bioihbjkbjnl/mcl2 huggingface dataset:
Dual-Task Performance in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous
      system. It is reported that 85% of patients with multiple sclerosis have gait disturbance,
      88% balance, and 35-90% fatigue (1, 2, 3). In addition, 65% of patients are reported that
      their cognitive functions have regressed (4).

      It is important to increase the independence of the MS patients in activities of daily living
      (ADL). Almost all of ADL requires many activities at the same time. For example,
      toothbrushing involves both the standing balance and the motor activity of the upper limb at
      the same time. It also requires cognitive tasks such as attention and focusing. Many
      activities that seem to be the only task are actually multitasking (5).

      The aim of this study is to investigate the effects of motor and cognitive additional task on
      balance, mobility and upper limb performances in MS patients and to determine the factors
      associated with dual-task performance.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      balance, mobility, upper extremity performance, cognitive function, fatigue, physical
      activity level, mood, sleep quality, quality of life will be evaluated once.

      We will use descriptive statistics and t-tests to compare demographic characteristics between
      groups and for the categorical variables chi-square. Effect of the group (MS patients or
      healthy controls), condition (Single task and dual-task conditions), and group × condition
      interaction will be compared using two-way repeated measures ANOVA. We will examine the
      correlations between fatigue severity, physical activity level, mood, sleep quality, quality
      of life using Pearson bivariate correlations. The significance level is set at p<0,05.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        MS patients who apply to the Neurological Rehabilitation Unit of Gazi University Faculty of
        Health Sciences will be invited to this study.
      
Keywords: Multiple sclerosis; Dual-task; Balance; Mobility; Cognition
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis
      and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be
      treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the
      effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
    


Intervention name(s): Placebo; PF-06835919; PF-06835919
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; 150 mg once daily; 300 mg once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Condition: Hepatic Fatty Acid Metabolism; Systemic Insulin Resistance; Oxidative Stress; Cardiovascular Status
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional

Summary: 
      Dietary consumption of fructose has increased by nearly 50% since 1960.

      A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin
      resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP
      stores, systemic oxidative stress and cardiovascular status are not fully known.
    

Detailed description: 
      The protocol will assess the following outcomes:

        1. The ultimate fate of this increased hepatic fatty acid production following a high
           fructose vs. glucose diet

        2. The effect of a high fructose vs. glucose diet on liver ATP stores

        3. The effect of a high fructose vs. glucose diet on markers of oxidative stress

        4. The effect of a high fructose vs. glucose diet on cardiovascular status

      Factors critical to carbohydrate metabolism such as systemic insulin resistance, body
      composition, energy expenditure, physical activity will also be assessed.

      32 centrally overweight healthy males with a low baseline fructose intake will be recruited.
      They will be randomised double blindly to receive 25% of their dietary energy requirements
      from either fructose or glucose for 14 days.

      The sugars will first be taken in an energy balanced and then an overfeeding setting.
    

Intervention name(s): high sugar diet
Intervention type(s): Dietary Supplement
Intervention description(s): 25% of dietary energy from fructose or glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: fructose; fatty liver disease; diet
Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the effect of rifampin, a potent cytochrome P450 3A4
      inducer, at steady-state on the systemic exposure of a single dose of pacritinib in healthy
      subjects.
    

Detailed description: 
      This was a single-center, open-label, one-way crossover, drug-interaction study. On Day 1,
      subjects received a single oral 400-mg dose of pacritinib. Following a 7-day washout period,
      600-mg oral doses of rifampin were administered once daily (QD) on Days 8 through 17. It was
      anticipated that steady-state concentrations of rifampin would be achieved by Day 17. On Day
      17, a single oral 400-mg dose of pacritinib was co-administered with the final 600-mg dose of
      rifampin.
    

Intervention name(s): Pacritinib; Rifampin; Pacritinib and Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects received a single oral 400-mg dose of pacritinib; Subjects received 600-mg oral doses of rifampin; administered QD following a 7-day washout period; On Day 17, a single oral 400-mg dose of pacritinib was co-administered with the final 600-mg dose of rifampin.
Other intervention name(s): PAC400 mg; Rifampin600 mg; PAC400 mg and rifampin 600mg
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug-Interaction Study
The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
Condition: Growth
Study type: Interventional

Summary: 
      In this clinical trial, weight gain (primary objective), and additional anthropometry
      (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant
      formula were evaluated and compared to a standard intact protein-based formula over a period
      of at least three months, until the age of 17 weeks.
    

Detailed description: 
      In this clinical trial, weight gain (primary objective), and additional anthropometry
      (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant
      formula were evaluated and compared to a standard intact protein-based formula over a period
      of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants,
      exclusively formula-fed were included.
    

