bioihbjkbjnl/mcl2 huggingface dataset:
A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety
      of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for
      the compliance and convenience of the patient in comparison to placebo. Further the rationale
      is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by
      the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily
      (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent
      asthma.

      Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to
      tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once
      daily (in the evening) or 2.5 µg tiotropium twice daily.
    


Intervention name(s): Tiotropium 2.5 µg b.i.d; Placebo; Tiotropium 5 µg q.d.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler; N/A (two actuations of placebo) delivered via Respimat® inhaler; 5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Binge Eating Anxiety and Mood
Condition: Binge-Eating Disorder; Binge Eating; Anxiety Disorders; Mood Disorders
MeSH terms: Bulimia; Anxiety Disorders; Feeding and Eating Disorders; Mood Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      Binge Eating Disorder (BED) is the most common eating disorder, and currently, the best
      behavioral treatments only work for 40-60% of adults. BED often co-occurs with mood and
      anxiety disorders, and both are associated with neurocognitive deficits related to executive
      function (EF). These EF deficits contribute to worsening BED symptoms and make it difficult
      for these adults to adhere to treatment recommendations. The proposed study aims to develop
      an EF training enhanced behavioral treatment for BED and compare its effectiveness to the
      standard cognitive behavioral therapy for patients with BED and a co-occurring mood or
      anxiety disorder.
    

Detailed description: 
      A randomized controlled trial (RCT) will evaluate an EF training enhanced cognitive
      behavioral therapy (CBT) for BED (EF-BED+CBT) compared to standard CBT in patients with BED
      and a comorbid mood/anxiety disorder to assess the feasibility, acceptability, and
      preliminary efficacy of EF-BED+CBT in reducing binge eating, impairment, and comorbid
      depression/anxiety symptoms. Adult participants with BED and comorbid mood/anxiety disorder
      will be randomized to a four month remote treatment of either EF-BED+CBT or CBT alone.
      Participants will be assessed at baseline, following treatment (month 4) and 2-month
      follow-up (month 6).
    

Intervention name(s): Executive Function- Enhanced CBT for BED (EF-BED+CBT); Cognitive Behavioral Therapy (CBT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): EF-BED+CBT will combine CBT (see description below) with executive function training. EF-BED will focus on teaching compensatory strategies to enhance adherence to the strategies recommended in CBT.; CBT will be based on the "Overcoming Binge Eating" book. All participants will be provided a copy of the book. CBT addresses disturbed eating patterns and problematic thoughts/beliefs related to eating, shape and weight that contribute to binge eating. CBT is the current gold standard treatment for BED.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Condition: Drug Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      We are proposing a small randomized clinical trial in which 100 substance users will complete
      the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well
      as a novel battery of assays to evaluate cognitive-affective functioning. After completing
      pretreatment assessments, participants will be randomized to either a (1) cognitive
      remediation program (training tasks) specifically designed to address cognitive-affective
      dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per
      week for 4 weeks, after which assessment batteries will be repeated. Finally, we will
      evaluate real-world behavior and the durability of the training via a one-month follow-up,
      which will include assessment of substance use as well as the cognitive-affective battery.
    

Detailed description: 
      Participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non-
      methadone/buprenorphine) treatment for any substance use disorder (other than PCP) at the
      Substance Abuse Treatment Unit in New Haven. As the goal of this project is to develop
      interventions that address self-regulation across multiple disorders, we will recruit
      individuals who have a range of substance use disorders and levels of severity. Our primary
      Specific Aim will be to evaluate the efficacy of the cognitive-remediation program relative
      to the control condition control on the indicators of cognitive-affective functioning and
      substance use, testing the hypothesis that individuals randomized to the cognitive
      remediation program will demonstrate improved functioning on the cognitive-affective battery
      as well as reduced real-world substance abuse. We will also explore potential moderators of
      response to the training, including baseline measures of cognitive-affective function.
    

Intervention name(s): TAU plus Cognitive Remediation Program; TAU plus Control Tasks
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.; Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug use Disorders; Cognitive Remediation
Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters
Condition: Renal Circulation; Renal Plasma Flow; Glomerular Filtration Rate; Fatty Acids, Nonesterified
Study type: Interventional

Summary: 
      Type 2 diabetes is frequently associated with elevation of plasma-free fatty acids (FFA).
      Studies indicate that elevation of plasma-FFA induces insulin resistance and also causes
      endothelial dysfunction as well as hemodynamic changes which are supposed to be involved in
      the pathogenesis of diabetic vascular disorders.

