Uncontrolled hypertension or diabetes
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior cycle 1, day 1
Uncontrolled hypertension or diabetes
Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
Uncontrolled hypertension or diabetes
Uncontrolled diabetes or hypertension
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to start of treatment
Uncontrolled diabetes or hypertension
Uncontrolled hypertension, uncontrolled pulmonary hypertension or uncontrolled diabetes within 14 days prior to enrollment
Uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
Uncontrolled hypertension or uncontrolled diabetes
Must not have any uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment.
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
Patients who exhibit uncontrolled hypertension (>= 140/90 mmHg) or uncontrolled diabetes within 14 days prior to registration are NOT eligible for participation
Uncontrolled diabetes, heart disease, hypertension
Uncontrolled hypertension or diabetes.
Uncontrolled diabetes or uncontrolled hypertension within 14 days prior to first dose
Uncontrolled hypertension or diabetes
Uncontrolled hypertension or uncontrolled diabetes despite medication
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to the first day of treatment
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
No uncontrolled hypertension or uncontrolled diabetes (as determined by the treating physician) within 14 days prior to cycle 1 day 1
Uncontrolled hypertension or diabetes
Uncontrolled hypertension or diabetes.
Uncontrolled hypertension or diabetes
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to signing consent
Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days prior to registration
Uncontrolled hypertension or diabetes
Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
Uncontrolled hypertension or diabetes
Uncontrolled hypertension or diabetes
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
Predisposing factors to retinal vein occlusion including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy.
Uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity.
Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
Major co-morbidities (e.g., uncontrolled diabetes, hypertension, etc.)
History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
Subjects who have diabetes or uncontrolled hypertension are not eligible; NOTE: for the purposes of this study, uncontrolled will be defined as diastolic pressure over 100 mmHg
Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
No evidence of intercurrent infection
Procurement: Patients with severe intercurrent infection
Patients with severe intercurrent infection
PROCUREMENT: Patients with severe intercurrent infection
TREATMENT: Patients with severe intercurrent infection
Patients with a severe intercurrent infection
Patients with severe intercurrent infection
EXCLUSION - INFUSION: Severe active intercurrent infection
Severe intercurrent infection
Severe intercurrent infection
Severe intercurrent infection
Severe acute infection
Patients with severe intercurrent infection
Severe intercurrent infection
EXCLUSION - TREATMENT: Severe intercurrent infection
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
AT THE TIME OF INFUSION: Severe intercurrent infection
TREATMENT: Severe intercurrent infection
Severe intercurrent infection
Severe intercurrent infection
Severe intercurrent infection
Severe intercurrent infection
AT THE TIME OF INFUSION: Severe intercurrent infection
Severe acute infection
Uncontrolled or severe intercurrent medical condition
Severe intercurrent infection
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
Severe systemic infection (i.e., sepsis)
Severe intercurrent infections
Uncontrolled or severe intercurrent medical condition
Patients with sepsis or severe infection
Patients with sepsis or severe infection
Patients with sepsis or severe infection
Patients with severe intercurrent infection
Patients with sepsis or severe infection
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
Significant history of medical conditions as listed in the protocol.
Conditions that could interfere with treatment or protocol-related procedures
Serious psychiatric or medical conditions that could interfere with treatment
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Presence of any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Patients must have no serious or uncontrolled medical conditions
Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
Have serious preexisting medical conditions.
Patients with a significant other medical conditions that would make them unsuitable for transplant
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Have serious preexisting medical conditions
Other concurrent severe and/or uncontrolled medical conditions
Co-existing medical conditions with life expectancy < 5 years
Serious psychiatric or medical conditions that could interfere with treatment
Serious psychiatric or medical conditions that could interfere with treatment
Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Serious psychiatric or medical conditions that could interfere with treatment or protocol-related procedures.
Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
Serious psychiatric or medical conditions that could interfere with treatment
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data
Other concurrent severe and/or uncontrolled medical conditions
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data
Serious psychiatric or medical conditions that could interfere with treatment
Patients with other medical conditions or concomitant medications that in the opinion of the principal investigator may interfere with the therapeutic treatment.