Intervention name(s): infant formula based on hydrolyzed protein; infant formula based on intact protein
Intervention type(s): Other; Other
Intervention description(s): infant formula based on hydrolysed protein; infant formula based on intact protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Modified Atkins Diet Plus KetoCal for Adult Epilepsy
Condition: Epilepsy; Seizure; Medically Resistant Epilepsy; Medically Resistant Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional

Summary: 
      The modified Atkins diet (MAD) has been shown to be effective in treating children and adults
      with medically resistant seizures. A recent study in children showed that the use of KetoCal®
      once per day in addition to the MAD appeared to be beneficial when used during the first
      month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one
      meal during the initial month of the MAD will produce urinary ketosis in more adult patients
      than the MAD alone and will lead to greater seizure reduction.
    


Intervention name(s): Modified Atkins diet; KetoCal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.; Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Other intervention name(s): KetoCal 4:1 liquid; KetoCal tetrapak
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: seizures; epilepsy; adult; intractable; medically refractory; Atkins; ketogenic; diet
Effects of Sleep Duration and Architecture on Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in
      comparison to "normal sleep", will:

        1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the
           hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.

        2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of
           endogenous glucose production, gluconeogenesis and glycogenolysis.
    

Detailed description: 
      Over the past 50 years, the incidence of diabetes has increased dramatically, while sleep
      duration in the US has decreased significantly. Epidemiological studies and small clinical
      trials suggest that these trends are causally related. In this study, our goal is to
      determine the mechanisms by which decreased sleep duration directly affects insulin
      sensitivity. The investigators will perform a clinical study in 20 healthy volunteers to
      determine whether 5 nights of sleep restriction decreases insulin sensitivity in the
      peripheral tissues (ie, skeletal muscle) or liver.

      Peripheral insulin sensitivity will be measured by the hyperinsulinemic-euglycemic clamp, and
      hepatic insulin sensitivity will be quantified by measurement of hepatic glucose production,
      gluconeogenesis and glycogenolysis (using stable isotope tracer methods). Subjects will be
      randomized to an initial period of "normal sleep" or sleep restriction and will be admitted
      to the Clinical Research Center (CRC) for 9 days to undergo comprehensive metabolic studies
      and sleep assessments under the assigned sleep condition. After a 1-month washout period,
      subjects will be re-admitted to the CRC to undergo these same assessments under the opposite
      sleep condition.
    

Intervention name(s): Sleep restriction
Intervention type(s): Behavioral
Intervention description(s): Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diabetes
Effect of AQW051 on Cognitive Function in Patients With Chronic Stable Schizophrenia
Condition: Schizophrenia Disorders
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients
      with chronic stable schizophrenia.
    


Intervention name(s): Placebo (single and multiple doses); AQW051 2 mg (single and multiple doses); AQW051 15mg (single and multiple doses); AQW051 100mg (single dose), and 50mg (multiple doses)
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hallucinations,; psychotic,; delusions,; cognitive deficits
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending
      Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114
      Tablets in HCV-infected Subjects
    

Detailed description: 
      A total of 24 evaluable patients will be enrolled in this study. The study randomly divided
      into three dose groups and HEC110114 tablets planned dose levels are 600, 800, and 1200 mg,
      sofosbuvir tablets planned dose levels are 400 mg .
    

Intervention name(s): HEC110114 Tablet; Sofosbuvir Tablet
Intervention type(s): Drug; Drug
Intervention description(s): administered orally once daily; administered orally once daily
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phenolic-rich Oats and Artery Improvement
Condition: Healthy
Study type: Interventional

Summary: 
      In this proposed human trial, the investigators aim to establish whether consumption of one
      portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in
      markers of cardiovascular disease risk relative to an energy matched control intervention in
      healthy men with high-normal to mildly elevated blood pressure.
    

Detailed description: 
      A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole
      grains contain a wide range dietary components including potentially vasoactive phenolic
      acids.
    

Intervention name(s): Oat; Control
Intervention type(s): Other; Other
Intervention description(s): The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.; 60g cream of rice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oats; Phenolic acid; FMD; LDI; Avenanthramide
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional

Summary: 
      Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the
      tolerability of the formulated placebo in subjects with heartburn. Candidates will have
      heartburn and be taking daily PPIs at up to twice the standard OTC or prescription dosage.
      Approximately 400 subjects (men and women of all races and ethnicities) will be randomly
      enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.
    

Detailed description: 
      This study will be conducted as a remote un-controlled trial to evaluate the tolerability of
      MHS-1031 and separately the tolerability of the formulated placebo in two similar subject
      groups with heartburn. Candidates will have heartburn and be taking daily PPIs at up to twice
      the standard OTC or prescription dosage.

      Approximately 400 subjects (men and women of all races and ethnicities) will be randomly
      enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.

