bioihbjkbjnl/mcl2 huggingface dataset:
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Placebo to Evolocumab
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypercholesterolemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9)

Summary:

      To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered
      every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from
      baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4
             weeks

          -  Fasting LDL-C ≥ 85 mg/dL

          -  Fasting triglycerides ≤ 400 mg/dL

        Exclusion Criteria:

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
             coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

          -  Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated
             Hemoglobin (HbA1c) > 8.5%)

          -  Uncontrolled hypertension

          -  New York Heart Association (NYHA) III or IV heart failure, or known left ventricular
             ejection fraction < 30%

          -  Uncontrolled cardiac arrhythmia
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
Condition: Pancreatic Cancer; Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: gemcitabine; placebo; Erlotinib; apricoxib
Intervention description: Gemcitabine: per package insert.; placebo: 100 mg tablets, 400 mg/day; Erlotinib - per package insert.; apricoxib: 100mg tablets, given orally
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with
      placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed adenocarcinoma of the pancreas that is
             locally advanced or metastatic.

          2. Life expectancy greater than or equal to 3 months.

          3. Patients must have measurable disease by RECIST.

          4. ECOG PS of 0, 1, or 2.

          5. Negative serum pregnancy test at the time of first dose for women of childbearing
             potential.

        Exclusion Criteria:

          1. Previous chemotherapy as primary treatment for locally advanced or metastatic
             pancreatic cancer(stage 3 T3 and T4, and all stage 4).

          2. RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational
             agents within 4 weeks of initiating study treatment.

          3. Evidence of New York Heart Association class III or greater cardiac disease.

          4. History of myocardial infarction, stroke, ventricular arrhythmia.

          5. Symptomatic central nervous system metastases.

          6. Pregnant or nursing women.

          7. Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides,
             aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).

          8. History of upper gastrointestinal bleeding, ulceration or perforation. History of
             lower GI bleeding, ulceration, or perforation within 12 months.

          9. Previous anti-EGFR kinase therapy.
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Condition: Advanced Bulky Malignancies
MeSH terms: Neoplasms
Intervention: Spatially Fractioned Radiation Therapy; Treatment Group 1; Standard radiation; Standard radiation
Intervention description: evaluate response to radiation therapy by a large bulky tumor influenced by adding a single dose of 15 Gy grid radiotherapy.; one treatment of Grid therapy followed by 15 treatments with standard radiation; 15 Standard radiation treatments; standard radiation treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: large tumors in the head & neck, lung, abdomen or pelvis

Summary:

      Expand clinical literature on the use of Grid radiation with conventional external beam
      therapy. Vast majority of therapy is for palliative care to provide relief from pain, but has
      also shown a reduction in the size of tumor mass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologic or cytologic diagnosis of primary or metastatic epithelial
             cancer or sarcoma located in the head and neck area, lung, abdomen or pelvis.

          -  Tumors must have an overall dimension greater than 24 cm2 (bidimensional) with one
             dimensions >6 cm, by x-ray, CT/MRI scan or clinical exam.

          -  Age >18

          -  Karnofsky > 70 with life expectancy >3 months.

          -  Patients may not begin new hormone therapy within 2 weeks of initiation of protocol
             treatment.

          -  No planned initiation of hormone therapy within 2 weeks of protocol therapy

          -  Adequate bone marrow function: Hb > 9, white blood cell count (WBC) > 2,000. Hepatic
             function < 3x upper limit of laboratory normal values.

          -  Laboratory studies will be obtained within 2 weeks prior to randomization.

          -  Patients with metastatic sites of disease including brain are eligible provided that
             life expectancy is > 3 months.

        Exclusion Criteria:

          -  Hematologic-related tumors.

          -  Tumors overlying critical central nervous system structures including spinal cord, eye
             or brainstem or require treatment portals over these vital structures.

          -  Central nervous system tumors

          -  Evidence of other primary malignancy except for carcinoma in situ of cervix or skin
             cancer excluding melanoma unless disease free for 2 years prior to randomization

          -  Patients with spinal cord compression.

          -  Prior radiation to treatment field.

