bioihbjkbjnl/mcl2 huggingface dataset:
Can 4 Weeks of Exercise Program Change Quadriceps Architecture in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid; Knee Osteoarthritis; Quadriceps Muscle Atrophy; Ultrasonography; Exercise
MeSH terms: Arthritis; Arthritis, Rheumatoid; Muscular Atrophy
Study type: Interventional

Summary: 
      Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA)
      patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF
      muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee
      isometric home-based training on QF muscle parts thickness and pennation angle measurements
      of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12
      patients with knee OA as positive control group and 13 volunteers as healthy control group.
      All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At
      baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of
      knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness
      and pennation angle measurements of QF muscle parts were evaluated by ultrasonography.
    


Intervention name(s): Quadriceps femoris isometric home-based exercise
Intervention type(s): Procedure
Intervention description(s): All 3 groups of participants were given 4-week (5 days/week) quadriceps-hamstring isometric home-based exercise training for their both knees. Exercises were performed (with maximal effort for 10 seconds) at a rate of 20 repetitions per day. Training was performed at outpatient clinic for 30 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway
Condition: Laryngeal Mask Airway
Study type: Interventional

Summary: 
      Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to
      insert in correct position because of it's flexible structure. Especially in classical way of
      manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal
      position, we could not guarantee the correct position of the LMA. Therefore several studies
      have been investigated to improve this.

      The light wand is a kind of stylet which have a light on the tip. Recently some studies
      demonstrated the usefulness of the light wand which could be used for indicating correct
      position of the LMA. We hypothesised there will be two advantages if the light wand is used
      as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible
      LMA, and second the lightness could confirm the correct position of the flexible LMA.
    


Intervention name(s): light wand
Intervention type(s): Device
Intervention description(s): The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in "light wand group", the correct position of the LMA is confirmed by the light.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Skin Diseases
Study type: Interventional

Summary: 
      The main objective of the study is to observe changes in the subjects' sleep quality, skin
      condition and life status after 4 weeks of using a sleep aid drink (AOXMED Poria
      γ-aminobutyric acid drink).

      This is a single-center, randomized, double-blind, controlled, 4-week (28-day) clinical study
      conducted in Chinese healthy women aged 25-55 years old who were offered a sleep aid drink.
    

Detailed description: 
      The study population is 70 healthy Chinese women aged 25-55 years with a PSQI ≥ 7 (presence
      of sleep disorder) who report current problems with dryness, roughness, dullness and lack of
      elasticity on their face. The subjects will be randomly divided into an experimental group
      and a control product group of 35 subjects each, and the distribution of age and total hours
      of sleep will be more or less equal in both groups.

      Subjects will be formally enrolled after on-site assessment and will undergo follow-up site
      visits and test product administration. During the test cycle, subjects in the experimental
      group will take a drink with the active ingredients of Poria, Poria and GABA, and subjects in
      the control product group will take a control drink without Poria, Date Palm and GABA
      ingredients for 4 weeks. To avoid the influence of different skincare products on the
      results, all subjects will be asked to use the basic skincare products with only moisturizing
      ingredients provided by the sponsor during the test period. The efficacy of the test products
      will be verified by comparing the changes in sleep quality, skin condition and life status of
      the subjects before and after taking the test products for 2 and 4 weeks, and by comparing
      the differences in sleep quality, skin condition and life status between the test and control
      groups.
    

Intervention name(s): Drinks with active ingredients such as poria and GABA
Intervention type(s): Combination Product
Intervention description(s): Take drinks half an hour before bedtime, 10ml/bag/day, daily. Subjects are uniformly using skin care products provided by the sponsor during the test.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: Sleep quality and skin conditions
Ultralow Dose PAH Binary Mixture Study
Condition: Environmental Exposure
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in
      plasma and urine over 48 hours following a 50 ng dose (5.4 nCi) alone or with 1250 ng
      phenanthrene.
    

Detailed description: 
      The pharmacokinetics for [14C]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass
      Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over
      48 hours following oral doses of 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene.
      Metabolite profiles and kinetics of elimination are predicted to be consistent with a BaP
      physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National
      Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP
      daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg
      individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de
      minimus risk.
    

Intervention name(s): [14C]-benzo[a]pyrene; [14C]-benzo[a]pyrene plus phenanthrene
Intervention type(s): Drug; Drug
Intervention description(s): Oral micro-dose (50 ng) (5.4 nCi); Oral micro-dose of 50 ng (5.4 nCi) [14C]-benzo[a]pyrene plus 1250 ng phenanthrene
Other intervention name(s): Carcinogenic PAH environmental pollutant; Binary mixture of carcinogenic PAH and non-carcinogenic PAH
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Benzo[a]pyrene; Accelerator Mass Spectrometry; Polycyclic Aromatic Hydrocarbons; Phenanthrene
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Condition: Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from
      dividing so they stop growing or die.

      PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in
      treating young patients with leukemia or lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the toxic effects of arsenic trioxide in pediatric patients with refractory
           leukemia or lymphoma.

        -  Determine the maximum tolerated dose of this drug in this patient population.

        -  Determine the plasma pharmacokinetics of this drug in these patients.

      OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
      disease (acute promyelocytic leukemia [APL] vs non-APL).

        -  Stratum I (APL patients): Patients receive standard-dose arsenic trioxide IV over 2
           hours daily 5 days a week for 4 weeks. Treatment continues every 6 weeks for up to 3
           courses in the absence of disease progression or unacceptable toxicity.

        -  Stratum II (Non-APL patients): Cohorts of 3-6 patients receive escalating doses of
           arsenic trioxide (according to the stratum 1 schedule above) until the maximum tolerated
           dose (MTD) is determined. The MTD is defined as the dose preceding that at which at
           least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
           determined, additional patients are accrued to receive treatment with arsenic trioxide
           at the recommended phase II dose.

      Leukemia patients in both strata without progressive disease who have not achieved complete
      remission after the first 20 doses may continue to receive arsenic trioxide for 2 additional
      weeks.

      Patients are followed every 3 months for 1 year.

      PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for stratum I of this study
      within 2-3 years. A total of 3-30 patients will be accrued for stratum II of this study
      within 1-2 years.
    

Intervention name(s): arsenic trioxide
Intervention type(s): Drug
Intervention MeSH terms: Arsenic Trioxide
Primary purpose: Treatment
Keywords: recurrent childhood acute myeloid leukemia; childhood acute promyelocytic leukemia (M3); recurrent childhood acute lymphoblastic leukemia; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; childhood chronic myelogenous leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an open label, balanced, randomized, two-treatment, two-period, two
      sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride
      tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran®
      (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in
      healthy, adult, human subjects under fed condition. 26 subjects are enrolled in the study,
      and 23 subjects are completed the study.
    

Intervention name(s): Ondansetron Hydrochloride; Ondansetron Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron Hydrochloride Tablets 8 mg; Zofran Tablets 8 mg
Other intervention name(s): Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories Limited)
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Ondansetron; crossover
Pharmacokinetics and Safety of Asasantin Extended Release (RAD-SP) Capsules in Japanese Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate pharmacokinetics, pharmacodynamics and safety of RAD-SP capsule in
      multiple administration to healthy adult male volunteers.
    


Intervention name(s): Asasantin®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Asasantin® extended release (RAD-SP)
Intervention MeSH terms: Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pregabalin Treatment for Trigger Points
Condition: Myofascial Pain Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      Myofascial pain syndrome (MPS) is a common problem in the general population. MPS should not
      be a local/peripheral painful syndrome and considered to be a syndrome of central
      sensitivity. We aimed to investigate the effect of pregabalin in patients with MPS in this
      study
    

Detailed description: 
      We randomized 40 patients into two groups, and 17 patients per group completed the study.
      Patients in group I received pregabalin and exercise therapy, whereas those in group II
      received exercise therapy alone. All patients were evaluated as follows: for pain by VAS;
      trigger-point pressure pain threshold-(PPT) by algometry; neuropathic pain using DN4 and
      quality of life with the SF36. Evaluations were performed pretreatment and at the end of the
      first and third months of treatment.
    

Intervention name(s): Pregabalin 150mg
Intervention type(s): Drug
Intervention description(s): Patients in group I received pregabalin at a dose of 75 mg twice daily during the first week that was increased to 150 mg twice daily thereafter and maintained at that level for 12 weeks.
Patients in two groups received exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: fibromyalgia, trigger point, myofascial pain, pregabalin
Prevalence of Human Papillomavirus in Men Living in the Northern Plains
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      HPV infection is associated with cervical and other anogenital cancers. HPV may also be
      associated with the development of prostate cancer. The purpose of the study is to determine
      the prevalence of HPV infection in men living in South Dakota.
    


Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Male residents of South Dakota.
      