      Screening phase: 14 days

      Product/Placebo phase: 56 days. From Day 1 through Day 28 each subject will continue taking
      their usual daily PPI. Beginning on Day 29 and through Day 56 subjects will be requested to
      not take a PPI. Subjects may re-start taking a PPI at any time.

      Product Phase: 28 days. All subjects will receive MHS-1031.

      Follow-Up Phase: Subjects who complete the Product Phase of the study will enter into a
      14-day Follow-up Phase, during which subjects will take neither placebo nor MHS-1031.

      For entry into the Screening Phase, subjects must have the following history: Heartburn
      experienced at least 1 day per week while taking a PPI.

      During the study, tolerability will be assessed via on-line validated PRO questionnaires and
      assessment of adverse events. Tolerability is defined as no overall worsening of heartburn
      measurement scores after 8 weeks of taking the product or the placebo compared to baseline
      scores.
    

Intervention name(s): Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml); Placebo 1.4 ml
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Active study product; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A remote, randomized, blinded, un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in two similar subject groups with heartburn.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Heartburn; microbiome; acid reflux; PIMO; indigestion
A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of
      single rising doses.

      The objective of the food effect (FE) part is to investigate the relative bioavailability of
      BI 764122 under fed and fasted conditions.
    


Intervention name(s): BI 764122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Price Changes and Hypothetical Food Purchases in Adult Grocery Shoppers
Condition: Effect of Taxes and Subsides on Food Purchases in Mothers
Study type: Observational

Summary: 
      The goal of the proposed study is to apply experimental economics in an online grocery store
      shopping model to examine the effects of pricing on hypothetical food purchases
    

Detailed description: 
      Participants will be lean and overweight primary grocery shoppers aged 18 years and older.
      Participants will be considered lean if their body mass index (BMI = kg/m2) is less than
      29.9, overweight if their BMI is greater than or equal to 30.12 To meet eligibility for the
      study, participants must be the guardian of a child at least 2 years or older, do the primary
      grocery shopping for the family, they must also report being weekly household grocery
      shoppers, and purchase the majority of their household's groceries once a week.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Lean and overweight Low and high socioeconimic status primary grocery shopper
Antidepressant Medication for Reducing HIV Risk Behavior in Depressed Intravenous Drug Users
Condition: Depression; Substance-Related Disorders; HIV Infections
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of antidepressant medication treatment in reducing
      HIV risk behaviors in intravenous drug users with depression.
    

Detailed description: 
      Depression and injection drug use often come hand-in-hand. This is especially true in
      populations with limited access to mental health care and with a high risk of illness and HIV
      transmission. Depressed injection drug users in these populations usually continue their drug
      use for extended periods of time, thereby further promoting the spread of HIV. This cycle has
      created a significant public health problem. It is necessary to explore new approaches to
      facilitate and maintain long-term behavior changes within this population. This study will
      evaluate the effectiveness of treatment with antidepressant medications in reducing HIV risk
      behaviors in depressed intravenous drug users.

      Participants in this open label study will be randomly assigned to receive either
      antidepressant treatment or no treatment. Participants in the treatment group will meet with
      a psychiatrist monthly for 12 months. Based on psychiatric evaluations and participants'
      medical histories, doctors will prescribe an appropriate antidepressant medication or a
      combination of medications. Participants in the treatment group may also receive referrals
      for other services if necessary. Participants assigned to receive no treatment will be
      contacted at Months 3 and 9 to verify their contact information; they will also receive any
      necessary referrals. All participants will partake in interviews at baseline and Months 6 and
      12 to assess changes in HIV risk behavior and depressive symptoms.
    

Intervention name(s): Antidepressant Medication
Intervention type(s): Drug
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Injection Drug Use; HIV Risk Behavior; HIV Seronegativity
Plyometric Exercise to Improve Rapid Force Production in Older Men
Condition: Exercise Training
Study type: Interventional

Summary: 
      Rapid force production declines as a consequence of ageing. Given the functional relevance of
      rapid force production, exercise interventions in older adults should aim at improving the
      capacity to produce force rapidly. To improve this capacity, exercises should be performed
      with the intention to develop high speeds, as supported by previous work.

      Human locomotion fundamentally consists of multi-joint movements and rapidly coupled
      eccentric-concentric muscle actions, known as stretch-shortening cycle (SSC) activities or
      plyometrics. Plyometrics might therefore be used to optimize power production. However, there
      is limited research on the feasibility of plyometrics in older adults and its potential
      effects on rapid force production and functional capacity. This study will test the
      feasibility of a 12-week plyometric exercise intervention in older men and compare its
      effects on rapid force production to a traditional resistance exercise or walking
      intervention.
    


Intervention name(s): Exercise intervention
Intervention type(s): Other
Intervention description(s): 12-week progressive training intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention