Patients with markedly decreased visual acuity
Markedly decreased visual acuity if attributed to other causes than GBM.
Patients with macular degeneration with markedly decreased visual acuity, patients with markedly decreased visual acuity (no specific etiology) or uncontrolled glaucoma
Patients with markedly decreased visual acuity in the opinion of the treating investigator after completion of screening ophthalmologic exam
Patients with macular degeneration, uncontrolled glaucoma or markedly decreased visual acuity
Patients with macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity based on physician’s assessment
Patients with macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity
Patients with known severe macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity
Macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity.
Patients with markedly decreased visual acuity
Patients with a history of hepatic sinusoid obstructive syndrome (veno-occlusive disease) within the prior 3 months
Active history of diverticulitis; note that diverticulosis is permitted
O2 saturation < 92% (on room air). 19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death.
Known history of myelodysplasia.
Participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.
History of or high suspicion of Gilbert’s disease (safety run-in, Part B only)
Any history of HIV-1 associated encephalopathy
History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy
History of thromboembolism within the past 5 years, history of catheter-related thrombophlebitis or other clinically significant thrombophlebitis are excluded.
History of proximal urethral stricture requiring dilatation.
Subjects with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins; or a history of prior acute hepatotoxicity attributable to phenytoin.
Has a history of vasculitis.
Patients with a history of external percutaneous transhepatic cholangiography catheter placement.
History of Wilson's disease.
History of hemochromatosis.
Has a history of vasculitis.
Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement
History of pericarditis
History of receiving more than 2 classes of ADT
Recent history of thyroiditis
Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity
History or clinical suspicion of neurofibromatosis
Known history of splenomegaly
History of tuberculosis or history of purified protein derivative (PPD) positivity
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay
Known family history of hereditary heart disease
History of vesicoureteral reflux or an indwelling urinary stent
Patients with any of the following cardiovascular conditions: patent foramen ovale, prior history of bacterial endocarditis, any existing thrombus (either arterial or venous) as well as known history of DVT, permanent pacemakers, AICDs, LVADs, or other intravascular cardiac device, known AV malformations.
History of proximal urethral stricture requiring dilatation.
History of proximal urethral stricture requiring dilatation
Patients with a prior history of pulmonary toxicity due to medications (Ex: history of carmustine [BCNU] toxicity).
Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
Patients with history of more than one symptomatic oxalate stone
History of radiation that would overlap with the intended treatment to the prostate bed
Patients with a history of prior hematopoietic stem cell transplantation (HSCT), elevated conjugated serum bilirubin at study entry, uncontrolled systemic fungal, bacterial, or other infection, a history of hepatitis B or C infection or a history of cirrhosis
History of anal cancer
History of urethral stricture disease;
History of osteonecrosis of the jaw
History of treatment with known kinase inhibiting agents
History of gout
History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives
History of keratitis;
Patients with prior history of ventilator support related to lung injury such as pneumonia, hemorrhagic pneumonitis, capillary leakage are excluded
History of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, capillary leakage)
History of anaphylaxis attributed to prior anti-GD2 therapy
History of major implant(s) or device(s), including but not limited to:\r\n* Prosthetic heart valve(s).\r\n* Artificial joints and prosthetics placed =< 12 months prior to treatment initiation.\r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed.
Has history of osteonecrosis of the jaw
Patients who are known to have a history of or a finding of corneal epitheliopathy at pre-study are excluded
History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration
History of VOD
Deferral of donors that:\r\n* Have traveled to active Zika virus zones \r\n* Are at potential risk of transmissible spongiform encephalopathy (TSE), including Creutzfeldt–Jakob disease (CJD), based on family and travel history
History of surgical castration.
History of vesicoureteral reflux.
Patients known to be colonized with multi-drug resistant organisms or with history of infection with multi-drug resistant organisms; patients with history of infection with extended-spectrum beta-lactamase producing organism
History of intolerance to somatostatin analogues
Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement.
A history of metal in the head or eyes
History of syncope within the last 6 months
Patients with known history of agammaglobulinemia
A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b
Has history of not tolerating interferon treatment
Subjects must have no prior history of veno-occlusive disease (VOD)
Known history of Wilson’s disease or a copper deficiency
History of non-transfusional hemosiderosis
All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of adverse reaction to the vaccine
Patients with a history of intolerance to Das or for whom Das might not be appropriate
History of oxalate nephrolithiasis or urine oxalate >60 mg/dL
History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility, for example, gastroparesis, history of extensive abdominal surgery
Known history of osteoporosis
Known history of macular edema
History of Wilson’s disease or family member with Wilson’s disease
History of hemochromatosis or family member with hemochromatosis
History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc unless the lead investigator obtains approval from Novartis
History of tuberculosis or history of purified protein derivative (PPD) positivity
Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure
No prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
History or presence of cardia arrest or unexplained syncope
History of Paget’s disease
Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
Active or history of diverticulitis; diverticulosis is permitted
History of
Known history of HIV or autoimmune diseases requiring immunosuppressant drugs
Prior history of receiving afatinib
History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
Patients with history of pneumonectomy
Have a history of neurological illness or closed head injury
A known history of intolerance to ketoconazole
A known history of intolerance to vincristine
Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
History of gastric or duodenal ulcers or untreated hyperacidity syndromes
History or behavior that would, in the investigator’s judgment, prohibit compliance for the duration of the study
History of arrhythmia requiring pharmacological or electrical treatment
Prior myocardial infraction (MI) ascertained from medical history and review of systems
History of priapism
Known history of retinitis pigmentosa
Any of the following concurrent severe and/or uncontrolled medical conditions:\r\n* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication\r\n* Angina pectoris\r\n* History of congestive heart failure =< 3 months, unless ejection fraction > 40%\r\n* Myocardial infarction =< 6 months prior to registration\r\n* Cardiac arrhythmia\r\n* Poorly controlled diabetes\r\n* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\r\n* Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for > 14 days, patients may be considered for participation in this study\r\n* >= Grade 2 hypertriglyceridemia\r\n* >= Grade 2 hypercholesterolemia\r\n* Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial
History of biliary colic attack
Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance
A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
History of proximal urethral stricture requiring dilatation
Patients with a history of keloid formation ( ID delivery group only)
History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral arterial disease or of recent MI whether or not treated with anti-platelet drugs
History of narcolepsy or any neurological condition which may impair consciousness
History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNING
History of claustrophobia 99m^TC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY
History of diagnosis of neurogenic bladder requiring intermittent catheterization.
History of prior mastectomy
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
Part 2: history of glaucoma
History of peritonitis or diverticulitis
History of prior bowel fistula, ulcerations, or perforations
History of tuberculosis or positive purified protein derivative (PPD) test
Suicidal ideation or history of suicide attempt
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Patient history:\r\n* Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months\r\n* No metastatic meningiomas (as defined by extracranial meningiomas) allowed\r\n* No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug\r\n* No known active hepatitis B or C\r\n* No current Child Pugh class B or C liver disease\r\n* No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)\r\n* No uncontrolled diabetes defined as a known diabetic with hemoglobin A1C (HBA1C) > 7.5 OR fasting glucose > 140\r\n* No uncontrolled hypertension defined as blood pressure (BP) > 140/90\r\n* No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration
Patients with any prior history of SOS irrespective of severity
History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
Patients who have a history of noninfectious (toxic, autoimmune) hepatitis or alcoholism
Patients with a lifetime history of porphyria or psoriasis
History of tuberculosis or purified protein derivative (PPD) skin test positivity
History of partial or total gastrectomy
Patients with a history of platelet alloimmunization
History of tuberculosis or history of purified protein derivative (PPD) positivity
History of a light-sensitive cutaneous disease
History of spontaneous pneumothorax
Prior history of SCCHN
History of another malignancy that makes determination of the source of the brain metastases uncertain
Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (> 2 x ULN)
History of prior IPHC/HIPEC
History of prior HIPEC
History of cholecystitis without cholecystectomy
History of syncope or family history of idiopathic sudden death
DONOR: History of medical illness that in the estimation of the PI or DTM/NMDP physician poses prohibitive risk to donation including, but not limited to, stroke, hypertension that is not controlled with medication, or heart disease; individuals with symptomatic angina or a history of coronary bypass grafting or angioplasty will not be eligible
History of:
Subject has a history of well-documented prior veno-occlusive disease (VOD).
Known history of hereditary hemorrhagic telangiectasia (HHT).
Appropriate treatment history for histological entity.
History of intracranial abscess within 6 months prior to study enrolment.
History of acute urinary retention within the last 12 months
History of Parkinson's disease or multiple sclerosis
Have a prior history of a documented hemolytic event.
Known history of positive serum human ADA.
a history of \double/triple hit\ genetics
Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.
Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement;
Echocardiogram (ECHO) cardiogram and cardiology consultation required within 7 days prior to registration for patients with a history of congestive heart failure or cardiovascular disease or history of exposure to cardiotoxic agents who are not already excluded
History of meningococcal disease
History and/or current evidence of uncontrolled endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc
History of immunization with LL37
Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
History of limb perfusion therapy
Family history of inherited colon cancer syndromes
Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
History of meningococcal disease
History of Raynaud’s disease, cryoglobulinemia
Patients with M1 disease or a history of M1 disease
History of median sternotomy
History of topotecan treatment for SCLC
History of
Known prior history of tuberculosis or positive purified protein derivative (PPD) test result
Family history consistent with thrombophilia or hypofibrinolysis
Prior history of chronic prostatitis or urethral stricture
Patients with history of erosive esophagitis should be excluded from the study
Patients must be questioned for a past medical history of gout; patients must not have a history of gout which can be exacerbated by perifosine
Documented history of vesicoureteral reflux
History of oxalate nephrolithiasis or urine oxalate > 60 mg/dL
Patients with any malignancy who will receive HDMTX given as a 5 g/m^2 infusion over 24 hours and a history of >= 1 of the following:\r\n* Documented decreased renal function, as defined as creatinine greater than 1.5 x baseline or glomerular filtration rate (GFR) < 65 ml/min/1.73m^2\r\n* History of prior nephrotoxicity with HDMTX as evidence by increased creatinine to 1.5 x baseline or need for dialysis or carboxypeptidase\r\n* History of grade 3 adverse event (AE) related to HDMTX (mucositis, myelosuppression, nephrotoxicity, hepatotoxicity) based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\r\n* Provider concern patient is at risk for MTX toxicity, such as a prior history of treatment with nephrotoxic chemotherapy, history of HDMTX-related neurotoxicity, or antimicrobial/antifungal therapy
History of RPLS
Recent history of myocardial infarct (less than 3 months) or history of active angina or arrhythmia
history of arteriovenous malformations of the brain,
history of brain infection (i.e., abscess, meningitis, or encephalitis),
History of tuberculosis or positive purified protein derivative (PPD) test
History of arterial/myocardial disease
History of angioedema
History of significant hypotensive episode requiring hospitalization
Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
Individuals with a history of allergic reactions to any of the agents being used in this trial, with the exception of PEG asparaginase; participants with a history of allergy to PEG asparaginase are allowed on study but should receive Erwinia asparaginase instead of PEG asparaginase; individuals with a history of allergy to both PEG and Erwinia asparaginase are excluded from the study
History of grade 3 (Gr. 3) or greater retinopathy or keratitis
A history of neurological complications due to poliovirus infection
History of any major disease that might interfere with safe protocol participation
Patients with a history of autoimmune diseases except for Hashimoto's thyroiditis
History of intracerebral abscess within 6 months prior to Day 1
History of immunization with gp100(g209-2M)
History of HIV positivity by (ELISA or Western blot)
History of heart disease
History of heart disease.
History of major immunologic reaction to any IgG containing agent.
The donor has existence or recent history of persistent pulmonary infiltrates, recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence of any lung disease including asthma, or current symptoms of upper respiratory tract infection
The donor has a documented or self-reported history of tuberculosis or recent travel to countries of endemic disease (last 8 weeks)
Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
History of intolerance to 5-FU at dose-intensity of 1800 mg/m^2/2 weeks or lower
History of known congenital hypercoagulable condition
A history of uveitis and/or scleritis
Medical history of orthostatic hypotension.