      Glomerular hyperfiltration, which is associated with glomerular hypertension and hypertrophy,
      a common finding in the early course of type 1 diabetes as well as type 2 diabetes, plays an
      important role in the development and progression of diabetic nephropathy. These hemodynamic
      changes are not well understood, but are most likely induced by dilatation of the
      (precapillary) glomerular arteriole.

      In humans the hemodynamic effect of FFAs has so far been investigated locally in brachial and
      femoral arteries and recently in the eye and skin, where FFAs induced a pronounced increase
      in blood flow probably due to a local decrease in vascular resistance.

      The aim of the present study is to characterise the hemodynamic effects of FFAs in the
      kidney. In addition we want to test the hypothesis that FFA-induced changes are mediated via
      endothelial derived nitric oxide (NO). The results of this study could provide information to
      what extent elevated FFA-plasma levels contribute to hyperfiltration in the early course of
      diabetes mellitus. The measurements will be done at baseline and during 4 hour infusion of a
      triglyceride or placebo infusion, combined with heparin.
    


Intervention name(s): NG-monomethyl-L-Arginine (L-NMMA); triglycerides (Intralipid 20%); heparin; somatostatin; insulin; glucose; inulin; paraamino hippurate (PAH)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Heparin; Soybean oil, phospholipid emulsion; Somatostatin; omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Renal Plasma Flow; Glomerular Filtration Rate; Free fatty acids
Augmenting Patching Treatment for Amblyopia With Physical Exercise
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      Researches are trying to establish whether moderate exercise enhances the treatment benefit
      of patching 2 hours a day for residual amblyopia in children.
    


Intervention name(s): Physical Exercise in addition to Patching
Intervention type(s): Other
Intervention description(s): Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Olmesartan Medoxomil in Atherosclerosis
Condition: Essential Hypertension; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study in hypertensive patients with atherosclerosis and increased cardiovascular
      risk. The efficacy of olmesartan medoxomil on atherosclerosis is measured.
    


Intervention name(s): Olmesartan medoxomil; Atenolol; Hydrochlorothiazide; olmesartan medoxomil; atenolol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablets; tablets; tablets
Intervention MeSH terms: Atenolol; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of morning versus evening
      intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with
      hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL)
      cholesterol percent change.
    


Intervention name(s): Simvastatin CR
Intervention type(s): Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of daratumumab following a
      single subcutaneous (SC) administration in healthy participants and to determine whether
      premedication with corticosteroids is required to improve the tolerability of SC
      administration of daratumumab in healthy participants.
    


Intervention name(s): Daratumumab; Placebo; rHuPH20
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single SC dose of daratumumab will be administered in each of 8 dose cohorts.; Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.; Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
Other intervention name(s): JNJ-54767414
Intervention MeSH terms: Daratumumab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
39946-I Laser and Bevacizumab Treatment for Retinopathy of Prematurity
Condition: ROP Threshold
MeSH terms: Retinopathy of Prematurity
Study type: Observational [Patient Registry]

Summary: 
      Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Vascular
      endothelium growth factor (VEGF) is an important component of this disease. The goal of
      treatment is to reduce the production of VEGF in the immature retina and to eliminate the
      abnormal growth of new vessels. Currently, laser photocoagulation of the peripheral avascular
      retina is the treatment standard. Intravitreal injection of anti-VEGF antibody Bevacizumab
      (IVB) has been used clinically off-label as an alternative therapy. However, VEGF is
      important for the development of neurons and vessels in the systemic organs in premature
      infants. Pharmaceutical study showed that IVB was absorbed into the bloodstream. It is
      unclear if the systemic absorption of Bevacizumab is dose related, and the short and longterm
      effects on ocular and systemic systems, especially neurological development. In this study,
      our goals are to establish the pharmacokinetics of Bevacizumab in the premature infant and to
      compare the short and long-term vision and neurodevelopmental outcomes of infants treated
      with IVB compared to laser ROP.
    

Detailed description: 
      This study will enroll preterm infants who were scheduled to receive treatment for ROP by
      laser or Bevacizumab. We will observe the patients in the hospital for the cure of ROP until
      54 weeks' postmenstrual age. We will check the changes of chemicals in the blood and observe
      short-term and long-term effects on visual system, brain and other body organs. Descriptive
      statistics from a two sample t-test or Fisher's exact test will be used to compare the short
      and long-term vision and neurological development outcomes. We predefined a statistical
      significance level p=0.05.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premature infants
      
Keywords: ROP; Bevacizumab; Laser; Development
Genetic Epidemiology of Blood Pressure Intervention
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To localize and identify new genes related to variation in blood pressure (BP) responses to a
      low dietary sodium intake, a high dietary sodium intake, oral potassium supplementation, and
      the cold pressor test.
    

