Significant bleeding disorder;
History of significant bleeding disorder unrelated to cancer
History of significant congenital or acquired bleeding disorder unrelated to cancer
Any history of significant bleeding disorder unrelated to cancer, including any congenital bleeding disorder or any acquired bleeding disorder within one year of start of study
History of significant bleeding disorder unrelated to cancer
History of significant congenital or acquired bleeding disorder unrelated to cancer
History of significant congenital or acquired bleeding disorder
History of significant congenital or acquired bleeding disorder unrelated to cancer
History of significant bleeding disorder unrelated to cancer
History of significant congenital or acquired bleeding disorder unrelated to cancer
Known presence of a significant congenital or acquired bleeding disorder unrelated to cancer
History of significant congenital or acquired bleeding disorder unrelated to cancer
Have a significant bleeding disorder unrelated to CML or Ph+ALL
History of significant congenital or acquired bleeding disorder unrelated to cancer
History of significant bleeding disorder unrelated to cancer, including:
History of significant bleeding disorder unrelated to CML
Known presence of significant congenital or acquired bleeding disorder unrelated to cancer
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.
Participants with unexplained anemia, and/or thrombocytopenia
Known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
History of thrombocytopenia with complications
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
Have a history of thrombocytopenia with complications
DONOR: Thrombocytopenia < 150,000 cells /mm^3 at baseline evaluation
Known adverse reactions to heparin (heparin-induced thrombocytopenia or any allergy)
Thrombocytopenia <100 x 103/ml, not resulting from therapy
Patients with documented contraindication to anticoagulation therapy such as heparin induced thrombocytopenia or a documented coagulopathy or hematologic disorder that would contraindicated undergoing treatment and use of the associated anticoagulant agents required during treatment
Patients with a history of hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia.
Thrombocytopenia (< 125,000 platelets/mm^3)
Platelets ? 75,000/mcL OR ? 50.000 if thrombocytopenia due to iBCL
Secondary immune thrombocytopenia from any cause including lymphoma, chronic lymphocytic leukemia, and drug-induced thrombocytopenia
hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or history of heparin induced thrombocytopenia;
History of coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
Subjects with coagulopathies, including thrombocytopenia
Platelets < 30,000/ mm3 for any reason, PT prolongation or thrombocytopenia that is not due to sepsis.
History of adverse reaction to heparin such as heparin-induced thrombocytopenia
Patients with known heparin induced thrombocytopenia
Known other causes of thrombocytopenia
Participants with known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
A history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products
Secondary immune thrombocytopenia
Drug induced thrombocytopenia
Thrombocytopenia (<30,000/uL)
Anemia (hemoglobin <11 mg/dL) or thrombocytopenia (platelets<100,000/?L).
History of heparin-induced thrombocytopenia.
Active autoimmune thrombocytopenia.
Known hypersensitivity to heparin or the presence of heparin-induced thrombocytopenia
Platelets < 150 mg/dL or history of thrombocytopenia
Thrombocytopenia
History of heparin induced thrombocytopenia
Known allergy to heparin or aspirin or a history of heparin induced thrombocytopenia
Grade >= 3 thrombocytopenia (platelets < 50 x 10^9/L) after the first 3 months of therapy with the TKI for patients with CML and platelets < 100 x 10^9/L for patients with MF after the first 3 months of therapy; thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the TKI
Thrombocytopenia that is considered to be unrelated to treatment with TKI or accelerated phase as defined above
History of heparin induced thrombocytopenia
Thrombocytopenia (platelet count < 50,000)
Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.
Thrombocytopenia (platelets < 100,000 cells/uL)
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g., hereditary hemorrhagic telangiectasia). Patients with bleeding cutaneous lesions not actively requiring transfusions are eligible. Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible
Active bleeding or pathologic condition that carries a high risk of bleeding. No bleeding diathesis.
Active uncontrolled bleeding
Active gastrointestinal bleeding
Active bleeding disorder in the past 6 months.
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Active bleeding conditions
If receiving warfarin: INR ? 3.0 and no active bleeding (i.e., no bleeding within 14 days prior to first dose of study therapy).
