bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
Condition: Diabetes Mellitus, Type 2; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; Placebo; Placebo; BI 10773; Placebo; Placebo
Intervention description: BI 10773 tablets once daily; Placebo tablets identical to BI 10773 low dose; Placebo tablets identical to BI 10773 high dose; BI 10773 tablets once daily; Placebo tablets identical to BI 10773 low dose; Placebo tablets identical to BI 10773 high dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 741.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic
      patients with renal impairment in order to provide these data for approval for BI 10773 as an
      antidiabetic agent by regulatory authorities.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus prior to informed consent and an estimated
             glomerular filtration rate of <90 ml/min.

          2. Male and female patients on diet and exercise regimen who are pre-treated with any
             antidiabetic therapy and are on the maximum tolerated dose which has been unchanged
             for 12 weeks prior to randomisation.

          3. HbA1c greater than or equal to 7.0% and less than or equal to 10.0% .

          4. Aged 18 years or above.

          5. Body Mass Index less than or equal to 45 kg/m2

        Exclusion criteria:

          1. Uncontrolled hyperglycaemia defined as >13.3 mmol/L after an overnight fast during
             placebo run-in.

          2. Impaired renal function, defined as an estimated glomerular filtration rate <15
             ml/min.

          3. Renal impairment requiring any form of chronic dialysis.

          4. Requiring acute dialysis within three months prior to informed consent.

          5. Renal transplant recipient.

          6. Myocardial infarction, stroke or Transient Ischemic Attack within three months prior
             to informed consent.

          7. Indication of liver disease.

          8. Bariatric surgery within the past two years.

          9. Medical history of cancer.

         10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell.

         11. Contraindications to pre-existing background antidiabetic therapy.

         12. Treatment with anti-obesity drugs.

         13. Current treatment with systemic steroids or change in dosage of thyroid hormones
             within six weeks prior to informed consent or any other uncontrolled endocrine
             disorder except Type 2 Diabetes.

         14. Pre-menopausal women who are nursing or pregnant or are of child-bearing potential and
             are not practising an acceptable method of birth control.
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Intervention: Rotarix (primary vaccination study); Placebo (primary vaccination study)
Intervention description: GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.; Two liquid oral doses of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1613.0
Sex: All
Minimum age: 32 Months
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intussusception; Gastroenteritis; Finland

Summary:

      To assess the long-term efficacy and safety of the subjects during the third year after
      priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the
      primary vaccination study (102247). The Rotarix vaccine was administered in the primary
      vaccination study. There was no vaccine/intervention in this long-term efficacy study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female who has completed the second year efficacy follow-up of the primary
             vaccination study in Finland.

          -  Written informed consent obtained from the parent or guardian of the subject.
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
Condition: Familial Chylomicronemia Syndrome; Lipoprotein Lipase Deficiency; Hyperlipoproteinemia Type 1
MeSH terms: Hyperlipoproteinemia Type I; Hyperlipoproteinemias; Hyperlipidemias; Syndrome
Intervention: Volanesorsen
Intervention description: 300 mg volanesorsen administered via SC injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants
      with FCS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must give written informed consent to participate in the study (signed and dated) and
             any authorization required by law.

          -  Able and willing to participate in a 65-week study.

        Group 1 and 2:

          -  Satisfactory completion of ISIS 304801-CS6 (NCT02211209) or ISIS 304801-CS16
             (NCT02300233) index studies with an acceptable safety profile, per Sponsor and
             Investigator judgment.

        Group 3:

          -  Participants who did not participate in the CS6 or CS16 index studies and meet
             additional inclusion criteria of FCS may enroll in the study.

          -  History of chylomicronemia.

          -  A diagnosis of FCS (Type 1 Hyperlipoproteinemia.)

          -  Fasting triglycerides greater than or equal to (≥)750 milligrams per deciliter [mg/dL]
             (8.4 millimoles per liter [mmol/L]) at Screening.

        Exclusion Criteria:

          -  Unwilling to comply with lifestyle requirements for the duration of the study.

        Group 1 and 2:

          -  Have any new condition or worsening of existing condition which in the opinion of the
             Investigator would make the participant unsuitable for enrollment, or could interfere
             with the participant participating in or completing the study.

        Group 3:

          -  Diabetes mellitus if newly diagnosed or if hemoglobin A1c (HbA1c)≥ 9.0%.

          -  Active pancreatitis within 4 weeks of screening.

          -  Acute Coronary Syndrome within 6 months of screening.

          -  Major surgery within 3 months of screening.

          -  Treatment with Glybera therapy within 2 years of screening.

          -  Have any other conditions in the opinion of the investigator which could interfere
             with the participant participating in or completing the study.
Safety Trial of OPC-61815 Injection in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815 injection
Intervention description: Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once
      daily for a maximum of 5 days to CHF patients with volume overload despite having received
      diuretics (injection) other than vasopressin antagonists and who have difficulty with or are
      incapable of oral intake.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving loop diuretic injection at a dose equivalent to furosemide 20
             mg/day or higher

          -  CHF patients in whom lower limb edema, pulmonary congestion, and/or jugular venous
             distension due to volume overload is present

          -  Patients who are judged by the investigator or subinvestigator to have difficulty or
             be incapable of oral intake, including patients who are judged by the investigator or
             subinvestigator to require nothing by mouth(NPO) management

          -  Patients who are currently hospitalized or who are capable of being hospitalized from
             the time of informed consent until the end of the treatment period

          -  Patients who are capable of giving informed consent

        Exclusion Criteria:

          -  Patients who are on a ventricular assist device

          -  Patients who have difficulty with spontaneous respiration or who have been on tracheal
             intubation under sedative therapy

          -  Patients with severe disturbed consciousness (ie, coma or stupor)
Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Asacol 400 mg; Asacol 400 mg
Intervention description: High dose:
17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM; Low dose:
17-<33 kg = 2 Asacol 400mg + 1 placebo in morning and 1 Asacol 400 +1 placebo in PM, 33-<54 kg = 3 Asacol 400mg +2 placebo in morning and 2 Asacol 400 + 2 placebo in PM, 54-<90 kg = 3 Asacol 400mg + 3 placebo in morning and 3 Asacol 400mg + 3 placebo in PM
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The overall objective of this study is to assess the safety and efficacy of high dose and low
      dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks
      to children and adolescents with mildly-to-moderately active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are male or female between the ages of 5 and 17 years, inclusive, at the time of the
             first dose of study medication, with a history of biopsy and endoscopy confirmed UC;

          -  have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as
             defined clinically by a Pediatric UC Activity Index (PUCAI) score 10 and 55, and, in
             the opinion of the Investigator, the patient does not require steroids;

          -  have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with
             stool less than half of the time) and stool frequency (1-2 stools greater than normal
             per day) as defined by the TM-Mayo Score

        Exclusion Criteria:

          -  have UC known to be confined to the rectum (isolated rectal proctitis);

          -  have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any
             component of the Asacol tablet;

          -  have a significant co-existing illness or other condition(s), including but not
             limited to cancer or significant organic or psychiatric disease on medical history or
             physical examination, that, in the judgment of the Investigator, contraindicate(s)
             administration of the study drug and/or any study procedures
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Alisporivir; Boceprevir; Peginterferon alfa-2a; Ribavirin
Intervention description: ALV 200 mg soft gel capsules administered orally; BOC 800 mg (4 x 200 mg soft gel capsules) administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C; Cyclophilin inhibitor

Summary:

      This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC),
      each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American
      participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1
      infection.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic HCV genotype 1 infection

          -  No previous treatment for HCV infection

          -  African American ethnicity

          -  Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or
             equivalent at screening visit, no upper limit

          -  A liver biopsy within 3 years prior to baseline

        Exclusion criteria:

          -  HCV genotype different from genotype 1 or co-infection with other HCV genotype

          -  Co-infection with Hepatitis B or HIV

          -  Any other cause of relevant liver disease other than HCV

          -  Presence or history of hepatic decompensation

          -  Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated
             bilirubin (> ULN) in past 6 months

