Patients with psychosocial conditions that would prevent study compliance
COMORBID CONDITIONS
No comorbid conditions that would cause life expectancy of less than 5 years
A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
Patients with any of the following conditions are NOT eligible for this study.
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.
Any of the following cardiac conditions:
Any medical conditions that, in the Investigator’s opinion, would impose excessive risk to the patient; examples of such conditions include any pre-existing kidney disease (acute or chronic, unless renal insufficiency is felt to be secondary to MM), hypertension, active seizure disorder or pulmonary diseases that would impose excessive risk to the patient
Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
- Patient presenting with cardiac disorders defined by at least one of the following conditions:
Women with skin conditions such as psoriasis, fungal infections, keloids etc., or tattoos and/or piercings, which in the opinion of the Investigator, would interfere with absorption of the IP.
Has significant, ongoing, co-morbid conditions which would preclude safe delivery of the study drug.
Any history of CTCAE grade ?2 non-dysrhythmia cardiac conditions within the last 6 months. Patients with asymptomatic grade 2 non-dysrhythmia cardiac conditions may be considered for inclusion, with the approval of the medical monitor, if stable and unlikely to affect patient safety.
Patients with hospitalization within 4 weeks of treatment initiation date for co-morbid conditions or any complication of disease or therapy that is deemed by the principal investigator as unstable or incompletely treated
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult; patients with reversible ischemic changes on cardiac stress test
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ? Grade 3 thromboembolic event in the last 6 months)
Subjects must be deemed unfit for RC due to comorbid conditions with a risk of mortality.
Has ocular conditions such as:
Known risk factors for ocular toxicity Exclusions Related to Autoimmune Conditions and Immunomodulatory Drugs
Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study, including:
Medical conditions, per the investigator’s judgment, that predispose the patient to untoward medical risk in the event of volume loading (e.g. intravenous [IV] fluid bolus infusion), tachycardia, or hypotension during or following treatment with Pexa-Vec
History of the following cardiac conditions:
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
Subjects with any of the following conditions are excluded:
Patients with inoperable conditions with resectable disease (T1-2NoMo)
Has ocular conditions such as:
The patient has cardiac conditions defined per protocol
Has a medical or psychosocial conditions that would prevent study compliance
Has a history of any of conditions that would contraindicate administration of an OC
cardiac conditions, including
Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject\r\n* Examples of such conditions include:\r\n** Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder\r\n** Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent\r\n** Active infection that requires parenteral anti-microbial or anti-parasitic treatment
Subject has any underlying conditions, which would contraindicate therapy with study treatment
Mild autoimmune conditions (such as localized psoriasis) requiring minimal treatment or systemic autoimmune conditions well controlled by target agents such as an anti-IL-17 that do not affect overall immune system
Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery
Patients with known genetic metabolic conditions, or other ongoing serious medical issues, must be approved by the Study Chair prior to registration
Patients with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the patient to cooperate and participate in the trial; other examples of such conditions would include COPD or diabetes mellitus that has required 2 or more hospitalizations in the last year; severe peripheral vascular disease; poorly controlled auto-immune conditions; recent serious trauma.
uncontrolled comorbid conditions
Any of the following cardiac conditions:
Any of the following conditions:
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic
Concurrent conditions as listed in the protocol.
Cardiac conditions per protocol
Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
No diagnosed psychosocial conditions that would hinder study compliance and follow-up
No psychosocial conditions that would hinder study compliance and follow-up
Untreated psychiatric conditions preventing informed consent
Maintenance of castrate conditions
History of, or at risk for, cardiac disease, as evidenced by 1 or more of the following conditions:
Has ocular conditions such as:
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or conditions such as common variable hypogammaglobulinemia
Any of the following cardiac conditions:
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this study
known glaucoma or other pre-existing ocular conditions that may put the patient at risk for ocular toxicities.
Presence or documented history of any of the following autoimmune conditions:
Patients with any of the following constitutional conditions are not eligible:\r\n* Fanconi anemia\r\n* Shwachman syndrome\r\n* Any other known bone marrow failure syndrome\r\n* Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 \r\nNote: enrollment may occur pending results of clinically indicated studies to exclude these conditions
Any of the following cardiac conditions:
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
Ophthalmological conditions
Medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject
COHORT A: Patients with underlying heart conditions who are deemed ineligible for surgery
Patients with malabsorption in the small intestine or other conditions that would preclude administration of oral medication
Other conditions or circumstances that could interfere with the study
Life-expectancy based on comorbid conditions > 2 years
Generally healthy other than for CTCL, or with other stable diseases/conditions that are adequately controlled
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Patients with psychosocial conditions that would prevent study compliance and follow-up, as determined by the principal investigator.
Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of active or incompletely treated local infection, severe pulmonary insufficiency),
Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Psychiatric conditions/diseases that impair the ability to give informed consent or to adequately co-operate
Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
Use of any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.
Patients with conditions that would prevent absorption of the study drug
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Cardiac conditions
Any conditions associated with non-compliance.
Patients with comorbid medical conditions that render them unfit for surgery
Any other significant co-morbid conditions that would impair study participation or cooperation
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Known intercurrent infections (including hepatitis C virus and human immunodeficiency virus or other conditions), or clinical evidence of these conditions
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Patients with underlying heart conditions who are deemed ineligible for surgery by cardiology consult
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis
Conditions that may increase intraocular pressure (e.g. glaucoma, acute globe injury)
Skin conditions involving open sores on the scalp that would prevent proper application of the electrodes
History of any cardiovascular disease (CVD) or any other medical conditions (e.g. severe osteoarthritis) that will prevent him from walking
Medical conditions that would prohibit the safe implementation of a yoga practice (e.g., vertigo, compromised mental status)
EXCLUSION - STUDY 1: Have other medical conditions that may affect their balance and gait, or are unable to ambulate without assistance
Skin conditions such as open sores that would prevent proper application of the electrodes
Conditions that could affect participation in yoga such as spinal disease or unstable joints
Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
Chronic inflammatory conditions
Skin conditions such as open sores that would prevent proper application of the electrodes
Skin conditions such as open sores that would prevent proper application of the electrodes
Major medical conditions involving the immune system such as autoimmune and/or inflammatory diseases
Significant cardiopulmonary disease, severe arthritis, glaucoma, or any other medical conditions that make yoga practice unsafe as determined by a study investigator
Evidence of any of the following conditions per subject self-report or medical chart review:
Neurological conditions that affect balance and, or muscle strength
Severe cardiovascular, pulmonary or other systemic conditions that prevent participation in the study
Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrhythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the American College of Radiology (ACR) contrast manual version 10.3 and hospital policy.
Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
Patients with other medical conditions judged by the investigator to be clinically relevant in the setting of this study, which may include active infectious processes, intractable emesis, or chronic diarrheal disease
Diabetic neuropathy or other neurological conditions
Conditions contraindicated to progesterone treatment.
PATIENT: Patients with cardiac shunts or unstable cardiopulmonary conditions
Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
Patients with cardiac shunts or unstable cardiopulmonary conditions.
Conditions which make repeat TRUS biopsies not feasible
Preexisting medical conditions or claustrophobic reactions, and any greater than normal potential for cardiac arrest
Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study
Patients with unstable cardiopulmonary conditions
Medical conditions such as ischemic heart or lung disease that may be considered an unacceptable risk.
Any medical conditions that would impose excessive risk to the patient, or would adversely affect his/her participation in the study