History of bleeding disorders which would put a patient at risk for bleeding with anti-coagulation or patients with an increased risk of thromboembolic or hemorrhagic events (e.g., stroke).
Brain lesions or intracranial abnormalities at risk for bleeding, by history or radiologic imaging (e.g., active metastases).
Patients with uncontrolled coagulopathies who are at increased risk of bleeding.
Evidence of active bleeding or bleeding disorder
Significant risk for bleeding
Patients with history of intra-abdominal bleeding or retroperitoneal bleeding within the last 3 years are excluded
Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding; subjects treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to enrollment are eligible
Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
Existing bleeding or condition associated with increased risk of bleeding
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g., hereditary hemorrhagic telangiectasia)
Platelet count > 30,000 cells/mm^3 (30 x 10^9/L) without transfusion support; evidence of mucosal bleeding; a known bleeding episode within 3 months of screening; or a history of a bleeding disorder
No active bleeding
Active and significant bleeding
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia); patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible
Active gastrointestinal bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
Patients with a history of bleeding disorders or evidence of intracranial abnormalities which would put them at risk for bleeding with anti-coagulation (e.g., strokes, active metastases).
active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
Have active uncontrolled bleeding or a known bleeding disorder
Evidence of active mucosal or internal bleeding.
Evidence of active mucosal or internal bleeding.
Patients with active or prior digestive tract bleeding.
Known, increased risk of bleeding
Active bleeding disorder or other history of significant bleeding episodes within 30 days before study entry
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving (in contact with, invading or encasing) major vessels
Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)
Patients with bleeding disorders are ineligible due to lymph node removal possibly causing excessive bleeding; bleeding disorder will be defined by an INR level of > 2.0
No evidence of active bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major vessels
History of active bleeding within the last 3 months requiring transfusion
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
Has active bleeding disorder or other history of significant bleeding episodes within 30 days of randomization.
Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding
Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia).
Active uncontrolled bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder or coagulopathy.
Ongoing major bleeding,
Contraindications to prophylactic dose low molecular weight heparin (LMWH), including \r\n* Patients with recent gastrointestinal bleeding \r\n* History of heparin induce thrombocytopenia on LMWH\r\n* Subjects with previous severe hemorrhagic events on LMWH\r\n* Recent central nervous system bleed, intracranial or spinal lesion at high risk for bleeding\r\n* Active bleeding (major): more than 2 units transfused in 24 hours\r\n* Spinal anesthesia/lumbar puncture\r\n* Chronic, clinically significant measurable bleeding > 48 hours\r\n* Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis)\r\n* Recent major operation at high risk for bleeding\r\n* Underlying hemorrhagic coagulopathy\r\n* High risk for falls (head trauma)
Active bleeding disorders and high likelihood of bleeding or conditions or medications known to increase the risk of bleeding; patients with bleeding diathesis and subjects who are receiving anticoagulation treatment with INR > 2 are excluded
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Patients with a history of significant tumor bleeding, or coagulation or bleeding disorders.
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Evidence of mucosal or internal bleeding
Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding
Active uncontrolled bleeding
Uncontrolled severe bleeding tendency or active GI bleeding
Active bleeding or bleeding susceptibility
Active bleeding or a pathological condition that is associated with a high risk of bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy (in the absence of therapeutic anticoagulation), or tumor involving major vessels.
For subjects with known or suspected cirrhosis, esophagogastroduodenoscopy ) within 12 months of signing the informed consent form, showing no evidence of untreated varices or stigmata of active bleeding (such as active ulcer, visible vessel, or blood) is required. Subjects with history of upper GI bleeding must have an EGD of 3 months or less prior to signing the consent form confirming adequate prior endoscopic therapy (eg, no evidence of any untreated varices, recent or active bleeding, stigmata suggesting high risk for bleeding, active ulcer). Subjects with history/suspected esophageal varices must be on optimal medical management (eg, proton pump inhibitor and non-selective beta-blocker) per local institutional policy.
Subjects with current/a history of bleeding disorder or coagulopathy or who are at particularly high risk for bleeding complications.
Ongoing risk of bleeding.
Active bleeding disorders or clinical signs of bleeding (Grade ?2).
Active bleeding that requires hospitalization during the screening period
Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
History of bleeding diasthesis
Ongoing major bleeding,
Active bleeding; pathological condition that carries a high risk of bleeding; risk of pseudoaneurysm of the internal carotid artery and carotid blowout syndrome.
Endometrial bleeding
Active bleeding
Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
Target bleeding site has moderate bleeding according to the Investigator's judgment.
The target bleeding site has a mild or severe bleeding.
If receiving warfarin: INR ? 3.0 (and no active bleeding, [i.e., no bleeding within 14 days prior to first dose of study therapy])
No active bleeding
No active bleeding
Active bleeding or high risk of bleeding
Active gastrointestinal bleeding
Active bleeding
Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels by imaging, regardless of whether any chance of requiring vascular reconstruction
Active bleeding
Active bleeding that requires hospitalization during the screening period
Evidence of active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorders, coagulopathy or tumor involving major vessels
No central lung metastases with excessive active bleeding
No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) within 14 days prior to registration
No clinical signs active of bleeding
Patients with overt bleeding
Active bleeding or high risk of bleeding in the opinion of the investigator
Active bleeding (grade 2 or higher) at the time of enrollment
Active bleeding
Participants with untreated or incompletely treated varices with bleeding or high-risk for bleeding
Active or serious bleeding within two weeks of enrollment
Active major bleeding
Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
Patients on anticoagulation or with bleeding disorders should be evaluated by a physician for risk/benefit of bleeding disorders with intramuscular injections prior to study enrollment; patients determined to be at high risk for bleeding with intramuscular injections will be excluded
Active bleeding condition (not limited to: thrombocytopenia, hemophilias, potential bleeding lesions, recent trauma or surgery, recent stroke, confirmed intracranial or intraspinal bleeding)
Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
Evidence of active mucosal or internal bleeding
active bleeding or at high risk of bleeding
Active vaginal bleeding requiring packing and emergent radiation therapy
Any condition resulting in increased risk of bleeding at biopsy.
No active bleeding
No active bleeding in the post-operative period
Active bleeding or high risk of bleeding
Bleeding and Thrombosis:
If active bleeding requiring acute surgical intervention, not eligible
Active bleeding or pathologic condition that carries a high risk of bleeding
Patients with uncontrolled coagulopathy or bleeding disorder are not eligible
Participants with active bleeding disorder/coagulopathy
Participant must not have a history of a coagulopathy or a platelet disorder.
History of coagulopathy
Bleeding disorder/coagulopathy
Uncontrolled coagulopathy
Has a clinically significant coagulopathy per investigator’s assessment
Uncontrolled coagulopathy or bleeding disorder
Patients with uncontrolled coagulopathy or bleeding disorder
Subject has first degree family member with a known hereditary coagulopathy.
Has evidence or a coagulopathy or hemostasis problem.
Uncontrolled coagulopathy
Active coagulopathy
Patients with uncontrolled coagulopathy or bleeding disorder
uncorrectable coagulopathy
Active coagulopathy
Patients with coagulopathy with an elevated INR ?1.5, or platelets <50
Current Grade 3 or higher coagulopathy, thrombosis and/or hemostasis disorders,
History of clinically significant coagulopathy
Patients with uncontrolled coagulopathy or bleeding disorder
Coagulopathy tests will be obtained within 2 weeks of enrollment
History of abnormal bleeding and coagulopathy
Use of full dose, therapeutic anti-coagulation or patients with uncontrolled coagulopathy or bleeding disorder
Uncontrolled coagulopathy
Has a clinically significant coagulopathy per investigator’s assessment
Patient has a coagulopathy or bleeding disorder
Known coagulopathy or bleeding disorders are controlled
Known bleeding disorder or coagulopathy
Coagulopathy characterized by an INR >1.40 without other known causes.
Coagulopathy which contraindicates transperineal and intraprostatic needle insertion
Known, existing uncontrolled coagulopathy
Known, existing coagulopathy or receiving anticoagulants
Patient has a coagulopathy or bleeding disorder which is uncontrolled.