Detailed description: 
      BACKGROUND:

      Systemic hypertension is a complex disease determined by both genetic and environmental
      factors and is of significant public health interest. In addition, identifying genes that
      interact significantly with dietary sodium and potassium intake, or even the cold pressure
      test may enable clinicians to target life style modification for prevention and treatment of
      hypertension.

      The study is conducted in response to a Request for Applications issued in October, 2001 on
      the Interaction of Genes and the Environment in Shaping Risk Factors for Heart, Lung, Blood,
      and Sleep Disorders.

      DESIGN NARRATIVE:

      The study uses a family intervention study design. The investigators will recruit 750
      sibships (n=1750 siblings) and their parents (n=1250) from 500 families, each family
      ascertained through a proband who has untreated high normal BP or stage-1 hypertension
      (systolic BP 130-160 mm Hg and diastolic BP 85-100 mm Hg) from rural China. They will collect
      baseline information on medical history, lifestyle risk factors, anthropometric measures, BP,
      and blood measures (renin activity, ACE, angiotensin II, natriuretic peptide, glucose,
      insulin, and lipids) in all participants, and dietary nutrient intake (three 24-hour recalls)
      and urinary sodium and potassium excretion (three 24-hour) in the siblings. They will conduct
      the following interventions in the siblings: a cold pressor test at baseline (day 2 or 3), a
      1-week low sodium-feeding study (40 mmol sodium/day on days 4-10), a 1-week high
      sodium-feeding study (280 mmol sodium/day on days 11-17), and a 1-week oral potassium
      supplementation (90 mmol potassium/day on days 18-24). They will measure BP and 24-hour
      urinary sodium and potassium excretion during the last 3 days of each intervention period.
      They will also perform genotyping for genomewide linkage scans and for candidate genes in all
      siblings and their parents. BP responses to the interventions will be analyzed primarily as
      quantitative traits. The primary analyses include linkage analysis,
      transmission/disequilibrium test, and association analysis between genetic markers and BP
      responses to the interventions.
Incidence of Lactose Intolerance Among Self-reported Lactose Intolerant People
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 3-sites, double-blinded, randomized, 2X2 cross-over study aiming to compare effects
      of milk containing only A2 type beta casein versus milk containing both A1 and A2 beta casein
      proteins on the gastrointestinal symptoms for the health people who self-reported to be
      lactose intolerant.
    

Detailed description: 
      Study sites: Shanghai, Guangzhou, Beijing

      Eligible subjects were enrolled in the study and randomized into one of the 2 study arms:

      Sequence A1-A2: Oral consumption of milk containing both A1 and A2 type beta casein at Visit
      1 and milk containing only A2 type beta casein at Visit 2; Sequence A2-A1: Oral consumption
      of milk containing only A2 type beta casein at Visit 1 and milk containing both A1 and A2
      type beta casein at Visit 2.

      Washout period: 2 weeks between Visit 1 and Visit 2
    

Intervention name(s): Oral consumption of milk with sequence A1-A2; Oral consumption of milk with sequence A2-A1
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).; Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ (ECOS Taiwan, Indonesia, Singapore)
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long
      Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for
      growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN®
      via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected both retrospectively and prospectively. This will allow the establishment of
      adherence profiles and explore the hypothesis that patient adherence support programs improve
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is,
           above, below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: easypod™; SAIZEN®
A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of administration of azilsartan in
      pediatric patients aged 6 to less than 16 years with hypertension.
    

Detailed description: 
      The drug being tested in this study is called azilsartan. Azilsartan is being tested to treat
      pediatric participants with hypertension.

      The study enrolled 27 participants. Following a 2-week Placebo Run-in Period, participants
      were assigned to one of the two treatment groups based on weight:

        -  Azilsartan 2.5 - 20 mg (Participants < 50 kg)

        -  Azilsartan 5 - 40 mg (Participants ≥ 50 kg)

      Participants weighing < 50 kg were asked to take an initial dose azilsartan 2.5 mg (titrated
      as needed to the highest dose of 20 mg) and participants weighing ≥ 50 kg were asked to take
      an initial dose of 5 mg azilsartan (titrated as needed to the highest dose of 40 mg).

      This multi-centre trial was conducted in Japan. The overall time to participate in this study
      is 56 weeks. The study consisted of a Run-in Period (Week -2 to Week 0), a 52-week Treatment
      Period, and a 2-week Follow-up Period (up to Week 54). Participants made multiple visits to
      the clinic and a final visit 2 weeks after the last dose of study drug for follow-up
      assessment.
    

Intervention name(s): Azilsartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Azilsartan granules and tablets; Placebo-matching azilsartan granules and tablets
Other intervention name(s): TAK-536; AZILVA ®
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment