bioihbjkbjnl/mcl2 huggingface dataset:
ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of
      single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and
      female subjects.
    


Intervention name(s): ASP8302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASP8302 will be administered orally.; Placebo will be administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety; ASP8302
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50
      mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week
      double-blind phase and a 52-week open-label phase.
    


Intervention name(s): agomelatine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: agomelatine, major depressive disorder, MDD, depression
Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      We hypothesize that (1) the hybrid therapy will induce greater improvements on some
      health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month
      follow-up; (3) better motor control and brain reorganization will be found in the hybrid
      therapy than the other therapies; (4) correlations will be found between brain activity and
      movement kinematics/health-related outcomes.
    

Detailed description: 
      Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then
      were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The
      participants in each group receive equivalent amounts of treatment.

      Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately
      performed for each outcome measure to test the effects of different intervention groups.
    

Intervention name(s): Mirror Therapy with tDCS; Mirror Therapy with sham-tDCS; Mirror Therapy; Control Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The MTtDCS group will receive a 20-minute tDCS at 1.5 mA current intensity per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.; The MTtDCS(m) group will receive a 20-minute sham-tDCS per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.; The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.; The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.
Other intervention name(s): MTtDCS; MTtDCS(m); MT; CI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke Rehabilitation; Hybrid therapy; Mirror Therapy; Transcranial Direct Current Stimulation
Yoga for Stress Management in Health Care Personnel
Condition: Yoga; Stress, Psychological; Stress, Physiological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if yoga can be an effective stress management
      technique for health care personnel.
    

Detailed description: 
      Stress, both job related and personal, is an increasing problem in the health care sector.
      Yoga is said to have a good stress-reducing effect.

      The participants will provide blood, urine, and saliva samples. They will take part in two
      different stress tests. They will also fill in various qualitative questionnaires, including
      the Swedish questionnaire on health related quality of life (SWEDQUAL), Antonovsky's sense of
      coherence scale (KASAM), and the Job stress survey (JSS), both before the study starts and
      after 3 months of participation.
    

Intervention name(s): Yoga as stress management; Rest without using any relaxation technique
Intervention type(s): Behavioral; Other
Intervention description(s): Yoga specially designed to reduce stress is practiced for approximately 30 minutes at least three times a week for three months, once in a group session led by a trained yoga instructor and twice or more at home. The yoga techniques used are physical postures or movements, meditation and breathing exercises. Every time they do the techniques, participants fill in a form detailing how they feel before and after and providing information on the experience of doing the exercises.; The participants rest at home at least 30 minutes, at least three times a week for three months and without using any relaxation technique
Other intervention name(s): Asanas(physical postures or movements); Pranayama (breathing exercises); Meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Yoga; Stress; Stress management; Hypothalamus-pituitary-adrenal axis
Long Protocol and Growth Hormone in Poor Responders
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The long down regulation protocol is widely used in the in vitro fertilization cycles, now it
      will be assessed regarding its efficacy, in poor responder females undergoing in vitro
      fertilization cycles, alone and after the addition of growth hormone.
    


Intervention name(s): Growth hormone
Intervention type(s): Drug
Other intervention name(s): Norditropin, Novo nordisk
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infertility
A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of rifampin on the single dose PK of
      PF-06463922.
    

Detailed description: 
      This will be a Phase 1, open-label, 2-period, 2-treatment, fixed-sequence, cross-over study
      in approximately 12 healthy subjects employing administration of a single oral dose of
      PF-06463922 in the fasted state alone, and with multiple dosing of rifampin 600 mg once a day
      to estimate the effect of multiple dose rifampin on the single dose PK of PF-06463922.
    

Intervention name(s): PF-06463922; rifampin
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg oral dose on day 1 in period 1 and on day 8 in period 2; 600 mg QD from day 1 to day 12 in period 2.
Other intervention name(s): lorlatinib; rifampicin
Intervention MeSH terms: Rifampin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: rifampin; pharmacokinetics; PF-06463922; drug interaction
The Acute Effects of Coffee on Glucose Metabolism
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The purpose of this study was to determine the acute effects of decaffeinated coffee,
      caffeinated coffee and caffeine on glucose metabolism in humans
    


Intervention name(s): decaff; caffcoff; caffeine; placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 2 mugs of decaffeinated coffee; 2 mugs of caffeinated coffee; 2 mugs of hot water containing caffeine; 2 mugs of hot water
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: coffee; caffeine; glucose metabolism; insulin sensitivity; diabetes
Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer
Condition: Cancer; Depression, Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      This is a prospective, multisite (but all within the UTSW IRB), observational study assessing
      the relationship of hope to anxiety and depression, QoL, and social support over time in the
      first year after cancer diagnosis or relapse in AYA (ages 15-29 years of age).
    

