bioihbjkbjnl/mcl2 huggingface dataset:
Study in Adolescents With Schizophrenia or Bipolar Disorder
Condition: Bipolar I Disorder; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Open-label safety study of oral olanzapine treatment in adolescents, aged 13 to 17 years,
      with bipolar I disorder (manic or mixed episodes) or schizophrenia.
    


Intervention name(s): Olanzapine; Standard behavioral weight intervention; Intense behavioral weight intervention
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks; One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only.; Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits.
Other intervention name(s): Zyprexa; LY170053
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; schizophrenia; bipolar I (manic or mixed); adolescents; weight management
Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants
      with moderate to severe atopic dermatitis.
    

Detailed description: 
      The study is divided into two stages, the first stage test (1-12 weeks): the main test; the
      second stage test (13-24 weeks): the extended test.

      The main test：The trial set up 4 treatment groups, including 3 dose exploration groups,
      Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.

      The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib
      50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded
      state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid,
      100mg Bid group) subjects still maintain the original dose after 12 weeks.
    

Intervention name(s): Jaktinib; Jaktinib; Jaktinib; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.; In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.; In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.; In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week
      dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random
      order for 1-week each as a daily disposable modality with a wash-out period of 1 week between
      the wearing periods.
    


Intervention name(s): ACUVUE® OASYS 1-DAY; ACUVUE® OASYS 1-DAY
Intervention type(s): Device; Device
Intervention description(s): senofilcon A contact lenses made with a novel manufacturing technology; senofilcon A contact lenses made with the current manufacturing technology
Other intervention name(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.
Condition: Sleep; Athlete; Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Sleep is a crucial factor for athletes' health and recovery. Many variables are able to
      negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high
      volume or high-intensity training period, and a nigth competition too. Therefore, the aim of
      this pilot study is to evalute how sleep quality changes in relation to a late nigth
      competition in athletes.
    


Intervention name(s): Sleep Profiler; PSQI; TQR
Intervention type(s): Other; Other; Other
Intervention description(s): A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.; Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.; Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sleep; Athlete; Sleep Profiler
Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after
      single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese
      male volunteers.
    

Detailed description: 
      This clinical trial is to characterize the pharmacokinetic profile after single oral doses of
      the proposed final market tablet formulations of paroxetine CR in Japan (the 12.5mg and 25mg
      tablets), at the dose levels of 12.5, 25 and 50mg in the healthy male Japanese volunteers.
      Treatment sequence of the 3 dose levels in each subject is randomized.
    

Intervention name(s): Paroxetine 12.5 milligrams tablet; Paroxetine 25 milligrams tablet; Paroxetine 50 milligrams tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.; Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.; Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: tolerance; single dose; paroxetine; controlled-release tablet; safety; pharmacokinetics; Japanese healthy male subjects
Safety, Tolerability, Pharmacokinetics and Efficacy of Twice Daily Application of Topical BioLexa in Adult Healthy Subjects and Patients With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomised, double-blind, vehicle controlled study to determine the
      safety, tolerability, PK and efficacy of twice daily application of topical BioLexa™ lotion,
      administered for 28 days in adult healthy subjects, in adult patients with mild to moderate
      AD and in adolescent patients with mild to moderate AD.
    

Detailed description: 
      This study will consist of 3 parts. Part A: Part A will consist of Cohort 1 constituting of
      heathy subjects. The total body surface area (BSA) dosed will be either 9% or 27% BSA for
      Cohort 1 subjects. Part A will include both an active-control (lotion base + 0.1% gentamicin)
      and a placebo control, applied at 9% or 27% BSA.

      Part B: Part B will consist of Cohort 2 made up of adult mild to moderate AD patients. The
      minimum %BSA dosed will be 3% BSA and the maximum will be 27% BSA for patients in Cohort 2.
      Part B will include both an active-control (lotion base + 0.1% gentamicin) and a placebo
      control.

      Open-Label Cohort: After closure of Part B, open-label enrolment of patients with mild to
      moderate atopic dermatitis affecting 3-27% BSA for treatment with BioLexa for 14 days
      (unblinded).
    

