bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3/Safety & Efficacy of Esomeprazole in Infants
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Intervention: Open Label Run In Esomeprazole; Double Blind Esomeprazole; Double Blind Placebo
Intervention description: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg); Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg); Double Blind Placebo
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: All
Minimum age: 1 Month
Maximum age: 11 Months
Healthy volunteers: No
Keywords: pediatrics; neonates

Summary:

      The purpose of this study is to look at the improvement of a once a day dose of esomeprazole
      for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
      This research study consists of a screening, open-label, and double-blind treatment
      withdrawal phase. The screening phase ensures the patient eligibility. No study medication is
      dispensed during the screening phase. During the open-label phase, patients are administered
      esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase,
      the patients are administered either his/her open-label dose or placebo. Double-blind means
      neither the physician, parent, or patient will know if patient is taking esomeprazole or
      placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients' parents must sign the informed consent prior to the beginning of any
             study-related procedures (according to local regulations)

          -  patients must have symptoms at study entry and have a clinical diagnosis of suspected
             GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a
             long tube inserted in the body for diagnostic exams

        Exclusion Criteria:

          -  patients who have used a PPI (proton pump inhibitors; used to reduce the amount of
             acid in the stomach) within 7 days before enrollment in the open label treatment phase
             (Day 0)

          -  patients with a history of acute life-threatening event
A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evacetrapib; Atorvastatin; Ezetimibe; Placebo
Intervention description: Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Atorvastatin; Ezetimibe; Evacetrapib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the ACCENTUATE study is to evaluate whether the study drug known as
      evacetrapib is effective in treating participants with high cholesterol and atherosclerotic
      cardiovascular disease (ASCVD) and/or diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening

          -  Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL

          -  Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)

          -  Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

        Exclusion Criteria:

          -  Have a hemoglobin A1c (HbA1c) >9.5%

          -  New York Heart Association (NYHA) class III or IV congestive heart failure

          -  History of either a transient ischemic stroke or ischemic stroke <30 days

          -  History of acute coronary syndrome (ACS) <30 days
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: D9421-C capsule 3 mg; Mesalazine tablets
Intervention description: Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.; Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 15 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: mild to moderate active Crohn's disease; affecting ileum; ileocecal region; ascending colon; score of 180-400 on the CDAI

Summary:

      The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily
      compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's
      disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of
      180-400 on the Crohn's Disease Activity Index (CDAI) by assessment of the remission after
      8-week treatment defined by a CDAI score of ≤ 150.
    

Eligibility criteria:

        Inclusion Criteria:

          -  15 years of age or older

          -  Main active disease of the ileal, ileocecal region, and/or ascending colon - - If
             treated with partial nutrition treatment (≤1200 kcal/day) or if treated with
             azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to
             randomisation until the study completion or discontinuation

          -  Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to
             moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

        Exclusion Criteria:

          -  Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g.
             lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis,
             fistulae, ostomy, short bowel or other uncontrolled concomitant disease)

          -  Patient who need any concomitant treatment for CD that may affect the assessment for
             efficacy of the study drug

          -  Patient who need any medication which is prohibited due to suspected influence to
             metabolism of the study drug

          -  Patient who is judged to be inadequate to participate in this study from the safety
             point of view Patient with well-founded doubt about protocol violation
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Silodosin
Intervention description: 8 mg daily
Intervention MeSH terms: Silodosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 661.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: benign prostatic hyperplasia, alpha blocker

Summary:

      A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term
      safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males in good general health and at least 50 years of age, who have completed SI04009
             or SI04010.

        Exclusion Criteria:

          -  Medical conditions that would confound the efficacy evaluation.

          -  Medical conditions in which it would be unsafe to use an alpha-blocker.

          -  The use of concomitant drugs that would confound the efficacy evaluation.

          -  The use of concomitant drugs that would be unsafe with this alpha-blocker.
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel
Condition: Chronic Stable Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: GP2015 Etanercept; Enbrel
Intervention description: Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.; Enbrel is used as reference product to GP2015.
Intervention MeSH terms: Etanercept; GP2015
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 531.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in
      patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75
      response rate at Week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women at least 18 years of age at time of screening

          -  Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline

          -  Moderate to severe psoriasis as defined at baseline by:

               -  PASI score of 10 or greater and,

               -  Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 -
                  4) and,

               -  Body Surface Area affected by plaque-type psoriasis of 10% or greater

          -  Chronic plaque-type psoriasis patients who have previously received phototherapy or
             systemic psoriasis therapy at least once or who are candidates for such therapies in
             the opinion of the investigator.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited treatments

          -  Previous exposure to etanercept

          -  Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of treatment with etanercept

        Other In-/Exclusion criteria may apply
Escitalopram in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; Placebo; Escitalopram
Intervention description: Escitalopram low dose, oral administration, once daily dosing for 8 weeks.; Placebo, oral administration, once daily dosing for 8 weeks; Escitalopram high dose, oral administration, once daily dosing for 8 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 877.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Major Depressive Disorder; Escitalopram

Summary:

      This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram
      in adult patients (18 to 65 years of age) with moderate to severe depression. Patients
      completing the study may be eligible to enter a long-term open-label extension study with
      escitalopram.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision
             (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.

          -  The patient's current depressive episode must be at least 8 weeks in duration.

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control.

