bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque Psoriasis Naive to Systemic Treatment
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Fumaric Acid Esters; Methotrexate; Ixekizumab
Intervention description: Administered orally; Administered orally; Administered SC
Intervention MeSH terms: Methotrexate; Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fumaderm

Summary:

      The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric
      acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque
      psoriasis who are naive to systemic treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of
             chronic psoriasis for at least 6 months before baseline.

          -  Participants who are candidates for systemic therapy and who are naive to systemic
             treatment for psoriasis.

          -  Have a (PASI score >10 or BSA >10) and DLQI >10 at screening and at baseline.

        Exclusion Criteria:

          -  Have predominant pattern of pustular, erythrodermic, and/or guttate forms of
             psoriasis.

          -  Have received systemic nonbiologic psoriasis therapy.

          -  Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis
             therapy.

          -  Have any condition or contraindication as addressed in the local labeling for MTX or
             FAE.

          -  Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric
             disorders or abnormal laboratory values at screening.

          -  Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal
             ulcer.

          -  Have had a serious infection or are immunocompromised.

          -  At screening, participants with significant, present, or early liver disease, e.g.,
             explained by alcohol consumption or hepatic insufficiency.
Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Danoprevir; Ritonavir; peginterferon alfa-2a; RBV
Intervention description: Danoprevir (DNV)administered orally 100mg BID for 12 weeks;; Ritonavir administered orally 100mg BID for 12 weeks;; PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;; RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
Intervention MeSH terms: Ritonavir; Peginterferon alfa-2a; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Danoprevir; non-cirrhotic; Chinese HCV G1; SVR12

Summary:

      The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08
      (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients
      Who Have Chronic Hepatitis Genotype 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Chronic HCV infection (≥ 6 months)

          -  Serum HCV RNA of ≥ 1 × 104 IU/mL are documented

          -  Hepatitis C virus GT1

          -  Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or
             host-targeting antivirals for HCV

          -  Non-cirrhosis patients: Non-cirrhosis is defined (1)Fibroscan defined as: ˂ 14.6 kPa
             during screening period, or liver biopsy determined 1 year before recruiting (Metavir
             score ˂ 3);(2) during screening period 9.6<Fibroscan indicator ≤12.9, liver biopsy
             need to confirm non-cirrhosis.

          -  Others as specified in the detailed protocol

        Exclusion Criteria:

          -  Patients with Fibroscan detection value > 12.9 kPa, or histologic examination for
             liver cirrhosis patients

          -  Presence or history of non-hepatitis C chronic liver disease (e.g. HH, AIH, Wilson's
             disease, α1 antitrypsin deficiency, drug- or toxin-induced liver disease)

          -  History of liver cell cancer, or suspected hepatocellular carcinoma (HCC) patients
             before or during screening , or imaging studies found suspicious nodules, or AFP > 50
             ng/mL

          -  Positive hepatitis A antibody，positive hepatitis B surface antigen，HIV antibody

          -  Presence or history of nervous system diseases and/or mental illness, inability to
             control oneself or express oneself.

          -  Patients with obvious cardiovascular dysfunction

          -  Pregnant or nursing female, nor unwilling to take reliable contraception

          -  Others as specified in the detailed protocol
30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease
Condition: Dyslipidemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Dyslipidemias
Intervention: ABT-335 plus rosuvastatin; Rosuvastatin
Intervention description: ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks; Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks
Intervention MeSH terms: Rosuvastatin Calcium; Fenofibric acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 280.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemia; Kidney Disease

Summary:

      The objective of this study is to evaluate the safety and efficacy of the combination of
      ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
    

Eligibility criteria:

        Inclusion Criteria

          -  Dyslipidemic participants with Chronic Kidney Disease Stage 3

          -  For entry into the Treatment Phase (Visit 3), the participant satisfied the following
             laboratory criteria (measured at the Screening Visit[s]):

               -  Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic
                  Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal
                  Disease formula (this includes a 10 percent variation in the upper limit of
                  estimated glomerular filtration rate that was allowed for the enrollment of
                  participants to account for variability in the creatinine assay).

