bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 1; HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; GS-7977; GS-5885; Ribavirin; Sofosbuvir; ledipasvir; Hepatitis C; Hepatitis C, Chronic; Liver Diseases; Virus Diseases; Antiviral Agents; HCV/HIV co-infection

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants who failed treatment in Study GS-US-334-0119 who meet relevant
             inclusion/exclusion criteria are eligible for retreatment in this study

          -  Chronic genotype 1 HCV infection

          -  HCV treatment-naive

          -  HCV RNA > 10,000 IU/mL at screening

          -  Absence of cirrhosis

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Infection with hepatitis B virus (HBV)

          -  Current or prior history of clinical hepatic decompensation

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment, or compliance with the protocol

          -  For HIV-1/HCV co-infected individuals:

               -  Opportunistic infection within 6 months prior to screening

               -  Active, serious infection (other than HIV-1 or HCV) requiring parental
                  antibiotics, antivirals or antifungals within 30 days prior to baseline

               -  Treatment with an antiretroviral (ARV) regimen other than one of those listed in
                  the study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 1356; BI 1356 + metformin; Bi 1356 + metformin; Metformin; metformin; matching placebo
Intervention description: BI 1356 high dose tablet, once daily; BI 1356 low dose tablet + Metformin 500 mg tablet, twice daily; BI 1356 low dose tablet + Metformin 1000 mg tablet, twice daily; Metformin 500 mg tablet, twice daily; metformin 1000 mg tablet, twice daily; matching placebo
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 857.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of the randomised part of the study is to investigate the efficacy and safety
      of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug
      naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic
      patients with insufficient glycaemic control. For the open-label part of the study the
      objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic
      patients with very poor glycaemic control for 24 weeks
    

Eligibility criteria:

        Inclusion criteria:

        Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic
        control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic
        control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be
        included in the open-label arm

        Exclusion criteria:

        Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute
        congestive heart failure, impaired hepatic function, treatment with rosiglitazone or
        pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic
        steroids, renal failure or impairment, gastric bypass
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Condition: Indolent Non-Hodgkin's Lymphomas
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Placebo; Rituximab; Idelalisib
Intervention description: Tablets administered orally twice daily; 375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions); 150 mg tablets administered orally twice daily
Intervention MeSH terms: Rituximab; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iNHL; indolent NHL; follicular lymphoma; CAL-101; Rituximab; Small lymphocytic lymphoma; lymphoplasmacytoid lymphoma; Waldenstrom macroglobulinemia; LPL; WM; Marginal zone lymphoma; MZL; SLL; FL; GS-1101; idelalisib

Summary:

      The primary objective of this study is to evaluate the effect of the addition of idelalisib
      to rituximab on progression-free survival (PFS) in adults with previously treated indolent
      non-Hodgkin lymphoma (iNHL).

      An increased rate of deaths and serious adverse events (SAEs) among participants with
      front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in
      combination with standard therapies was observed by the independent data monitoring committee
      (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data
      and terminated this study in agreement with the DMC recommendation and in consultation with
      the US Food and Drug Administration (FDA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
             to the following:

               1. Follicular lymphoma (FL) Grade 1, 2, or 3a

               2. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10^9/L at
                  the time of diagnosis

               3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

               4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

        Key Exclusion Criteria:

          -  History of lymphoid malignancy other than those allowed per inclusion criteria

          -  Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic
             liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic
             obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.

          -  Received previous treatment with rituximab that was not effective.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-659/TEZ/IVA; IVA
Intervention description: Fixed-dose combination tablets for oral administration qd in the morning.; IVA tablet qd in the evening.
Intervention MeSH terms: Ivacaftor; VX-659
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 484.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and tolerability of VX-659 in triple
      combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis
      (CF) who are homozygous or heterozygous for the F508del mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study drug treatment in a parent study; or had study drug interruption(s) in
             a parent study but completed study visits up to the last scheduled visit of the
             Treatment Period in the parent study.

        Exclusion Criteria:

          -  History of drug intolerance in a parent study that would pose an additional risk to
             the subject in the opinion of the investigator.

          -  Current participation in an investigational drug trial (other than a parent study)

        Other protocol defined Inclusion/Exclusion criteria may apply.
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hyperlipidemia, Familial Combined; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Comparator: ezetimibe/simvastatin + niacin (ER); Comparator: Placebo to ezetimibe/simvastatin; Comparator: niacin (ER) tablet; Comparator: ezetimibe (+) simvastatin; Comparator: Placebo to Niacin (ER); Comparator: ezetimibe/simvastatin and niacin (ER); Comparator: ezetimibe and simvastatin; Comparator: Placebo to niacin (ER)
Intervention description: ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks; ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.; niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks; ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.; Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.; ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks; ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks; Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1220.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high
      cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to
             500 mg/dL

          -  Patient willing to be on a low-cholesterol diet

        Exclusion Criteria:

