bioihbjkbjnl/mcl2 huggingface dataset:
Telecommunications System in Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: TLC-Asthma; TLC-health education
Intervention description: Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens; A telephone-linked communication system (TLC) to provide general health education.
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Disease Management; Telecommunications; Health Services; Quality of Life; Patient Compliance

Summary:

      This project is investigating whether application of a telecommunications system to the care
      of adult patients with asthma will improve self-management by enhancing compliance with
      preventive medication regimens and fostering the use of peak-flow-based action plans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician diagnosis of asthma

          -  Receiving treatment with one or more daily controller (i.e., preventive) medications

          -  Age = 18 years

          -  Less than 30 pack years of cigarette smoking

          -  FEVi greater than 50% of predicted

          -  FEVi bronchodilator response of at least 12%

          -  Ability to use a telephone without assistance

        Exclusion Criteria:

        N/A
AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Condition: Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Apixaban; Unfractionated Heparin (UFH); Warfarin
Intervention description: 10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks); Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more; Dosing for 24 weeks to target INR range between 1.5-2.5
Intervention MeSH terms: Heparin; Calcium heparin; Warfarin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: DVT; PE; VTE

Summary:

      The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE
      subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as
      initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total
      treatment period is 24 weeks)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute symptomatic proximal DVT with evidence of proximal thrombosis

          -  Acute symptomatic PE with evidence of thrombosis in segmental or more proximal
             branches

        Exclusion Criteria:

          -  Active bleeding or high risk for bleeding contraindicating treatment with UFH and a
             VKA.

          -  Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood
             pressure > 110 mm Hg

          -  Subjects requiring dual anti-platelet therapy
Evaluation of a New Cardiac Biomarker Assay
Condition: Acute Coronary Syndrome; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Infarction
Intervention: ARCHITECT STAT High Sensitive Troponin I Assay
Intervention description: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.
Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the performance and intended use of a new cardiac
      biomarker test, Troponin I, in an intended use population. Blood specimens will be tested
      using the new investigational test that detects the level of Troponin I. Results will be
      compared to the diagnosis of whether or not an acute myocardial infarction (MI) occurred.
    

Eligibility criteria:

        Inclusion Criteria:

          -  presenting to the Emergency Department with symptoms consistent with or suggestive of
             Acute Coronary Syndrome (ACS) defined as at least 5 minutes of chest pain (or symptoms
             consistent with myocardial ischemia) up to 6 hours prior to initial evaluation.

          -  an Electrocardiogram (ECG) result within 2 hours of presentation for observation of
             Acute Coronary Syndrome (ACS).

          -  greater than 18 years of age.

          -  not known to be pregnant.

          -  agreement to the follow-up required by the study.

        Exclusion Criteria:

          -  prior participation in this study.

          -  require dialysis for end stage renal disease.

          -  history of a previous heart transplant.

          -  coexisting disorder associated with limited life expectancy.

          -  currently participating in another investigational device or drug study.
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51; JE-VAX
Intervention description: IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28; JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 867.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51
      compared to JE-VAX in healthy subjects aged > or = 18 years
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Written informed consent obtained prior to study entry

        Exclusion Criteria:

          -  History of clinical manifestation of any flavivirus infection

          -  History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue
             fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for
             inclusion, these subjects will be part of the safety population, but will not be
             analyzed for immunogenicity in the per-protocol analysis)

          -  Use of any other investigational or non-registered drug or vaccine in addition to the
             study vaccine during the study period or within 30 days preceding the first dose of
             study vaccine

          -  Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

          -  A family history of congenital or hereditary immunodeficiency

          -  History of autoimmune disease

          -  Any acute infections within 4 weeks prior to enrollment

          -  Infection with HIV, Hepatitis B or Hepatitis C

          -  Pregnancy, lactation or unreliable contraception in female subjects
Bloodstream Absorption of Avastin and Lucentis After Injection Into the Eye
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Bevacizumab; Ranibizumab
Intervention description: Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.; Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
Intervention MeSH terms: Bevacizumab; Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vascular endothelial growth factor; macular edema; diabetic retinopathy

Summary:

      Currently, two similar medications are available for injection into the eye to treat a
      variety of eye diseases. These medications are called ranibizumab (Lucentis) and bevacizumab
      (Avastin). They both have a similar mechanism of action and work equally well, however only
      ranibizumab was designed for use in the eye. It is significantly more expensive per injection
      than bevacizumab (by a factor of roughly 40x).

      In published studies trends have been noted towards an increased rate of systemic side
      effects such as heart attacks and strokes. This is presumably due to absorption of the
      drug(s) from the eye into the bloodstream, however this has never been shown before. The
      purpose of the investigators study was to compare the bloodstream levels of bevacizumab and
      ranibizumab at various time points after injection into the eye. This required the creation
      of a sophisticated assay to measure blood levels of the drugs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients in whom anti-vascular endothelial growth factor (VEGF) therapy is indicated
             for the treatment of diabetic macular edema

          -  able to return for extra clinic visits according to study schedule

        Exclusion Criteria:

          -  active malignancy

          -  previous retinal laser treatment

          -  previous anti-VEGF therapy

          -  previous vitrectomy
A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin degludec; insulin aspart; insulin aspart
Intervention description: For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).; For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).; For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.; For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of the trial is to compare efficacy of insulin
      degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD)
      versus basal bolus with insulin degludec (IDeg) OD + IAsp three times a day (TID) in
      controlling glycaemia by evaluating glycosylated haemoglobin (HbA1c). The trial is an
      extension to trial NN5401-3941 (NCT01680341).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HbA1c equal to or above 7.0% measured after 26 weeks of treatment in NN5401-3941
             (NCT01680341), by central laboratory

        Exclusion Criteria:

          -  Uncontrolled or untreated severe hypertension defined as systolic blood pressure equal
             to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg

          -  Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate
             aminotransferase (ASAT) equal to or above 2.5 times upper limit of normal

          -  Impaired renal function defined as serum-creatinine equal to or above 125 micromol/L
             (equal to or above 1.4 mg/dL) for males and equal to or above 110 micromol/L (equal to
             or above 1.3 mg/dL) for females
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
Condition: MPN (Myeloproliferative Neoplasms)
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Myeloproliferative Disorders
Intervention: Ruxolitinib; Placebo
Intervention description: Ruxolitinib phosphate tablets 5 mg administered as oral doses.; Matching placebo tablets were administered as oral doses in the same manner as active drug.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis

Summary:

      This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib
      (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis
      (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or
      Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia
             vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF)
             according to the 2008 World Health Organization criteria

          -  Subjects with myelofibrosis requiring therapy must be classified as high risk OR
             intermediate risk level 2 according to the prognostic factors defined by the
             International Working Group

          -  Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,
             2 or 3

          -  Subjects who have not previously received treatment with a Janus kinase (JAK)
             inhibitor

        Exclusion Criteria:

          -  Subjects with a life expectancy of less than 6 months

          -  Subjects with inadequate bone marrow reserve as demonstrated by specific clinical
             laboratory counts

          -  Subjects with inadequate liver or renal function

          -  Subjects with clinically significant bacterial, fungal, parasitic or viral infection
             which require therapy

          -  Subjects with an active malignancy over the previous 5 years except specific skin
             cancers.

          -  Subjects with severe cardiac conditions

          -  Subjects who have had splenic irradiation within 12 months
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Condition: Glaucoma; Angle-Closure
MeSH terms: Glaucoma; Glaucoma, Angle-Closure
Intervention: XEN45
Intervention description: XEN45 unilaterally implanted in the study eye
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with
      Angle Closure Glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present
        in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye -
        Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion
        Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of
        bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood
        thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation -
        Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile
        glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study
        eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic
        keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as
        Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial
        keratoplasty o previous laser or incisional intraocular surgery that might interfere with
        the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in
        the study eye - Active or history of chronic uveitis in the study eye - Unable to
        discontinue contact lens wear in the study eye during the study
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Condition: Agitation in Dementia, Including Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Intervention: ITI-007; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled study comparing the efficacy and
      safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation
      in patients with dementia, including Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of probable Alzheimer's disease

          -  Clinically significant symptoms of agitation secondary to probable Alzheimer's disease

          -  Able to attend outpatient clinic visits with primary caregiver

        Exclusion Criteria:

          -  Unable to comply with study procedures

          -  Considered medically inappropriate for study participation
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention description: Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 615.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naïve; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder

Summary:

      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing specific forms of birth control

          2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at
             screening)

          3. HCV genotype 1 infection per screening laboratory result

        Exclusion Criteria:

          1. Use of contraindicated medications within 2 weeks of dosing

          2. Abnormal laboratory tests

          3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody

          4. History of solid organ transplant, clinical evidence of Child-Pugh B or C
             classification or clinical history of liver decompensation

          5. Presence of hepatocellular carcinoma at screening
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
Condition: Hypercholesterolemia, Familial
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Comparator: niacin (+) laropiprant (MK0524A); Comparator: placebo
Intervention description: niacin (+) laropiprant (2 g) po qd.; niacin (+) laropiprant (2 g) placebo po qd.
Intervention MeSH terms: Niacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 937.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia
      on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess
      the affects of MK0524A on carotid intima media thickening using ultrasound compared to
      patients taking placebo. There will be 12 scheduled clinic visits involving review of medical
      history, physical exam, vital signs, laboratory testing, ultrasound imaging, and
      electrocardiograms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia
             and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to
             400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy

        Exclusion Criteria:

          -  A condition which, in the opinion of the investigator, might pose a risk to the
             patient or interfere with participating in the study

          -  Patients with less than 80% drug study compliance

          -  Patients with chronic medical conditions known to influence serum lipids or
             lipoproteins or significantly affect the ultrasound acoustic window

          -  Patients with unstable dose of medications

          -  Pregnant or lactating women, or women intending to become pregnant are excluded

          -  Patient with diabetes mellitus that is poorly controlled, or is taking new or recently
             adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

          -  Patients with the following conditions: high grade stenosis (greater than 75%) of the
             carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias,
             unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV
             positive, episode of gout (within 1 year)