bioihbjkbjnl/mcl2 huggingface dataset:
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Condition: Upper Respiratory Infection; Common Cold
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Common Cold
Study type: Observational

Summary: 
      This study examines the cold processes of children aged 6 to less than 14. Children will be
      seen by the study staff 6 days in a row during the course of their naturally-acquired colds.
      Nasal secretions will be examined for chemicals that the body creates during a cold. Skin
      cells will be collected by brushing the inside of the child's cheek with a small brush. The
      cells will be examined for genes that may hold control the creation of these chemicals.
    

Detailed description: 
      Leukotrienes are chemicals that are naturally made by your body. Leukotrienes are increased
      in the bodies of adults and children with asthma and allergies and cause some of the symptoms
      of these diseases. Leukotrienes are increased in the bodies of adults who have common colds
      and are believed to cause some of the symptoms of the common cold. It is not known if
      increases in leukotrienes are related to the symptoms of the common cold in children. There
      are also genes that may control levels of leukotrienes and other chemicals in your body
      during the common cold. If you enroll your child in this study, he/she will be tested for
      allergies and for genes that may control the levels of leukotrienes and other chemicals.

      STUDY DESIGN:

      There will be 40 subjects enrolled into the study between the ages of 6 to < 14 years of age.
      However, approximately 80 participants may have to sign the consent form and undergo
      screening activities in order enroll these 40 subjects. The study will last approximately 1
      month and will require you and your child to return to our clinic approximately 7 times over
      the study duration. You and your child will be required to return to our clinic six days in a
      row for testing.

      Testing will include skin testing for allergies, nasal secretion collection, and skin cell
      collection.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and Female subjects ages 6 to under 14 years with common cold symptoms of less than 24
        hours in duration.
      
Biospecimen description: 
      Buccal brushing for genotyping
    
Keywords: Upper Respiratory Infection; Common Cold
Effect of Repeated Doses of YF476 on Stomach Acidity
Condition: Hypergastrinaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study were:

        1. To show that a single dose of YF476 blocks gastrin receptors in healthy subjects

        2. To show that YF476 retains its ability to block gastrin receptors after repeated dosing
           despite losing its ability to suppress gastric acidity.
    

Detailed description: 
      The rationale for this study was as follows.

      On the basis of the pre-clinical studies, the original target disease for YF476 was
      gastro-oesophageal reflux disease (GORD), not only because of the excellent anti-secretory
      activity of YF476 but also because of its potential for increasing gastric emptying. But loss
      of the anti-secretory effect of YF476 in healthy subjects after repeated dosing excludes its
      use as an anti-secretory agent in patients with GORD. However, there is some evidence from
      within our repeated-dose studies in healthy subjects that gastrin receptors are blocked
      despite loss of the anti-secretory activity of YF476. Further evidence that repeated doses of
      YF476 cause sustained blockade of gastrin receptors comes from several types of study in
      animals. First, in the 13-week toxicology studies, all dose levels of YF476 reduced the ECL
      population, unlike other anti-secretory agents, histamine H2-antagonists and proton-pump
      inhibitors, which increase the ECL population. Second, YF476 at doses of 0.1 and 1.0 mg/kg
      subcutaneously twice daily for 14 days in rats abolished the increase in gastric output
      induced by pentagastrin on Days 1, 7 and 14.

      This protocol describes a study in healthy subjects using inhibition of pentagastrin-induced
      gastric acid output as a surrogate marker of efficacy of YF476. Pentagastrin has been used
      for many years to test gastric function in healthy subjects and patients. Intravenous
      infusion of 0.6 micrograms/kg/hour is a submaximal and well-tolerated dose.
    

Intervention name(s): YF476; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject took one capsule of YF476 100 mg twice daily on Days 1-6 and once on Day 7. Each capsule taken with water 150 mL.; On Days 0 and 14, each subject took a placebo capsule. Each capsule taken with water 150 mL.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: YF476; gastrin receptor antagonist; gastrin; gastric aspiration; healthy subjects
Long-Term Safety of Febuxostat in Subjects With Gout.
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD),
      in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
    

Detailed description: 
      Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate
      concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams
      per deciliter [mg/dL]), is a common biochemical abnormality. Aberrations in any of the
      multiple mechanisms involved in the production and/or excretion of uric acid may increase
      serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid
      monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not
      sufficient) risk factor for monosodium urate crystal deposition in tissues and is the
      fundamental pathophysiological process underlying the clinical manifestations of gout, which
      is a chronic disease characterized by urate crystal formation and deposition in joints and
      bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling
      chronic disorder characterized by deforming arthropathy; destructive deposits of urate
      crystals (tophi) in bones, joints, and other organs; structural and functional renal
      impairment due to interstitial urate crystal deposition; and urinary tract stones composed
      entirely or in part of uric acid crystals. Management of gout requires chronic treatment
      aimed at lowering serum urate into a subsaturating range (usually <6.0 mg/dL) in which
      crystal formation and deposition are prevented or reversed.

      Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as
      an orally administered agent for management of hyperuricemia in patients with gout.

      Subjects who want to participate in this study will have successfully completed study
      TMX-00-004 (NCT00174967).

      All participants will initially receive an 80 mg dose. Dose titrations will occur in order to
      obtain and maintain clinically acceptable serum urate levels.
    

Intervention name(s): Febuxostat; Febuxostat; Febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.; Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.; Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Other intervention name(s): TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric
Intervention MeSH terms: Febuxostat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uric acid; xanthine oxidase; tophi; Drug Therapy
Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study is designed to evaluate the reproductibility and the performance of the 3 minutes
      sit-to-stand test in patients with idiopathic pulmonary fibrosis.

      To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis
      in 2 centers (Grenoble university hospital and Lyon university hospital).

      Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the
      hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute
      sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also
      perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.

      The investigators will then analyse the results by comparing numbers of cycle, functional
      response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The
      investigators will also compare the functional response obtained during the 3 minutes
      sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.

      Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate
      and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on
      cycle ergometer.
    


Intervention name(s): 3 minutes sit-to-stand test
Intervention type(s): Diagnostic Test
Intervention description(s): 3 minutes sit-to-stand test, 1 minute sit-to-stand test, 6 minutes walk test will be performed 2 times for each patients 3 minutes sit-to-stand test with oxygen uptake measurement will be performed one time for each patient
Other intervention name(s): 6 minutes walk test; 1 minute sit-to-stand test; 3 minutes sit-to-stand test with oxygen uptake measurement
Intervention model: Single Group Assignment
Intervention model description: The investigators want to test the reproductibility of a 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis.
For this, patient perform the test during 2 visits and the investigators are going to compare the results of the two visits.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Idiopathic pulmonary fibrosis; 3 minutes sit-to-stand test; Interindividual reproductibility
Triage Now: an Observational, Prospective Multimarker Study of Biomarkers in Patients Presenting With Chest Pain
Condition: Acute Coronary Syndrome; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction; Chest Pain
Study type: Observational

Summary: 
      Study of diagnostic tests for heart attack for patients with chest pain.
    

Detailed description: 
      Study of multiple biomarkers, including myeloperoxidase, in the evaluation of patients
      presenting with suspected acute coronary syndrome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting with chest pain and ACE in differential diagnosis.
      
Keywords: ACS; NSTEMI; Myeloperoxidase; nonST segment elevation myocardial infarction
Lantus Versus Levemir Treat-To-Target
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in
      term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment
      period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56
      mg/dL (3.1 mmol/L)

      Secondary objectives:

        -  To compare between the 2 treatment groups, the percentage of patients who reach the
           target of HbA1c < 7% and < 6.5% at the end of the treatment period

        -  To compare the changes in HbA1c and fasting plasma glucose (FPG)

        -  To compare the evolution of blood glucose profiles

        -  To compare the day to day FPG variability, the insulin doses

        -  To determine in each treatment group the biochemical and patient-related determinants of
           failure to reach HbA1c targets

        -  To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal
           symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L)

        -  To compare over the treatment period, the overall incidence and rate of symptomatic
           hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]),
           of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of
           severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL

        -  To compare the overall safety: incidence of adverse events (including serious
           hypoglycemia and local tolerance at injection site), change in body weight, in waist
           circumference and in waist / hip ratio

        -  To assess the quality of life and treatment satisfaction
    


Intervention name(s): Insulin glargine; Insulin Detemir
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, once a day in the evening; Subcutaneous injection, twice a day at breakfast and before dinner
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanisms of Interplay Between Allergy and Viruses in Asthma
Condition: Rhinovirus Infection in Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of this study is to investigate the mechanisms of interplay between allergy (IgE and
      Th2 mediated inflammation) and virus infection in the development of asthma, as well as the
      risk and severity of acute exacerbations of asthma. Understanding these mechanisms should
      identify new approaches for novel therapies for the prevention of asthma development and for
      prevention/treatment of asthma exacerbations. Such treatment has potential to have a major
      impact on patient quality of life and to result in enormous reductions in health care costs.

      A human model will be used to identify dysregulated genes/proteins and determine
      relationships with disease outcomes. This study will compare lower airway responses between
      asthmatic and healthy control subjects undergoing rhinovirus (RV) experimental infection
      (subjects will be infected with rhinovirus as part of the study). This will have the dual
      advantage of investigating mechanisms in the most natural model possible, as well as
      developing a better model for testing novel therapeutic approaches. The investigators will
      analyse the samples from both subject groups, to determine their relevance to the human
      disease. Any genes/proteins shown to be dysregulated and related to disease outcomes in the
      human model will be very strong candidates for immediate translation into human intervention
      studies.