Patients with uncontrolled coagulopathy or bleeding disorder
Known, existing uncontrolled coagulopathy
History of coagulopathy or known thrombophilias
Known, existing uncontrolled coagulopathy
Known, existing uncontrolled coagulopathy
No history of clinical coagulopathy
No known coagulopathy
Nonreversible or uncorrectable coagulopathy. INR should not be >1.5,
Patients with uncontrolled coagulopathy or bleeding disorders
Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
Known bleeding disorder or coagulopathy
Clinically significant coagulopathy or bleeding disorder.
Uncorrected coagulopathy
Subjects with uncorrected coagulopathy
Uncorrectable coagulopathy
Coagulopathy
Patient has an uncorrectable coagulopathy
Uncontrollable coagulopathy
Coagulopathy
Uncontrolled coagulopathy or bleeding disorders
History of coagulopathy or bleeding disorders
Coagulopathy
Known inherited bleeding disorder or coagulopathy
Severe coagulopathy or bleeding disorder
Uncorrectable coagulopathy
Uncorrectable coagulopathy
Known coagulopathy
Uncorrectable coagulopathy prohibiting biopsy. (INR > 1.5 and/ or platelets < 50,000)
Coagulopathy
Evidence of a coagulopathy
Patients with clinically controlled thyroiditis or pituitary disorders on stable replacement therapy are eligible
Any history of hereditary bleeding disorders
Participants with clear evidence of myeloproliferative disorders, or myelodysplastic disorders in the marrow
Uncontrolled electrolyte disorders.
Cardiac or pulmonary disorders within 6 months of enrollment.
Known immunodeficiency disorders, either primary or acquired
Significant bleeding disorders.
Neurological or psychiatric disorders which may influence understanding of study and informed consent procedures.
Participants will be excluded for medical conditions that are contraindications to XRT and/or might confound the relationship among fatigue, and inflammation, including pregnancy, unstable major psychiatric disorders, autoimmune (active within the past 6 months) or inflammatory disorders, chronic infectious diseases (e.g. human immunodeficiency virus [HIV], hepatitis B or C), neurologic disorders and uncontrolled cardiovascular, metabolic, pulmonary or renal disease (as determined by medical history, physical examination or laboratory testing) unless otherwise approved by the PI or PI’s designee
History of psychiatric drug abuse that cannot be ended, or subjects with mental disorders that will prevent compliance or evaluation including uncontrolled schizophrenia, uncontrolled depression or other uncontrolled disorders.
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
Participants with inherited or acquired bleeding disorders
Subjects with a history of connective tissue disorders.
Subjects with a history of depression, anxiety, or psychotic disorders (due to tolcapone adverse event profile).
Psychiatric disorders that would interfere with consent
History or evidence of thrombotic disorders within 6 months before first study treatment unless stable on anticoagulation for > 3 months
Patients with uncharacterized eye disorders
Patients with known serious mood disorders
Known bleeding disorders
Patients with known bleeding disorders or more than punctate intratumoral hemorrhage are excluded
Renal and hepatic disorders with values of >1.5 times the upper limit of normal (ULN) or blood disorders (upon clinician judgment);
Patients with a history of bleeding disorders
Active substance abuse or psychiatric disorders; in case, the patient falls under the lower spectrum of psychiatric disorders and is able to function well under medication, the patient could be accrued at the discretion of the physician
History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded
Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
Patients with known disorders associated with hemolysis
Known bleeding disorders
Serious concurrent medical condition including CNS disorders.
History of thrombocytopenia with complications (including hemorrhage or bleeding ? Grade 2, based on NCI-CTCAE v4.03 criteria), hemolytic condition, or coagulation disorders that would make subjects unsafe based on the judgment of the Investigator
Patients with active, uncontrolled psychiatric disorders including: psychosis, major depressive, and bipolar disorders
Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders
If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders
Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (discretion of the attending physician)
Patients with known urea cycle disorders (i.e.: ornithine transcarbamylase deficiency)
History or presence of any significant bleeding disorders
Uncontrolled medical or psychiatric disorders
Patients with GI disorders who have failed standard therapy
Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen
Concurrent or Intercurrent Illness: Impaired wound healing due to diabetes; Significant concurrent or intercurrent illness, psychiatric disorders or alcohol or chemical dependence that would compromise Subject safety or compliance or interfere with interpretation of the study; Uncontrolled thyroid disease or cystic fibrosis; Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders; Current encephalopathy or current treatment for encephalopathy; Variceal bleeding requiring hospitalization or transfusion within 4 months of screening; History of human immunodeficiency virus or acquired immune deficiency syndrome; The clinical presence of ascites.
History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
Myeloproliferative disorders\r\n* Idiopathic myelofibrosis\r\n* Polycythemia vera\r\n* Essential thrombocytosis\r\n* Chronic myelomonocytic leukemia\r\n* Patients with myeloproliferative disorders must be end-stage, which is primarily defined as disease severity refractory to splenectomy
Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
Have a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
Patients with known history of liver disorders.
Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders.
Moderate eye disorders
Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts
Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
Major psychiatric disorders which would limit compliance
Has a history of epilepsy, depression or other psychiatric disorders.
Subject has a contraindication to receiving IM injections (eg, bleeding disorders, anticoagulant use).
History of or current major gastrointestinal, pulmonary, cardiovascular, genitourinary or hematologic disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator
Known immunodeficiency disorders
Known history of Wilson's disease or other copper-related disorders
Patients with known bleeding disorders or more than punctate intratumoral hemorrhage are excluded
Patients with neuromuscular disorders that are associated with elevated CK
Participants with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert’s syndrome)
Participants with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert’s syndrome)
Patients with neuromuscular disorders that are associated with elevated CK.
Patients who have a history of bleeding disorders including congenital or acquired coagulopathies
Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.
Concurrent uncontrolled or active hepatobiliary disorders, untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, biloma or abscess (to be eligible, the subjects have to be treated and disorders/complications should be resolved within 2 weeks prior to the first dose of ARQ 087)
History of significant cardiac disorders:
i. Untreated psychiatric disorders
Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders
Patient with any active or chronic corneal disorders
Evidence or history of congenital or acquired hypocoagulability disorders
Patients with a history of thrombotic or hemorrhagic disorders
History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to first dose of mirvetuximab soravtansine
Documented hypercoagulable disorders or vasculopathies
Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
Significant gastrointestinal disorders, in the opinion of the Investigator
Bleeding or thrombotic disorders requiring anticoagulant therapy such as warfarin, or similar agents requiring therapeutic INR monitoring
Other preexisting sleep disorders
Patients with a history of/or active bleeding disorders
History of eye surgery within 6 months, presence of cataracts or other ocular disorders significantly affecting vision
No known bleeding disorders
Patients with a history of familial bleeding disorders
Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
History of significant neurological or psychiatric disorders
History of bleeding disorders
CORTISOL EXCLUSION: Participants with endocrine disorders (e.g., diabetes and thyroid disorders) or on steroid-based medications are excluded from the cortisol portion of the study (with the exception of topical hydrocortisone that is permitted)
Patient has motility/neurologic disorders including autonomic failure (spinal cord lesions, tumor invasion of nerves) and/or poorly controlled endocrine/metabolic disorders (hypercalcemia, hypokalemia, diabetes, hypothyroidism), as determined by the investigator
Severe sleep disorders (e.g., narcolepsy)
Subject with known congenital bleeding disorders or platelet dysfunction
Have a current diagnosis of major Axis I psychiatric disorders (e.g. depressive disorders), neurological impairments, or muscular dystrophies
Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis
Severe sleep disorders (e.g., Narcolepsy)
Is known or suspected to have neuromuscular disorders (ex: myasthenia gravis)
Known bleeding disorders
Eating disorders
Unstable psychiatric disease (psychotic disorders or major depression identified using Brief Psychiatry Rating Scale [unless stable in treatment for 3 months]) - smokers with stable psychiatric disease will be eligible
Treatment for serious psychological disorders (e.g., schizophrenia) in the last 6 months
Uncontrolled medical or psychiatric disorders
Subjects with metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes, rheumatologic disease etc.); subjects with metabolic disorders (a) who are otherwise eligible, (b) treated for hypothyroidism by their primary MD with Synthroid (levothyroxine) and (c) with the approval of the Moffitt treating oncologist will not be excluded from the study
Have no documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
Have no documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with participation (e.g., blindness, deafness, psychosis, or dementia)
Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician
Uncontrolled major psychiatric disorders, such as major depression or psychosis
Known bleeding disorders or taking any dose of warfarin or heparin
Patients with uncontrolled major psychiatric disorders, such as major depression or psychosis, will not be eligible for this trial; patients with a history of depression or anxiety who are stable on or off psychiatric medications will be eligible
History of gold-induced disorders, including but not limited to, necrotizing enterocolitis, pulmonary fibrosis, exfoliative dermatitis, bone marrow aplasias or other severe hematologic disorders; history of severe allergic or anaphylactic reactions or hypersensitivity to auranofin or other gold compounds
Known bleeding disorders or taking any dose of warfarin or heparin
Known urea cycle disorders based on history
Patients have a current diagnosis of major Axis I psychiatric disorders, neurological impairments, or muscular dystrophies
The subject has a history of significant bleeding disorders
Individuals with neurological, mental or psychiatric disorders
Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia)
Clinical history of severe psychiatric disorders
Bone marrow failure disorders:\r\n* Paroxysmal nocturnal hemoglobinuria (PNH)\r\n* Hereditary bone marrow failure disorders include Diamond-Blackfan anemia, Shwachman- Diamond syndrome, Kostmann syndrome, and congenital amegakaryocytic thrombocytopenia\r\n* Other non-malignant hematologic or immunologic disorders that require transplantation:\r\n** Quantitative or qualitative congenital platelet disorders (including but not limited to congenital megakaryocytopenia, absent-radii syndrome, Glanzmann’s thrombasthenia)\r\n** Quantitative or qualitative congenital neutrophil disorders (including but not limited to chronic granulomatous disease, congenital neutropenia)\r\n** Congenital primary immunodeficiencies (including but not limited to severe combined immunodeficiency syndrome, Wiskott-Aldrich syndrome, CD40 ligand deficiency, T-cell deficiencies)\r\n** Hemoglobinopathies (including sickle cell disease and thalassemia)
Patients with diagnosis of major depression or any other psychiatric disorders
Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
Subjects with active auto immune disorders/processes or active neurological or inflammatory disorders
Significant psychiatric or neurologic disorders that would impair compliance with study protocol
acute rheumatic disorders
Patients with severe metabolic disorders that would preclude administration of calcitriol
The patient has a lack of bleeding disorders, and
Patients must lack bleeding disorders, and be able to provide informed consent; the latter two criteria will be assessed from the patient’s history and the consenting interview
All patients with existing plasma cell disorders and no history of psychiatric disorders and can receive conscious sedation are eligible to participate in the trial
Neurologic disorders (dementia)
Participants must lack bleeding disorders, and be able to provide informed consent; the latter two criteria will be assessed from the patient’s history and the consenting interview
Lack bleeding disorders
Known inherited or acquired bleeding disorders.
Severe cardiac rhythm disorders within the last 7 days
Bleeding disorders
Presence of significant medical illness: autoimmune/inflammatory diseases, cardiopulmonary disorders (i.e., angina, congestive heart failure, severe chronic obstructive pulmonary disease [COPD]), uncontrolled endocrine disorders (i.e., hypothyroidism, diabetes), vestibular neuritis, Meniere's syndrome, benign paroxysmal positional vertigo, or known or previously diagnosed structural disorder of the peripheral vestibular system
History of any coagulation, bleeding, or blood disorders (e.g. anemia)
No known bleeding disorders
Immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
History or presence of significant bleeding disorders
Has a history of any major neurological disorders, including stroke, multiple sclerosis, or neurodegenerative disease.
not experiencing psychiatric neurological disorders (assessed through clinical team members) that would prevent obtaining consent.
currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.
Subjects with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders
Bleeding or thrombotic disorders.