          -  Concomitant chemotherapy or chemotherapy within past 2 weeks. Planned initiation of
             chemotherapy within 2 weeks of completing protocol treatment
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib 150 mg tablet will be given orally daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will evaluate the efficacy and safety of erlotinib
      (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer
      (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic NSCLC with EGFR mutations

          -  Measurable disease according to RECIST criteria

          -  Adequate hematological, renal and liver function

        Exclusion Criteria:

          -  Previous chemotherapy or therapy against EGFR for metastatic disease

          -  Symptomatic cerebral metastases

          -  Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic
             carcinomatosis

          -  History of another malignancy except for carcinoma in-situ of the cervix, adequately
             treated basal cell skin carcinoma, or radically treated prostate carcinoma with good
             prognosis

          -  Concomitant use of coumarins
Effectiveness of Mexiletine for Treating People With Non-Dystrophic Myotonia
Condition: Myotonia; Non-Dystrophic Myotonia
MeSH terms: Myotonia
Intervention: Mexiletine; Placebo
Intervention description: 200 mg three times a day; in pill form; Placebo three times a day; in pill form
Intervention MeSH terms: Mexiletine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Nondystrophic myotonias (NDM) are neuromuscular disorders caused by genetic abnormalities in
      certain muscle cell membrane proteins. The proteins affect muscle contraction. Individuals
      with NDM experience limited muscle relaxation, which then can cause pain, weakness,
      incoordination, and impaired physical activity and function. Because NDM is very rare,
      information on the best way to treat people with the disorders is lacking, and there are no
      FDA-approved therapies. The purpose of this study is to determine the effectiveness of the
      medication mexiletine in treating people with NDM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical symptoms or signs suggestive of myotonic disorders

          -  Presence of myotonic potentials on electromyography (EMG)

          -  Participant in the Non-Dystrophic Natural History study (RDCRN 5303) or a new patient
             with confirmed non-dystrophic myotonia

        Exclusion Criteria:

          -  Other neurological condition that might affect the assessment of the study
             measurements

          -  Genetic confirmation of DM1 (more than 50 repeats of CTG) or DM2

          -  Existing cardiac conduction defects, as evidenced on EKG, including but not limited to
             the following conditions: malignant arrhythmia or cardiac conduction disturbances
             (e.g., second degree AV block, third degree AV block, or prolonged QT interval)

          -  Existing permanent pacemaker

          -  Current use of any of the following antiarrhythmic medications for a cardiac disorder:
             flecainide acetate, encainide, disopyramide, procainamide, quinidine, propafenone, or
             mexiletine

          -  Use of medications for myotonia, such as phenytoin and flecainide acetate, within 5
             days of study entry; carbamazepine and mexiletine within 3 days of study entry; or
             propafenone, procainamide, disopyramide, quinidine, and encainide within 2 days of
             study entry

          -  Use of medications that produce myotonia, which may include fibrate acid derivatives,
             hydroxymethylglutaryl CoA reductase inhibitors, chloroquine, and colchicines

          -  Kidney or liver disease

          -  Heart failure

          -  Seizure disorder

          -  Pregnant or breastfeeding
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Condition: Tumors With Aberrations in ALK or ROS1
MeSH terms: Neoplasms
Intervention: Ceritinib
Intervention description: Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally,once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days. There were no breaks between dosing cycles.
Intervention MeSH terms: Ceritinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hematological malignancy; solid tumor malignancy; mutation; translocation; rearrangement; amplification; ALK; ROS1; NSCLC; B-cell lymphoma

Summary:

      The purpose of this signal seeking study was to determine whether treatment with ceritinib
      demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic
      malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or
             hematological malignancy and was in need of treatment because of radiologic
             progression or relapse.

          -  Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive
             mutation, translocation, rearrangement or amplification. The qualifying alteration
             must have been assessed and reported by a CLIA-certified laboratory. ALK positivity as
             assessed by IHC or FISH were allowed.

          -  Patient must have received at least one prior treatment for recurrent, metastatic
             and/or locally advanced disease and for whom no standard therapy options were
             anticipated to result in a durable remission.

          -  Patient had progressive and measurable disease as per RECIST 1.1 or other appropriate
             hematological guidelines.

          -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

        Exclusion Criteria:

          -  Patient had received prior treatment with ceritinib.

          -  Patients with symptomatic CNS metastases who were neurologically unstable or required
             increasing doses of steroids within the 2 weeks prior to study entry to manage CNS
             symptoms.

          -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for
             nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Intervention: CervarixTM; HPV investigational vaccine GSK568893A, different formulations
Intervention description: Subjects were administered three doses of HPV vaccine; Subjects were administered three doses of HPV investigational vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 383.0
Sex: Female
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic
      types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also
      evaluating novel HPV vaccines formulations. This study will evaluate the long-term
      immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects
      who received the novel vaccine or the control vaccine administered in the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female who enrolled in the study 102115 and received three doses of vaccine.