Biospecimen description: 
      Epithelial skin swabs collected for the purpose of HPV DNA detection. DNA extraction and HPV
      testing will be performed.
24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active
      Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin
      Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes
      Mellitus (T2D) Inadequately Controlled with Metformin Monotherapy
    


Intervention name(s): Saxagliptin; Acarbose
Intervention type(s): Drug; Drug
Intervention description(s): The dose of saxaglitpin will be 5mg oral qd.; Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.
Other intervention name(s): Onglyza; Glucobay
Intervention MeSH terms: Saxagliptin; Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Saxagliptin; Acarbose; Type 2 Diabetes; Metformin
Study of Glycogen Storage Disease Expression in Carriers
Condition: Glycogen Storage Disease
MeSH terms: Glycogen Storage Disease; Metabolic Diseases
Study type: Observational

Summary: 
      The purpose of the study is to determine whether carrier status for any type of glycogen
      storage disease (GSD) predisposes the carrier to GSD markers, like high cholesterol, by
      testing blood, urine, and saliva samples.
    

Detailed description: 
      Subjects will be asked to contribute about a teaspoon of blood, 1 oz of urine, and 2
      tablespoons of saliva samples in the morning before they have had anything to eat. The blood
      and urine samples will be tested for the markers of GSD, while the saliva sample will be used
      for genetic testing. Subjects' height and weight will also be measured.

      Subjects will also be asked to fill out a questionnaire about symptoms common to full GSD
      expression that they may have experienced, as well as if they are currently on any medication
      to control their cholesterol.
    

Intervention name(s): Glycogen Storage Disease markers
Intervention type(s): Genetic
Intervention description(s): Blood and urine tests will be performed on all groups to measure markers of GSD. A saliva DNA test will be used to determine the specific mutation the carrier has or to ensure noncarrier status. A questionnaire will also be filled out.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parents and other family members of patients currently undergoing treatment for GSD at the
        University of Florida
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1, randomized, open-label, two-period crossover study is to
      characterize and compare the pharmacokinetic (PK) profiles and evaluate the safety of the
      AG-348 tablet and capsule formulations after single-dose administration in healthy adult
      subjects. Pharmacokinetic sampling will take place serially at specified times during conduct
      of the study.
    


Intervention name(s): AG-348 Sequence A; AG-348 Sequence B
Intervention type(s): Drug; Drug
Intervention description(s): Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)
Washout Period 7 days
Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet); Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)
Washout Period 7 days
Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteers
Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to test the feasibility of measuring body composition by air
      displacement plethysmography (ADP) in rapidly growing, medically stable late gestation [32-35
      weeks post-menstrual age (PMA)] premature infants.
    

Detailed description: 
      1. To assess the feasibility of measuring body fat deposition by ADP in medically stable
           late gestation (32-35 weeks), premature infants during a period of rapid postnatal
           growth.

        2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the
           relationship between these fat measures with bone measures by quantitative ultrasound
           and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.

        3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP
           measurements.

        4. Compare growth, body composition and bone strength between infants born preterm to
           infants born full term.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature and full term infants admitted to the University of Utah Newborn Intensive Care
        Unit, Intermediate Nursery or Well Baby Nursery
      
Biospecimen description: 
      Saliva; Urine
    
Keywords: premature birth
Acute Exercise on Neurocognitive Function Among Adults With/Without Generic Risk of AD
Condition: Alzheimer Disease 2 Due to Apoe4 Isoform
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This study explores the acute exercise effect on neurocognitive function and also its
      potential moderators in an exercise setting and Apolipoprotein E (APOE) genetic risk.
    

Detailed description: 
      Acute exercise has emerged as a modifier to multiple aspects of cognitive function; however,
      its effect on populations with different risks of Alzheimer's disease (AD) and the role of
      exercise variance and APOE genotype within the effect reminds underestimated. The current
      study aimed to examine the acute exercise effect on neurocognitive function from behavioral
      and neuroelectric perspectives among cognitively normal late-middle-aged adults.
      Additionally, we determined whether variations in exercise intensity and duration and the
      presence of the APOE ɛ4 allele modulated the effect.
    

Intervention name(s): LI-40; MI-30; HI-16
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants were asked to complete a volume-matched light-intensity exercise for 30-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.; Participants were asked to complete a volume-matched moderate-intensity exercise for 20-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.; Participants were asked to complete a volume-matched high-intensity exercise for 16-min. The exercise volume was pre-determined based on the energy expenditure (kcal) calculated with 5-min warm-up stage, 20-min main exercise stage (i.e., moderate intensity as 50%-60 % heart rate reserve, HRR), and 5-min cool-down stage.
Other intervention name(s): Light intensity 40-min exercise; Moderate intensity 30-min exercise; High intensity 16-min exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The present study adopted a counterbalanced design. All participants were instructed to complete four counterbalanced treatments: a) longer duration (LI-40), b) moderate-intensity with 30 min (MI-30), c) high-intensity with shorter duration (HI-16), and d) control treatments.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aerobic exercise; APOE genotype; event-related potential; executive function; exercise prescription