bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Asacol 800 mg (mesalamine); Asacol 400 mg (mesalamine)
Intervention description: tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily; tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is a prospective clinical study to evaluate the safety and efficacy of two
      different doses of Asacol for the treatment of moderately active ulcerative colitis. In
      addition, a new tablet formulation will be evaluated at one of the two doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female between 18 and 75 years of age;

          -  have a confirmed diagnosis of ulcerative colitis with the extent varying from
             proctitis to pancolitis;

          -  currently demonstrating moderately active disease

        Exclusion Criteria:

        Patients will be excluded from admission to the study if they have/are:

          -  a history of allergy or hypersensitivity to salicylates or aminosalicylates;

          -  a history of extensive small bowel resection (>1/2 the length of the small intestine)
             causing short bowel syndrome;

          -  current renal or hepatic disease;

          -  participated in any drug or device clinical study within 30 days of entry;

          -  currently enrolled in any other clinical study;

          -  received any oral, intravenous, intramuscular, or rectally administered
             corticosteroids within 1 month prior to the Baseline Visit;

          -  received any other topical rectal therapy during the week prior to the Screening
             Visit;

          -  received immunomodulatory therapy including, but not limited to, 6-mercaptopurine,
             azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline
             Visit;

          -  received a dose of mesalamine-containing compound by any route from which more than
             1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit
             (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6
             g/day of mesalamine);

          -  received antibiotics, other than topical antibiotics, within 1 week prior to the
             Screening Visit;

          -  received aspirin (except for cardioprotective reasons up to a maximum dose of 325
             mg/day) or NSAIDs within 1 week prior to the Baseline Visit;

          -  if female, positive pregnancy test, or lactating.
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: Sitagliptin; Comparator: Placebo; Comparator: Pioglitazone
Intervention description: sitagliptin 10 mg tablet, once daily for 54 weeks; Placebo oral tablet once daily for 24 weeks; Pioglitazone 30 mg tablet once daily for 30 weeks
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical study is to determine the safety and efficacy of an
      investigational drug in patients with Type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

        Exclusion Criteria:

          -  Patients with Type 1 Diabetes Mellitus
An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Carcinoma, Neuroendocrine; Thyroid Diseases
Intervention: ZD6474 (Vandetanib)
Intervention description: once daily oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 437.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ZD6474; MTC; Hereditary Medullary Thyroid Cancer; Sporadic Medullary Thyroid Cancer; Medullary Thyroid Cancer

Summary:

      The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer
      patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body,
      about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or
             sporadic Medullary Thyroid Cancer.

          -  Presence of measurable tumor

          -  Able to swallow medication

        Exclusion Criteria:

          -  Major surgery within 4 weeks before randomization

          -  Last dose of prior chemotherapy received less than 4 weeks prior to randomization

          -  Radiation therapy within the last 4 weeks prior to randomization(with exception of
             palliative radiotherapy)

          -  Brain metastases or spinal cord compression, unless treated at least 4 weeks before
             first dose and stable without steroid treatment for 10 days

          -  Significant cardiac events

          -  Previous ZD6474 treatment
Varenicline for Adolescent Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; placebo
Intervention description: participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.; participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 157.0
Sex: All
Minimum age: 14 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21.
      After assessment and inclusion into the study, participants will be randomized to receive a
      12-week double blind course of varenicline or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 14-21

          -  Daily smoker for ≥6 months

          -  Desire to quit smoking, with at least one prior failed quit attempt and willingness to
             participate in a treatment study

          -  If under age 18, parent(s) or guardian(s) able to participate in informed consent and
             initial assessment (unless the participant provides evidence of emancipated status)

          -  If female, agreement to use birth control (any form of hormonal contraception such as
             Depo-Provera, daily oral contraception, transdermal patch, or Nuva-ring; intrauterine
             device; sterilization; or double barrier contraception, which is a combination of any
             two of the following methods: condoms, spermicide, diaphragm) to avoid pregnancy

        Exclusion Criteria:

          -  Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive
             disorder, bipolar disorder, schizophrenia)

          -  Lifetime history of suicidality, homicidality, or clinically significant
             hostility/aggression

          -  Current substance dependence, other than nicotine

          -  Current unstable major medical disorder

          -  Current pregnancy or breastfeeding

          -  Current use of medications with smoking cessation efficacy

          -  Known hypersensitivity to varenicline
Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure
Condition: Coronary Artery Disease
MeSH terms: Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ivabradine; Placebo
Intervention description: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.; Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19102.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in
      patients with coronary artery disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of coronary artery disease

          -  Sinus rhythm and resting heart rate equal or higher than 70 bpm

        Exclusion Criteria:

          -  Unstable cardiovascular condition

          -  Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy polyethylene glycol-epoetin beta
Intervention description: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of subcutaneous Mircera for
      correction of anemia in participants with chronic kidney disease who are not treated with
      erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will
      receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight,
      will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic renal anemia;

          -  hemoglobin value less than or equal to (<=) 10.5 grams/deciliter (g/dL).

        Exclusion Criteria:

          -  prior ESA therapy during previous 3 months;

          -  acute or chronic bleeding requiring therapy during previous 2 months;

          -  transfusion of red blood cells during previous 2 months;

          -  active malignant disease (except non-melanoma skin cancer).
Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
Condition: Acne
Intervention: Tretinoin microsphere 0.1%; Brand Retin-A Micro tretinoin microsphere gel 0.1%; placebo microsphere gel
Intervention description: Treatment of acne vulgaris; Treatment of acne vulgaris; treatment of acne vulgaris
Intervention MeSH terms: Tretinoin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 480.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear
      Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal, healthy male and female children and adult

          -  Written and verbal informed consent must be obtained. Patients age 12 to 17
             (inclusive) must sign an assent for the study and a parent or a legal guardian must
             sign the informed consent.

          -  Women of child-bearing potential must be non-pregnant and non-nursing, and must be
             willing to avoid pregnancy during the course of the study and during the menstrual
             cycle following completion of their participation in the study.

          -  Able to refrain from the use of all other topical acne medications or antibiotics
             during the treatment period.

          -  Considered reliable and capable of understanding their responsibility and role in the
             study.

        Exclusion Criteria:

          -  Significant history or clinical evidence of auto-immune, cardiovascular,
             gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.

          -  Abnormal pre-existing skin condition which might affect the normal course of acne
             vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).

          -  Use topical acne therapy during the two week period prior to study initiation.

          -  Use of systemic retinoid treatment within six months prior to study initiation.

          -  Pregnant or breast-feeding.

          -  Serious psychological illness.

          -  Participation in any clinical research study during the 30 day period preceding study
             initiation.
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Placebo; Golimumab; Golimumab (placebo group)
Intervention description: Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20; Golimumab 50 mg SC injection every 4 weeks for 48 weeks; Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing Sponylitis, injection, golimumab, simponi

Summary:

      The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese
      patients with ankylosing spondylitis
    

Eligibility criteria:

        Inclusion Criteria:

        - Have a diagnosis of definite akylosing spondylitis for at least 3 months

          -  Have symptoms of active disease at screening and at baseline

          -  no active infections

        Exclusion Criteria:

          -  Have other inflammatory diseases that might confound the evaluations of benefit from
             the golimumab therapy

          -  Have complete ankylosis of the spine

          -  Have a history of latent or active granulomatous infection

          -  Have had a serious infection, or have been hospitalized for an infection, or have been
             treated with intravenous (IV) antibiotics for an infection within 2 months prior to
             first administration of study agent.
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A; Botulinum toxin type A; Placebo
Intervention description: I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.; I.M. injection on day 1 of treatment cycle 1.; I.M. injection on day 1 of treatment cycle 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate how well a new drug called Dysport NG works and how
      safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be
      compared to an approved drug called Dysport.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dystonia with at least 18 months duration since onset.

          -  Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks
             since the last injection.

          -  TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15,
             Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.

        Exclusion Criteria:

          -  Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component
             in the study drug formulation (including cow milk protein).

          -  Pure anterocollis or pure retrocollis.

          -  In apparent remission from Cervical Dystonia.

          -  Known clinically significant underlying swallowing or respiratory abnormality which
             might be exacerbated by BTX treatment.

          -  Previous poor response to BTX treatment or known presence of BTX neutralising
             antibodies.

          -  Previous phenol or alcohol injections into the neck muscles.

          -  Previous myotomy or denervation surgery involving the neck or shoulder region.
Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: Diet; Comparator: Physical Activity
Intervention description: sitagliptin 100 mg once daily. Duration of treatment: 26 Weeks; Diet; Physical Activity
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1512.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of three strategies of lifestyle changes associated with Januvia
      (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately
      controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three
      strategies of lifestyle changes was expected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose
             of metformin, with documented or high likely inadequate control of diabetes (HbA1c
             6.5-9%)

        Exclusion Criteria:

          -  Daily insulin treatment or one insulin dose or more within the last 8 weeks or
             expected insulin treatment within the next 3 months.

          -  Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis

          -  Known hypersensitivity or contraindication to metformin
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Icotinib; Gefitinib
Intervention description: 125 mg three times daily (375 mg per day) by mouth; 250 mg every 24 hours by mouth
Intervention MeSH terms: Gefitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Efficacy; Safety; EGFR-TKI; phase III; NSCLC

Summary:

      The purpose of this study is to determine whether Icotinib is at least non-inferior to
      Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one
      or two chemotherapies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed NSCLC with Histology or cytology; advanced （IIIb/IV).

          2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior
             chemotherapy must be completed at least 4 weeks before study enrollment; =.

        Exclusion Criteria:

        1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin,
        erbitux.
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
Condition: Alpha 1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: alpha-1 proteinase inhibitor (human)
Intervention description: 60 mg/kg weekly for 20 weeks
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: alpha 1-Antitrypsin Deficiency; alpha 1-Antitrypsin; pulmonary emphysema

Summary:

      The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in
      adult Alpha1-antitrypsin deficient patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of congenital Alpha1-antitrypsin deficiency

          -  Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted
             value within last 6 months.

          -  Signed written informed consent prior to initiation of any study related procedures.

        Exclusion Criteria:

          -  Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling
             to practice adequate contraception throughout the study

          -  Use of systemic steroids within the 2 weeks prior to receiving study treatment (this
             does not include the use of inhaled steroids used on a routine or as needed basis).

          -  Subjects who have had exacerbations of their disease within one month of trial entry