Patients with co-existing medical conditions with life expectancy < 2 years
Patients who have any severe and/or uncontrolled medical conditions
Serious psychiatric or medical conditions that could interfere with treatment
Clinically relevant serious co-morbid medical conditions.
Other serious illness or medical conditions
Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study
Subjects with certain medical conditions
Patients must not have any severe and/or uncontrolled medical condition or other\n             conditions that could affect their participation in the study, including, but not\n             restricted to:
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study a known history of human immunodeficiency virus (HIV) seropositivity
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
Medical Conditions
Unstable or serious concurrent medical conditions in the previous 6 months.
Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
Has certain serious illnesses or medical conditions
Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
Severe or uncontrolled medical conditions
Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications
Have other significant medical conditions well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1
Certain serious illnesses or medical conditions
Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
Conditions that could interfere with treatment or protocol-related procedures
Serious psychiatric or medical conditions that could interfere with treatment
Serious psychiatric or medical conditions that could interfere with treatment
Serious psychiatric illness (e.g., depression, psychosis) or medical conditions that could interfere with treatment
Serious psychiatric or medical conditions that could interfere with treatment
Other acute or chronic medical or psychiatric conditions.
Patients with a significant other medical conditions that would make them unsuitable for transplant
Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Excluded medical conditions:
Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Medical conditions that require hospitalization.
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
Patients must not suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities
Other concurrent severe and/or uncontrolled medical conditions.
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct
Patients with serious psychiatric or medical conditions that could interfere with treatment
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection
Other serious medical conditions that may be expected to limit life expectancy to less than 2 years (e.g., active liver cirrhosis) or a serious illness in medical opinion of the clinical investigator.
Serious psychiatric or medical conditions that could interfere with treatment
Serious cardiac illness or medical conditions
Any significant or severe medical conditions or psychiatric or social conditions that would preclude adherence to the protocol or compliance with study treatments
Have serious preexisting medical conditions (left to the discretion of the investigator).
Exclusionary concurrent medical conditions:
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Conditions that could interfere with treatment and procedures
Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Serious psychiatric or medical conditions that could interfere with treatment
Must not have a serious preexisting medical conditions or concomitant disorders.
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study
Other conditions that could interfere with treatment
Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
Serious psychiatric or medical conditions that could interfere with treatment
Participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Patients must have no serious or uncontrolled medical conditions
Uncontrolled or unstable medical conditions
Serious psychiatric or medical conditions that could interfere with treatment
Patients with any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator’s decision)
Patients who have any severe and/or uncontrolled medical conditions
Serious preexisting medical conditions
Have serious preexisting medical conditions
Any other serious uncontrolled medical disorders or psychological conditions
Serious psychiatric or medical conditions that could interfere with treatment
No co-existing medical conditions with life expectancy < 5 years
Subjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditions
Uncontrolled concurrent medical conditions that would limit compliance with study requirements
There must be no uncontrolled active infections or medical conditions that the investigator feels will compromise the safety of the treatment and/or the assessment of the efficacy of therapy
Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data
Subjects who have used massage as a therapeutic modality (medical or psychological) at any point in their lives for the treatment of medical conditions
Able to list all current medications and medical conditions
Conditions that could interfere with treatment or protocol-related procedures
Patients who have any severe and/or uncontrolled medical conditions such as:
Uncontrolled or unstable medical conditions
Have serious preexisting medical conditions (left to the discretion of the investigator).
Other Medical Conditions as noted in the protocol.
Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
Any uncontrolled medical or psychiatric disorder that would preclude participation as outlined
Any uncontrolled active medical disorder that would preclude participation as outlined
Any uncontrolled active medical disorder that would preclude participation
Any uncontrolled medical or psychiatric disorder that would preclude participation
Any uncontrolled active medical disorder that would preclude participation as outlined
Any uncontrolled active medical disorder that would preclude participation
Any uncontrolled active medical disorder that would preclude participation as outlined
Any uncontrolled active medical disorder that would preclude participation as outlined
Psychiatric disorder or social or geographic situation that would preclude study participation.
Psychiatric disorder that would preclude study participation