bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Baricitinib and Simvastatin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine the effects of baricitinib on the time it takes
      to remove simvastatin from the body and to look at how well-tolerated and safe baricitinib is
      when given alone and in combination with simvastatin. Side effects will be documented. The
      study will last approximately 7 days from the first dose to the end of the study (not
      including screening or follow-up).
    


Intervention name(s): Baricitinib; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Optimal Antiplatelet Therapy for Chinese Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients
      with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy
      are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to
      demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients,
      and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18
      years old who were diagnosed as CAD and received antiplatelet therapy were prospectively
      enrolled in this national wide, non-intervention registry. All medications and laboratory
      tests were physician discretion.
    

Detailed description: 
      Antiplatelet therapy is the cornerstone for the prevention of atherothrombosis in patients
      with coronary artery disease (CAD). However, the efficacy and safety of antiplatelet therapy
      are varied due to ethnic and/or individual variability. The aim of the OPT-CAD study was to
      demonstrate contemporary status and outcomes of antiplatelet therapy in Chinese CAD patients,
      and to explore predictors of ischemic or bleeding events in such cohort.Patients above 18
      years who were diagnosed as CAD and received antiplatelet therapy were prospectively enrolled
      in this national wide, non-intervention registry. All medications and laboratory tests were
      at physician discretion.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient of coronary heart disease receiving any antiplatelet therapy
      
Keywords: Coronary Artery Disease; antiplatelet therapy
Number of Meals With Adequate Protein Intake and Functionality in Middle to Older Aged Mexican Adults
Condition: Aging
Study type: Observational

Summary: 
      The objective of this study was to analyze if the number of meals with adequate protein
      intake is associated with functionality in middle to older aged mexican adults.
    

Detailed description: 
      Dietary protein intake per meal was assessed with 24-h dietary recalls to determine the
      number of meals with adequate protein intake (>30 g, >0.4 g/kg). Functionality was assessed
      with self-reported questionnaires about daily living activities (Barthel), and instrumental
      activities of daily living (Lawton). Subjects were categorized according the number of meals
      with adequate protein intake (zero meals, one meal, two or three meals), and their
      functionality score for both questionnaires (high, middle, and low scores).

      With multinomial logistic regression, the investigators assessed if consuming zero or one
      meal with adequate protein intake could be associated with lower functionality in comparison
      with consuming two or three meals with enough protein. The logistic regression was adjusted
      for covariables (age, sex, BMI categories for the elderly, number of diagnosed diseases,
      inadequate protein intake per day [<1.2 g/kg/d]).
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Cross-sectional
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Middle to older aged Mexican adults attending to the Geriatrics Department at the Western
        General Hospital (Hospital General de Occidente) for their usual medical screening or first
        time assessment.
      
Keywords: Protein intake; Older adults; Mexican adults; Functionality
The Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Exploring the safety, tolerability, and pharmacokinetic (PK) characteristics of oral TPN171H
      tablets in patients with Pulmonary Arterial Hypertension under continuous multiple
      administration conditions, providing a basis for determining the administration plan and
      recommended dosage in phase II clinical study.
    

Detailed description: 
      This study was divided into screening period, treatment period and medication follow-up
      period, and the treatment period included 3 cycles.

      First cycle: subjects receiving the test drug 2.5mg QD for 2 consecutive weeks, PK blood
      collection on Day 1 and Day 7, and the subjects discharged and returned to the hospital on
      Day 14 for medication monitoring blood collection, safety examination and efficacy
      assessment.

      Second cycle: up to 14 weeks; the second cycle is divided into monitoring and observation
      cycles; subjects who complete the first cycle and examinations enter the second cycle, with a
      14 day monitoring period and 12 week observation period, with the second cycle dose of 5 mg
      QD, subjects received PK sampling on Day 7.

      Third cycle:The third cycle lasts for 8 days, subjects receive 10mg QD for 8 days; subjects
      received PK sampling on Day 7; subjects who completed an 8-day safety observation period on
      Day 8 without abnormal safety tests may be discharged. After discharge into the medication
      follow-up period.

      Medication follow-up period: up to 2 years; subjects entering the follow-up period will
      continue to take the dose of the last treatment period, return to hospital once every 12
      weeks for safety examination and efficacy assessment until the subject intolerance or
      withdrawal from the study or expiration of 2 years (whichever occurs first).
    