          -  Pregnant or lactating women or intending to become pregnant

          -  Patient with sensitivity or intolerance to ezetimibe, simvastatin, or
             ezetimibe/simvastatin combination tablet

          -  Patient with sensitivity or intolerance ro niacin, any component or niacin extended
             release or aspirin

          -  Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an
             unacceptable risk
Gel-200 Versus Placebo in Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Gel-200; Placebo
Intervention description: Single intra-articular injection; Single intra-articular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 379.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a single intra-articular injection of Gel-200 is
      superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with
      symptomatic osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the
             knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

        Exclusion Criteria:

          -  Subjects with Grade 4 on K-L score

          -  Subjects with inflammatory diseases of the knee other than osteoarthritis such as
             rheumatoid arthritis

          -  Serious systemic diseases

          -  Female subjects who are pregnant or lactating
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Condition: Prolonged Air Leak; Lung Resection
Intervention: Hemopatch; standard preventive measures
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Prevention PAL Prolonged Air Leak (PAL); Lung Resection; Thoracic Surgery; Post-operative Thoracic Air Leak

Summary:

      The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection
      procedures remains unproved. The investigators hypothesize that one of the main reasons for
      that is the heterogeneity of previously studied populations. Since currently the risk of
      postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to
      investigate the effect of routine application of a novel tissue sealant in patients selected
      on the basis of a high risk of PAL estimated before surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled anatomical lung resection indicated for any non-infectious disease
             (excluding Pneumonectomy)

          -  Patients classified in class D according estimated risk of PAL

          -  Age between 18 and 80 years

        Exclusion Criteria:

          -  Those patients that according to Investigator assessment are not going to tolerate the
             procedure

          -  Clinical and anesthetic criteria that contraindicate surgery

          -  Severe uncontrolled illness

          -  Pregnancy

          -  Patients that are under Investigational New Drug treatment or have participated in
             study with a investigational drug (authorized or not) in 30 days before randomization.

          -  Lack of Informed Consent or patient refusal

          -  Postsurgery mechanical ventilation or repeated surgery in follow-up month.
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera]
Intervention description: 1 g was given by intravenous infusion on Days 1 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of MabThera in patients with active
      rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha
      inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous
      inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated
      with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate
      therapy. The anticipated time on study treatment is 2+ years, and the target sample size is
      100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  rheumatoid arthritis for >=6 months;

          -  previous inadequate response to a single anti-TNF alpha inhibitor;

          -  methotrexate at a stable dose range 7.5-25 mg/week.

        Exclusion Criteria:

          -  other chronic inflammatory articular disease or systemic autoimmune disease;

          -  previous treatment with MabThera or intolerance to MabThera;

          -  corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at
             unstable doses within last 2 weeks;
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Oxcarbazepine XR
Intervention description: Open Label Study
Intervention MeSH terms: Oxcarbazepine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 66 Years
Healthy volunteers: No

Summary:

      Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine
      Extended-Release (OXC XR)
    

Eligibility criteria:

        Inclusion Criteria

          1. Able to provide written informed consent and agree to comply with study procedures.

          2. Male or female aged 18 to 66 years, inclusive.

          3. Successful completion of the 804P301 study.

          4. Sexually active women, unless surgically sterile (at least 6 months prior to Study
             Medication [SM] administration) or at least 1 year post-menopausal, must use an
             effective method of avoiding pregnancy (including oral, transdermal, or implanted
             contraceptives [any hormonal method in conjunction with a secondary method],
             intrauterine device, female condom with spermicide, diaphragm with spermicide,
             cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile
             [at least 6 months prior to SM administration] sexual partner) for at least four weeks
             prior to SM administration, and must agree to continue using such precautions through
             the End of Study visit. Cessation of birth control after this point should be
             discussed with a responsible physician.

        Exclusion Criteria

          1. Clinically significant change in health status that, in the opinion of the
             Investigator, would prevent the subject from participating in this study or
             successfully completing this study.

          2. Any reason which, in the opinion of the Investigator, would prevent the subject from
             participating in the study.
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Hypoglycemic Agents; Standard glycemia control; Intensive BP treatment; Standard BP control; Fenofibrate; Simvastatin; Placebo
Intervention description: Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%; A strategy of glycemia drugs for HbA1c 7% - 7.9%; A strategy of multiple BP agents to reduce SBP less than 120 mm Hg; A strategy of BP drugs for SBP less than 140 mm Hg; Blinded fenofibrate; Simvastatin 20-40 mg/d; Placebo
Intervention MeSH terms: Hypoglycemic Agents; Simvastatin; Fenofibrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3472.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Cardiovascular Diseases

Summary:

      Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can
      cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes
      (ACCORD) study is examining the effect of various treatments on cardiovascular disease in
      people with diabetes. This current study will examine the effects of the ACCORD treatments on
      the progression of DR in people participating in the ACCORD study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participating in the ACCORD study

        Exclusion Criteria:

          -  Has had laser photocoagulation for DR

          -  Has had vitrectomy surgery for DR