               -  Fasting lipid results following greater than or equal to 12-hour fasting period:

          -  Triglycerides level greater than or equal to 150 mg/dL,

          -  High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50
             mg/dL for females, and

          -  Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion
             Criteria

          -  Participants with certain chronic or unstable medical conditions.

          -  Participants with unstable dose of medications or receiving coumarin anticoagulants,
             systemic cyclosporine, or certain other medications.

          -  Pregnant or lactating women, or women intending to become pregnant.

          -  Participants with diabetes mellitus that is poorly controlled.

          -  Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean,
             Vietnamese, or Asian-Indian origin).
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BG00012; Placebo; Glatiramer Acetate
Intervention MeSH terms: Glatiramer Acetate; Dimethyl Fumarate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1417.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing; multiple sclerosis; oral; remitting

Summary:

      To determine if treatment with BG00012 can decrease the number of MS relapses during a
      certain time period. Other goals of the study are to determine if, over time, BG00012
      treatment can decrease the number of certain types of brain lesions commonly seen in MS
      patients and slow down the time it takes for MS to get worse.

      Other objectives of the study are to determine the safety and tolerability of BG00012, as
      well as the effect it may have on tests and evaluations used to assess MS. Additionally,
      glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
    

Eligibility criteria:

        Unless otherwise specified, to be eligible to participate in this study, candidates must
        meet the following eligibility criteria at the time of the randomization:

        Key Inclusion Criteria:

          -  Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4

          -  Must have a baseline EDSS between 0.0 and 5.0, inclusive.

          -  Must have relapsing-remitting disease course.

        Key Exclusion Criteria:

          -  Other chronic disease of immune system, malignancies, urologic, pulmonary,
             gastrointestinal disease

          -  Pregnant or nursing women

        Note: Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
Condition: Contact Lens Lubrication
Intervention: carboxymethylcellulose based eye drop formula; carboxymethylcellulose sodium based eye drop solution
Intervention description: 1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.; 1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the safety and efficacy of a new carboxymethylcellulose based eye
      drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
    

Eligibility criteria:

        Inclusion Criteria:

        -Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

        Exclusion Criteria:

          -  Wearing monovision lenses

          -  Have had refractive surgery within the previous 12 months

          -  Have infection of the eye, eyelids or eye structures.
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: IW-3718; placebo; Standard-dose PPIs QD
Intervention description: oral tablet; oral tablet; background therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitor; IW-3718

Summary:

      The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to
      patients with GERD who continue to have persistent symptoms, such as heartburn and
      regurgitation, while receiving once-daily (QD), standard dose PPIs.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following criteria to be eligible for enrollment in this
        study:

          -  Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18
             years old at the Screening Visit.

          -  Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
             regurgitation) while taking standard PPI therapy.

          -  Patient has evidence of pathological acid reflux.

          -  Female patients must not be pregnant and must agree to avoid pregnancy for the
             duration of the study.

          -  Patient must comply with study procedures.

        Exclusion Criteria:

        Patients who meet any of the following criteria will not be eligible to participate in the
        study:

          -  Patient has a history of complete lack of GERD symptom response to PPI therapy.

          -  Patient has a significant medical or surgical history including conditions that would
             impact drug absorption or metabolism (such as bowel obstruction, poorly controlled
             diabetes, gastroparesis, hiatal hernia).

          -  Patient reports pain or burning behind the breastbone or in the center of the upper
             stomach as his or her predominant symptom at the Screening Visit.

          -  Patient has received an investigational drug during the 30 days before the Screening
             Visit, or is planning to receive another investigational drug or use an
             investigational device at any time during the study.

        NOTE: Other inclusion and exclusion criteria apply, per the study protocol.
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide once weekly suspension; Exenatide twice daily
Intervention description: Exenatide suspension 2 mg weekly subcutaneous injection; 5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 377.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once
      weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with
      type 2 diabetes mellitus.

      To examine the long-term (52 weeks of treatment) safety and effect on glucose control of
      exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  Diagnosed with type 2 diabetes mellitus

          -  HbA1c 7.1 to 11%, inclusive, at screening

          -  Fasting plasma glucose <280 mg/dL (15.5 mmol/L)

          -  Body mass index (BMI) <=45 kg/m2, inclusive, at screening

          -  Treated with diet and exercise or a stable regimen of metformin, sulfonylurea,
             pioglitazone or any 2 of these agents

        Exclusion Criteria:

          -  History of pancreatitis or triglycerides >=500 mg/dL

          -  Medullary carcinoma or multiple endocrine neoplasia (MEN2) or a family history of
             either

          -  Active cardiovascular disease

          -  Presence of congestive heart failure

          -  Liver disease

          -  History of severe gastrointestinal diseases

          -  Repeated severe hypoglycemia within the last 6 months

          -  Any previous use of exenatide or other glucagon-like peptide-1 (GLP-1 ) analog

          -  Dipeptidyl peptidase-4 (DPP-4) inhibitor use in the last 3 months
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Xyrem®
Intervention description: flexible dosing
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FMS; Fibro; Pain; Body Pain; Tenderness; Joint pain; Stiffness; Muscular Pain

Summary:

      The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term
      use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008
             (NCT00371137).

          -  Subject is able, in the opinion of the investigator, to take Xyrem® for approximately
             9-1/2 months.

        Exclusion Criteria:

          -  Subject terminated early from either study 06-009 or 06-008.

          -  Subject experienced any serious adverse event related to study drug in either study
             06-009 or 06-008.

          -  Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or
             06-008 that may prevent him/her from safely participating in this study.
Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Vardenafil ODT (STAXYN, BAY38-9456); Placebo
Intervention description: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT); Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Intervention MeSH terms: Vardenafil Dihydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 339.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erectile Dysfunction

Summary:

      This study investigates the safety and efficacy of a new dosage form of Vardenafil, an
      orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo
      (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase,
      patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be
      determined by laboratory and other evaluations. Efficacy will be determined by the results of
      different questionnaires and the patient diary that will be used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males 18 years-of-age or older.

          -  Stable, heterosexual relationship for at least 6 months.

          -  A history of erectile dysfunction (ED) for at least 6 months

        Exclusion Criteria:

          -  Any underlying cardiovascular condition, including unstable angina pectoris

          -  History of myocardial infarction, stroke or life-threatening arrhythmia within 6
             months prior to visit 1

          -  Uncontrolled atrial fibrillation / flutter at screening

          -  History of congenital QT prolongation

          -  History of surgical prostatectomy due to prostate cancer

          -  Hereditary degenerative retinal disorders

          -  History of loss of vision because of NAION (Non-arteritic anterior ischemic optic
             neuropathy), temporary or permanent loss of vision

          -  Presence of penile anatomical abnormalities

          -  Spinal cord injury

          -  Resting or postural hypotension or hypertension

          -  Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens,
             alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole
             or ketoconazole, and clarithromycin and erythromycin.

          -  Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3
             anti-arrhythmics.

          -  Subjects who have been confirmed with phenylketonuria (PKU).

          -  Use of any treatment for ED within 7 days of Visit 1.
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Condition: Acute Gastrointestinal Graft vs Host Disease
MeSH terms: Graft vs Host Disease
Intervention: oral beclomethasone 17,21-dipropionate; Placebo
Intervention description: Two tablets QID for 50 days; Two tablets QID for 50 days
Intervention MeSH terms: Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BDP; orBec; GVHD; beclomethasone dipropionate; bone marrow transplant; hematopoietic cell transplant; HCT; stem cell transplant; marrow transplant; SCT; beclomethasone 17,21-dipropionate

Summary:

      Use of an oral topically-active glucocorticoid with limited side effects will control the
      gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receipt of allogeneic hematopoietic cell transplant

          -  Diagnosis of GI graft vs. host disease (GVHD)

          -  No GI infection

          -  Must be able to swallow tablets

          -  Must be able to read and understand informed consent

          -  Adequate birth control methods for the duration of the study

        Exclusion Criteria:

          -  Significant Skin GVHD

          -  Liver GVHD

          -  Persistent vomiting

          -  HIV positive

          -  Pregnancy/lactation