Intervention name(s): TPN171H
Intervention type(s): Drug
Intervention description(s): TPN171H 2.5mg TPN171H 5mg TPN171H 10mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Technology Assisted Programs That Promote Mental Health for Teenagers
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The mission of this project is to develop novel systems of care that can provide efficacious,
      scalable, cost-effective, participant friendly behavioral intervention technologies (BITs)
      for the prevention of depression in adolescents. The investigators define BITs as
      interventions that use information and telecommunications technologies such as the internet,
      mobile or traditional phones, computers and/or other technologies to support and deliver
      psychological and behavioral interventions. Through usability testing, focus interviews, and
      field trials, investigators may modify the technologies and intervention based on immediate
      usage data.
    

Detailed description: 
      The mission of this project is to develop novel systems of care that can provide efficacious,
      scalable, cost-effective, participant friendly behavioral intervention technologies (BITs)
      for the prevention of depression in adolescents. The investigators define BITs as
      interventions that use information and telecommunications technologies such as the internet,
      mobile or traditional phones, computers and/or other technologies to support and deliver
      psychological and behavioral interventions. Through usability testing, focus interviews, and
      field trials, investigators may modify the technologies and intervention based on immediate
      usage data.
    

Intervention name(s): Networked Peer Support with Peer Guide; Networked Peer Support with Clinician Coach
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.; Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression prevention; Technology Assisted; Adolescents; Peer networked
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose
      regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy
      for cognitive deficits in subjects with chronic symptoms of schizophrenia.
    


Intervention name(s): PF-3463275; PF-3463275; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-3463275 10mg; PF-3463275 25mg; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus
Condition: Obesity; Endocrine; Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of the current study is to evaluate the safety and efficacy of Montelukast in
      treatment of obese patients with type 2 diabetes (T2DM).
    


Intervention name(s): Montelukast 10mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.; Placebo tablet once daily
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluating the Relationship Between Tobacco Use, Anxiety Sensitivity, and Panic in Adolescents
Condition: Panic Disorder
MeSH terms: Hypersensitivity; Panic Disorder
Study type: Observational

Summary: 
      This study will determine whether there is a relationship between tobacco use and a
      heightened response to panic-producing events among adolescents. This study is fundamental
      research. It was not a Clinical Trial.
    

Detailed description: 
      Growing up is hard enough, and adolescence can be a particularly stressful time in people's
      lives as they adjust to the transition from childhood to adulthood. Peer pressure can add to
      this anxiety, making it more likely for teens to take part in risky behaviors such as smoking
      cigarettes. Every day, more than 4,000 teens smoke their first cigarette and nearly half of
      those teens will become regular, daily smokers. Cigarette smoking is associated with a
      multitude of health risks, including an increased likelihood of experiencing panic attacks,
      anxiety disorders, and depression. This study will evaluate a group of teens, ranging from
      those who have never smoked to those who smoke daily, to determine whether there is a
      relation between adolescent smoking history and their vulnerability to panic-producing
      situations.

      Participants in this study will undergo a brief medical screening, followed by a short
      interview that will include several questionnaires regarding emotions, experiences, and
      personal habits. Participants will then attend a series of laboratory assessments for 1 hour.
      The first assessment will include a 3-minute voluntary hyperventilation procedure in which
      participants will be directed when to breathe in and when to breathe out, at a faster rate
      than normal. Participants will then take part in two computerized tasks: one will be a
      computerized task that involves blowing up a balloon and deciding when to quit before the
      balloon pops; the other task will involve choosing hypothetical amounts of money now or after
      a period of delay. During the laboratory assessments, all participants will have electrodes
      attached to their bodies and sensors around their chests to measure heart rate, palm
      sweating, and muscle tension. Results from this study will be used to evaluate the
      association between smoking and increased panic levels under stressful conditions among
      adolescents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be 180 psychologically healthy adolescents, evenly divided across the
        various stages of smoking uptake (i.e., non-smokers, tried smoking, experimenters, regular
        smokers, and daily smokers).
      
Keywords: Cigarette Smoking; Tobacco Use; Adolescents; Anxiety Sensitivity (AS)
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Condition: Myasthenia Gravis, Generalized
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients
      with myasthenia gravis receiving prednisone, or other corticosteroids. During the study,
      patients will undergo gradual corticosteroid dose reduction, if they respond to treatment.
      The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): mycophenolate mofetil (CellCept); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1g bid for 36 weeks; po bid for 36 weeks
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sperm Micro-swim up Technique; Process and Select in the Same Dish: a Sibling-oocyte-split Design
Condition: Assisted Reproductive Technology; Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      A sibling-Oocyte-split design will be conducted on oocytes before denudation and divided into
      two groups : control group (MII oocytes will be injected using sperm processed by Density
      gradient method) and sample group ( MII oocytes will be injected by sperm processed using
      micro-swim up technique)
    

Detailed description: 
      In This study investigators compare a novel sperm processing and selection method which is
      (fast, cheap and safe) with the well known processing method of sperm "Density gradient (DG)"

      The dishes will be prepared with droplets of handling medium for oocytes (droplet volume 10
      μL), and an H pattern using PVP will be produced, finally, all the droplets will be overlaid
      with mineral oil.

