bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Monotherapy; Partial Onset Seizures

Summary:

      The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16
      years and older with epilepsy. This study permits continued access to treatment for subjects
      who participated in a previous epilepsy study. The study will explore the long-term safety
      and efficacy of brivaracetam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with epilepsy who participated in previous brivaracetam trials which allow
             access to the present trial.

          -  Subjects from whom the Investigator believes a reasonable potential benefit from the
             long-term administration of brivaracetam may be expected.

        Exclusion Criteria:

        • Severe medical, neurological and psychiatric disorders, including current suicidal
        ideation or behaviour, or laboratory values which may have an impact on the safety of the
        subject, as determined by the investigator.
A Study of S6G5T3 in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: S6G5T-3; S6G5T-8
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 434.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12
      weeks in participants with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 9 years of age and older.

          3. Have 2 or fewer cysts or nodules.

        Exclusion Criteria:

          1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or
             equal to 5 millimeter [mm] in diameter).

          2. Acne conglobata, acne fulminans and secondary acne (for example, chloracne,
             drug-induced acne).

          3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia,
             multiple myeloma).

          4. Underlying disease that requires the use of interfering topical or systemic therapy.

          5. Other dermatological conditions that require the use of interfering topical or
             systemic therapy or that might interfere with study assessments such as, but not
             limited to, atopic dermatitis, perioral dermatitis, or rosacea.
An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Perampanel
Intervention description: Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; Perampanel

Summary:

      To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in
      participants with epilepsy. This study will be continued until perampanel is commercially
      available.
    

Eligibility criteria:

        Inclusion Criteria

          1. Participants participating in the designated perampanel study as below, and who in the
             opinion of the investigator continue to benefit from treatment with perampanel
             Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of
             total exposure to perampanel).

          2. Provide written informed consent/assent signed by participant or legal guardian prior
             to entering the study or undergoing any study procedures. If the written informed
             consent is provided by the legal guardian because the participant is unable to do so,
             a written or verbal assent from the participant must also be obtained.

          3. Female participants of childbearing potential must agree for the duration of the study
             and for a period of at least 1 month following the last dose of perampanel to be
             abstinent or to commit to the consistent and correct use of a medically acceptable
             method of birth control (eg, a double-barrier method [condom plus spermicide, condom
             plus diaphragm with spermicide]).

        Exclusion Criteria

          1. Participants residing in countries where perampanel is commercially available with
             respect to the indication or formulation of the designated perampanel study.

          2. Female participants who are nursing, pregnant, or planning to become pregnant.
Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion
Condition: Abortion; Blood Loss
MeSH terms: Hemorrhage
Intervention: Misoprostol; Folic acid
Intervention description: 400 mcg buccally 2 hours prior to procedure; 2mg buccally 2 hours prior to procedure
Intervention MeSH terms: Folic Acid; Misoprostol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to
      aid in softening the cervix as well as decreasing blood loss after abortion or vaginal
      delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in
      decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled
      trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester
      surgical abortion decreases blood loss from the procedure. The investigators will also assess
      whether misoprostol improves cervical dilation, changes the length of the procedure, changes
      the need for additional mechanical dilation, changes the subjective ease of the procedure,
      and changes a woman's pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking

          -  Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound
             dating on the day of enrollment

          -  Ultrasound used for dating purposes must be within the last two weeks.

          -  Women 18-50 years of age undergoing surgical termination of pregnancy

        Exclusion Criteria:

          -  Spontaneous fetal demise

          -  Ruptured membranes or intrauterine infection

          -  Fibroids that significantly distort the uterine shape

          -  Uterine abnormality such as unicornuate uterus

          -  Prior transmural myomectomy

          -  Severe oligohydramnios

          -  Morbid obesity with BMI>45

          -  Inability to place osmotic dilators
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-661 plus ivacaftor combination; Ivacaftor; Placebo (matched to VX-661 plus ivacaftor combination); Placebo (matched to ivacaftor)
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 168.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through
      Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del
      mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR
      mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive
      [NR]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF defined as a sweat chloride value greater than or equal to
             (>=)60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis.

          -  Heterozygous for the F508del-CFTR mutation and with a second CFTR mutation that is not
             likely to respond to VX-661 and/or ivacaftor therapy, genotype to be confirmed via
             assessment at the Screening Visit.

          -  Forced Expiratory Volume in 1 Second (FEV1) >=40 percent (%) and less than or equal to
             (<=)90% of predicted normal for age, sex, and height at Screening Visit.

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             participant.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
             (first dose of study drug).

