bioihbjkbjnl/mcl2 huggingface dataset:
Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomised, single-blind, placebo-controlled, repeat dose study of
      otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will
      receive a single dose of adalimumab (HUMIRA, Abbott) as rescue medication to assess
      additional concomitant safety and tolerability issues.
    

Detailed description: 
      Otelixizumab is a humanized, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb)
      directed against the ε domain of the human lymphocyte antigen CD3, which is currently
      undergoing phase III clinical trials in adult new-onset type I diabetes mellitus patients and
      has been evaluated in rheumatoid arthritis and psoriasis patients in small exploratory
      studies. Otelixizumab has been administered via the subcutaneous route as a single dose in
      type I diabetes patients. This study is a randomised, single-blind, placebo-controlled,
      repeat dose study of otelixizumab administered subcutaneously in rheumatoid arthritis
      patients. One cohort will receive a single dose of adalimumab (HUMIRA, Abbott) as rescue
      medication to assess additional concomitant safety and tolerability issues.

      This study will consist of a screening phase, followed by an in-house phase whereby
      otelixizumab will be administered to cohorts in a staggered fashion. Six cumulative doses
      will be evaluated covering a 10-fold dose range in seven cohorts. The starting regimen will
      be three doses (1.5 mg cumulative dose), increasing to 15 doses (15 mg cumulative dose).
      Cohorts 1a and 1b have been included as optional lower doses. Serial blood samples will be
      obtained for clinical laboratory testing, determination of pharmacodynamic markers, serum
      otelixizumab PK parameters, and immunogenicity. Safety and pharmacodynamic data from the
      previous dose(s) will be evaluated prior to dose escalation or modification to ensure safety
      and to achieve target systemic peripheral blood pharmacology. Adverse events, laboratory
      values, vital signs and ECG's will be monitored closely during this study. All subjects in
      the study will undergo long-term follow-up out to 48 months to monitor and ensure patient
      safety.
    

Intervention name(s): subcutanious administration; Placebo
Intervention type(s): Drug; Other
Intervention description(s): drug will be administered subcutaneously in varying amounts over a verying time period according to details stated in the 'arms' section; Placebo will be given to one member of each cohort.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; repeat dose; pharmacodynamics; pharmacokinetics; subcutaneous; safety; Otelixizumab; long term follow up; tolerability
Drug-drug Interaction Study Between UIC201601 and UIC201602
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and
      pharmacokinetics after co-administration of UIC201601 and UIC201602 in healthy male
      volunteers.
    


Intervention name(s): UIC201602 and co-administration of UIC201601 and UIC201602; UIC201601 and co-administration of UIC201601 and UIC201602
Intervention type(s): Drug; Drug
Intervention description(s): UIC201602 4 Cap/day for 14 days
Wash out 21 days
UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days; UIC201601 4 Tab/day for 7 days
Wash out 14 days
UIC201601 4 Tab + UIC201602 4 Cap / day for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Detection of Pressure Areas for Two Elastomeric Impressions
Condition: Diabetes Free Completely Edentulous Patients
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Forty completely edentulous patients were selected and randomly distributed into two groups
      20 patients each.Group I received complete dentures constructed from elastomeric impression
      with wax spacer,group II received complete dentures constructed from elastomeric impression
      with no wax spacer.then on time of denture insertion pressure areas were detected using
      pressure indicating paste and the denture retention was detected.The results showed less
      pressure areas in group I and more denture retention values than group II.
    

Detailed description: 
      This study was conducted to evaluate the significance of using wax spacer in the impression
      technique regarding the pressure areas and retention of the complete dentures constructed.
      Forty patients with edentulous maxillary arches were selected from the outpatient clinic of
      removable prosthodontics department, faculty of oral and dental medicine, Cairo university
      .The patients were randomly divided into two groups. Group I received dentures constructed
      from impression technique with wax spacer while group II received dentures constructed from
      impression technique with no spacer. On the day of denture insertion pressure areas were
      detected using pressure indicating paste and denture retention was measured using force
      gauge. The data was collected and analyzed using student's t-test.
    

Intervention name(s): impression technique
Intervention type(s): Other
Intervention description(s): impression technique with and without wax spacer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The measurements are done on the day of denture insertion with no follow up timing intervals
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pressure area; polyether elastomeric impression; wax spacer
Tolerability of Antistax® in Patients Suffering From Chronic Venous Insufficiency (CVI)
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Main objective: Safety and tolerability of Antistax® film coated tablets

      Secondary objective: Effect of Antistax® film coated tablets on subjective symptoms of
      chronic venous insufficiency
    


Intervention name(s): Antistax film coated tablets
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose
      combination of mitiglinide/metformin, compared with free combination of mitiglinide and
      metformin in healthy male subjects.
    

Detailed description: 
      The Korean clinical practice guidelines on DM recommend that a second oral agent with a
      different mechanism of action be combined to the regimen when adequate glycemic control is
      difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore,
      a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an
      insulin secretagogue, could be an effective and ideal regimen for management of diabetes.
    

Intervention name(s): mitiglinide and metformin; mitiglinide and metformin
Intervention type(s): Drug; Drug
Intervention description(s): Free combination of Mitiglinide 10mg and Metformin 500mg; Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg
Intervention MeSH terms: Metformin; Mitiglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: mitiglinide; metformin; Pharmacokinetics; Safety
The Impact of Thumb Carpometacarpal Osteoarthritis on General Health
Condition: Thumb Arthritis
MeSH terms: Arthritis; Osteoarthritis
Study type: Observational

Summary: 
      This study is designed to define the impact of thumb arthritis on patient's general health.
      As a secondary objective, data will be analyzed to determine the effects of medical and
      musculoskeletal comorbidities on the rating of upper extremity function by the patient.
    

Detailed description: 
      This study is designed to define the impact of thumb arthritis on patient's general health.
      As a secondary objective, data will be analyzed to determine the effects of medical and
      musculoskeletal comorbidities on the rating of upper extremity function by the patient.

      Potential Contribution: The data that we intend to gather could further our understanding of
      the overall health impact of thumb osteoarthritis and allow surgeons to more accurately
      interpret patient-rated measures of upper extremity function in the presence of
      comorbidities.

      Osteoarthritis of the thumb carpometacarpal joint is one of the most common sites of
      arthritic degeneration in the hand. To date, no study has examined this conditions impact on
      overall health using a validated health measure (e.g. SF-36). Additionally, no study has
      examined the impact of medical and musculoskeletal comorbidities on patient-rated measures of
      upper extremity function in these patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients presenting for treatment have thumb arthritis
      
Keywords: thumb; arthritis; Impact of thumb arthritis on health
Longitudinal Follow-up of High School Athletes
Condition: Elite Athlete; Healthy
Study type: Observational

Summary: 
      In this study the investigators will study the lung function and airway inflammation in elite
      athletes starting at the elite sport school (age: 12-13 year) and the change in lung function
      parameters and airway inflammation after 1 and 2 years at the elite sport school in
      comparison to age-matched controls (exercising at a recreational level, <4 hours/week).
    

Detailed description: 
      A group of elite athletes (from the elite sport school in Leuven (n=35) in cooperation with
      'Sportmedisch Advies Centrum' (SMAC) UZ Leuven) and the future team of the Flemish Swimming
      Federation (n=15) will be recruited at the start of their career (first level) as an elite
      athlete. A group of healthy subjects (n=20) will be recruited to serve as a control.

      The investigators will compare lung function parameters and airway inflammation at the first
      visit in the autumn of 2011 and the second and third visit (one and two years later,
      respectively).

      Lung function will be assessed by spirometry. Sputum will be induced with an aerosol of
      inhaled hypertonic saline in concentrations of 3%, 4% and 5% for 7 minutes generated by a De
      Vilbiss nebuliser (Ultra-Neb 2000 model 200HI) after pretreatment with 400 mg inhaled
      salbutamol. Sputum will be processed as previously described and the obtained cell
      suspensions will be used for differential cell counts and cytokine mRNA analysis. The
      supernatant will be used to measure cytokine and chemokine levels.

      EIA diagnosis (visit 1,2 and 3) will be assessed by a diagnostic test for asthma (positive
      reversibility test with salbutamol) and a positive EIB-test. Eucapnic voluntary
      hyperventilation test will be used as a test for EIB (gold standard of IOC-MC). Dynamic lung
      function parameters will be assessed before and immediately after, 5' after, 10' after and
      15' after eucapnic hyperventilation. Patients were asked to breath at 85% of the maximal
      ventilation (predefined as maximal voluntary volume) for 6 minutes through a mouthpiece
      connected to a reservoir. The reservoir is be filled with a gas mixture of 21% 02, 5% CO2 and
      74% N2. The test is considered positive when a drop in FEV1 of >10% occurred at one of the
      time points after eucapnic hyperventilation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A group of elite athletes at the start of their career (both from the elite sport school in
        Wilrijk (n=15) and Leuven (n=35) in cooperation with 'Sportmedisch Advies Centrum' (SMAC)
        UZ Leuven) are recruited. Three sport disciplines are included: basketball players,
        football players and swimmers.

        A group of healthy subjects (n=20) is recruited to serve as a control.
      
Biospecimen description: 
      induced sputum sample and venous blood (serum)
    
Keywords: individual
Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

        -  To evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe
           active Crohn's Disease（CD）

        -  To evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active
           CD.
    


Intervention name(s): MT-1303; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease
Life Style Modifications Prevents Type 2 Diabetes in Asian Indians
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Three year prospective randomised controlled trial in IGT subjects to study the effect of
      metformin and lifestyle modification in preventing the conversion to diabetes
    

Detailed description: 
      Lifestyle modification helps in primary prevention of diabetes in multiethnic Americans,
      Finnish and Chinese populations. In a prospective community based study, we tested if the
      conversion to diabetes could be influenced by interventions in native Asian Indians with
      impaired glucose tolerance (IGT) who were younger, leaner and more insulin resistant than the
      above populations.

      We randomized 531 (Men : Women, 421 : 110) subjects with IGT [mean age of 45.9 + 5.7 years
      and body mass index (BMI) of 25.8 + 3.5 kg/m2 into four groups. Group 1 was the control
      (CON), Group 2 was advised lifestyle modification (LSM), Group 3 was treated with metformin
      (MET) and Group 4 with LSM plus MET. Primary outcome measure was type 2 diabetes diagnosed by
      the WHO criteria.

      In a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%,
      39.3%, 40.5% and 39.5% in group 1 to 4 respectively. The relative risk reduction was 28.5%
      with LSM (95 % confidence interval (CI), (20.5 - 37.3), (p=0.018), 26.4% with MET (95% CI,
      19.1 - 35.1) (p = 0.029) and 28.2% with LSM plus MET (95% CI, 20.3 - 37.0), (P=0.022) versus
      control group. The numbers needed to treat to prevent one incident case of diabetes were 6.4
      for LSM, 6.9 for MET and 6.5 for LSM+MET.

      Conversion of IGT to diabetes is high in native Asian Indians. LSM and metformin
      significantly reduced the incidence of diabetes in Asian Indians with IGT. There was no added
      benefit by combining both.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Impaired glucose tolerance; Intervention; Prevention
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the progression of diabetic retinopathy in type 2 diabetic patients with
      mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.
    

Detailed description: 
      Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen
      to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic
      retinopathy of severity 53/<53 on the ETDRS scale, for 5 years of followup. Outcomes measured
      by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.
    

Intervention name(s): Insulin glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetic Retinopathy
Myopia Progression After Ceasing Myopia Control Contact Lens Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a continuation study for subjects who were previously fit with test or control
      lenses; all will stop wearing their study lenses assigned in the previous study and will
      start to wear an FDA-approved marketed spherical soft contact lens.
    


Intervention name(s): 1 Day Acuvue Moist
Intervention type(s): Device
Intervention description(s): Lenses will be worn in a daily wear modality
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nicotine Patch - Bioequivalence Study
Condition: Healthy Smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine
      patch to that of a reference formulation following repeated applications
    


Intervention name(s): Test treatment : V0116 transdermal patch; Reference treatment : Nicotine transdermal patch
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Smoking cessation; Nicotine; Tobacco Use Disorder; Central Nervous System Agents
Study of Broader Efficacy of Atomoxetine in the Treatment of ADHD in Children/Adolescents
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the hypothesis that children/adolescents with ADHD, who are treated with atomoxetine
      hydrochloride in comparison to standard current therapies have greater improvements in their
      quality of life.
    


Intervention name(s): Atomoxetine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
Condition: Urticaria
MeSH terms: Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the dosis of DL which is sufficient to
      inhibit cold urticaria symptoms.
    

Detailed description: 
      A total of 30 patients (male and female) with ACU will be included in this study
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): Every day,per mouth,in the evening, for 14 +- 2 days.
Other intervention name(s): No arm names.
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACU; acquired cold urticaria
Effect of Docosahexaenoic Acid on the Inflammatory Response and Clinical Outcomes From Surgical Patients
Condition: Severe Sepsis; Organ Dysfunction Syndrome
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration
      attenuates the inflammatory cytokines and improve clinical outcomes in neonates who underwent
      cardiovascular surgery
    

Detailed description: 
      Severe sepsis and organ failure are leading causes of death in surgical patients. Several
      studies indicate that a causal relationship exists between the surgical or traumatic injury
      and the predisposition to develop septic/infectious complications and multiple organ failure;
      this is attributable to uncontrolled inflammatory response. Since neonates have an immature
      immune system, they are in a higher risk to develop uncontrolled inflammatory response and
      adverse clinical outcomes.

      N-3 long chain polyunsaturated fatty acids (L-PUFAs) such as docosapentaenoic and
      docosahexaenoic acids (EPA and DHA) have been shown to reduce the inflammatory response by
      reducing cytokines, infection rates and length of hospitalization in patients with abdominal
      surgery. Therefore, acute and enteral administration of DHA may improve clinical outcomes in
      neonates with cardiovascular surgery
    

Intervention name(s): Docosahexaenoic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): DHA have oil form. Each neonate is receiving 75 mg/kg/day of DHA in 188 uL/kg/day in two doses per day, since two days before surgery and over six days following cardiovascular surgery; Placebo have oil form. Each neonate is receiving 188uL/kg/day of sunflower oil as placebo in two doses per day, since two days before surgery and over six days following cardiovascular surgery
Other intervention name(s): n-3 LC-PUFAs; omega 3 fatty acids; Long chain polyunsaturated fatty acids; Life's DHA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Docosahexaenoic acid; n-3 Long Chain Polyunsaturated Fatty Acids; omega 3 fatty acids; neonates; clinical outcomes; critically ill patients; Inflammatory and antiinflammatory cytokines; Length of intensive care stay
Efficacy Study of EVT 201 to Treat Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a compound known as EVT 201 is effective in
      treating people diagnosed with primary insomnia ( difficulty sleeping with no other
      significant contributing factor, such as depression).
    


Intervention name(s): EVT 201
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment