolized by the kidney. Collectively, these molecules are termed Uremic
      Retention Molecules (URMs) or toxins. It is increasingly recognized that colonic bacterial
      metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and
      excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity.
      Indeed, these URMs have been linked to increased levels of inflammation markers, chronic
      kidney disease (CKD) progression, cardiovascular disease and overall mortality in CKD and/ or
      hemodialysis patients. Therefore, interventions that target the production or absorption of
      URMs from the gut might decrease inflammation and oxidative stress that are commonly seen in
      the uremic milieu. The National Health and Nutrition Examination Survey III (NHANES III) data
      show that high dietary fiber intake is associated with decreased serum levels of C-reactive
      protein (CRP) in those with and without CKD and these associations are much stronger in the
      CKD population. A possible explanation of this effect is that a high fiber diet in CKD
      patients modulates the bacterial production, intestinal absorption and finally the serum
      levels of URMs like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease
      in inflammation.

      OBJECTIVES:

      Hypothesis:

        1. Higher serum levels of markers of inflammation such as high sensitivity C-reactive
           protein (hsCRP), interleukin 6 (IL-6) and tumor necrosis factor (TNF) -α seen in stage 4
           CKD (estimated Glomerular Filtration Rate 15-29 ml/min/1.73 m2) compared to stage 2 CKD
           (estimated Glomerular Filtration Rate 60-89 ml/min/1.73 m2) is partly explained by the
           higher circulating levels of URMs (p-cresyl sulfate and indoxyl sulfate) in stage 4 CKD,
           and

        2. Dietary supplementation in stage 4 CKD with 30g/d of a soluble fiber Psyllium (brand
           name-Metamucil TM) will decrease circulating URMs levels and thereby, decrease serum
           levels of inflammation markers and urinary levels of transforming growth factor (TGF)-β,
           a marker of kidney fibrosis.
    


Intervention name(s): psyllium
Intervention type(s): Dietary Supplement
Intervention description(s): 15 grams/day for 1 week, followed by 30 grams/day for 4 months
Other intervention name(s): Metamucil
Intervention MeSH terms: Psyllium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney Disease; Fiber; Dietary Intervention
Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
Condition: Physical Activity; Sedentary Lifestyle; Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to test whether deposit contracts, wherein individuals invest
      their own money with the study to serve as the incentive, with or without daily feedback
      about progress help individuals to increase step counts and more often meet a step goal
      compared to self-monitoring only.
    

Detailed description: 
      Approximately 68% of adults are overweight or obese, which is associated with increased risk
      for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These
      individuals are more often sedentary than the general population, which compounds the risk
      for these same conditions. While the benefits of engaging in physical activity are
      well-established, few individuals are able to successfully increase activity to recommended
      levels. Existing intervention programs, often derived from theories such as social cognitive
      theory or related theories, have had limited success. Behavioral economics offers a promising
      alternative, suggesting that engagement in any behavior is based on the maximizing utility
      and happiness. Interventions based on this theory aim to increase the immediate benefit of
      engaging in physical activity, often using a financial incentive.

      This study will last for 16 weeks. Each participant will invest $42 with the study, and be
      exposed to to each of three interventions. All participants will have the use of a FitBit for
      ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition,
      these will be the only interventions you receive. In one condition, you will receive a
      monetary consequence for meeting or not meeting the goal. Each day during the incentive
      conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or
      to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for
      meeting the goal. In the third condition, you will have daily feedback mid-afternoon about
      your distance from the goal and the money you stand to gain or lose. You will be made aware
      of what condition you are in.
    

Intervention name(s): Self-monitoring; Incentives; Feedback
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will have access to a wrist-worn activity monitor and have a daily step goal; Participants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached; Participants will receive text message feedback each day about progress towards their goal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ADME Study of [14C]- Rongliflozin in Healthy Male Subjects
Condition: Healthy Adult Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]- Rongliflozin
      in healthy male subjects.
    


Intervention name(s): [14C]- Rongliflozin
Intervention type(s): Drug
Intervention description(s): Patients will receive single dose of orally [14C]- Rongliflozin on Day 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Cardiorespiratory Fitness, Apolipoprotein E Genotype, and Cognitive Functions: A Prospective Study
Condition: Aging; Cognitive Change
Study type: Observational

Summary: 
      The current research project aims to investigate the interaction of cardiorespiratory fitness
      (CRF) and the ApoE genotype with neurocognitive functions.
    

Detailed description: 
      The current research project aims to investigate the interaction of cardiorespiratory fitness
      (CRF) and the ApoE genotype with neurocognitive functions. The three main purposes of the
      current research project seek to achieve:

        1. An exploration of the associations of, as well as the interactions between, CRF assessed
           at the Baseline Stage, and the ApoE genotype, along with cognitive functions in
           cognitively healthy late-middle-aged older adults.

        2. The employing of an event-related potential (ERP) to investigate the associations
           between the baseline CRF, the ApoE genotype, and cognitive functions in cognitively
           healthy late-middle-aged older adults, as well as the potential underlying
           neuroelectrical mechanisms.

        3. An investigation of the interactions between the changes of CRFs assessed at the
           Baseline and the Follow-Up Stages and the ApoE genotype in relation to neurocognitive
           function, as well as the underlying neuroelectrical mechanisms, in cognitively healthy
           late-middle-aged older adults.
    

Intervention name(s): Data collections
Intervention type(s): Other
Intervention description(s): Data collections of cognitive function, neuroelectrical activities, ApoE genotype, and physical fitness.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cognitively healthy late-middle-aged older adults recruited from the northern part of
        Taiwan.
      
Keywords: physical fitness; Apolipoprotein E; event-related potential
Food Effect Study of Linerixibat Tablets in Healthy Adult Participants
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of food on the Pharmacokinetic (PK) and Pharmacodynamic
      (PD) parameters of linerixibat administered in fed and fasted states in heathy adult
      participants
    


Intervention name(s): linerixibat
Intervention type(s): Drug
Intervention description(s): linerixibat will be administered per the treatment sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to one of the 2 sequences. In sequence AB, participants will receive linerixibat under fed state (Treatment A) in Period 1, then linerixibat under fasted state (Treatment B) in Period 2. In Sequence BA, the 2 treatments will be reversed. The washout period will be of at least 7 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Pharmacodynamic; Food effect; Ileal bile acid transporter (IBAT) inhibitor; Linerixibat
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate safety and pharmacokinetic properties of the two
      treatments, the administration of CJ-30056 and the co-administration of atorvastatin and
      metformin XR, in healthy volunteers.
    


Intervention name(s): Atorvastatin 20mg and Metformin XR 500mg (Reference); CJ-30056 20/500mg (Test)
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.; Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.
Intervention MeSH terms: Metformin; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK
      Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines
      including OPV in HIV positive infants. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      HIV infected infants as determined prior to study entry (screening) and asymptomatic or
      mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two
      groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at
      approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation)
      vaccinations will be administered concomitantly with the study vaccines. At the time of first
      dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity
      and immunogenicity of the HRV vaccine relative to the placebo.
    

Intervention name(s): Rotarix; Placebo; Tritanrix-HB+Hib; Polio Sabin
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Oral vaccination; Oral administration; Concomitant routine vaccination, IM administration; Oral administration, concomitant routine vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
AmplifEYE Colonoscopy vs Standard Colonoscopy
Condition: Colon Polyp; Adenoma Colon; Serrated Polyp; Colonic Neoplasms
MeSH terms: Adenoma; Colonic Neoplasms; Polyps
Study type: Interventional

Summary: 
      Colonoscopy screening is proven to reduce mortality rates for colorectal cancer, which relies
      on early detection and removal of colonic polyps. AmplifEYE is a FDA-approved device with a
      row of flexible detection arms attached to the tip of colonoscope which can separate colonic
      folds during scope withdrawal and is believed to improve polyp detection. Real-life clinical
      data on this relatively new device is lacking and this study aims to compare the adenoma and
      polyp detection rates in AmplifEYE-assisted colonoscopy versus standard colonoscopy.
    

Detailed description: 
      This is a prospective, randomized controlled study. Patients admitted to Queen Elizabeth
      Hospital and Our Lady of Maryknoll Hospital for colonoscopy are randomly allocated 1:1 to
      receive either colonoscopy equipped with AmplifEYE (AC) or standard colonoscopy (SC). All
      study team members will have a prior run-in phase of performing at least 5 AmplifEYE
      colonoscopies before starting the study. The colonic polyp detection rate (PDR), adenoma
      detection rate (ADR), serrated polyp detection rate (SDR), caecal intubation time,
      colonoscope withdrawal time, procedure pain and any adverse events were analyzed in each
      group.
    

Intervention name(s): AmplifEYE
Intervention type(s): Device
Intervention description(s): AmplifEYE colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: colonoscopy; adenoma detection rate; colorectal cancer screening; new technology
A Study of Evaluating the Efficacy and Safety of SHR4640 in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to
      placebo and Allopurinol in patients with gout
    


Intervention name(s): SHR4640 dose1; SHR4640 dose2; Placebo oral tablet; Allopurinol 300 MG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablets，dose1，QD; tablets，dose2，QD; tablets，QD; tablets，300mg，QD
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Coffee and Metabolic Health Outcomes
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the long-term (24 weeks) effects of coffee
      consumption on insulin sensitivity in insulin resistant individuals.
    

Detailed description: 
      Coffee is a major source of the phenolic acid chlorogenic acid and a substantial source of
      trigonelline, niacin, lignans magnesium, and potassium. Several of these compounds have been
      shown to improve glucose metabolism in animal models. Consumption of coffee was inversely
      associated with the risk of type-2 diabetes in prospective cohort studies across the world.
      Consumption of 3 to 4 cups of coffee per day was associated with an approximately 25% lower
      risk of type-2 diabetes. However, direct evidence of the efficacy of coffee to reduce blood
      glucose and insulin resistance parameters in humans from randomized trials is still lacking.
      In recent small trials of short duration (up to 6 weeks) coffee consumption increased levels
      of the insulin-sensitizing hormone adiponectin, but did not significantly improve insulin
      sensitivity These results suggest that a larger longer-term trial of the effects of coffee
      consumption on directly measured insulin sensitivity is warranted.
    

Intervention name(s): Coffee; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Insulin resistance; Coffee; Glucose metabolism