History of uveitis
History of cranial nerve palsy.
Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
Patients with recent history of hemorrhage and patients predisposed to hemorrhage due to coagulopathies or structural anomalies.
History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
History of depression or active treatment for depression
History of hypothyroidism or hyperthyroidism
History of suspected history, or presence of heparin induced toxicity (w/ or w/o thrombosis)
History of orthostatic hypotension
Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded
History of myocardial infarction (MI) documented by elevated cardiac enzymes with persistent regional wall motion abnormality on assessment of left ventricular (LV) function (patients with history of MI must have an echocardiogram (echo) instead of/in addition to a MUGA to evaluate LV wall motion)
History of kidney, ureteral, or bladder stones within the last 5 years
Prior history of a pathologic fracture
History of glaucoma
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays
Prior history of a pathologic fracture
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
Recent history of cellulitis in the affected extremity (within last 3 months)
History of non-healing wounds or ulcers.
Patients with known history of Trisomy 21 (Down Syndrome), history of congenital immunodeficiency or inherited marrow failure disorder.
Prior history of HNC
Prior history of a pathologic fracture
Prior history of myositis or rhabdomyolysis.
Prior history of a pathologic fracture
History of treatment with an asparaginase agent
PART I: History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline
PART II: History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline
Prior history of psoriasis
Prior history of chronic prostatitis
Prior history of urethral stricture
History of lobectomy involving > 50% of lobe
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Patients with a history of D835 mutations
History of porphyria.
Excluded from Arm B:\r\n* Patients with a history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active autoimmune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with fhIL7 therapy\r\n* Corrected QT (QTc) prolongation defined as a QTc greater than or equal to 470 ms or a prior history of cardiovascular disease, arrhythmias, or significant electrocardiogram (ECG) abnormalities
History of:
History of major implant(s) or device(s), including but not limited to: \r\n* Prosthetic heart valve(s) \r\n* Artificial joints and prosthetics placed =< 12 months prior to treatment initiation \r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
Prior history of rhabdomyolysis
History of Parkinson’s disease, multiple sclerosis or fibromyalgia
History of or active glaucoma
A history of orchiectomy
History of unexplained syncope or family history of idiopathic sudden death
History of cerebellar toxicity or cerebellar neurological findings on exam
History of endometrial neoplasia
Patient must not have a history of Raynaud’s disease
History of intolerance of oxycodone.
History of interstitial cystitis
Patients with a confirmed history of calcium oxalate nephrolithiasis are excluded; patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, inflammatory bowel disease [IBD] or other, as determined by the treating physician) are excluded; patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (> 1000 IU)
No history of celiac disease or non-celiac gluten sensitivity
Male patients with a history of untreated hypogonadism
PATIENTS: History of myasthenia gravis or acute narrow angle glaucoma
PATIENTS: History of Parkinson’s disease or Alzheimer’s dementia
Patients who have a history of duodenal ulcer or duodenal fibrosis
History of neurologic illness such as stroke, multiple sclerosis, multi-infarct dementia, or Parkinson’s disease or history of dementia or chronic fatigue syndrome
Recent history of falls or balance problems
As per self-report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
A history of gastric or duodenal ulcers or hyperacidity syndromes
Documented history of Alzheimer’s disease, dementia, or other neurologic deficit that could impact decision-making
History of serious mood disorder or attempted suicide as determined by patient’s history and physical and by using the Depression Screening; subjects with a score of greater than 10 or those answering #5 with scores greater than a \0\ will be deemed ineligible to be enrolled on study
History of angioedema
Patients with a history of enfuvirtide resistance
Co-morbid disease or incurrent illness such as:\r\n* History of head trauma \r\n* History of nasal surgery other than biopsy (before cancer was diagnosed)\r\n* History of sinus surgery other than biopsy (before cancer was diagnosed)\r\n* Chronic rhinosinusitis with or without polyp \r\n* Pregnancy \r\n* Cognitive dysfunction \r\n* History of brain surgery \r\n* Psychiatric or neurologic diseases interfering with sense of smell \r\n* Congenital disorders of olfactory dysfunction \r\n* Olfactory loss prior to onset of nasopharyngeal carcinoma
Medical history of concussions
Have a history of dementia or major neurological illness
Known re-expandable lung:\r\n* History of recurrent transudative (by Light’s criteria) pleural effusions of known etiology, AND\r\n* Has undergone multiple prior thoracenteses, without history of significant chest discomfort, AND\r\n* Strong clinical suspicion that the current effusion is uncomplicated and due to the known underlying etiology
Strong, self-reported history of postoperative nausea and vomiting
History of multiple CDI
History of or current neurological illness that significantly impacts cognition (e.g. stroke, multiple sclerosis, Parkinson's disease, Alzheimer's disease, head injury, epilepsy, etc)
Have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia
No history of untreated narrow angle glaucoma within 6 weeks prior to registration
Documented history of vesicoureteral reflux or the presence of an indwelling ureteral stent or nephrostomy tube at the time of screening.
