Patients with a history of any grade autoimmune disorder are not eligible; asymptomatic laboratory abnormalities (e.g. antinuclear antibody [ANA], rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder
Patient must not have intercurrent organ damage or medical problems that will jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)
Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
Patients with a genetic disorder of fat metabolism
History of a bleeding disorder
Patients must have a histologically confirmed CD20+ lymphoproliferative disease that is related to an immunosuppressed state (e.g., post-transplant lymphoproliferative disorder [PTLD], diffuse large B-cell lymphoma [DLBCL] of the elderly, iatrogenic immunodeficiency-associated lymphoproliferative disorder [LPD]) and for which rituximab monotherapy would be considered to be appropriate frontline therapy
Patients with an identified familial hyperlipidemia disorder
history of bleeding disorder
Subject has a known gastrointestinal disorder that in the opinion of the treating investigator is concerning for malabsorption of oral medications
Patients with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV), or an autoimmune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible; Note: patients that are currently using inhaled, intranasal, ocular, topical or other non-oral or non-intravenous (IV) steroids are not necessarily excluded from the study but need to be discussed with the study chair
History of documented seizure disorder, presence of cerebellar dysfunction, dysphasia or altered mental status on neurological examination
Diagnosis of bipolar disorder, schizophrenia, post-traumatic stress disorder (PTSD) and or adult attention deficit hyperactivity disorder (ADHD)
Generalized Anxiety Disorder (GAD)-7 scale of 15 or higher
Active keratitis or current corneal disorder.
Evidence or history of bleeding disorder.
Patients should not have an autoimmune disorder that requires active immunosuppression
Has a bleeding disorder or a screening platelet count < 100×109/L.
Presence of active neurological disorder(s).
Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the ophthalmologist
Anti-coagulant therapy, bleeding or clotting disorder
Underlying psychiatric disorder requiring pharmacological intervention or a Hospital Anxiety and Depression Scale (HADS) score of 8 or more
Neurological disorder (Parkinson’s disease, dementia, multiple sclerosis)
Documented or known bleeding disorder.
Bipolar disorder
Breast cancer survivors with a severe current psychiatric diagnosis (e.g. bipolar disorder)
Current diagnosed neurologic disorder
Any psychiatric disorder that prohibits obtaining informed consent
The patient has a history of uncontrolled hereditary or acquired thrombotic disorder
Known mania-associated psychiatric disorder
Histologically confirmed histiocytic disorder or histologic findings compatible with a histiocytic disorder in the context of confirmatory radiologic findings
History of clinically significant liver disease, urea cycle disorder, or genetic liver problem caused by a mitochondrial disorder (e.g., Alpers-Huttenlocher syndrome)
Documented or known bleeding disorder.
Subjects must not have a history of neurodegenerative or central nervous system movement disorder
Active neurologic disorder (i.e. weakness, altered mental status) – peripheral neuropathy alone does not exclude a patient
Any concomitant serious physical illness other than cancer (i.e., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing
Documented or known bleeding disorder.
Currently taking selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), or tricyclic antidepressant (TCA) regimen for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient’s treating psychiatrist)
Patients with known active autoimmune disorder
Patients with history of bleeding disorder or with history of spontaneous haemorrhage tumour
Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
History of an active connective tissue disorder
Patients with severe personality disorder or mental illness that would preclude compliance with the study
Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
Subject has an underlying bleeding disorder
Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
Known malabsorptive disorder
Contraindications to use of bupropion (i.e., concurrent use of other forms of bupropion, MAO inhibitors, anti-depressant medication, seizure disorder or any clinical situation that might increase risk for seizures, past head injury, current or prior diagnosis of bulimia or anorexia nervosa; bipolar disorder).
History of bipolar disorder.
Autoimmune disorder
Unmanaged/uncontrolled mental health disorder
Patients with known active autoimmune disorder
Chronic myeloproliferative disorder, i.e. myelofibrosis
Patient has a Generalized Anxiety Disorder (GAD)-7 mood scale score >= 15
Any of the following conditions: \r\n* Serious or non-healing wound, ulcer, or bone fracture\r\n* Current use of therapeutic warfarin; Note: low molecular weight heparin is allowed; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria\r\n* History of bleeding disorder, including patients afflicted with hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding\r\n* History of hemoptysis in excess of 2.5 mL (1/2 teaspoon ) within 8 weeks prior to first dose of study drug\r\n* Poorly controlled depression or anxiety disorder, or recent (=< 6 months) suicidal ideation\r\n* HIV-positive patients on combination antiretroviral therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Patients with a history of a psychiatric disorder that may interfere with the understanding and compliance with this protocol and the required follow up
Patients with a known coagulation disorder are excluded; patients with a first-degree relative with a history of venous thrombosis before age 50 years (yrs) or an arterial thrombosis before age 40 yrs must have the following testing performed prior to enrollment to exclude a heritable disorder; patients with a suspected disorder will be excluded
History of psychiatric disorder (e.g. depression)
History of autoimmune disorder (e.g. hepatitis)
The participant has a significant bleeding disorder or vasculitis.
Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)
No autoimmune disorder that requires active immunosuppression
Have a history of uncontrolled hereditary or acquired thrombotic disorder.
History of Wilson’s disease or other copper-metabolism disorder
Patients with an uncontrolled bleeding disorder
Patients with a known or suspected urea cycle or other metabolic disorder are not eligible
Current evidence of corneal disorder/keratopathy
Has a known blood clotting disorder requiring treatment
Has uncontrolled disease-related metabolic disorder
Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the investigator in consultation with the ophthalmologist.
Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnoses for psychotic disorders, bipolar disorder, attention deficit hyperactivity disorder (ADHD), major depressive disorder within the last 3 months, substance dependence within the last 3 months with the exception of nicotine and marijuana dependence
Patient has a bleeding disorder or a screening platelet count <100×109/L.
Known history of an autoimmune disorder
Active liver disease, for example, due to autoimmune hepatic disorder, or sclerosing cholangitis
Subjects with uncontrolled bleeding disorder which cannot be controlled with anticoagulants
Other conditions which could jeopardize the subject's ability to comply with the protocol including but not limited to dementia, psychosis, or other major psychiatric disorder.
Patient has a Generalized Anxiety Disorder (GAD)-7 mood scale score >= 15
Known history of an autoimmune disorder
History of bipolar disorder
History of eating disorder such as anorexia or bulimia
Known HIV or other history of immunodeficiency disorder.
Uncontrolled thrombotic or hemorrhagic disorder
History of Wilson's disease or other copper-metabolism disorder
Patients with known or suspected brain metastases, carcinomatous meningitis, uncontrolled seizure disorder, active intracranial bleeding or active neurologic disorder are excluded
Any active or chronic corneal disorder and Sjogren's syndrome.
History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs
Known immunosuppression (i.e. chronic steroid use) or autoimmune disorder
Previous history of primary platelet disorder or bleeding disorder
No medical disorder that increases risks of radiation or temozolomide (TMZ) chemotherapy; no uncontrolled infection; no known positivity for human immunodeficiency virus (HIV); no other disorder limiting expected survival to < 5 years
Bleeding disorder
History of underlying bleeding disorder, such as hemophilia
Pre-existing severe psychiatric condition or a history of a psychiatric disorder requiring hospitalization or a history of suicidal ideation or attempt
Patient has a history of autoimmune disorder or immune deficiency disorder
Known systemic bleeding or platelet disorder
History of major psychiatric disorder including use of anti-depressive medications, mood stabilizers, or anti-psychotic drugs
Has known psychiatric disorder that would interfere with fulfilling the requirements of the study
Suffering from a known bleeding disorder.
History of or active systemic autoimmune disorder or immunodeficiency syndromes
History of therapy for an autoimmune disorder
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Previous diagnosis of bipolar disorder
Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder
Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
History of Wilson's disease or other copper-related metabolic disorder
PART I: History of bleeding disorder
PART I: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
PART II: History of bleeding disorder
PART II: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
Uncorrected bleeding disorder.
Any prior or current malignancy or myeloproliferative or immunodeficiency disorder.
Any prior or current malignancy or myeloproliferative disorder.
Mentally incapacitated or has a significant emotional or psychiatric disorder
Current unstable major medical disorder
Myeloproliferative disorder (MPD)
Have a known major sleep disorder documented by prior diagnosis, such as: a) sleep disordered breathing b) narcolepsy c) periodic limb movement disorder d) parasomnias
History of Wilson's disease or other copper-related metabolic disorder
Patient has a General Anxiety Disorder (GAD)-7 mood scale score >= 15
Patients with active bipolar disorder
History of or currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia, or substance abuse by patient record and/or self-report
Active or a history of Tourette’s syndrome or tic disorder
Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, antithrombin [AT]-III deficiency, etc.), platelet disorder or bleeding disorder
History of major psychiatric condition (e.g. psychosis) in parent or child; severe neurodevelopmental disorder in child (e.g. Down's syndrome)
Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
Serious accompanying cardiac disorder
Serious accompanying cardiac disorder.
