bioihbjkbjnl/mcl2 huggingface dataset:
A Study for Patients With Diabetes Mellitus (IOPA)
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Human insulin 30/70; Insulin lispro low mix
Intervention description: Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks; Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: diabetes; type 1; type 2

Summary:

      The purpose of this study is to compare glycemic control (HbA1c) in Chinese patients with
      type 1 or type 2 diabetes when treated with insulin lispro low mixture and human insulin
      30/70.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed type 1or type 2 diabetes for at least 2 months

          -  Aged between 18 and 70 (inclusive)

          -  Have been treated with human insulin mix 30/70 twice daily for at least 2 months prior
             to entering the study

          -  Have glycosylated hemoglobin (Hb1Ac) between 1.2 and 1.7 times the upper limit of
             normal reference range within 2 weeks prior to or at Visit 1

          -  Compliance with diet and insulin therapy and performs regular blood glucose monitoring

        Exclusion Criteria:

          -  Have used oral antidiabetic agents within 30 days prior to entry into the study

          -  Receive a total daily dose of insulin >2 units/kilogram

          -  Have had more than two episodes of severe hypoglycemia within 6 months prior to entry
             into the study

          -  Have a body mass index >35 kilograms per square meter (kg/m2)

          -  Receive chronic systemic glucocorticoid therapy
Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: eletriptan
Intervention description: oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
Intervention MeSH terms: Eletriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Women are followed prospectively for 3 months, recording headaches, other symptoms, and
      menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan
      for 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18-45 healthy menstruating female

        Exclusion Criteria:

          -  cardiac or other conditions precluding use of eletriptan
Comparison of Sirolimus and Azathioprine in Lung Transplantation
Condition: Delayed Graft Function; Acute Graft Rejection
MeSH terms: Delayed Graft Function
Intervention: azathioprine; sirolimus
Intervention description: azathioprine 2mg/kg; sirolimus 2-4mg daily
Intervention MeSH terms: Sirolimus; Azathioprine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rejection in lung transplant

Summary:

      The purpose of this study is to compare the safety and effectiveness of two different
      anti-rejection drug regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lung transplant recipients between the age of 18 and 65 years of age.

          -  Females who are capable of becoming pregnant must have a negative pregnancy test prior
             to consent. (Females of childbearing potential must be using a medically acceptable
             method of birth control for the duration of the study.)

          -  All patients must be able to give written informed consent.

        Exclusion Criteria:

          -  White blood cell count (WBC) < 4.0/mm3

          -  Platelet count < 100,000/mm3

          -  Severe hypercholesterolemia (> 350 mg/dl) or hypertriglyceridemia (> 500 mg/dl)

          -  Uncontrolled systemic infection at the time of consent.

          -  Previous organ transplant

          -  Treatment with a drug within the last 30 days that has not received regulatory
             approval at the time of study entry or for the duration of the study (3 years).

          -  Use of maintenance immunosuppression other than daclizumab, tacrolimus, azathioprine,
             or prednisone prior to randomization.
Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study
Condition: Orthostatic; Hypotension, Neurogenic
MeSH terms: Hypotension, Orthostatic; Hypotension
Intervention: Midodrine; Pyridostigmine Bromide; Midodrine + pyridostigmine
Intervention MeSH terms: Midodrine; Bromides; Pyridostigmine Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic
      hypotension and investigate the quality of life of treatment of neurogenic orthostatic
      hypotension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >=18 patients who complained of dizziness

          -  Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or
             diastolic blood pressure drop >=10

        Exclusion Criteria:

          -  Drug-induced hypotension, if necessary, evaluate patient after discontinuing the
             causative drug for one month

          -  Heart failure or Chronic renal failure

          -  Patients who cannot or do not want to write questionaires.

          -  Poor drug compliance
Telephone Based Management of Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Self Monitoring Lipid Analyzer
Intervention description: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Internet based monitoring system

Summary:

      The purpose of the study is to demonstrate that systematic self measurement of blood lipids
      reduces LDL cholesterol more effectively than standard care. The hypothesis is that
      cholesterol lowering medication adherence will be improved with self monitoring and reporting
      of frequent blood lipids and the percentage of patients achieving LDL goal will be greater
      than without home monitoring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  LDL > 130mg/dl

        Exclusion Criteria:

          -  Pregnant patients

          -  liver disease

          -  allergic reaction to statins
CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Condition: Chronic Myelogenous Leukemia in Chronic Phase
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML; Chronic Myelogenous Leukemia; Leukemia; CML-CP; Nilotinib

Summary:

      "This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in
      adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic
      myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and
      deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate
      of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years
        of age. Patients must have adequate end organ function.

        Exclusion Criteria:

        Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the
        following exception: While awaiting study start, patients may be treated with anagrelide
        (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14
        day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline
        treatment. Patients taking a TKI prior to study entry must have at least a one day washout
        from their last dose of medication and have recovered from any side effects of such
        therapy.

        Impaired cardiac function as defined by the protocol. Patients with contraindications to
        receiving nilotinib, including concomitant medications.
A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]
Intervention description: tocilizumab 8 mg/kg intravenous infusion once in 4 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm, non-randomized study will evaluate the adherence and persistence
      to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who
      have an inadequate clinical response to non-biologic DMARDs. Patients will receive
      tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with
      methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time
      of study treatment is 6 months. The target sample size is 20-50 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >/= 18 years of age

          -  moderate to severe active rheumatoid arthritis

          -  inadequate response, or intolerance to previous therapy with one or more traditional
             DMARDs

          -  DAS >3.6

          -  pneumology examination (including chest x-ray and quantiferon)

        Exclusion Criteria:

          -  < 18 years of age

          -  active infection

          -  active tuberculosis

          -  uncontrolled hyperlipoproteinaemia

          -  demyelinating disorders

          -  concomitant anti-TNF drugs

          -  history of intestinal ulceration and diverticulitis
Understanding Disparities in Quitting in African American and White Smokers
Condition: Smoking Cessation
Intervention: Varenicline
Intervention description: 1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to describe the differences in quitting smoking between African
      Americans (AA) and White smokers treated with varenicline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-Hispanic African American or non-Hispanic White

          -  ≥ 18 years of age

          -  Smoked 3-20 cigarettes per day

          -  Smoked on >25 days of the past 30 days

          -  Functioning telephone

          -  Interested in quitting smoking

          -  Interested in taking 3 months of varenicline

          -  Willing to complete all study visits

        Exclusion Criteria:

          -  Renal impairment

          -  Evidence or history of clinically significant allergic reactions to varenicline

          -  A cardiovascular event in the past month Hospitalization in the past 2 months for any
             cardiovascular disease, including but not limited to:

               -  Angina

               -  Myocardial infarction

               -  Peripheral vascular disease

               -  Stroke

          -  New onset of chest pain or arrhythmia in the past 2 months

          -  History of alcohol or drug dependency in the past year

          -  Major depressive disorder in the last year requiring treatment

          -  History of panic disorder, psychosis, bipolar disorder, or eating disorders

          -  Use of tobacco products other than cigarettes in past 30 days

          -  Use of pharmacotherapy in the month prior to enrollment, including prior use of
             varenicline

          -  Pregnant, contemplating getting pregnant, or breastfeeding

          -  Plans to move from Kansas City during the treatment and follow-up phase

          -  Another household member enrolled in the study
Mask Leak With Nasal Cannula in Noninvasive Positive Pressure Ventilation
Condition: Mechanical Ventilation Pressure High
Intervention: Nasal cannula; Non-invasive positive pressure ventilation
Intervention description: Placement of nasal cannula under non-invasive positive pressure ventilation mask; Non-invasive positive pressure ventilation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective randomized cross over study of healthy volunteers undergoing continuous
      positive airway pressure ventilation via a noninvasive ventilation (NIV) mask with and
      without the addition of nasal cannulas. Mask leak will be measured by the ventilator after 60
      seconds of spontaneous resting ventilation, with each subject serving as his or her own
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Volunteer for study

        Exclusion Criteria:

          -  Known cardiac disease

          -  Known pulmonary disease (to include respiratory infections)
Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: KAD-1229; Placebo; Insulin
Intervention MeSH terms: Mitiglinide
Phase: Phase 4
Study type: Interventional
Enrollment: 178.0
Sex: All
Minimum age: 20 Years
Keywords: Type 2 Diabetes Mellitus; HbA1c

Summary:

      The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination
      therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2
      Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or
      insulin and oral hypoglycemic agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who has been receiving dietary therapy and a stable dose and regimen of
             insulin over 8 weeks before at the time of an observation term start

          -  Patients whose HbA1c at the time of an observation term start is 7.5% or more and less
             than 10.0%

        Exclusion Criteria:

          -  Type 1 Diabetes Mellitus

          -  Patients with serious diabetic complications and other serious complications
Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Placebo
Intervention description: A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.; 3 capsules of placebo have to be taken once daily in the morning, with or without food.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter
      trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6
      through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an
      inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured
      during once or bi-weekly visits, three times per visit-day, by a computer based Continuous
      Performance Test. Following an initial 3-28-day screening and washout phase, patients will be
      assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week
      atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7
      week period at the target dose of 1.2 mg/kg per day.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who are at least 6 years of age, and who will not have reached
             their 13th birthday

          -  Diagnosis of ADHD

          -  Normal intelligence

          -  Able to swallow capsules

        Exclusion Criteria:

          -  Weight less than 20 kg or more than 60 kg at study entry

          -  Prior treatment with atomoxetine

          -  History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3
             months

          -  History of severe allergies or multiple adverse drug reactions

          -  Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT
             prolongation, inherited cardiac disorders
Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
Condition: Cystocele; Uterine Prolapse; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Cystocele; Uterine Prolapse; Prolapse
Intervention: grafted anterior prolapse repair; sutured anterior vaginal prolapse repair
Intervention description: anterior vaginal prolapse repair with graft; anterior vaginal prolapse repair with suture
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 75.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cystocele; uterine prolapse; urinary incontinence

Summary:

      The purpose of this study is determine whether grafted anterior vaginal prolapse repair is
      more effective and associated with less complications than prolapse repair with suture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  stage II or greater anterior vaginal prolapse requiring surgical correction

          -  age 21 years and older

        Exclusion Criteria:

          -  less than Stage II anterior vaginal prolapse

          -  decline participation

          -  pregnant or contemplating future pregnancy

          -  prior anterior vaginal prolapse repair with biologic or synthetic graft

          -  active or latent systemic infection

          -  compromised immune system

          -  previous pelvic irradiation or cancer

          -  known hypersensitivity to polypropylene

          -  uncontrolled diabetes mellitus

          -  unable or unwilling to give valid informed consent

          -  unable or unwilling to comply with the protocol

          -  scheduled to undergo concomitant Burch colposuspension or pubovaginal sling
Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Facial Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Intervention: Duac; Ziana gel
Intervention description: Clindamycon and benzoyl peroxide topical gel once a day for 12 weeks; Clindamycin and tretinoin gel once a day for 12 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Acne

Summary:

      The purpose of the study is to determine the development of microbial resistance when using
      one of two topical acne therapies for the treatment of facial acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient at least 12 years of age. Female subjects of childbearing potential must
             have a negative urine pregnancy test result at baseline and practice a reliable method
             of contraception throughout the study.

          -  Mild to moderate facial acne vulgaris

          -  Able to understand the requirements of the study and sign informed consent/HIPAA
             authorization forms. Subjects under the legal age of consent in the state where the
             study is conducted must also have the written, informed consent of a parent or legal
             guardian.

        Exclusion Criteria:

          -  Female subjects who are pregnant (positive urine pregnancy test), breast feeding or
             who are of childbearing potential and not practicing a reliable method of birth
             control

          -  Allergy or sensitivity to any component of the test medication

          -  Known hypersensitivity to to any component of the investigational formulations

          -  Known history of enteritis (regional enteritis, ulcerative colitis, pseudomembranous
             colitis, or antibiotic-associated colitis

          -  Beards or sideburns

          -  Skin disease/disorder that might interfere with the diagnosis or evaluation of acne
             vulgaris

          -  Evidence of recent alcohol or drug abuse

          -  Participation in an investigational drug study within 30 days of the baseline visit