Intervention name(s): BioLexa- Cohort 1; BioLexa- Cohort 2; Placebo; Gentamicin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects; Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients; Twice daily (BID) application of placebo for 14 days; Twice daily (BID) application of Gentamicin for 14 days
Intervention MeSH terms: Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed
      in 5 different forms:

      i) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive
      oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched
      fat-free dairy drink
    

Detailed description: 
      This postprandial study will recruit healthy males and females aged 18 and over. Upon
      completion of informed consent procedures and successful screening, the volunteers will
      complete 4 study visits. Participants will consume a standardised meal the evening before
      each test day, and will arrive in the morning to the research facility in UCD after an
      overnight fast of 12 hours.

      On the study test days, volunteers will be given one of the following vitamin D treatments in
      a dairy drink, followed by a low-fat breakfast.

        1. mixed micelles

        2. olive oil

        3. fish oil

        4. fat-free

      Participants will also be given a low-fat lunch 5 hours after the supplement is consumed.
      Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood
      sample will be taken. Following ingestion of the vitamin D supplements blood samples will be
      taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time
      point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake
      will be recorded during the visit.
    

Intervention name(s): Vitamin D supplement
Intervention type(s): Dietary Supplement
Intervention description(s): This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
Intervention MeSH terms: Vitamin D
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The is a 4 arm single-blinded crossover study
Masking: Single (Participant)
Primary purpose: Prevention
Non-invasive Chromosomal Examination of Trisomy Study
Condition: Trisomy 21
MeSH terms: Down Syndrome; Trisomy
Study type: Observational

Summary: 
      The purpose of this blinded, multi-center, prospective, case-controlled study is to compare
      the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester
      prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total
      hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in
      a general screened population.

      The performance characteristics of these two test modalities will be assessed relative to the
      clinical reference standard of genetic analysis of the fetus or phenotypic characterization
      and genetic analysis of the newborn.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women presenting for combined first trimester screening as part of routine
        prenatal care
      
Keywords: Pregnancy; Fetal aneuploidy; Trisomy 21; Down Syndrome; Prenatal screening; Non-invasive prenatal testing; First trimester; Combined screening; Nuchal translucency; PAPP-A; hCG; cell free DNA; cf DNA; DNA; Performance characteristics of non-invasive first trimester screening; Harmony Prenatal Test
Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)
Condition: Chronic Obstructive Pulmonary Disease - COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg)
      twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized
      formoterol fumarate (20 μg and 40 μg).
    

Detailed description: 
      This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover,
      placebo and active comparator (open-label) controlled, multicenter clinical trial to assess
      the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID
      administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg
      BID and 40 μg single dose) administered as an inhalation solution via a standard jet
      nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation
      Solution). The drug product is an inhalation powder comprising of micronized aclidinium
      bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier,
      presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved
      under the trademarks of Genuair® and/or Pressair® in some territories.
    

Intervention name(s): Formoterol fumarate (6 μg); Formoterol furmarate (20 μg); Placebo for formoterol fumarate; Formoterol fumarate (12 μg); Formoterol fumarate (40 μg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI); Oral Inhalation (via a standard jet nebulizer connected to an air compressor.; Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI); Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI); Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
Other intervention name(s): Formoterol (Pressair®); Perforomist® Inhalation Solution; Placebo (Pressair®); Formoterol (Pressair®); Perforomist® Inhalation Solution
Intervention MeSH terms: Pharmaceutical Solutions; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Perforomist; Pressair; COPD; Cigarette smoking; Formoterol fumarate; long-acting β2-adrenergic agonists (LABA); long-acting muscarinic antagonists (LAMA)
Trial of VLTS-589 in Subjects With Intermittent Claudication
Condition: Intermittent Claudication; Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Intermittent Claudication; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of VLTS-589 compared
      with placebo, administered bilaterally to the lower extremities, in subjects with
      intermittent claudication and to determine the effect of VLTS-589 in peak walking time (PWT)
      for subjects receiving VLTS-589 compared with subjects receiving placebo.
    


