bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Exenatide on Oral Contraceptive Pharmacokinetics in Healthy Females
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the examine the effect of taking exenatide on the blood levels
      (pharmacokinetics) of orally-administered contraceptives.
    


Intervention name(s): ethinyl estradiol and levonorgestrel; exenatide; ethinyl estradiol and levonorgestrel; exenatide; ethinyl estradiol and levonorgestrel; exenatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily; Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily; Oral contraceptive is ethinyl estradiol (30 μg) and levonorgestrel (150 μg) one time daily, per 28-day treatment period; Study drug (exenatide 10 mcg) is subcutaneously injected twice daily
Other intervention name(s): Byetta; AC2993; Byetta; AC2993; Byetta; AC2993
Intervention MeSH terms: Exenatide; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; Amylin; Lilly
Computerized Single-Session Interventions for Indian Adolescents
Condition: Well-being; Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The overall aim of this project is to understand if single-session interventions are
      acceptable, culturally appropriate, and effective for Indian adolescents. The investigators
      will be examining the effects of three interventions on the well-being and mental health of
      adolescents. The investigators hypothesize that at least one of the three interventions will
      yield statistically significant improvements in wellbeing and mental health relative to a
      study skills control condition.
    


Intervention name(s): Growth Mindset; Gratitude; Behavioral Activation; Study Skills
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Reading and writing activities designed to instill the belief that people can change.; Reading and writing activities designed to practice noticing and appreciating good things in life.; Reading and writing activities designed to identify and schedule positive activities.; Reading and writing activities designed to learn evidence-based study strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Estrogen Use in Protection From Cognitive Decline
Condition: Aging; Menopause
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This study is designed to assess the effects of estrogen therapy among postmenopausal women
      at risk for cognitive decline.
    

Detailed description: 
      A total of 71 postmenopausal women ages 50-65 on estrogen therapy will be randomized to
      continue or discontinue use of estrogen and will be followed for two years.

      Participants will undergo PET and MRI scans and neuropsychological assessments initially and
      at the end of the two-year follow-up period. These procedures will allow us to evaluate brain
      metabolism and cognitive performance at baseline and two years following continuation or
      discontinuation of estrogen therapy.

      We hypothesize that women who discontinue estrogen will show more evidence of decline than
      those who continue estrogen. This project will expand current knowledge of effects of
      estrogen by 1) determining whether estrogen use among postmenopausal women at risk for
      cognitive decline is protective of brain metabolism, 2) identifying early predictors for
      cognitive decline, and 3) developing guidelines for estrogen use in postmenopausal women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 45 and 65 years of age, currently on estrogen therapy for 1 year
        prior to enrollment in study, and at risk for cognitive decline.
      
Biospecimen description: 
      whole blood serum urine
    
Keywords: Aging; Menopause; Estrogen Replacement Therapy; Cognitive Decline
Bioavailability Study With GLPG1972
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to determine the pharmacokinetics of a new tablet formulation of
      GLPG1972 and to compare it with this of the liquid solution used during the First-in-Human
      study (GLPG1972-CL-101). The impact of food intake on the oral bioavailability of GLPG1972
      administered as tablet will also be investigated in this study. A dose of 600 mg has been
      selected. The study is a phase I randomized open-label cross-over study with three single
      dose treatments:

      A) 600 mg GLPG1972 oral solution after overnight fast,

      B) 600 mg GLPG1972 oral tablet after overnight fast,

      C) 600 mg GLPG1972 oral tablet 30 minutes after high-fat high-calorie breakfast.

      A washout of at least 6 days between subsequent dosing days is respected so that no
      measurable plasma levels or biologically significant effects are remaining. There will be
      frequent assessment of adverse experiences post-dose. Twelve healthy male subjects will be
      selected according to the inclusion and exclusion criteria and 2 subjects each will be
      randomized to one of the 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
    


Intervention name(s): GLPG1972 600 mg oral solution fasted; GLPG1972 600 mg oral tablet fasted; GLPG1972 600 mg oral tablet fed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dosing after overnight fasting; dosing after overnight fasting; dosing after high-fat high-calorie breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is to compare the short-term clinical performance and subjective acceptance of two
      silicone hydrogel soft contact lenses.
    

Detailed description: 
      This is a double-masked, randomized, bilateral crossover study to compare the short-term
      clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for
      approximately six hours on separate study days, in random sequence.
    

Intervention name(s): Lens A (comfilcon A lens); Lens B (lehfilcon A lens)
Intervention type(s): Device; Device
Intervention description(s): 6 hours; 6 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Impact of a Nutritional Product on Cognition in Healthy Teenagers
Condition: Healthy
Study type: Interventional

Summary: 
      Nutritional products such as spearmint extract, alpha-glyceryl phosphoryl choline and
      phosphatidylserine may have anti-oxidative and anti-inflammatory effect that may be effective
      in improving cognition. This study aims to evaluate the impact of a nutritional product on
      cognition in healthy teenagers.
    