          -  Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic
             episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive
             disorder.

          -  Patients who are considered a suicide risk

          -  Patients with a history of seizures (including seizure disorder), stroke, significant
             head injury, central nervous system tumors, or any other condition that predisposes
             patients to a risk for seizure.
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Esomeprazole
Intervention description: Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Intervention MeSH terms: Esomeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heartburn

Summary:

      This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of
      frequent heartburn
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant ,non-lactating females 18 years or older

          -  Experience heartburn at least 2 days a week

          -  Having heartburn that has responded to heartburn medication

          -  Must discontinue any current heartburn medications

        Exclusion Criteria:

          -  Having a history of erosive esophagitis verified by endoscopy

          -  Having a history of GERD which was diagnosed by a physician

          -  Inability to take study medication or complete the study and all study procedures

          -  Subjects that have required more than one 14-day course of PPI treatment within the
             past 4 months
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]
Intervention description: 2mg iv every 2 months; 2.5mg po daily; 3mg iv every 3 months
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1395.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of intravenous administration of Bonviva
      regimens in women with post-menopausal osteoporosis, compared to oral daily administration.
      Patients will also receive daily supplementation with vitamin D and calcium. The anticipated
      time of study treatment is 2+ years, and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women 55-80 years of age;

          -  post-menopausal for >=5 years;

          -  ambulatory.

        Exclusion Criteria:

          -  malignant disease diagnosed within the previous 10 years (except basal cell cancer
             that has been successfully removed);

          -  breast cancer within the previous 20 years;

          -  allergy to bisphosphonates;

          -  previous treatment with an intravenous bisphosphonate at any time;

          -  previous treatment with an oral bisphosphonate within the last 6 months, >1 month of
             treatment within the last year, or >3 months of treatment within the last 2 years.
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: Cilofexor; Placebo
Intervention description: 100 mg tablet administered orally once daily; Tablet administered orally once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 419.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether cilofexor reduces the risk of
      fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of large duct PSC

          -  Liver biopsy at screening that is deemed acceptable for interpretation and
             demonstrates stage F0 - F3 fibrosis in the opinion of the central reader

          -  Individual has the following laboratory parameters at the screening visit, as
             determined by the central laboratory:

               -  Platelet count ≥ 150,000/mm^3

               -  Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as
                  calculated by the Cockcroft-Gault equation

               -  Alanine transaminase (ALT) ≤ 8 x upper limit of the normal range (ULN)

               -  Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's
                  syndrome or hemolytic anemia

               -  International normalized ratio (INR) ≤ 1.4, unless due to therapeutic
                  anticoagulation

               -  Negative anti-mitochondrial antibody

        Key Exclusion Criteria:

          -  Current or prior history of any of the following:

               -  Cirrhosis

               -  Liver transplantation

               -  Cholangiocarcinoma or hepatocellular carcinoma (HCC)

               -  Ascending cholangitis within 30 days of screening

          -  Presence of a percutaneous drain or biliary stent

          -  Other causes of liver disease

          -  Current or prior history of unstable cardiovascular disease

          -  Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative
             colitis, Crohn's disease, and indeterminate colitis)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Lifitegrast; Placebo
Intervention description: Lifitegrast Ophthalmic Solution 5%, BID for 84 days; Placebo to match active treatment, BID for 84 days
Intervention MeSH terms: Lifitegrast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent
      history of artificial tear use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient-reported history of Dry Eye Disease in both eyes.

          -  Use of over the counter artificial tears within the past 30 days.

          -  A negative urine pregnancy test for females and willingness to use adequate birth
             control throughout the study.

          -  Able and willing to comply with all study procedures.

        Exclusion Criteria:

          -  Presence of an ocular condition that could affect the study parameters such as active
             ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.

          -  Unwilling to stop wearing contact lenses during the study.

          -  LASIK or other ocular surgical procedures within 12 months prior to or during the
             study.

          -  Use of prohibited medications

          -  Significant medical conditions that could affect the study parameters.
Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Lurasidone; Placebo
Intervention description: Tablets 20-120 mg, PM dosing,daily for 6 weeks; Equivalent to Lurasidone dosing
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 356.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar I Depression; Lurasidone; Latuda

Summary:

      Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression.
      This clinical study is designed to test the hypothesis that Lurasidone in combination with
      either Lithium or Divalproex is effective among patients with bipolar I depression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent and is 18 to 75 years of age inclusive.

          2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4
             weeks and less than 12 months) without psychotic features.

          3. Has a lifetime history of at least one bipolar manic or mixed manic episode.

          4. Currently being treated with lithium or divalproex or willing to begin treatment with
             lithium or divalproex.

          5. Not pregnant or nursing and is not planning pregnancy within the projected duration of
             the study.

          6. Females of reproductive potential agree to remain abstinent or use adequate and
             reliable contraception throughout the study and for at least 30 days after

          7. Good physical health on the basis of medical history, physical examination, and
             laboratory screening.

        Exclusion Criteria:

          1. Subject is considered by the investigator to be at imminent risk of suicide or injury
             to self, others, or property.

          2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).

          3. Hospitalization for a manic or mixed episode within the past two months.

          4. Used investigational compound within past 6 months.

          5. Clinically significant history of alcohol or substance abuse within the past 3 months
             or alcohol or substance dependence within the past 12 months.