bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, double-blind, randomized, comparative pharmacokinetic and
      pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy
      Volunteers.
    

Detailed description: 
      After successful screening, each subjects will be randomly allocated to one of the following
      six possible sequences, according a 1:1:1:1:1:1 randomization scheme:

      Sequence_1: Treatment A -> Treatment B -> Treatment C ; Sequence_2: Treatment A -> Treatment
      C -> Treatment B ; Sequence_3: Treatment B -> Treatment A -> Treatment C ; Sequence_4:
      Treatment B -> Treatment C -> Treatment A ; Sequence_5: Treatment C -> Treatment A ->
      Treatment B ; Sequence_6: Treatment C -> Treatment B -> Treatment A ;

      In study Period 1, Subjects will be administered MYL-1401H (Treatment A),
      EU-Neulasta(Treatment B) or US-Neulasta (Treatment C).

      After the 1st crossover, subjects will enter Study period 2 and will receive one of the
      remaining alternate treatments.

      After the 2nd crossover, subjects will enter Study period 3 and will receive the other
      alternate treatment.

      The washout between drug administrations is at least 4 weeks. Final follow-up visit is
      scheduled 4 weeks after the last study drug administration.
    

Intervention name(s): MYL-1401H; EU-Neulasta; US-Neulasta
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Recombinant human granulocyte colony-stimulating factor (G-CSF); Pegfilgrastim; Recombinant human granulocyte colony-stimulating factor (G-CSF); Pegfilgrastim; Recombinant human granulocyte colony-stimulating factor (G-CSF); Pegfilgrastim
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Pegfilgrastim; G-CSF; Pharmacokinetics; Pharmacodynamics
Vitamin D Influence on Oocyte Donation
Condition: Disorder of Phosphate, Calcium and Vitamin D Metabolism; Female Infertility Due to Diminished Ovarian Reserve; Hormonal Requirement; Reproductive Disorder
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      Objective: To investigate the correlation between total and bioavailable serum 25-OH vitamin
      D, ovarian reserve and ovarian response to controlled stimulation in egg donors.
    

Detailed description: 
      Design: Retrospective study. Setting: University affiliated private IVF center. Intervention:
      Serum analysis of vitamin D, bioavailable vitamin D, antimullerian hormone (AMH), antral
      follicular count (AFC), reproductive outcome of oocytes recipients Main outcome measure: AMH,
      AFC, number of oocytes retrieved and number of mature oocytes, pregnancy and implantation
      rate of donated oocytes'recipients.
    

Intervention name(s): vitamin D,AMH, AFC, reproductive outcome egg recipients
Intervention type(s): Other
Intervention description(s): observational study of 269 donnors
Intervention MeSH terms: Vitamin D
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        oocytes' donors who underwent ovarian stimulation cycles in our clinic from June 2013 to
        April 2014
      
Keywords: Egg donation; vitaminD; ovarian reserve; ovarian stimulation
The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of BMS-986195 in combination with an
      oral contraceptive in healthy female patients.
    


Intervention name(s): BMS-986195; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of specified dose on specified days; Oral Contraceptive
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Estradiol; Branebrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Immune Response to Heplisav in Healthy Older Adults
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the response of the immune system to a hepatitis B (HB) vaccine
      in healthy adults 50 to 70 years of age. This study is partially funded by the National
      Institute of Allergy and Infectious Diseases.
    

Detailed description: 
      The purpose of this study is to examine how the immune system responds to vaccination with
      HEPLISAV.
    

Intervention name(s): HEPLISAV
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Heplisav
Effects of Blue-light Blocking Lens on Visual Functions
Condition: Effects of Blue-light Blocking Lens on Visual Functions
Study type: Interventional

Summary: 
      Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity,
      accommodative response, color vision, and subjective grading of the quality of life and
      vision.

      Purpose: To determine and compare the visual performances after wearing the blue-light
      blocking lenses in participants with and without presbyopia.

      Methods: One hundred and sixty computer users (computer usage >2 hours/day) with (n=120, aged
      >40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of
      ophthalmic lenses will be prescribed for the participants, in which one pair of them will be
      the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for
      intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in
      non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre-
      and post-treatment contrast sensitivity, accommodative response and color vision will be
      measured. The participants will also be asked to complete questionnaires about their quality
      of life and vision, and the performances of these ophthalmic lenses.

      Significance: The blue-light blocking lens reflects the short-wavelength lights and protects
      the retina from "blue-light hazards"; however, blue lights are essential for various visual
      function and circadian rhythms. This study will evaluate the impact of the blue-light
      blocking lenses on visual function and quality of life, and determine whether the blue-light
      blocking lenses are good choices for extra ocular protection.
    


Intervention name(s): clear lens with regular coating; regular coating lens with yellow tint; clear lens with blue-light blocking coating
Intervention type(s): Device; Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
Condition: Gas Pain Related Intake
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in
      pediatric patients with predominant gas-related symptoms.
    

Detailed description: 
      Most patients with functional gastrointestinal disorders complain of gas-related symptoms
      which can negatively affect quality of life, even in pediatric age.

      Dietary and life-style changes, administration of simethicone, activated charcoal and
      probiotics may reduce intestinal gas but often results are unsatisfactory.

      Literature shows that α-galactosidase is effective to reduce gas production and related
      symptoms in adults.
    

Intervention name(s): α-galactosidase; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:
children < 20kg: 4 drops;
children > 20kg and < 40kg: 8 drops;
children > 40kg: 1 tablet.; Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:
children < 20kg: 4 drops;
children > 20kg and < 40kg: 8 drops;
children > 40kg: 1 tablet.
Other intervention name(s): Sinaire
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome (IBS); bloating; abdominal distension; flatulence; α-Galactosidase
Neuroimaging Studies of Depression in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to investigate similarities and differences in the neural
      pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy
      controls using magnetic resonance imaging (MRI) of the brain and neuropsychological
      assessment.
    

Detailed description: 
      Depression is a common and potentially serious complication of Parkinson's disease (PD).
      Studies show that approximately 40 percent of PD patients are depressed. There is evidence
      that these patients have deficits in neuropsychological function relative to non-depressed PD
      patients. Despite the widespread toll on emotional health posed by PD, few studies have
      undertaken a comprehensive examination of the neural underpinnings of Parkinsonian
      depression. In this project, we will compare depressed versus non-depressed Parkinson
      patients to a sample of demographically-matched healthy controls using neuropsychological
      assessment and magnetic resonance imaging (MRI). To investigate possible effects of
      anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients
      will be tested both off and on Parkinsonian medications.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neurology clinics, community sample
      
Keywords: Parkinson's Disease; Magnetic Resonance Imaging (MRI); neuropsychological assessment
Study of Recombinant Human Insulin-Like Growth Factor I in Patients With Severe Insulin Resistance
Condition: Insulin Resistance; Hyperglycemia
MeSH terms: Insulin Resistance; Hyperglycemia
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the efficacy and toxic effects of recombinant human insulin-like
      growth factor I (rhIGF-I) on carbohydrate tolerance, insulin action, insulin secretion,
      hyperandrogenism, and hyperlipidemia in patients with severe insulin resistance who have
      failed other therapies.

      II. Determine the dose and time response of rhIGF-I on carbohydrate homeostasis and secondary
      abnormalities in this patient population.

      III. Determine the effect of rhIGF-I on insulin clearance, the regulation of insulin-like
      growth factor binding protein 1, the regulation of sex hormone binding globulin, and
      hypothalamic pituitary gonadal axis in this patient population.
    

Detailed description: 
      PROTOCOL OUTLINE: This is an open label study. Patients receive the first dose of
      subcutaneous recombinant human insulin-like growth factor I (rhIGF-I) on day 7.

      Patients receive rhIGF-I twice daily 15-30 minutes before breakfast and dinner, and are
      hospitalized for the first week of therapy. Patients return for an outpatient exam on day 19
      of rhIGF-I therapy. Approximately 30 days into the therapy, patients are readmitted to the
      clinical center for repeat screening tests. Patients then receive maintenance therapy of
      rhIGF-I for up to 6-12 months. A washout period follows the maintenance therapy phase.

      Patients are followed weekly, biweekly, or monthly depending on blood glucose response of
      patients off rhIGF-I therapy. Weekly phone contact with study coordinator is mandatory during
      this time.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): insulin-like growth factor I
Intervention type(s): Drug
Intervention MeSH terms: Mitogens
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endocrine disorders; insulin resistance; rare disease
Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems
Condition: Electronic Cigarette Use; Tobacco Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to estimate nicotine uptake and assess subjective effects during
      ad libitum use sessions of 4 flavors of JUUL ENDS (also referred to as nicotine salt pod
      system; NSPS) products (i.e., Virginia Tobacco, Mint, Menthol and Mango) with 2 different
      nicotine concentrations. Subjective effects will also be assessed to gain an understanding of
      the user's experience during and after JUUL ENDS product use to evaluate the abuse liability
      of the products. The subject population will consist of healthy adult, male and female
      smokers, 21 to 65 years of age.
    


Intervention name(s): JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
Intervention type(s): Other
Intervention description(s): JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine
Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
Condition: Gastric Motor Function
Study type: Interventional

Summary: 
      In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility
      monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure
      measurement similar to high-resolution manometry (HRM).

      In addition, the study aims to contribute to the design and development of a position
      confirmation functionality integrated in the VIPUN Gastric Monitoring System by establishing
      volume-pressure relations in the stomach and esophagus.
    