Detailed description: 
      There is a growing interest in the nootropic properties of nutritional supplements,
      especially for improving cognitive processes such as attention, perception, evaluation, and
      working memory. Spearmint extract, alpha-glyceryl phosphoryl choline, and pyrroloquinoline
      quinone have antioxidative properties that may contribute to cognitive function, and
      spearmint extract has demonstrated attention-enhancing effects in young adults and
      memory-improving effects in elderly population. Phosphatidylserine is a phospholipid found
      abundantly in the brain that has also been evidenced to be effective in improving cognition.

      This randomized, double-blind study will be conducted to determine whether a nutritional
      supplement containing spearmint extract, phosphatidylserine, alpha-glyceryl phosphoryl
      choline, and pyrroloquinoline quinone ("Brain Doctors Formula Mega Brain Boost") is safe and
      effective in improving cognitive function in healthy participants aged 12 to 18 years.
    

Intervention name(s): Investigational; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 tablets are taken with water around the same time every day, ideally after a meal; 2 tablets are taken with water around the same time every day, ideally after a meal
Other intervention name(s): BDF Mega Brain Boost
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization at 1:1 ratio for active or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the
      study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in
      healthy male participants after a single intravenous ([IV] within a vein) dose
      administration.
    

Detailed description: 
      This is a double-blind (neither the researchers nor the participants know what treatment the
      participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an
      inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical
      trial with a drug to test if the drug has a real effect), and single-center study. The study
      will consist of Screening Period (2 to 21 days prior to participants' dose administration),
      Double-blind Treatment Period (single dose of JNJ-49122944 or placebo on Day 1), and Safety
      Follow-up Period (4 to 7 days after discharge). The total duration of participation for each
      participant, including screening, will be up to approximately 4 weeks. Blood samples will be
      collected for assessment of pharmacokinetic parameters. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): JNJ-49122944, 5 milligram (mg); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.; Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Healthy; JNJ-49122944; Placebo
Interaction of Genetic and Environmental Factors for Body Fat Mass Control
Condition: Unrecognized Condition
Study type: Observational

Summary: 
      Although the effect of interaction between genetic and environmental factors on body fat mass
      (BFM) has been proposed, how lifestyle changes affect body weight with regard to the genetic
      composition needs to be verified. The investigators designed an observational study,
      consisting of healthy adults with single nucleotide polymorphism (SNP) genotyping and
      longitudinal monitoring of lifestyle including food consumption and physical activities. The
      investigators recruited the participants who desired to control their body fat mass.
      Participants freely choose one of the options among carbohydrate intake reduction, fat intake
      reduction or exercise amount increment to control their body fat mass. Their lifelog on
      exercise and diet were collected, using a wearable device, for three months. Further, the
      investigators assessed anthropometric and serologic markers to measure the effect of
      participant's lifestyle modification. The investigators evaluate the influence of genetic
      compositions on body fat reduction induced by lifestyle change. Four different genome-wide
      polygenic scores (GPS) of volunteers are calculated to test the genetic effects of each
      modification. In this lifestyle observational study, the investigators expect to validate the
      interaction of genetic and environmental factors in determining BFM, and implicate the
      healthcare utility of lifestyle modifications using personalized and genomic perspective.
    


Intervention name(s): lifestyle
Intervention type(s): Behavioral
Intervention description(s): Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are all lived in South Korea in Seoul and Kyeonggi-do.
A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT
Condition: Coronary Artery Occlusive Disease
Study type: Interventional

Summary: 
      Current consensus papers recommend statin medication to reduce Low density lipoprotein (LDL)
      cholesterol level less than 100mg/dL (optional 70mg/dL) in patients with coronary artery
      disease. However, there is lack of solid evidence whether a specific kind of statin have the
      superiority against other statins in clinical outcomes. Furthermore, recent data have showed
      that several kinds of statin could have an adverse effect on glucose metabolism and increase
      the risk of development of diabetes. Carotid Intimamedia thickness (CIMT) is a surrogate
      marker of atherosclerosis to predict long term cardiovascular outcomes in not only general
      population but also patients with established coronary artery disease. Consequently, we will
      evaluate the efficacy of high dose of pravastatin on CIMT, comparing with moderate dose of
      rosuvastatin in patients with established coronary artery disease. Additionally, we will
      assess the clinical outcomes of pravastatin after percutaneous coronary intervention as well
      as adverse outcomes including insulin resistance and new onset diabetes compared with
      rosuvastatin. Our main hypothesis is that pravastatin 40mg would be non-inferior to
      rosuvastatin 20mg regarding CIMT at 1 year follow up.
    