Detailed description: 
      The principal investigators' ongoing work suggests hope is a target for intervention to
      improve quality of life (QoL) and reduce anxiety and depression (A/D) among adolescents/young
      adults (AYA). No study to the investigators' knowledge has evaluated the promising impact of
      hope interventions in AYA cancer patients. To address this gap, the investigators will expand
      the investigators' prior research on hope, A/D, and QoL to AYA receiving care across three
      diverse healthcare systems.

      Patients will be approached for participation within 3 months of their initial/relapse cancer
      diagnosis. Eligible patients (and the parent/caregiver for minor patients) will be approached
      in a private area of the clinic or hospital room to explain the research aims and informed
      consent process. After obtaining informed consent/assent (from parents if patients are under
      18, from AYA if patient is 18 or older), participants (patients) will utilize an iPad to
      complete measures via Redcap.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents and young adults newly diagnosed as having a malignancy
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg
      subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; [2-hour infusion])
      supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to
      evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single
      therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.
    

Detailed description: 
      This will be a randomized, double-blind, single-site, crossover study in healthy male and
      female subjects to determine if mipomersen administered as a single therapeutic (200 mg) SC
      and a single supra-therapeutic (200 mg) IV dose delays cardiac repolarization as determined
      by the measurement of QT/corrected QT (QTc) interval. A total of 60 healthy male and female
      subjects will be enrolled in this 4-way crossover study, randomly assigned to 1 of 8
      treatment sequences, and cross over into 4 treatment periods where each subject will receive
      both a single SC injection and a single IV infusion during each period.
    

Intervention name(s): mipomersen sodium; mipomersen sodium; moxifloxacin hydrochloride (Avelox®); placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg of mipomersen intravenous (IV) (single dose); 200 mg of mipomersen subcutaneous (SC) (single dose); 400 mg of moxifloxacin intravenous (IV) single dose; placebo intravenous (IV) single dose; placebo subcutaneous (SC) single dose
Other intervention name(s): ISIS 301012; ISIS 301012
Intervention MeSH terms: Moxifloxacin; Mipomersen; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antisense; ApoB (Apolipoprotein B); LDL (low density lipoprotein); thorough QT
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Condition: Allergic Rhinitis; Chronic Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety of the oral formulation of
      levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis
      or chronic urticaria of unknown origin.
    


Intervention name(s): Levocetirizine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks; Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Xyzal; Levocetirizine; Allergy; Children; Seasonal Allergies
Effects of a Wholegrain Diet on Body Composition and Energy Balance
Condition: Overweight; Obesity; Pre-diabetic
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to compare a diet containing whole grains versus an energy
      matched diet using refined grains on body composition and metabolism.
    

Detailed description: 
      The investigators hypothesis is that a diet high in whole-grains reduces abdominal fat. These
      findings might have clinical and public health significance for reducing obesity and related
      co-morbidities like type 2 diabetes and cardiovascular disease. Using a double-blind
      cross-over design, energy expenditure, body composition and metabolic health will be
      assessed. Three day inpatient study visits to the Cleveland Clinic Clinical Research Unit
      (CRU) will be implemented for metabolic control and testing. Total daily energy expenditure
      will be measured using the doubly labeled water (DLW) method. Body fat and glucose/protein
      metabolism will be assessed by imaging and isotope techniques, respectively. Blood, urine,
      and stool samples will also be collected for cardiometabolic and digestive health outcomes.
      After baseline testing, subjects will begin an 8 week dietary intervention, where all food
      and non-water beverages will be supplied by the study center. Dietary compliance will be
      assessed by weigh back measurements two times a week. To assess time course effects of diets
      differing in the amount of fiber on body composition and metabolic health, subjects will
      provide plasma and urine samples 2, 4, and 8 weeks after initial testing. Imaging and isotope
      analysis will be performed baseline and at week 8. All post testing will be conducted after
      week 8 following similar pre-testing control conditions. Subjects will then undergo an 8-10
      week washout period where they will be instructed to return to their normal diet (except for
      any supplements). After the washout period, subjects will start the second arm of the
      intervention and consume the alternate diet (i.e. refined or whole grain diet). All energy
      expenditure, body composition and metabolic testing procedures will be repeated during the
      alternative arm of the study as described above.
    

