bioihbjkbjnl/mcl2 huggingface dataset:
ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Cetuximab; Panitumumab
Intervention description: Administered by intravenous infusion; Administered by intravenous infusion
Intervention MeSH terms: Cetuximab; Panitumumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1010.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Panitumumab; Vectibix; Colon Cancer; Colorectal Cancer; Rectal Cancer; Cetuximab; Erbitux; Metastatic

Summary:

      The primary objective of this study is to compare the effect of panitumumab versus cetuximab
      on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among
      patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or
             rectum, metastatic disease

          -  Wild-type KRAS tumor status

          -  Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2

          -  Must have failed a prior regimen containing irinotecan for metastatic disease and a
             prior regimen containing oxaliplatin for metastatic disease

          -  Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil,
             capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of
             colorectal cancer (CRC)

          -  Adequate hematologic, renal, hepatic and metabolic function

        Exclusion Criteria:

          -  Symptomatic brain metastases requiring treatment

          -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab
             or cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib,
             erlotinib, lapatinib)

          -  Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody
             therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before
             randomization.

          -  Clinically significant cardiovascular disease

          -  Active infection requiring systemic treatment or any uncontrolled infection ≤14 days
             prior to randomization
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
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Twinrix™ Adult; Twinrix™ Junior
Intervention description: Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.; Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 3 Years
Maximum age: 13 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Combined hepatitis A and B vaccine; Twinrix™

Summary:

      To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface
      antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of
      the study vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in primary study

          -  Written informed consent obtained before each long term follow up visit.
Open Label Extension Study of Epratuzumab in Subjects With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Epratuzumab; Epratuzumab
Intervention description: 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles; 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
Intervention MeSH terms: Epratuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus; Monoclonal antibody; B-Cell immunotherapy; Epratuzumab

Summary:

      The primary objective of the study is assess the safety and tolerability of long-term
      epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010
             (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to
             lack of efficacy and would, in the opinion of the investigator, continue to benefit
             from continued epratuzumab treatment

          -  Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881),
             and would, in the opinion of the investigator, continue to benefit from continued
             epratuzumab treatment

          -  Women of childbearing potential must agree to use an acceptable method of birth
             control

        Exclusion Criteria:

          -  Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
             element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease

          -  Subjects with active, severe SLE disease activity which involves the renal system

          -  Subjects with concurrent relevant medical conditions like defined chronic infections
             or high risk of new significant infections

          -  Substance abuse or dependence

          -  History of malignant cancer

          -  Subjects with any other condition which, in the investigator's judgment, would make
             the subject unsuitable for inclusion
Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
Condition: Lung Biopsy
MeSH terms: Pneumothorax
Intervention: ABPI; BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug
Intervention description: If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.; If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 454.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Experimental: autologous blood patch injection (ABPI); Experimental: BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug; 14-141

Summary:

      The purpose of this study is to compare two methods that are currently used at the end of a
      CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the
      chance of air leaking out of the hole. The two techniques consist of either injecting a very
      small amount of your the blood called a blood patch into the biopsy hole or injecting a
      gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed
      into the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years of age

          -  Referred for CT guided biopsy of lung lesion

          -  Target lesion of any size

          -  Target lesion located 1.5 cm or more away from visceral pleura based on the needle
             path

          -  Skin thickness ≤7 cm (from skin to pleura)

          -  Needle path without transgression of pleural fissure bleb, or bulla is possible

          -  Coaxial biopsy technique using Angiotech 19-Gauge introducer needle

          -  Needle length ≤15

        Exclusion Criteria:

          -  Passage through non-aerated lung or tissue

          -  More than 1 biopsy on the same side requiring more than 1 pleural puncture

          -  History of prior ipsilateral lung interventions including:

          -  Chest tube placement

          -  Surgery

          -  Pleurodesis

          -  Radiation treatment
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)
Condition: Seasonal Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Loteprednol etabonate 0.2%; Olopatadine 0.1%
Intervention description: 1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.; 1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
Intervention MeSH terms: Loteprednol Etabonate; Olopatadine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ocular allergy

Summary:

      This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%)
      versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief
      of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular
             itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due
             to seasonal allergy at Visit 1.

        Exclusion Criteria:

          -  Subjects who have a known hypersensitivity to the study medications or their
             components or contraindications to ocular corticosteroids.

          -  Subjects who use any of the disallowed medications throughout the duration of the
             study and during the period indicated prior to Visit 1.