Intervention name(s): Plasmid based Gene Transfer product-VLTS-589
Intervention type(s): Genetic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5
      years of age with endoscopically proven symptomatic GERD.
    


Intervention name(s): pantoprazole sodium enteric-coated spheroid
Intervention type(s): Drug
Intervention description(s): pediatric spheroids taken daily x 8 weeks
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: GERD; Children; Child; Child, Preschool
Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is an experimental, randomized, double blind, prospective intervention study

      Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow:

      For adult (18-40 years old)
    

Detailed description: 
      Each study age group/arm will be divided into two groups of treatment. One group will receive
      investigational product and one other group will receive active comparator. This Study is
      sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed
      by children (10-17 years old) ). Before the study started, the subjects will be assessed for
      anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before
      immunization, additional 2 doses will be required with 1 month interval.
    

Intervention name(s): Recombinant Hepatitis B (Bio Farma) Vaccine; Recombinant Hepatitis B (Bio Farma) Vaccine®
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant Hepatitis B vaccine produced by Bio Farma; Registered Recombinant Hepatitis B vaccine produced by Bio Farma
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) )
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: vaccine; hepatitis b; infection; virus
Effects of a 5:2 Diet on Weight Loss and Cardiovascular Risk Factors in Obesity
Condition: Obesity; CVD; Dietary Modification
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      A randomized clinical trial comparing the effect on weight reduction and cardiometabolic risk
      factors of intermittent energy restriction and a isocaloric continuous energy restriction in
      obese subjects.
    

Detailed description: 
      Background: The optimal diet for treating obesity and cardiovascular disease (CVD) risk is
      still not clarified. Could a five plus two diet, a form of intermittent energy restriction
      lead to good adherence, similar weight loss and reduction in CVD risk factors as a isocaloric
      continuous energy restrictions in obese subjects.

      Methods: The study is a randomized controlled clinical trial in 120 men and women between 21
      to 70 years with BMI (BMI 30-45 kg/m2), stable weight within ±3 kg last 3 months and 1
      additional metabolic syndrome risk component.

      Dietary intervention: Randomization will be to one of two diet groups. Participants in the
      intervention group will follow av 5:2 diet and participants in the control group will follow
      an isocaloric continuous energy restriction.

      Primary research question: Compare the effect on weight reduction of intermittent energy
      restriction and a isocaloric continuous energy restriction in obese subjects? Secondary
      research questions Compare the effect of intermittent energy restriction and an isocaloric
      continuous energy restriction on cardiometabolic risk factors and tolerability and safety in
      obese subjects. The project consist of to randomized controlled clinical trials.
    

Intervention name(s): dietary intervention intermittent energy restriction; continuous energy restriction
Intervention type(s): Other; Other
Intervention description(s): Randomized clinical trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam
Condition: Japanese Healthy Adult Males
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of repeated-dose administration of
      itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose
      administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese
      adult males.
    

Detailed description: 
      In Cohort 1, the effect of repeated-dose administration of itraconazole on the
      pharmacokinetics of TAK-272 was evaluated by comparing between participants receiving TAK-272
      alone and those receiving TAK-272 in combination with itraconazole. In Cohort 2, the effect
      of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam
      was evaluated by comparing between participants receiving digoxin or midazolam alone and
      those receiving either of the drugs in combination with TAK-272.
    

Intervention name(s): TAK-272; Digoxin; Itraconazole; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TAK-272 tablet.; Digoxin tablet.; Itraconazole oral solution; Midazolam syrup.
Intervention MeSH terms: Itraconazole; Digoxin; Midazolam; Imarikiren hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepatocellular Carcinoma Recurrence and Anesthesia
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      The investigators will verify the prognosis of hepatocellular carcinoma (HCC) according to
      the main anesthetic agents used for the general anesthesia.
    


Intervention name(s): Volatile anesthetics; Intravenous anesthetics
Intervention type(s): Other; Other
Intervention MeSH terms: Anesthetics; Anesthetics, Intravenous
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery due to the HCC.