      Up to 12 asthmatic and/or healthy subjects will be recruited for a preliminary pilot study.
      These subjects will be ineligible to enter the main study due to the presence of neutralizing
      antibody to RV16 (~50% of subjects otherwise suitable for the study). These subjects will
      meet all other inclusion/exclusion criteria for the main study. The 12 participants will
      undergo tests including a single bronchoscopy, nasal sampling and blood tests allowing for
      optimisation of all sample processing techniques. They will not be infected with RV-16.

      In the main study the investigators will aim to study up to 15 healthy volunteers and 15
      volunteers with moderate asthma (all on inhaled steroid treatment). Subjects will undergo a
      single baseline bronchoscopy 2 weeks prior to inoculation with the RV16 virus. Following
      infection with the virus participants will be required to attend for regular sample
      collection including 2 further bronchoscopies post-infection. Patients will be followed until
      convalescence 6 weeks post infection.
    


Intervention name(s): Rhinovirus Infection
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Relationship Between Increasing Loading and Kinematic Parameters
Condition: Gait
Study type: Interventional

Summary: 
      The aim of this study is to investigate the influence of increasing loading to kinematic
      parameters of normal people while walking on the treadmill.
    


Intervention name(s): Loading level
Intervention type(s): Procedure
Intervention description(s): Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The gait analysis system will collect the data while they walk on the treadmill in barefoot with selected weight loading suit at 3.0km/h.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Knee; Loading; Kinematics
Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed as an open labeled pilot trial to analyze the acute responses of
      glucose, GLP-1, GIP, insulin secretory,and glucagon to a mixed meal tolerance test (MMTT) or
      intravenous glucose tolerance tests (IVGTT) with and without pretreatment with Exenatide
      (Byetta) 5 mcg sc.

      The investigators will also test the effects of Exenatide on gastric emptying during the
      MMTT.
    


Intervention name(s): Exenatide
Intervention type(s): Drug
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
Condition: Idiopathic Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This is a Phase IV, prospective, observational, post-marketing study designed to obtain
      additional data on the effect of XADAGO on motor and non-motor symptoms in Parkinson's
      Disease patients newly prescribed XADAGO.
    

Detailed description: 
      This Phase IV, multicenter, prospective, observational study to evaluate clinician-reported
      outcomes and patient-reported outcomes related to motor and non-motor symptoms, health
      status, quality of life and treatment satisfaction in PD patients who have been newly
      prescribed XADAGO according to Package Insert indication.

      This study also will gather "real world" data from a PD population in the US regarding their
      overall experience and degree of satisfaction with the use of XADAGO as an add-on treatment
      to their L-dopa regimen. Treatment experience will be captured using patient self-rating
      assessments as well as clinician ratings on assessments.
    

Intervention name(s): XADAGO (safinamide)
Intervention type(s): Drug
Intervention description(s): XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.
Other intervention name(s): XADAGO; safinamide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's Disease patients who have been newly prescribed XADAGO
      
Keywords: Parkinson's disease; Safinamide; Xadago; MAO-B inhibitor; off; non-motor symptoms; motor symptoms; levodopa; PD
Drug Therapy for Alcohol Detoxification
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This project will provide relevant clinical information for primary care practitioners
      treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo-
      controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and
      carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated
      alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a
      1-week posttreatment followup.
    


Intervention name(s): lorazepam (Ativan); carbamazepine (Tegretol)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carbamazepine; Lorazepam
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open-labelled, prospective 96-week study comparing the antiviral
      efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining
      lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.
    

Detailed description: 
      Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those
      of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in
      patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more
      prolonged viral suppression to undetectable level by PCR method, compared to patients with
      continuous lamivudine treatment. The results of this study will provide a rationale for
      switch treatment from one antiviral to another one, especially from LAM to ETV.
    

Intervention name(s): Entecavir; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): entecavir 0.5 mg QD; lamivudine 100 mg QD
Other intervention name(s): Baraclude 0.5mg; Zeffix 100mg QD
Intervention MeSH terms: Lamivudine; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Lamivudine; Entecavir
Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      The clinical study is a randomized-controlled, double-masked, crossover clinical trial with
      two study treatments to compare two study lens types and the initial performance, in terms of
      the subjective response after a period of lens dispensing. The study will last approximately
      2 to 4 months.
    


Intervention name(s): JJV Investigational senofilcon A Multifocal Lens1; JJV Investigational senofilcon A Multifocal Lens2
Intervention type(s): Device; Device
Intervention description(s): CONTROL; TEST
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment