bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Intervention: Mipomersen; Placebo
Intervention description: 200 mg (1 mL), weekly subcutaneous injections for 26 weeks; 1 mL weekly subcutaneous injections for 26 weeks
Intervention MeSH terms: Mipomersen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for
      26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated
      lipid-lowering regimen and who are not on apheresis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C ≥200 mg/dL (5.1 mmol/L) at screening and the presence of at least 1 of
             the following criteria:

               -  Myocardial infarction (MI)

               -  Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

               -  Coronary artery disease documented by angiography or any other accepted imaging
                  technique

               -  Positive exercise test (≥1 mm ST-depression at maximal exercise or test
                  terminated because of angina) or a perfusion defect (e.g., thallium or single
                  photon emission computed tomography)

               -  Other clinical atherosclerotic diseases: peripheral artery disease, symptomatic
                  carotid artery disease, abdominal aortic aneurysm

               -  Or, if alternative above were not met, fasting LDL-C ≥300 mg/dL (7.8 mmol/L)

          -  On stable, maximally tolerated statin therapy for 8 weeks

          -  On stable, medication from an additional class of hypolipidemic agents for 8 weeks.

          -  On stable, low fat diet for 12 weeks

          -  Stable weight for 6 weeks

        Exclusion Criteria:

          -  Significant health problems in the recent past including heart attack, stroke,
             coronary syndrome, unstable angina, heart failure, significant arrhythmia,
             hypertension, blood disorders, liver disease, cancer, digestive disorders, Type I
             diabetes, or uncontrolled Type II diabetes

          -  Apheresis within 3 months prior to Screening or expected to start apheresis during the
             treatment phase
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
Condition: Vaginal Dryness
Intervention: Ospemifene; Placebo
Intervention description: 60 mg tablet; Tablet identical to the ospemifene tablet without drug
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 631.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vulvo-vaginal Atrophy; menopause

Summary:

      The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once
      daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause
      in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is postmenopausal.

          -  Subject has moderate to severe vaginal dryness as the self-reported MBS of VVA.

        Exclusion Criteria:

          -  Subject has clinically significant abnormal findings in the physical examination.

          -  Subject has a body mass index (BMI) equal to or greater than 38 kg/m^2

          -  Subject has uncontrolled hypertension.

          -  Subject has clinically significant abnormal findings in the gynecological examination
             other than signs of vaginal atrophy.

          -  Subject has uterine/vaginal bleeding of unknown origin.

          -  Subject has a vaginal infection requiring medication (may be treated and be eligible
             for study).
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone
Intervention description: 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Drug Therapy; Treatment Outcome

Summary:

      The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in
      patients with schizophrenia who are switched from an oral atypical antipsychotic to
      Paliperidone ER. In this study patients and physicians know the name and the dose of the
      study drug. Newly diagnosed patients will also be included in the study. In general, the
      recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a
      higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can
      be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was
      chosen to best mimic actual clinical practice.The safety assessments to be conducted
      throughout this study including the regular monitoring and recording of all Adverse Events
      and Serious Adverse Events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must satisfy the following criteria to be eligible for this study: patients
             with diagnoses of schizophrenia according to the DSM-IV criteria including newly
             diagnosed patients

          -  Out-patients or in-patients with expected discharge within 8 weeks

          -  Patients or their legally acceptable representatives must have signed an informed
             consent document indicating that they understand the purpose of and procedures
             required for the study and are willing to participate in the study.

        Exclusion Criteria:

          -  Patients who meet any of the following criteria will be excluded from participating in
             the study: patients who are resistant to antipsychotic treatment

          -  Patients who have been on clozapine or long-acting injectable antipsychotic medication
             during the last 3 months

          -  Patients with CGl-S scores > 6 or who who have been hospitalized for longer than 8
             continuous weeks during the past 6 months

          -  Pregnant or breast-feeding females

          -  Patients with a history or current symptoms of tardive dyskinesia or neuroleptic
             malignant syndrome.
A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Intervention: Certolizumab Pegol
Intervention description: Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis; Joint pain; Inflammation; Rheumatoid Arthritis

Summary:

      To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment
      period measured by Power/Color Doppler and Gray scale Ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years

          -  Active RA

          -  Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment

          -  Subject can have attempted no more than one previous Anti Tumor Necrosis factor
             (anti-TNF) and discontinued due to drug intolerance

        Exclusion Criteria:

          -  Subject cannot have a second non-inflammatory musculoskeletal condition

          -  Subject cannot have a diagnosis of any other inflammatory arthritis

          -  Subject cannot have any previously infected prosthesis

          -  Subject cannot have arthroplasties in any of the joints assessed in the study

          -  Subject cannot have a history of chronic infections

          -  Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or
             latent TB infection

          -  Subject cannot have a history of or current Lymphoproliferative disorder

          -  Subject cannot have known Human Immunodeficiency Virus (HIV) infection

          -  Subject cannot have received a live or attenuated vaccine within 8 weeks

          -  Subject cannot have current or history of malignancy

          -  Subject cannot have a history of blood disorders

          -  Subject cannot have a current or recent history of severe, progressive, and/or
             uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
             cardiac, neurological or cerebral disease

          -  Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a
             protein medicinal product, or ultrasound gel applied to the skin
Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Recurrence
Intervention: melatonin; placebo
Intervention description: 20 mgs ingested nightly; similar to experimental in all ways except for lack of active ingredient
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 709.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: melatonin; natural health product (NHP); lung cancer; complementary and alternative medicine (CAM); randomized clinical trial

Summary:

      There is evidence to support the use of melatonin, a natural health product, as an additional
      treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20
      milligrams of melatonin for one year can lower the incidence of developing lung cancer
      recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are
      eligible for surgical resection can participate in the trial. The study will also be
      assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression
      amongst the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of non small cell lung cancer

          -  Eligible for surgical resection

          -  Willingness to adhere to randomized treatment

          -  Availability for follow-up schedule of visits

        Exclusion Criteria:

          -  Taking exogenous melatonin
Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Empagliflozin; Empagliflozin; Placebo
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin
      regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion
      (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period,
      an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week
      follow-up period.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or female patient receiving insulin for the treatment of documented diagnosis of
             Type 1 Diabetes Mellitus (T1DM) for at least 1 year at the time of Visit 1

          -  Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at Visit 2 measured by the
             central laboratory

          -  Use of, and be willing, based on the Investigator's judgement, to continue throughout
             the duration of the trial, either:

               -  Multiple Daily Injections (MDI) of insulin consisting of at least one basal
                  insulin injection and at least three daily bolus injections OR

               -  Continuous Subcutaneous Insulin Infusion (CSII) of any insulin type, with at
                  least 5 months experience of using CSII prior to Visit 1

          -  HbA1c >/= 7.5% and </= 10.0% at Visit 5 measured by the central laboratory

          -  Age >/= 18 years at Visit 1

        Additional inclusion criteria may apply

        Exclusion criteria:

          -  History of Type 2 Diabetes Mellitus (T2DM), maturity onset diabetes of the young
             (MODY), pancreatic surgery or chronic pancreatitis

          -  Pancreas, pancreatic islet cells or renal transplant recipient

          -  T1DM treatment with any other antihyperglycaemic drug (e.g. metformin,
             alpha-glucosidase inhibitors, Glucagon-like-peptide 1 (GLP-1) analogues,
             Sodium-Glucose Co-Transporter (SGLT-2) inhibitors, pramlintide, inhaled insulin,
             pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months
             prior to Visit 1

          -  Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that
             required hospitalisation or hypoglycaemia-related treatment by an emergency physician
             or paramedic within 3 months prior to Visit 1 and until randomisation

          -  Occurence of Diabetic Ketoacidosis (DKA) within 3 months prior to Visit 1 and until
             randomisation

        Additional exclusion criteria may apply
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Roflumilast 0.3% cream; Vehicle Cream
Intervention description: Roflumilast 0.3% cream for topical application.; Vehicle cream for topical application.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 439.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is a double-blind, parallel group, vehicle-controlled study to assess the safety and
      efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of
      chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of
      CPP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consent and if appropriate
             assent as required by local laws

          -  Males and females ages 2 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for
             children) as determined by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial
             sunlight, tanning bed or other LED.

          -  Females who are pregnant, wishing to become pregnant during the study, or are
             breast-feeding.

          -  Previous treatment with ARQ-151 or its active ingredient

          -  Subjects with any serious medical condition or laboratory abnormality that would
             prevent study participation or place the subject at significant risk, as determined by
             the Investigator.

          -  Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation
             of investigational product

          -  Subjects who are unable to communicate, read or understand the local language, or who
             display another condition, which in the Investigator's opinion, makes them unsuitable
             for clinical study participation
A 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: 495.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitors; 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.
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta; Epoetin alfa
Intervention description: 120, 200 or 360 micrograms iv/month (starting dose); As prescribed
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of monthly administration of
      intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in
      hemodialysis patients with chronic renal anemia. Participants currently receiving maintenance
      treatment with epoetin alfa will be randomized either to receive monthly injections of 120,
      200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa
      they were receiving in the week preceding study start, or to continue on epoetin alfa
      treatment. The anticipated duration of study is 32 weeks, and the target sample size is 146
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  chronic renal anemia;

          -  continuous iv maintenance epoetin alfa therapy, with the same dosing interval during
             the previous month to and during SVP;

          -  regular hemodialysis for greater than or equal to (>=) 3 months

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months

          -  poorly controlled hypertension requiring interruption of epoetin alfa treatment in
             previous 6 months;