No prior history of anal cancer, including SISCCA
History of gynecologic cancer
History of myasthenia gravis or acute narrow angle glaucoma
History of Parkinson’s disease or dementia
History of xerostomia prior to head and neck radiation therapy or history of Sjögren's disease or another underlying systemic illness known to cause xerostomia
History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
History of pure red cell aplasia
No history of Paget’s disease
History of phenylketonuria (PKU)
History of polycythemia
Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks and incompletely healed surgical incision before randomization
Evidence of empyema or history of empyema of the affected hemithorax
Patients with a prior history of colonic surgeries
Patient with prior history of colon cancer
No history of CRC
CONTROL (HEALTHY) GROUP: No history of cancer
History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months
History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
History of known sarcoid disease
History of known nephrolithiasis (kidney stones)
History of chronic sinusitis or recent nasal polyps
History of autoimmunity that has not been controlled with treatment in the last 12 months
Prior history of cervical, vulvar, or vaginal cancer
Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible; history of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject
No history of celiac disease or non-celiac gluten sensitivity
Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire
Patients with a history of hypocalcemia
Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum
History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer
Individual with history of gastric bypass due to any reason
History of diabetic ketoacidosis
Healthy on the basis of medical history
History of serious side effects from nicotine or from any nicotine replacement therapies
History of gastroduodenal ulcers documented =< 1 year
Has a history of anaphylaxis attributed to the azole class of antifungal agents
History of coronary heart disease (history of myocardial infarction or symptoms of angina), diabetes, stroke, orthopedic conditions which limit mobility
History of 1 or more adenomatous polyps
History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
History of known sarcoid disease
History of known nephrolithiasis (kidney stones)
History of relapse of ALL
History of chronic sinusitis or recent nasal polyps
History of gastroparesis
History of celiac disease
Have a history of gallstones
Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
History of childhood cancer
History of bone fracture after the conclusion of chemotherapy\r\n* History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible
History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
History of anal or cervical cancer
History of hemibody external radiotherapy as assessed by medical record review
Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
History of Meniere’s disease
History of median sternotomy
History of secondary hyperparathyroidism
Has a history of:\r\n* Neuropathy or numbness/tingling suspicious for neuropathy prior to the first dose of chemotherapy for ovarian cancer\r\n* History of prior treatment for other cancers that includes drugs known to cause neuropathy; these drugs include but are not limited to vinca-alkaloids, platinums, taxanes, bortizomib.\r\n* B12 deficiency\r\n* Known peripheral vascular disease\r\n* Chronic daily headache or headache more than 14 days of the month
Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
History of reactive hypoglycemia
Patients with a known history of psychiatric issues
EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure
History of respiratory tract cancer
Have a history of alcoholism
History of Crohn's disease, celiac sprue or other malabsorption syndrome which may interfere with digestion and absorption of broccoli sprout extract
history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
History of head injury or dementia.
History of iritis or episcleritis.
History of glaucoma
History of colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases or proximal urethral stricture requiring dilatation
History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum.
History of heart disease
Known history of positive serum human ADA.