      Control group : Oocytes will be injected using sperm after processing with DG and will be
      selected from control PVP microdroplets

      Sample group: Sperm will be directly loaded in specific ICSI dishes where is the PVP
      microdroplets is prepared on "H" Pattern and will be selected from the far point from the
      deposition point and will be injected into the oocytes from the sample group All injected MII
      oocytes from both groups will then be cultured, with each group demarcated in separate place
      in the culture dish then according to the randomisation embryo transfer will be selected from
      one of both groups then the quality of the embryos will be reported and the pregnancy rate
    

Intervention name(s): Micro-swim up technique
Intervention type(s): Procedure
Intervention description(s): processing and selection of the sperm for ICSI in the same dish
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Single group of patients will be recruited in the study and each patient's oocytes will be divided into two groups and each group of patients will be injected with sperm processed by normal DG or H pattern micro- swim up technique. The PVP was used to produce the H pattern (length of about 2 cm from one side of the plate to the middle of the disk, total volume 10 μL). A small amount of semen (3 μL) was placed on one side of the H, and some time was allowed for it to migrate to the other side where the sperm was then collected. The dishes were incubated for three minutes allowing sperm migration along the outer perimeter of the H. After the completion of sperm migration, the plate was turned before the upload to avoid the contamination of the injection pipette by the sample.The injection pipette was introduced into the H-ICSI™ and used to immobilize a single sperm by crushing the membrane of its tail.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Sperm; micro-swim up; ICSI; Semen processing; density gradient
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the bioavailability of PTG-300 following subcutaneous and intramuscular
      administration in healthy volunteers.
    

Detailed description: 
      This is a single center, open-label study in healthy males. Subjects will be screened for
      eligibility within 28 days of dosing.

      Twelve subjects will receive single doses of the following treatments in a fixed sequence:

      Treatment A: Intravenous injection of 1.5 mg PTG-300. Treatment B: 40 mg (40 mg/mL) PTG-300
      administered subcutaneously. Treatment C: 40 mg (200 mg/mL) PTG-300 administered
      subcutaneously. Treatment D: 40 mg (40 mg/mL) PTG-300 administered intramuscularly.

      There will be a washout period of at least 7 days between Treatment A and Treatment B and at
      least 12 days between Treatments B, C, and D.

      Subjects' safety will be monitored, and blood samples will be collected for pharmacokinetics
      and pharmacodynamics (serum iron, serum ferritin, serum transferrin, and transferrin
      saturation [TSAT]).
    

Intervention name(s): PTG-300
Intervention type(s): Drug
Intervention description(s): Active drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single group of subjects will sequentially receive PTG-300 as IV, subcutaneous, and intramuscular administration
Masking: None (Open Label)
Primary purpose: Other
To Investigate If Single Doses Of GSK618334 Are Safe And To Investigate Blood Levels Of GSK618334
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK618334 is being developed as an innovative treatment for substance dependence and
      potentially other compulsive behavioral disorders. This study will evaluate the safety,
      tolerability and pharmacokinetics of single doses of GSK618334 in healthy volunteers.
    


Intervention name(s): GSK618334; GSK618334 matching placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): GSK618334 will be available as white to off-white coated tablets. GSK618334 will be swallowed with 250 milliliters (mL) of water.; GSK618334 placebo tablets visually match the active GSK618334 tablets and contain the same excipients except for the omission of the active ingredient. GSK618334 matching placebo will be swallowed with 250 mL of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Safety,; GSK618334; pharmacokinetics,; repeat dose,; tolerability,; pharmacodynamics,; placebo,
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is structured to estimate the effect of denosumab, compared to placebo and
      alendronate, on several bone parameters.
    


Intervention name(s): Alendronate; Denosumab; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alendronate 70 mg PO QW; denosumab 60 mg SC q 6 mos; Placebo for alendronate and placebo for denosumab
Intervention MeSH terms: Denosumab; Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Menopausal; Osteoporosis; MicroCT; Amgen; denosumab; Extreme CT; XCT; Fosamax; Alendronate
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol
      (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD)
      so that optimal dose(s) could be chosen for testing in later studies.
    


Intervention name(s): Indacaterol 150 μg; Indacaterol 300 μg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Indacaterol 300 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic obstructive pulmonary disease; COPD; QAB149; indacaterol; long acting β2-agonist