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.