Intervention name(s): Whole grains
Intervention type(s): Dietary Supplement
Intervention description(s): Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.
Other intervention name(s): Diet; Body composition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Body composition; Health markers; Diet
A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of
      simvastatin and rosuvastatin in healthy subjects.
    


Intervention name(s): MT-8554; rosuvastatin; simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the cholesterol lowering effect of a drinkable
      low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly
      hypercholesterolemic subjects treated or not by statins.
    


Intervention name(s): 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit; 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit; 3- Low fat drinkable fermented dairy product without plant sterols(control)
Intervention type(s): Other; Other; Other
Intervention description(s): 1 = Intervention 1 (1 test product/day); 2 = Intervention 2 (1 test product/day); 3 = Intervention 3 (1 control product/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Plant sterol; Hypercholesterolemia; diet; dairy; LDL-C; Mildly hypercholesterolemic subjects
Effect of Glucuronosyltransferase (UGT) Genetic Variation on Pharmacokinetics of Empagliflozin
Condition: Pharmacogenomic; Pharmacokinetics
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this works is to investigate the effect of genetic polymorphism of snps on human
      response to treatment with empagliflozin and its correlation with with pharmacokinetic
      parameters in Egyptian subjects
    

Detailed description: 
      Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor indicated as an adjunct
      to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
      SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular
      filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal
      absorption and lowers the renal threshold for glucose, therefore resulting in increased
      glucose excretion. Additionally, it contributes to reduced hyperglycaemia and also assists
      weight loss and blood pressure reduction.

      ABSORPTION Following oral administration, peak plasma concentrations were reached at 1.5
      hours post-dose and then declined in a biphasic manner with a rapid distribution phase and a
      relatively slow terminal phase. Administration following a high-fat and high-calorie meal
      results in a slightly lower exposure with area under the curve (AUC) decreasing by
      approximately 16% and Cmax decreasing by approximately 37% compared to fasted condition.

      METABOLISM In vitro studies suggest that empagliflozin is primarily metabolized by
      glucuronidation by 5'-diphospho-glucuronosyltransferases UG2B7, UGT1A3, UGT1A8, and UGT1A9.
      The most abundant metabolites are three glucuronide metabolites: 2-O-, 3-O-, and
      6-O-glucuronide. Empagliflozin does not inhibit, inactivate, or induce CYP450 isoforms. It is
      a substrate for p-glycoprotein (p-gp), however in vitro studies suggest that it is unlikely
      to cause interactions with drugs that are p-gp substrates.

      After oral administration, empagliflozin was 41.2% eliminated in feces and 54.4% eliminated
      in urine.

      Terminal elimination half life was found to be 12.4 h based on population pharmacokinetic
      analysis.
    

Intervention name(s): Empagliflozin 10 milligram
Intervention type(s): Drug
Intervention description(s): antihyperglycemic medication
Other intervention name(s): Jardiance
Intervention MeSH terms: Empagliflozin
Intervention model: Single Group Assignment
Intervention model description: open label, single-dose, one-period, design
Masking: None (Open Label)
Primary purpose: Other
Keywords: UGT polymorphism; Pharmacokinetics; Empagliflozin
Evaluation of Knowledge Among Adolescents With Sickle Cell Disease.
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      Evaluation of knowledge about contraception in sickle cell adolescents.
    

Detailed description: 
      Sickle cell teenagers receive regular hospital medical care.

      Adolescence is the time when the pathophysiology of the disease is re-explained and when
      questions around puberty (possibly delayed), sexuality and contraception are discussed.

      Sickle cell disease, like any chronic disease, can have repercussion on the development and
      behavior of young patients.

      Knowledge and understanding of young patients with sickle cell disease around these issues
      may be insufficient.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The teenagers from 14 to 19 years old followed in the STYLE for a sickle cell disease.
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The aim of the present study is to assess the effectiveness of resistance training with swiss
      ball in the treatment of patients with ankylosing spondylitis.
    

Detailed description: 
      A randomized, controlled, single-blind, prospective trial being conducted involving 54
      patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will
      be randomized in intervention group (n = 27) conduct training for muscle strengthening with
      the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention.
      Eight exercises will be conducted with intent to engage all muscle groups.
    

Intervention name(s): Exercise; Drug treatment
Intervention type(s): Other; Other
Intervention description(s): Resistance Training exercise with swiss ball; Drug treatment
Other intervention name(s): Experimental group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment; exercise; resistance training; swiss ball; functional capacity