        Other protocol-defined inclusion/exclusion criteria may apply
BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: BRII-196; BRII-198; Placebo; Remdesivir
Intervention description: BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.; BRII-198 is a fully human IgG-1 mAb derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 353.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Infections; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of BRII-196/BRII-198 in treating COVID-19 in
      people who have been hospitalized with the infection. Participants in the study will be
      treated with either BRII-196/BRII-198 plus current standard of care (SOC), or with placebo
      plus current SOC. This is ACTIV-3/TICO Treatment Trial H3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refer to the master protocol (NCT04501978)

        Exclusion Criteria:

          -  Refer to the master protocol (NCT04501978)

          -  Additional Exclusion Criteria:

               -  Pregnant women

               -  Nursing mothers

          -  In addition, prior to the initial futility assessment which is performed when
             approximately 150 participants have been enrolled on BRII-196/BRII-198 and 150 on
             placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the
             pulmonary ordinal outcome) will be excluded. These patients may be eligible for the
             trial if the initial futility assessment is passed by this agent.
Prucalopride in Pediatric Subjects With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Intervention: prucalopride; Placebo; PEG 4000
Intervention description: prucalopride
subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
subjects with weight >50 kg: prucalopride 2 mg tablet once daily; Matching oral solution or oral tablets given once daily
Intervention MeSH terms: Prucalopride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional
      constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label
      comparator (PEG) controlled part will follow, to document safety and tolerability up to 24
      weeks.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Boys and girls, aged ≥ 6 months and < 18 years.

          2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome
             III criteria.

        Main Exclusion Criteria:

          1. Children with underlying GI abnormalities and causes for defecation disorders.

          2. Constipation is thought to be drug-induced.

          3. Subjects suffering from secondary causes of chronic constipation.
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: Simvastatin + Lovaza® (omega-3-acid ethyl esters)
Intervention description: Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention MeSH terms: Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: High triglycerides; Lovaza; simvastatin; omega-3-acid ethyl esters

Summary:

      In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4
      g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with
      simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This
      extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza®
      (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin
      plus placebo to simvastatin plus Lovaza® for lowering non-High Density
      Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at
      12 and 24 months.
    

Eligibility criteria:

        For LOV111818/OM6X - Subjects were included in the study if they had met all relevant
        inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6
        and completed Study LOV111858/OM6 to Week 8.

        FYI - entry criteria for LOV111818/OM6 (double-blind study)

        Inclusion Criteria:

          -  Men and women ages 18-79 years, inclusive

          -  Current therapy with a statin drug

          -  Triglyceride levels between 200 and 499 mg/dL

          -  Normally active and in good health on the basis of medical history, brief physical
             examination, electrocardiogram, and routine laboratory tests

          -  Provide written informed consent and authorization for protected health information
             disclosure

        Exclusion Criteria:

          -  Sensitivity to statin drugs or omega-3 fatty acids

          -  Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia

          -  Unexplained muscle pain or weakness

          -  History of pancreatitis

          -  Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or
             cancer (except non-melanoma skin cancer)

          -  Poorly controlled diabetes, or receiving insulin therapy

          -  Pregnant or lactating females. Women of childbearing potential who are not using a
             medically approved method of contraception.

          -  Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic,
             antifungal and antiviral drugs, and cardiac drugs

          -  Use of warfarin (Coumadin)
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: placebo; Xyrem®
Intervention description: Oral Solution; two doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 573.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FMS; Fibro; pain; Body pain; tenderness; stiffness; muscular pain; joint pain

Summary:

      The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to
      placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled,
      parallel group trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, 18 years or older who meet the American College of
             Rheumatology (ACR) diagnostic criteria for fibromyalgia.

        Exclusion Criteria:

          -  Subjects will be excluded if they have a history of rheumatic disease or other
             disorders that may compromise reliable representation of subjective symptoms.

          -  Any other condition that will cause a risk to subjects if they participate in the
             trial is also a reason for exclusion.