bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the effect of ethinyl estradiol
      (EE)/norgestimate, a weak cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK)
      of lomitapide and 2 primary metabolites, M1 and M3.
    

Detailed description: 
      This study will be a single center, randomized, open-label, 2 arm study to evaluate the
      effects of EE/norgestimate, a weak CYP3A4 inhibitor, on the PK of lomitapide in healthy
      female subjects when EE/norgestimate is administered simultaneously with lomitapide and when
      administration is separated by 12 hours.
    

Intervention name(s): lomitapide; EE/norgestimate
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg; 1x0.035-mg EE/0.25-mg norgestimate tablet
Other intervention name(s): Juxtapid; Ortho Cylclen
Intervention MeSH terms: Norgestimate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Effect; Ethinyl Estradiol/Norgestimate; Pharmacokinetics; Lomitapide.
Effects of Vitamin D Supplementation in Muscle Strength and Balance Training
Condition: Osteoporosis, Osteopenia; Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      Introduction: In Brazil, a person who is sixty years old or more is considered elderly. The
      incidence of osteoporosis and osteopenia has been increasing, as have fractures resulting
      from falls. Vitamin D deficiency can cause muscular atrophy in type II fibers (fast
      contraction and strength), which can increase the risk of falls. The aging process produces
      reduction in the ability of postural control system to maintain postural balance, which may
      increase postural instability and consequently increase the elderly risk to falls. Objective:
      To evaluate if vitamin D supplementation associated with regular exercise in vulnerable older
      women improves muscle strength and postural balance in 12 weeks. Methods: This will be a
      randomized prospective clinical trial, double blind, placebo-controlled intervention. Will be
      part of the study 40 elderly women vulnerable, who meet the inclusion criteria and that will
      be coming from the community through calls made by radio and social network. The volunteer
      will undergoing to blood test, body composition and bone mineral density, Mini Mental State
      Examination, Geriatric Depressive Scale, Falls Efficacy Scale, WHOQOL-OLD and WHOQOL-BREF
      instruments, functional capacity tests (MiniBEST, Time up and Go, Chair Rising Test,
      Six-minute walk test), muscular strength assessment (isokinetic dynamometry, handgrip and 1RM
      test) and postural balance (AccSway force platform for static postural balance and NeuroCom's
      Balance Master for dynamic postural balance) before and after 12 weeks of intervention with
      vitamin D supplementation and resistance and postural balance exercise. The intervention that
      will be perform during the 12 weeks with a progressive resistance training program.
    


Intervention name(s): Physical exercise + Vitamin D3; Physical exercise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Strength exercise + Supplementation of vitamin D3 50,000 IU / week; Strength exercise
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective clinical trial, double-blind, placebo-controlled intervention
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Supplementary Feeding; vitamin D; Muscle Strength; postural balance; exercise; aged
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using
      automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.
    

Detailed description: 
      This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using
      automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

      Each subject will be randomly allocated to a sequence of four treatments, three single doses
      of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog®
      Mix25 at 0.8 U/kg on four separate dosing visits.

      Subjects will come in a fasted state to the clinical trial centre in the morning of each
      dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been
      terminated.
    

Intervention name(s): BioChaperone® Combo 75/25 at 0.6 U/kg; BioChaperone® Combo 75/25 at 0.8 U/kg; BioChaperone® Combo 75/25 at 1.0 U/kg; Humalog® Mix25 at 0.8 U/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Injection of BioChaperone® Combo 75/25 at 0.6 U/kg; Injection of BioChaperone® Combo 75/25 at 0.8 U/kg; Injection of BioChaperone® Combo 75/25 at 1.0 U/kg; Injection of Humalog® Mix25 at 0.8 U/kg
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Haemodynamic Effects of Apelin Agonists and Antagonists in Man in COPD With Raised Pulmonary Artery Pressures
Condition: COPD; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary
Study type: Interventional

Summary: 
      The investigators are interested in studying how Pulmonary Hypertension occurs. A substance
      called 'apelin', that naturally occurs in the body has been shown to have an important role
      in heart disease. Previous studies have shown that it can make blood vessels get wider, and
      help blood flow around the body and thus improve the way the heart and lungs work.

      The investigators are looking to recruit both healthy and COPD pulmonary hypertension
      patients to study 3 types of apelin. The purpose of this study is to help the investigators
      understand how Pulmonary Hypertension occurs which may will help with the development of
      future treatments.
    

Detailed description: 
      The purpose of this study:

      To investigate the physiological role of apelin in the cardiovascular system in patients with
      COPD with raised pulmonary artery pressures.

      Study Aim and hypotheses:

      The primary objective is to test the above hypotheses using forearm blood flow and systemic
      infusions of apelin peptides.

      Hypotheses:

        1. Apelin agonists are vasodilators in human resistance vessels and this effect will be
           altered in patients with pulmonary hypertension.

        2. Apelin peptides improve right ventricular and pulmonary haemodynamics in patients with
           elevated pulmonary artery pressures.

      Study 1a - A validation dose study of 3 apelin agonists performed in healthy volunteers and
      COPD patients with elevated pulmonary artery pressures.

      Study 1b- A validation dose study of apelin receptor antagonist, in healthy volunteers and
      COPD patients with elevated pulmonary artery pressures.

      Study 2a - To define the haemodynamic response to apelin agonists in healthy volunteers and
      evaluate the response.

      Study 2b - To investigate the haemodynamic response to 3 apelin agonists in COPD patients
      with elevated pulmonary artery pressures.
    

Intervention name(s): Forearm plethysmography; Haemodynamic studies
Intervention type(s): Procedure; Procedure
Intervention description(s): Dose response study; Dose response study
Other intervention name(s): Innocor; Bioimpedance; Echocardiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: COPD; Apelin; agonist; antagonist
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men
Condition: Asthma; Chronic Obstructive Pulmonary Disease COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the
      safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics
      [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as
      single and multiple ascending doses once daily by inhalation to healthy male Japanese
      subjects, compared with placebo (non-active drug)
    

Detailed description: 
      This is a phase I, randomized, single-blind, placebo controlled, sequential-group design
      study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
      AZD7594 after single and multiple ascending doses given once daily by inhalation in healthy
      male Japanese subjects, compared with placebo
    

Intervention name(s): AZD7594 inhalation powder (200 μg); AZD7594 inhalation powder (400 μg); AZD7594 pressurized inhalation suspension (200 μg); AZD7594 placebo inhalation powder; AZD7594 placebo pressurized inhalation suspension
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI); Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI; 400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI); AZD7594 placebo inhalation powder via multi-dose DPI; AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Safety; Pharmacokinetics; Pharmacodynamics; Glucocorticoid receptor modulator; Healthy male subjects
Mass Balance Study of MT-1303
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the absorption, metabolism and excretion of
      MT-1303 in healthy subjects.
    


Intervention name(s): MT-1303
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease
Condition: Magnetic Resonance Imaging; Alzheimer's Disease; Dementia; Adult Children; Risk
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is to use fMRI techniques to explore a certain part of the brain
      associated with Alzheimer's disease known as the posterior cingulate. Determining the
      functionality of this brain region may help us diagnose AD more accurately, thus allowing
      earlier treatment.
    

Detailed description: 
      The posterior cingulate is a key brain region suggested by recent studies to be affected in
      people at risk for Alzheimer's Disease (AD). Because the PC is affected very early in the
      course of AD and the region may have reduced function even prior to the onset of symptoms,
      further understanding of its functional role and its relationship to other brain regions may
      be helpful in detecting AD earlier and in monitoring disease progression and treatment. This
      project examines the role of the PC and its connections to other brain regions using
      functional magnetic resonance imaging (fMRI), a technique that allows us to examine the brain
      at work during tests of memory and decision-making. The main goal is to see if functional
      connections between brain regions are modulated by risk for AD.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        People who are enrolled in the Wisconsin Registry for AD Prevention (WRAP), recruited from
        Memory clinics and the community.
Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human dose-titration and open-label extension study to assess safety,
      tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy
      (DMD) patients with deletions amenable to exon 45 skipping.
    

Detailed description: 
      This is a randomized, placebo-controlled dose-titration study to assess safety, tolerability,
      and pharmacokinetics of 4 dose levels of SRP-4045 in genotypically confirmed advanced-stage
      DMD patients with deletions amenable to exon 45 skipping.

      After completion of the dose-titration portion of the study and SRP-4045 is determined to be
      safe, all patients will be evaluated on open-label SRP-4045 for the duration of the study.

      Safety, including adverse event monitoring, routine laboratory assessments, and cardiac
      testing will be monitored through the duration of the dose-titration and open-label portions
      of the study.

      Clinical efficacy will be assessed at regularly scheduled study visits via quality of life
      questionnaires and tests of pulmonary and upper extremity function through the duration of
      the dose-titration and open-label portions of the trial.
    

Intervention name(s): SRP-4045; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SRP-4045 solution for IV infusion.; SRP-4045 placebo-matching solution for IV infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; Exon Skipping
The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM).
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal
      challenge. Specifically we will be measuring the following parameters of postprandial
      metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3.
      Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate
    

Detailed description: 
      Previously type 2 diabetes mellitus (T2DM) was considered a disease of the adult; however,
      the incidence of T2DM in children is on the rise. Consequently, complications may occur at an
      earlier age, underscoring the importance of improving glycemic control in the pediatric
      population. Postprandial hyperglycemia contributes significantly to poor glycemic control in
      T2DM. We now understand that in addition to insulin other hormones (glucagon, amylin and
      GLP-1) may play a role in the postprandial glucose metabolism. The role of gastric emptying
      has been increasingly recognized as an important factor in regulating glucose appearance into
      the circulation. Abnormalities in the pancreatic hormone amylin and the incretin GLP-1 have
      emerged as contributors to the alterations in gastric emptying and postprandial hyperglycemia
      in T2DM. Although much is know about the abnormalities related to postprandial hyperglycemia
      in adults with T2DM, little information is available in the pediatric population. This
      protocol will examine gastric emptying, glucagon, GLP-1 and amylin secretions in healthy
      lean, obese children with and without diabetes post-ingestion of a mixed meal. The subject
      will be age and Tanner stage matched. The goal of this project is to better understand the
      metabolic adaptations of postprandial glucose homeostasis in T2DM by comparing our study
      group to obese (normal glucose tolerance) and healthy (lean) controls. The long-term goal for
      the PI is to use the data gathered with this protocol to develop a K-23 proposal
      incorporating new therapeutic options through the use of amylin and GLP-1 analogs in children
      with T2DM to improve postprandial hyperglycemia.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents age 12-18
      
Biospecimen description: 
      serum
    
Keywords: Type 2 diabetes; Lean; Obese
The Relaxation vs. Retreat Study
Condition: Stress; Ageing; Wellbeing
Study type: Interventional

Summary: 
      The purpose of this research study is to examine whether a short term meditation intervention
      can improve health, mood, and biological markers of cellular stress and aging in novice and
      experienced meditators compared to controls.
    

Detailed description: 
      There are 3 parts to this research study, Part A, B, and C.

      In Part A, participants complete a brief online questionnaire sent to them via email by the
      study coordinator.

      During Part B of the study, participants stay at La Costa Resort in Carlsbad, CA for 6 nights
      and participate in a meditation retreat being held at the resort, or stay at the resort
      without participating in the retreat. During their stay, participants attend two in-person
      research assessments throughout the week. Assessments will be 4 days (96 hours) apart for all
      participants and will include a fasting blood draw, body measurements, and self-report
      questionnaires.

      Part C of the study includes a brief online questionnaire that is completed 1 month after
      participants leave La Costa Resort.

      This study includes 3 groups: a group of "novice meditators" from the greater San Diego
      Region that are randomized into either the 1) Relaxation (Control) group or 2) Retreat group.
      The third group is comprised of self-selected "experienced meditators" who are already
      enrolled in the retreat. In total, 99 participants were recruited for this study.

      The Retreat group stays at La Costa Resort and attends a 6 day meditation retreat
      intervention as well as completes all research study assessments and questionnaires.

      The Relaxation (Control) group stays at La Costa Resort for 6 nights, but does not attend the
      meditation retreat. They attend once daily lectures on science topics and complete all
      research study assessments and questionnaires.

      The Experienced Retreat group participants have an ongoing meditation practice and have
      enrolled themselves in the April 2013 meditation retreat. All of the Experienced meditators
      attend the meditation retreat and complete all research study assessments and questionnaires.
    

Intervention name(s): Meditation Retreat; Active Comparator Relaxation Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is a one week meditation and yoga retreat hosted at the La Costa Resort and Spa in Carlsbad, CA.; Participants are randomized to stay at La Costa Resort and Spa for 6 days. Participants will receive daily meals similar to the meals for those in the retreat group. Participants will also receive a daily one hour lecture on topics related to longevity and health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Telomerase; Telomere Length; Psychological Stress; Amyloid beta proteins; Meditation
Improvement of Transient Elastography Applicability and Diagnostic Accuracy to Identify Significant Fibrosis by Experienced Operators Using the M and XL Probe.
Condition: Chronic Liver Diseases (CLD)
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Transient elastography (TE)is the reference method to identify liver stiffness (LSM) but
      fails to obtain a measurement in 3% of cases and results are considered unreliable in 16%.
      The aim of this study is to evaluate the applicability and diagnostic accuracy of TE
      performed by trained operators (<500 explorations), after a second evaluation by experienced
      explorers (>500 explorations) and after a third exploration using XL probe. Inadequate LSM
      will be re-evaluated by experienced operators with the M (standard size) probe. A third
      register will be performed with XL (obese size) probe in those patients with inadequate M
      probe determination. Diagnostic accuracy will be estimated in patients with liver biopsy to
      identify significant fibrosis with a TE cut-off value of 7.6 kPa (kilo pascal).
    


Intervention name(s): Trained operator with M probe.; Experienced operator with M probe.; Experienced operator with XL probe.
Intervention type(s): Device; Device; Device
Intervention description(s): Trained operator with M probe: non-drug intervention, baseline comparator.; Experienced operator with M probe: non-drug intervention, longitudinal comparator.; Experienced operator with XL probe: non-drug intervention, longitudinal comparator.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with liver stiffness