Intervention name(s): VIPUN Gastric Monitoring System prototype
Intervention type(s): Device
Intervention description(s): The Investigational Medical Device (IMD) is used simultaneously with the reference device (solid state high-resolution manometry) to record gastric intraluminal pressure for approximately 2.5 hours.
Other intervention name(s): VIPUN GMS
Intervention model: Single Group Assignment
Intervention model description: A prospective, interventional, single-arm, monocentric, investigation in a cohort of adult healthy subjects comprising a screening visit and a single study visit.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Medical device investigation
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Condition: Stroke; Hemiplegia, Spastic; Muscle Spasticity
MeSH terms: Muscle Spasticity; Stroke; Hemiplegia
Study type: Interventional

Summary: 
      There are few studies on whether botulinum toxin treatment and extracorporeal shock wave
      therapy are more effective than botulinum toxin alone treatment for post-stroke spasticity.
    

Detailed description: 
      If the study results can be drawn that the group receiving extracorporeal shock wave therapy
      along with botulinum toxin treatment can increase the effect of botulinum toxin treatment and
      lengthen the treatment period compared to the group with botulinum toxin treatment only, it
      can be widely used as an auxiliary treatment for botulinum toxin treatment. This study was
      carried out with the expectation that it would be possible to provide a basis for this.
    

Intervention name(s): Extracorporeal shock wave therapy; Botulinum toxin treatment
Intervention type(s): Device; Procedure
Intervention description(s): Stimulation was given to the brachial muscle, 1000 times, 4Hz, and energy flux density was 0.030mJ/mm2.; The toxin dose was established for each patient: it ranged between 80 unit and 300 unit.
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study of Benzoyl Peroxide Cream for Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream
      formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the
      treatment of acne vulgaris.
    

Detailed description: 
      The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5%
      cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for
      mild to moderate acne vulgaris.
    

Intervention name(s): Benzoyl Peroxide; Moisturizing Lotion
Intervention type(s): Drug; Drug
Intervention description(s): Benzoyl Peroxide 2.5%
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne
Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the bioequivalence between two oral nicotine
      sublingual tablets, 2 mg and 4 mg.
    

Detailed description: 
      The study is a single-dose, randomized, 2 x two-way cross-over study. The investigational
      products will be given as single doses at separate visits. Periods without Nicotine
      Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits.
      Blood will be sampled at each treatment visit for pharmacokinetic analyses pre-dose, and at
      5, 10, 15, 20, 30, and 45 minutes, as well as 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after
      start of product administration. The time until complete product dissolution will be
      recorded. Subjects will also be monitored to capture any adverse events that may occur. The
      trial is open in the sense that subjects and study personnel will be aware of what product is
      administered at a given visit. However, the treatment labels will not be known by the people
      performing bioanalysis or analyzing pharmacokinetic data.
    

Intervention name(s): Nicotine Sublingual Tablet Mint (NSTM); Marketed Nicotine Tablet
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of an experimental NSTM, with a 36-hour washout between visits; A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
Other intervention name(s): Not marketed; Nicorette® Microtab
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Smoking Cessation; Nicotine pharmacokinetics
Study on the Psychotherapeutic Treatment of Chronic Nightmares
Condition: Nightmare Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a change in the content of nightmares is
      necessary at all in the treatment of chronic nightmares or if a single confrontation with
      their content is sufficient to reduce nightmare frequency significantly.
    

Detailed description: 
      The inclusion and exclusion criteria are assessed during a telephone interview. If the
      participants meet the criteria, they are randomly assigned to two intervention groups or an
      active control group. In the first session the participants who suffer from chronic
      nightmares are interviewed using the Structured Clinical Interview for DSM-IV (SCID-I and
      -II) to determine the clinical diagnosis; in addition, they are given questionnaires and
      record sheets to obtain baseline data. They are asked to record their nightmares in a "dream
      diary" up until the next session four weeks later. At that session they learn one of three
      interventions to reduce nightmares. The first group receives imagery rehearsal treatment in
      which participants learn to consciously alter the contents of their nightmares and then to
      visualize the new set of images. The second group is subjected to confrontation treatment in
      which they are instructed to confront their nightmares until habituation. The third group,
      the psychotherapeutic placebo group, just learn an imagination technique, without reference
      to their nightmares. At the end of the intervention session all participants receive written
      instructions on how to perform the learned method at home. They must also record their dreams
      up until the next session. That session and the last one are used for data acquisition. At
      these sessions, the participants are asked to fill in the questionnaires given to them at the
      beginning of the treatment.
    

Intervention name(s): Imagery Rehearsal Treatment; confrontation; imagination
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Imagery Rehearsal Therapy; Confrontation; Imagination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic nightmare sufferers; nightmares; Imagery Rehearsal Therapy IRT; sleep disturbance; treatment of nightmares; confrontation; People who suffer of chronic nightmares
A Phase I Clinical Pharmacology Study of TAK-233 in Healthy Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to examine the clinical pharmacology properties of
      TAK-233 in healthy female subjects
    

Detailed description: 
      The primary objective of this study is to examine the pharmacodynamics and the safety of
      TAK-233 administered as a single dose in healthy women.
    

Intervention name(s): TAK-233; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of TAK-233; Oral admininstration of Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science