          -  History of solid organ or hematological transplantation.

          -  Ongoing or prior participation in an investigational drug study or use of commercially
             available CFTR modulator within 30 days of screening.

          -  Pregnant or nursing females.
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ipilimumab; Nivolumab; Carboplatin; Paclitaxel; Pemetrexed; Cisplatin
Intervention description: Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Paclitaxel; Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 719.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with
      chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as
      the first treatment given for the disease
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or
             non-squamous histology, with no prior systemic anticancer therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

          -  Measurable disease by CT or MRI per response evaluation criteria in solid tumors
             version 1.1 (RECIST 1.1) criteria

          -  Participants must have PD-L1 IHC testing with results performed by a central
             laboratory during the screening period

        Exclusion Criteria:

          -  Participants with known epidermal growth factor receptor (EGFR) mutations which are
             sensitive to available targeted inhibitor therapy (including, but not limited to,
             deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded

          -  Participants with known anaplastic lymphoma kinase (ALK) translocations which are
             sensitive to available targeted inhibitor therapy are excluded

          -  Participants with untreated CNS metastases are excluded. Participants are eligible if
             CNS metastases are adequately treated and participants are neurologically returned to
             baseline (except for residual signs or symptoms related to the CNS treatment) for at
             least 2 weeks prior to first treatment

        Other protocol inclusion/exclusion criteria may apply
3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Condition: Ureter Injury
Intervention: 3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%; Saline spray
Intervention description: Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To determine whether the use of 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium
      0.8% Solution for injection provides a visualization advantage compared to saline when used
      as an aid in the determination of ureteral patency
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between ≥ 18 and ≤ 85 years old.

          -  Subjects who signed written, IRB approved, informed consent form.

          -  Subjects scheduled for urological or gynecological surgical procedures in which the
             patency of the ureter must be assessed by the surgeon during the procedure

        Exclusion Criteria:

          -  Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR <30
             mL/min/1.73m2 (using the MDRD) or need for dialysis in the near future, or having only
             1 kidney.

          -  Subjects with known severe hypersensitivity reactions to IC or other dyes including
             contrast agents.

          -  Known history of drug or alcohol abuse within 6 months prior to the time of screening
             visit.

          -  Subjects, as assessed by the Investigator, with conditions/concomitant diseases
             precluding their safe participation in this study (e.g. major systemic diseases).

          -  Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is
             uncooperative or has a condition that could lead to non-compliance with the study
             procedures.

          -  Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist,
             study coordinator, other staff or relative thereof directly involved in the conduct of
             the protocol;

          -  Subjects with life expectancy < 6 months;

          -  Requirement for concomitant treatment that could bias primary evaluation.

          -  Subjects who are pregnant or breast-feeding.
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: Blood sampling; Cervico-vaginal secretion (CVS) samples
Intervention description: Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.; CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 525.0
Sex: Female
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical cancer; HPV vaccine

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. This study is designed to evaluate the long-term immunogenicity and
      safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the
      first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals
      with objectives & outcome measures of the extension phase from Year 5 to Year 10. The
      objectives & outcome measures of the primary phase and extension phase up to year 4 are
      presented in a separate protocol posting (NCT00196937).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believed that they could and would comply with the
             requirements of the protocol.

          -  A female who had been enrolled in NCT00196937 study and received three doses of
             HPV-16/18 vaccine.

          -  Written informed consent obtained from the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Chronic administration (defined as more than 14 consecutive days) of
             immunosuppressants or other immune-modifying drugs occurring less than three months
             prior to blood sampling.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.

          -  Administration or planned administration of any HPV vaccine, other than the three
             doses of HPV-16/18 vaccine administered in NCT00196937 study.
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Intervention: Peginterferon Lambda-1a; Peginterferon Alfa-2a; Ribavirin; Telaprevir
Intervention description: Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response; Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response; Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response; Tablets, Oral, 750 mg, three times a day, 12 weeks only
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 881.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined
      with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis
      C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects

          -  Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA)
             based]

          -  Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on
             prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after
             discontinuation of treatment). Capped at 20%

          -  HCV RNA ≥ 100,000 IU/mL

          -  Subjects with compensated cirrhosis can be enrolled and will be capped at
             approximately 10%

          -  Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen
             (HBsAg)

          -  Men or women, 18-70 years of age

        Exclusion Criteria:

          -  Chronic liver disease due to causes other than chronic HCV

          -  Current or past evidence of decompensation

          -  Conditions that preclude the use of Alfa/RBV/TVR per respective labels

          -  Diagnosed or suspected hepatocellular carcinoma