          -  Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or
             any type of glaucoma.

          -  Subjects who have a history of any severe/serious ocular pathology or medical
             condition that could result in the subject's inability to complete the study or affect
             the subject's safety or trial parameters.
Study of Safety of RVL-1201 in Treatment of Blepharoptosis
Condition: Blepharoptosis
MeSH terms: Blepharoptosis
Intervention: RVL-1201; Vehicle ophthalmic solution
Intervention description: RVL-1201 ophthalmic solution, 0.1%; Vehicle placebo ophthalmic solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 234.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment
      of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female 9 years of age or older

          2. Females must not be pregnant or planning to get pregnant and must use acceptable form
             of contraception

          3. Must be able to self-administer study medication

          4. Must be able to understand and sign an Informed Consent Form (ICF). For minor
             subjects, the subject's parent or legal guardian must provide permission by signing an
             ICF on behalf of the subject and the subject should provide assent.

        Exclusion Criteria:

          1. Congenital ptosis

          2. Horner syndrome

          3. Myasthenia gravis

          4. Mechanical ptosis

          5. Previous ptosis surgery

          6. Resting heart rate outside the normal range

          7. Hypertension with resting diastolic blood pressure

          8. Pregnancy or lactation
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX; Placebo
Intervention description: 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food; Tablet administered orally once daily with food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of treatment
      with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
      virus (HCV) infection who have previously received treatment with direct-acting antiviral
      therapy.

      Participants randomized to placebo may be eligible for deferred treatment with active
      SOF/VEL/VOX.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  Treatment experienced with a direct acting antiviral medication for HCV

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%; Moxifloxacin AF Vehicle
Intervention description: Eye drops; Inactive ingredients used as a placebo for masking purposes
Intervention MeSH terms: Moxifloxacin; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1179.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: pink eye; conjunctivitis; moxifloxacin; fluoroquinolone

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF
      Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial
      conjunctivitis in patients one month of age or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with bacterial conjunctivitis in 1 or both eyes;

          -  Able to understand and sign an informed consent form. If subject is <18 years of age,
             the informed consent must be understood and signed by the subject's legally authorized
             representative;

          -  Agrees to comply with the visit schedule and other requirements of the study;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;

          -  Presence of concomitant viral infection;

          -  Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical
             origin;

          -  Infants whose birth mothers had any sexually transmitted disease within 1 month prior
             to delivery;

          -  Infants undergoing treatment for retinopathy of prematurity;

          -  Contact lens wear during the course of the study;

          -  Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80)
             or better;

          -  Use of medications, as specified in the protocol;

          -  Any systemic or ocular disease or disorder, complicating factors or structural
             abnormality that could negatively affect the conduct or outcome of the study;

          -  Known or suspected allergy or hypersensitivity to fluoroquinolones;

          -  Pregnant, lactating, or of childbearing potential and not using adequate birth control
             to prevent pregnancy;

          -  Other protocol-specified exclusion criteria may apply.
Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin; Placebo
Intervention description: Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily; Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in
      subjects with major depressive disorder who have an inadequate response to antidepressant
      therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients, aged 18 years and above

          2. A clinical diagnosis of major depressive disorder (MDD)

          3. Is being treated with one of the following SSRI or SNRI antidepressants:

               1. Citalopram

               2. Escitalopram

               3. Paroxetine

               4. Fluoxetine

               5. Sertraline

               6. Duloxetine

               7. Venlafaxine

               8. Desvenlafaxine

               9. Venlafaxine XR

          4. Inadequate response to SSRI/SNRI antidepressant treatment is confirmed

          5. If the subject is female, she must not be pregnant or breastfeeding. She must also be
             of non-childbearing potential OR must agree to use acceptable methods of contraception

        Exclusion Criteria:

          1. Has a history of psychotic disorder or is currently being treated or requires
             treatment for post-traumatic stress disorder, acute stress disorder, panic disorder,
             or obsessive compulsive disorder

          2. Has current evidence of delirium or an unstable neurological, cardiovascular,
             respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
             including cancer or malignancies that would affect the patient's ability to
             participate in the program

          3. Has a known history or symptoms of long QT syndrome

          4. Is determined to be inappropriate for the study for any reason

        Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to
        ensure that all criteria for study participation are met. Patients may be excluded from the
        study based on these assessments (and specifically, if it is determined that their baseline
        health and psychiatric condition do not meet all pre-specified entry criteria).