          -  Written informed consent obtained from the subject prior to enrolment.

        Exclusion Criteria:

          -  Use (or planned use during the study period) of any investigational or non-registered
             product or off-label use of licensed product (drug or vaccine).

          -  Chronic administration of immunosuppressants or other immune-modifying drugs occurring
             less than three months prior to blood sampling.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.

          -  Planned administration of any HPV vaccine, other than that foreseen by the study
             protocol, during the study period.
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Condition: Asthma Patients
MeSH terms: Asthma
Intervention: AZD1981; AZD1981; Placebo
Intervention description: AZD1981 twice daily; AZD1981 once daily; Placebo to match AZD1981
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Efficacy; safety; tolerability; dose finding; asthma patients

Summary:

      The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active
      compound in asthmatic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women. Women must be surgically sterilized/postmenopausal or use double
             barrier method contraception

          -  6 months history of asthma according to ATS definition

          -  Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2

          -  Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal

          -  A total ACQ5 score of 1.5 or more

        Exclusion Criteria:

          -  Respiratory infection significantly affecting the asthma

          -  Any significant disease and disorder that may put the patient at risk or influence
             study results

          -  Any clinically relevant abnormal findings

          -  A smoking history of more than 10 pack years

          -  Intake of oral, rectal or parenteral glucocorticosteroids
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo (for teriflunomide); Glatiramer Acetate (GA)
Intervention description: Film-coated tablet
Oral administration; Film-coated tablet
Oral administration; Solution in prefilled syringe for subcutaneous injection
Intervention MeSH terms: Teriflunomide; Glatiramer Acetate; (T,G)-A-L
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; glatiramer acetate; adjunctive therapy; relapses

Summary:

      The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide
      administered once daily for 24 weeks, compared to placebo, in patients with multiple
      sclerosis [MS] with relapses who were on a stable dose of Glatiramer Acetate [GA].

      The secondary objectives were:

        -  to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in
           combination with a stable dose of GA on Magnetic Resonance Imaging [MRI] parameters,
           relapse rate and patient-reported fatigue;

        -  to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with
           a stable dose of GA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Definite MS diagnosis according to McDonald's criteria;

          -  Relapsing clinical course, with or without progression;

          -  Expanded Disability Status Scale [EDSS] less or equal to 5.5 (ambulatory);

          -  Stable dose of Glatiramer Acetate [GA] for at least 26 weeks prior to the screening
             visit;

          -  No onset of MS relapse in the preceding 60 days prior to randomization;

          -  Clinically stable for 4 weeks prior to randomization.

        Exclusion Criteria:

          -  Other chronic disease of the immune system, liver function impairment or chronic
             pancreatic disease;

          -  Pregnant or nursing woman;

          -  Alcohol or drug abuse;

          -  Use of cladribine, Mitoxantrone, or other immunosuppressant agents such as
             Azathioprine, Cyclophosphamide, Cyclosporin, Methotrexate or Mycophenolate before
             enrollment;

          -  Human immunodeficiency virus [HIV] positive status;

          -  Any known condition or circumstance that would prevent in the investigator's opinion
             compliance or completion of the study.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Gemfibrozil for Nicotine Smoking Cessation
Condition: Smoking Cessation
Intervention: Gemfibrozil; smoking cessation counseling
Intervention description: FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use); smoking cessation counseling
Intervention MeSH terms: Gemfibrozil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This project will test whether gemfibrozil, a well-studied medication for high cholesterol,
      will help people stop smoking nicotine cigarette smoking. The study will also test whether
      gemfibrozil decrease cravings for cigarette and the desire to smoke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-64 years

          -  Meet DSM-5 criteria for tobacco use disorder based on cigarette use

          -  Desire to quit smoking

          -  Able to complete assessments and interview in English

        Exclusion Criteria:

          -  Psychiatric co-morbidity posing safety risk, including current suicidality or
             psychosis as assessed on clinical interview

          -  Concurrent use of a statin medication (HMG-CoA reductase inhibitor),anticoagulant, or
             repaglinide

          -  Concurrent use of any FDA-approved medication for smoking cessation

          -  Use of any form of tobacco or nicotine (including vaporizer) other than cigarette
             smoking

          -  Any DSM-5 substance use disorder other than nicotine use disorder

          -  History of intolerance to any fibrate medication

          -  History of gallbladder disease and cholestectomy has not been performed

          -  Baseline liver function tests > twice the upper limit of normal

          -  Severe impairment of renal function (baseline serum creatinine ≥ 2 mg/dL)

          -  Currently pregnant or nursing