araag2/HINT huggingface dataset:
Clinical trial NCT02162771 (phase 3, status: completed)
Conditions: lymphoma, follicular
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, vincristine, prednisone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          1. Patient is male or female older than 18 years.

          2. Patient has histologically confirmed FL according to the World Health Organization
             2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.

          3. Patient has at least 1 measurable tumour mass that has not previously been irradiated,
             and the mass must be:

               -  greater than 1.5 cm in the longest dimension or

               -  between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the
                  shortest axis

          4. Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue
             obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central
             independent reviewer to detect pathological type.)

          5. Patient has Ann Arbor stage III or IV disease.

        Exclusion Criteria:

          1. Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or
             vincristine.

          2. Patient has allergies or hypersensitivity to murine, chimeric, human or humanised
             proteins, cyclophosphamide, vincristine, or prednisone.

          3. Patient has evidence of histological transformation to high-grade or diffuse large
             B-cell lymphoma.

          4. Patient has known central nervous system involvement.

          5. Patient has received previous treatment for NHL:

               -  Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or
                  surgery (except previous biopsy)

               -  All doses of corticoid therapy for treatment of NHL

               -  Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with
                  prednisone >20 mg per day for the treatment for any purpose
Clinical trial NCT02163499 (phase 3, status: completed)
Conditions: hyperkalemia
ICD codes: E87.5, P74.31
Drugs: sodium zirconium cyclosilicate
SMILES: O.O.[Na+].[Na+].O[Si](O)(O)O.O[Si](O)(O)O.O[Si](O)(O)O.O[Zr](O)(O)(O)([O-])[O-]
Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent.

          -  Over 18 years of age.

          -  Two consecutive i STAT potassium values, measured 60 (+/- 15) minutes apart, both >/=
             5.1 mmol/L and measured within 1 day before the first dose of ZS on Acute Phase Study
             Day 1.

          -  Ability to have repeated blood draws or effective venous catheterization.

          -  Women of childbearing potential must be using 2 forms of medically acceptable
             contraception (at least 1 barrier method) and have a negative pregnancy test at Acute
             Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal
             for at least 2 years are not considered to be of childbearing potential.

          -  Controlled diabetic subjects.

        Exclusion Criteria:

          -  Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to
             excessive fist clenching to make veins prominent, difficult or traumatic venipuncture,
             or history of severe leukocytosis or thrombocytosis.

          -  Subjects treated with lactulose, rifaximin, or other non-absorbed antibiotics for
             hyperammonemia within 7 days prior to first dose of ZS on Acute Phase Study Day 1.

          -  Subjects treated with sodium polystyrene sulfonate (SPS; eg, Kayexalate®) or calcium
             polystyrene sulfonate (eg, Resonium®) within 3 days prior to first dose of ZS on Acute
             Phase Study Day 1.

          -  Subjects with a life expectancy of less than 12 months.

          -  Subjects who are severely physically or mentally incapacitated and who, in the opinion
             of investigator, are unable to perform the subjects' tasks associated with the
             protocol.

          -  Women who are pregnant, lactating, or planning to become pregnant.

          -  Subjects with diabetic ketoacidosis.

          -  Presence of any condition which, in the opinion of the investigator, places the
             subject at undue risk or potentially jeopardizes the quality of the data to be
             generated.

          -  Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.

          -  Treatment with a drug or device within the last 30 days that has not received
             regulatory approval at the time of study entry.

          -  Subjects with cardiac arrhythmias that require immediate treatment.

          -  Subjects on dialysis.

          -  Subjects randomized into the previous ZS-002, ZS-003, ZS-004, or ZS-004E studies.

          -  Documented GFR <15 mL/min within 90 days prior to study entry.
Clinical trial NCT02163824 (phase 3, status: completed)
Conditions: ocular infections, irritations and inflammations
ICD codes: H30.893, H01.8, H30.891, H30.892, H30.899
Drugs: kpi-121 0.25%, kpi-121 1.0%, vehicle of kpi-121 0.25%, vehicle of kpi-121 1.0%
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CC1=CC(O)=CC(C)=C1Cl, CC1=CC(O)=CC(C)=C1Cl
Eligibility criteria:

        FURTHER STUDY DETAILS PROVIDED BY KALA PHARMACEUTICALS, INC.

        Inclusion Criteria:

          -  Candidates for routine, uncomplicated cataract surgery

          -  In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole
             method of at least 20/200 in study eye.

        Exclusion Criteria:

          -  Known hypersensitivity/contraindication to study product(s) or components.

          -  History of glaucoma, IOP >21 mmHg at the screening or randomization visits, or being
             treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance;
             severe/serious systemic disease or uncontrolled medical condition that in judgment of
             Investigator could confound study assessments or limit compliance; or have been
             exposed to an investigational drug within the 30 days prior to screening or 19 days
             following surgery.

          -  In the opinion of Investigator or study coordinator, be unwilling or unable to comply
             with study protocol or unable to successfully instill eye drops.
Clinical trial NCT02164864 (phase 3, status: completed)
Conditions: atrial fibrillation, percutaneous coronary intervention
ICD codes: I48.0, I48.21, I48.91, I48.11, I48.19, I48.20, Y35.312S, Y35.313S, Y35.412S, Y35.413S, Y35.812S, Y35.813S, Y35.92XS
Drugs: dabigatran etexilate 110mg, warfarin 3mg, aspirin, dabigatran etexilate 150mg, clopidogrel or ticagrelor, clopidogrel or ticagrelor, warfarin 5mg, clopidogrel or ticagrelor, warfarin 1mg
SMILES: CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, CC(=O)OC1=CC=CC=C1C(O)=O, CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1, N[C@@H](CCCNC(N)=N)C(O)=O, N[C@@H](CCCNC(N)=N)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, N[C@@H](CCCNC(N)=N)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2
Eligibility criteria:

        Inclusion criteria:

          -  Male or female patients aged >=18 years

          -  Patients with Non Valvular Atrial Fibrillation

          -  Patient presenting with:

        An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI
        [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either
        Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at
        least one lesion eligible for PCI that was successfully treated by elective PCI and
        stenting (either BMS or DES)

          -  The patient must be able to give informed consent in accordance with International
             Conference on Harmonisation Good Clinical Practice guidelines and local legislation
             and/or regulations.

        Exclusion criteria:

          -  Patients with a mechanical or biological heart valve prosthesis

          -  Cardiogenic shock during current hospitalisation

          -  Stroke within 1 month prior to screening visit

          -  Patients who have had major surgery within the month prior to screening

          -  Gastrointestinal haemorrhage within one month prior to screening, unless, in the
             opinion of the Investigator, the cause has been permanently eliminated

          -  Major bleeding episode including life-threatening bleeding episode in one month prior
             to screening visit

          -  Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced
             thrombocytopenia (platelet count <100 x 109/L) at screening

          -  Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by
             Cockcroft-Gault equation) <30mL/min at screening

          -  Active liver disease
Clinical trial NCT02165111 (phase 3, status: completed)
Conditions: scleroderma, raynaud's syndrome
ICD codes: L94.1, L94.0
Drugs: onabotulinumtoxin a, sterile saline solution
SMILES: [Na+].[Cl-]
Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years and older

          -  Diagnosed with scleroderma.

          -  Symptoms of Raynaud's syndrome affecting both hands (not necessarily to equal extents)

          -  Ability to return/be available for follow-up evaluations

          -  Able and willing to give informed consent

          -  Able to speak and read in the English language.

        Exclusion Criteria:

          -  A history of Myasthenia gravis.

          -  Reported allergy or hypersensitivity to any Botulinum toxin preparation.

          -  Active infection in either hand.

          -  Patients who have ever received Botulinum toxin vaccine.

          -  Pregnant or lactating women.

          -  Females unable or unwilling to maintain abstinence or use contraception for 28 days
             following the injections.

          -  Patients who have previously undergone any vascular surgery on the upper extremity,
             including surgical sympathectomies.

          -  Current use of any aminoglycoside antibiotic
Clinical trial NCT02168491 (phase 3, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: lixisenatide, insulin glargine
SMILES: [V].[H][C@](C)(O)[C@]([H])(N=C(O)CN=C(O)[C@]([H])(CCC(O)=O)N=C(O)CN=C(O)[C@@]([H])(N)CC1=CN=CN1)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CC(O)=O)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCC(O)=N)C(O)=N[C@@]([H])(CCSC)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(C)C(O)=N[C@@]([H])(C(C)C)C(O)=N[C@@]([H])(CCCNC(N)=N)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CC1=CC=CC=C1)C(O)=N[C@]([H])(C(O)=N[C@@]([H])(CCC(O)=O)C(O)=N[C@@]([H])(CC1=CNC2=CC=CC=C12)C(O)=N[C@@]([H])(CC(C)C)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CC(O)=N)C(O)=NCC(O)=NCC(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CO)C(O)=NCC(O)=N[C@@]([H])(C)C(=O)N1CCC[C@@]1([H])C(=O)N1CCC[C@@]1([H])C(O)=N[C@@]([H])(CO)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N[C@@]([H])(CCCCN)C(O)=N)[C@@]([H])(C)CC)[C@@]([H])(C)O, [Na+].[Na+].[O-]P([O-])(F)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 - 70a

          -  Subjects understand study related activities and give written informed concent

          -  HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections)

        Exclusion Criteria:

          -  Females of child-bearing age

          -  History of hypoglycemia unawareness

          -  Gastrointestinal disease associated with prolonged nausea and vomiting

          -  Impaired liver function (transaminase >2x than normal)

          -  Impaired kidney function (creatinin > 1,2 mg/dl)

          -  Known intolerance against GLP-1 receptor agonists

          -  History of pancreatitis or pancreas tumor

          -  Malignancies, autoimmune diseases

          -  Severe dyslipidemia (serum triglycerides > 400 mg/dl, cholesterol > 300 mg/dl)

          -  Psychiatric disorder

          -  Oral glucose lowering medication except for metformin
Clinical trial NCT02174094 (phase 3, status: withdrawn)
Conditions: dravet syndrome
ICD codes: G40.833, G40.834
Drugs: clobazam, placebo
SMILES: CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    the study was terminated due to recruitment challenges
  
Eligibility criteria:

        Inclusion Criteria:

          -  Onset of seizures in the first year of life

          -  History of fever-induced prolonged seizures as determined by the Investigator

          -  These may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

          -  Multiple seizure types which may include:

               -  generalised tonic-clonic (required for inclusion)

               -  clonic (required for inclusion)

               -  myoclonic jerks/seizures

               -  history of normal development prior to seizure onset followed by development
                  delay or regression after seizure onset

               -  abnormal EEG consistent with Dravet Syndrome 2. The patient has a history of
                  approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is
                  treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal
                  Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4.
                  Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

        Exclusion Criteria:

          1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken
             these drugs in the past, they need to have been off drug for 5 half-lives

          2. The patient is taking a sodium channel blocker including, but not limited to,
             phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and
             rufinamide. If patients have taken these drugs in the past, they need to have been off
             drug for 5 half-lives

          3. The patient is on cannabidiol, medical marijuana, or any drug that contains
             cannabinoids

          4. The patient has received chronic treatment (≥2 weeks for any indication) with a
             benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for
             prolonged seizures is allowed

          5. The patient has received clobazam within 3 months prior to the Screening Visit. If the
             patient has received clobazam in the past, discontinuation must not have been for
             adverse events or lack of efficacy

        Other protocol-defined inclusion and exclusion criteria may apply.
Clinical trial NCT02177266 (phase 3, status: terminated)
Conditions: atrial fibrillation, post-pericardiotomy syndrome, constriction
ICD codes: I48.0, I48.21, I48.91, I48.11, I48.19, I48.20
Drugs: colchicine, placebo
SMILES: COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    difficulty in recruiting patients
  
Eligibility criteria:

        Inclusion Criteria:

          -  All consecutive adult patients (age > 40) undergoing standard (non-minimally invasive)
             coronary artery bypass surgery and/or aortic valve surgery will be approached for
             enrollment.

          -  All patients must be able to provide informed consent and comply with the 3 month
             follow-up.

          -  For women of reproductive capability, contraception is necessary and required.

        Exclusion Criteria:

          -  Epidermal growth factor receptor (eGFR) < 30 mL/min/1.73 m^2, serum creatinine > 2.5
             mg/dL or requiring dialysis

          -  Known permanent or current atrial fibrillation (history of paroxysmal atrial
             fibrillation allowed if in sinus rhythm at present)

          -  Allergy to colchicine or already treated with colchicine.

          -  Known blood dyscrasia (acute or chronic leukemia, pancytopenia, aplastic anemia,
             leukopenia)

          -  Known serious gastrointestinal disease

          -  Known severe liver disease (cirrhosis, aspartate aminotransferase (AST)/alanine
             aminotransferase (ALT) > 2x the upper limit of normal, Model End Stage Liver Disease
             (MELD) score > 20)

          -  Women of childbearing potential not using contraception.

          -  Patients with HIV or AIDS as the use of protease inhibitors can result in serious
             colchicine toxicity.

          -  Patients who are treated with strong CYP3A4 inhibitors (clarithromycin/erythromycin,
             chloramphenicol, ketoconazole/itraconazole, and nefazodone).

          -  There is a risk of rhabdomyolysis with the use of digoxin and colchicine, we will
             exclude patients who require ongoing treatment with digoxin.

          -  Inability or unwillingness of the individual to give written informed consent.
Clinical trial NCT02179151 (phase 3, status: terminated)
Conditions: prader-willi syndrome, obesity
ICD codes: Q87.11, E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: zgn-440 for injectable suspension, zgn-440 placebo for injectable suspension
SMILES: CO[C@@H]1[C@@H](CC[C@]2(CO2)[C@H]1[C@@]1(C)O[C@@H]1CC=C(C)C)OC(=O)\C=C\C1=CC=C(OCCN(C)C)C=C1, CO[C@@H]1[C@@H](CC[C@]2(CO2)[C@H]1[C@@]1(C)O[C@@H]1CC=C(C)C)OC(=O)\C=C\C1=CC=C(OCCN(C)C)C=C1
Reason stopped: 
    fda clinical hold
  
Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed genetic diagnosis of Prader-Willi Syndrome

          -  Age 12-65

          -  Obesity

          -  Age 12-17: BMI ≥ 95th percentile for age and gender

          -  Age 18-65: BMI ≥27 to ≤60 kg/m2

        Exclusion Criteria:

          -  Subjects living in a group home ≥ 50% of the time

          -  Recent use (within 3 months) of weight loss agents including herbal medication

          -  Poorly controlled severe psychiatric disorders
Clinical trial NCT02179658 (phase 3, status: completed)
Conditions: clostridium difficile
ICD codes: A04.71, A04.72
Drugs: opt-80, vancomycin
SMILES: CC[C@H]1\C=C(C)\[C@@H](O)C\C=C\C=C(CO[C@@H]2O[C@H](C)[C@@H](OC(=O)C3=C(CC)C(Cl)=C(O)C(Cl)=C3O)[C@H](O)[C@@H]2OC)\C(=O)OC(C\C=C(/C)\C=C(C)\[C@@H]1O[C@@H]1OC(C)(C)[C@@H](OC(=O)C(C)C)[C@H](O)[C@@H]1O)[C@@H](C)O, CCCCCCCCCC(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H]1[C@@H](C)OC(=O)[C@H](CC(=O)C2=C(N)C=CC=C2)NC(=O)[C@@H](NC(=O)[C@@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCN)NC(=O)CNC1=O)[C@H](C)CC(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Inpatients who have symptoms of CDAD as defined by;

               -  (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for
                  subjects having rectal collection devices) and

               -  (2)Presence of either toxin A and/or B of C. difficile in the stool

          -  Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.)
             aiming at CDAD treatment before the study

        Exclusion Criteria:

          -  Life-threatening or fulminant CDAD

          -  Ileus paralytic or toxic megacolon

          -  Likelihood of death before the completion of study from any cause

          -  Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of
             CDAD

          -  The anticipated need to continue other antibacterials for a period exceeding seven
             days from providing the informed consent

          -  Subjects who in the opinion of the investigator require other drugs to control
             diarrhea

          -  Need of change in dosage regimen of opiates during the study period

          -  Need of change in dosage regimen of probiotic products during the study period

          -  History/complications of ulcerative colitis or Crohn's disease

          -  Multiple occurrences of CDAD within the past three months

          -  Hypersensitivity to vancomycin

          -  Previous exposure to OPT-80 (fidaxomicin)

          -  Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to
             become pregnant during the course of study

          -  Participation in other clinical research studies or Post Marketing Clinical Trials
             utilizing an investigational agent within one month prior to providing the informed
             consent or within five half-lives of the investigational agent, whichever is longer
Clinical trial NCT02181673 (phase 3, status: completed)
Conditions: arthritis, psoriatic
ICD codes: L40.52
Drugs: placebo, golimumab
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Have had psoriatic arthritis (PsA) for at least 6 months prior to the first
             administration of study agent

          -  Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more
             tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per
             deciliter (mg/dL) at Screening

          -  Have active plaque psoriasis or a documented history of plaque psoriasis

          -  Have active PsA despite current or previous disease-modifying antirheumatic drugs
             (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is
             defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance.
             NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID
             intolerance

        Exclusion Criteria:

          -  Have other inflammatory diseases that might confound the evaluations of benefit of
             Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing
             spondylitis, systemic lupus erythematosus, or Lyme disease

          -  Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
             the study or within 4 months after receiving the last administration of study agent

          -  Have used any biologic agents that are targeted for reducing tumor necrosis factors
             (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab,
             Golimumab, and Certolizumab Pegol

          -  Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen
             mustard, or other Alkylating agents