Intervention name(s): Pravastatin 40mg; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Pravastatin 40mg PO daily for 1year from the day of BES implantation; Rosuvastatin 20mg PO daily for 1year from the day of BES implantation
Intervention MeSH terms: Rosuvastatin Calcium; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Statin; CIMT; BES
Submental Study (Sequential Treatment Approach)
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area
      using multiple therapeutic tools.
    

Detailed description: 
      The Zeltiq CoolSculpting System and the sequential use of the injectable drug Kybella for
      non-invasive and then minimally invasive fat reduction in the submental area will be
      evaluated during the study.
    

Intervention name(s): The ZELTIQ CoolSculpting System; Kybella 20 MG in 2 ML Injection
Intervention type(s): Device; Drug
Intervention description(s): The CoolSculpting machine will be used to perform the treatments.; Injectable drug called KYBELLA® (deoxycholic acid)
Intervention MeSH terms: Deoxycholic Acid
Intervention model: Sequential Assignment
Intervention model description: Kybella and Zeltiq CoolSculpting CoolMini
Masking: None (Open Label)
Primary purpose: Treatment
Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
Condition: Cesarean Section Complications; Hypotension; Spinal Anesthesia; Perfusion Index; Pleth Variability Index
MeSH terms: Hypotension
Study type: Observational

Summary: 
      Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular
      resistance and cardiac output and may cause hypotension in a significant portion of the
      parturients. Hypotension during delivery may cause maternal and fetal complications. If
      parturients who are likely to develop hypotension after spinal anesthesia can be identified
      before surgery, anesthesiologists would have opportunity to take measures such as
      prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry
      reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This
      is a non-invasive method of assessing the relative vascular tone with the use of pulse
      oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the
      blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index
      (PVI) is calculated using maximum and minimum values of perfusion index during respiratory
      cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are
      several studies investigating the predictive value of finger PI and PVI on hypotension after
      spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects
      the lower extremity perfusion. So, in this study we aimed to investigate whether the right
      toe PI and PVI values at supine and left lateral positions can predict hypotension during
      caesarean section.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to examine whether the administration of estrogen to
      post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their
      memory and their capacity for learning.
    

Detailed description: 
      Estrogen (EST) may have significant benefits in preserving cognitive functioning in normal
      aging after menopause and in decreasing the incidence of Alzheimer's disease (AD). On a
      molecular level, EST has effects on a variety of cholinergic neuronal and receptor-mediated
      mechanisms that may be responsible for these beneficial effects. These neurons have critical
      relevance for the development of age-related cognitive changes and dementing disorders.
      However, little is known about the clinical relevance of EST-cholinergic interactions, either
      in normal aging or in AD.

      The primary goal of this study is to test the hypothesis that three months of administration
      of EST to 1) normal post-menopausal women, and 2) female patients with mild-moderate AD who
      are concurrently treated with anticholinesterase therapy (donepezil), will positively change
      or blunt the negative and behavioral effects of drugs that block central cholinergic
      receptors (both muscarinic and nicotinic). Participants will be blindly placed on EST or
      placebo for three months each. After each three month period, they will be cognitively
      assessed after receiving single doses of the cholinergic antagonists scopolamine and
      mecamylamine. These results will have direct implications for the use of EST in
      post-menopausal women as well as interactive treatment with cholinergic drugs for AD.
      Researchers plan to recruit a total of 45 women (30 healthy, and 15 patients with AD).

      NOTE: This study is only recruiting participants with Alzheimer's Disease at this time.
    

Intervention name(s): Donepezil; Estrogen; Progesterone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Donepezil; Progesterone; Estrogens
Masking: Double
Primary purpose: Treatment
Keywords: Alzheimer disease; Estrogen therapy; Post-menopausal women
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
Condition: Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Tetanus; Acellular Pertussis; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and
      6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK
      Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
    


Intervention name(s): Infanrix hexa; Pediarix; ActHIB; Pentacel; Engerix-B; Infanrix; Hiberix; Prevnar13; Rotarix
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses administered intramuscularly in the right thigh.; 3 doses administered intramuscularly in the right thigh; 4 doses administered intramuscularly in the upper left thigh; 4 doses administered intramuscularly in the right thigh; 2 or 3 doses administered intramuscularly in the upper left thigh; 1 dose administered intramuscularly in the right thigh; 1 dose administered intramuscularly in the left thigh; 3 doses administered intramuscularly in the lower left thigh; 2 doses administered orally
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infants; Safety; Healthy; Infanrix Hexa; Immunogenicity
Clinical, Neurophysiological and Radiological Evaluation of Patients With Basal Ganglia Lesions
Condition: Basal Ganglia Lesions
MeSH terms: Ganglion Cysts; Synovial Cyst
Study type: Observational

Summary: 
      Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The
      aim of this study is to precisely evaluate patients with basal ganglia focal lesions both
      with or without loss of psychic-self activation.
    


Intervention name(s): Magnetic resonance imaging
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with lesion of the basal ganglia structures
      
Keywords: basal ganglia; loss of psychic self-activation