No history of mood disorder
History of bipolar disorder diagnosis
History of eating disorder (ever uncontrolled or any within the last two years)
Subjects with a history of substance use disorder other than nicotine, such an opiate use disorder
History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
Documented attention deficit hyperactivity disorder (ADHD) predating cancer diagnosis
A significant anxiety disorder
PATIENT: No evidence of thought disorder, delusions, or active suicidal ideation is observed or reported
PATIENT: Evidence of thought disorder, delusions, hallucinations, or suicidal ideation
Patients who have a cognitive disorder which impacts the ability to follow directions or adhere to safety rules; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
Patients who have a neurological or structural disorder which would impact use of exercise equipment; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
Significant uncontrolled psychiatric disorder (e.g. psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g. dementia, cognitive impairment) which the treating clinician believes prohibits informed consent or participation in the study
Subjects with bipolar disorder that have experienced a manic episode within 6 months of study entry will be excluded or at the principal investigator (PI)’s discretion
Survivors who report ever being diagnosed with bipolar disorder will be excluded
Known bleeding disorder per patient reported history
Significant physiological or psychological impairment that interferes with participation (e.g., migraines, bipolar disorder, psychosis, seasonal affective disorder)
Neurologic disorder that impairs ambulation (e.g. Parkinson’s)
Substance use disorder within the prior six months
History of oropharyngeal swallowing disorder prior to cancer diagnosis
A principal diagnosis of major depressive disorder (MDD)
History of bipolar affective disorder or psychosis
Medical history of cancer other than colorectal cancer or non-melanoma skin cancer, untreated or unstable mental or psychiatric disorder, learning disability, traumatic brain injury, drug or alcohol abuse, debilitating medical disorder such as advanced cardiac, respiratory or renal disease
Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of attention-deficit hyperactivity disorder (ADHD) does NOT exclude a child from participation
Major psychiatric disorder (e.g., psychosis, personality disorder)
A score above 45 on the Wender Utah Rating Scale for attention deficit disorder (ADD) (WURS)
Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
Individuals with pre-existing neurological disorder (i.e. brain tumors, dementia, Parkinson’s disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer
Individuals with a current substance use disorder will also be excluded
History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any other reason, which in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits informed consent or participation in the study
Untreated endocrine abnormality, such as hypothyroidism, parathyroid hormone disorder
Subject has previously been diagnosed with a serious immunodeficiency disorder.
Patients with an identified familial hyperlipidemia disorder.
Uncontrolled hereditary or acquired thrombotic or bleeding disorder.
Patients must not have a severe bleeding disorder
Mental incapacitation or significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
Congenital bleeding disorder or predisposition to priapism that is contraindicative to vacuum constriction\r\ndevices (VCD) use
History of Post-traumatic Stress Disorder
Previous diagnosis of radiosensitivity disorder (i.e., ataxia telangiectasia)
Presence or recent history of any systemic disorder or conditions, such as:
Patients will be between 6 months and 4-years post radiation treatment; ongoing chemoprevention therapy is permissible; based on International Classification of Diseases (ICD)-10 proposed criteria, a diagnosis of CRF will require evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of comorbid psychiatric disorders (schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium or obsessive–compulsive disorder [OCD])
Currently in treatment for a major psychiatric disorder
History of demyelinating disorder
Diagnosis of major depressive episode, acute anxiety disorder, liver or kidney dysfunction (defined by SGOT and creatinine levels 1.5 x upper limit of normal) as listed in the patient’s medical history in the chart within the past year and by self report
Any neurologic or psychiatric disorder
Any neurologic or psychiatric disorder except depression, anxiety, or attention-deficit disorder/attention-deficit hyperactivity disorder
History of disordered eating as indicated by the Eating Disorder Examination Questionnaire (EDEQ)
Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on principal investigator (PI) judgment
Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) or designated expert(s) feels that it would affect the results of the electroencephalogram (EEG)
Major depressive disorder in the last year requiring treatment
History of panic disorder, psychosis, bipolar disorder, or eating disorders
Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that\r\nin the opinion of the principal investigator (PI) feels that it would affect the results of the electroencephalogram (EEG)
Patients with serious, concomitant disorder, including active systemic infection, autoimmune disease, proven or suspected immunosuppressive disorder or any other major medical illnesses of the cardiovascular or respiratory system, concurrent malignancy except for nonmelanoma skin lesions
Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders) or substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI])\r\n* Alcohol use disorder: current mild disorder is eligible; moderate disorder is eligible if in early remission (3-12 months); severe disorder, current or early remission, is not eligible\r\n* Substance use disorder is as follows: current disorder is not eligible; mild or moderate in early remission is eligible; severe disorder in early remission is not eligible
Hospitalization due to a psychiatric disorder in the past 3 years
Subjects with systemic autoimmune disorder;
History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators
Is mentally incapacitated or has a significant emotional or psychiatric disorder
Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation
Major depressive disorder in the last year requiring treatment
History of panic disorder, psychosis, bipolar disorder, or eating disorders
Bleeding disorder
Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)
Any known psychiatric disorder other than mild depression or anxiety that may affect adherence to the study requirements.
Acute painful perianal disorder
Contraindications to TRUS/prostate biopsy (BX)\r\n* Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder\r\n* Active urinary tract infection\r\n* Acute painful perianal disorder (i.e. rectal abscess)
Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
PATIENTS: Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
Any concomitant serious physical illness other than cancer (e.g., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing. No history of autoimmune disease.