Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient would not be eligible if he/she has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
COHORT 1: Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
COHORT 2: Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
Patients who have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are not eligible
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Known psychiatric or substance abuse disorders that would interfere with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial in the opinion of the treating provider
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with adherence to the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the protocol
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
History of known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Subject has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
REGISTRATION TO TREATMENT (STEP 1): Patient must not have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Known psychiatric or substance abuse disorder that would interfere with the ability of the patient to comply with trial requirements
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the protocol
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Patients who are unwilling or unable to comply with the protocol or have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial are not eligible
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including arterial thrombosis, or symptomatic pulmonary embolism)
Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the subject to high risk of noncompliance with the protocol.
A history of substance abuse as defined by version IV of the Diagnostic & Statistical Manual of Mental Disorders (DSM IV).
SAFETY RUN-IN: Active substance abuse or psychiatric disorders
RANDOMIZED PHASE II CLINICAL TRIAL: Active substance abuse or psychiatric disorders
Participants with an unstable major psychiatric disorder, as assessed by study clinician, or a diagnosis of alcohol abuse (more than 5 drinks in a 24 hour period) or substance dependence within the past 1 year (as determined by a standard psychiatric interview) will be excluded unless otherwise approved by the PI or PI’s designee
Active substance abuse
Documented History of Alcoholism and or drug abuse
Known substance abuse or receiving concurrent treatment with non-permitted drugs.
Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
History of active ethanol abuse
Active, uncontrolled psychiatric disorders or substance (drug/alcohol) abuse that interfere with patient’s safety, ability to provide informed consent, or ability to comply with the protocol
Known to have recent history of drug abuse or alcoholism.
History of alcohol or other substance abuse within the last year.
Known significant mental illness or other conditions such as active alcohol or other substance abuse/addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol
Psychiatric illness, substance abuse
History suggestive of substance abuse
Patient has alcohol or substance abuse which, in the opinion of the investigator, would interfere with compliance or safety
Meet criteria for the following psychiatric and/or substance use disorders as assessed by the MINI International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum - past 6 months only; current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physician
Testing positive on a urine drug screen for drugs of abuse/potential abuse
Patients with substance abuse or other medical or psychiatric conditions that, in the opinion of the investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study.
Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.
Known or suspected substance abuse or alcohol abuse
Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.
Past or present history of active substance abuse (drug or alcohol)
Substance abuse or other concurrent medical or psychiatric conditions that, in the\n             Investigator's opinion, could confound study interpretation or affect the patient's\n             ability to tolerate or complete the study
History of active substance or alcohol abuse within the last year
History of active substance or alcohol abuse within the last year
Known significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.
Psychiatric disorders and substance (drug/alcohol) abuse
History of alcohol or substance abuse
Any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study
Subject has addictive/substance abuse problems.
Use of any substance known to cause AME
DONOR: Active substance abuse
Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
Has known psychiatric or substance abuse disorders.
Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (day 0) when the consent form is signed
Active substance abuse
History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment
Donor must not have active alcohol or substance abuse within 6 months of study entry.
Recipient must have no active alcohol or substance abuse within 6 months of study entry.
Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
History of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the principal investigator, would preclude safe treatment
Self-reported active alcohol or substance abuse within the last 30 days
History of substance abuse.
Have a current diagnosis of seasonal affective disorder or substance abuse
Are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse)
History of substance abuse
History of substance abuse
Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation
Illicit substance abuse within the past 6 months
History of substance abuse
Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances)
History of marked anxiety disorder, or history of substance abuse
Patients with history of alcohol or substance abuse by using Cut-down, Annoyed, Guilty, Eye-opener adapted to include Drug use questionnaire (CAGE-AID) score of 2 or higher
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)
Parents of ALL or AML survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Parent/Caregiver: parents with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Child: survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
History of opioid abuse
Ongoing or recent history of drug abuse.
Patients have a known history of seasonal affective disorder or substance abuse
Active alcohol or substance abuse issue
Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - alcohol addendum-past 6 months only; current alcohol dependence), J (substance abuse - substance abuse addendum - past 6 months only; current substance dependence), K (psychotic disorder or mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator
Psychiatric conditions, social situations or substance abuse that precludes the ability of the subject to cooperate with the requirements of the trial and protocol therapy
Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI); items C (current manic or hypomanic episode only), I (alcohol abuse-Alcohol Addendum-past 6 months only; current alcohol dependence), J (substance abuse-Substance Abuse Addendum-past 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features); individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the principal investigator and/or study physician
Recent history (within 6 months) of alcoholism or drug abuse
Recent extended history of constant-recurrent substance abuse or another medical condition that might compromise safety or the successful completion of the study
Subjects with drug, alcohol, or substance abuse reported within the last three years (subject reported);
Have a history of alcohol or substance abuse, unless in full remission for greater than 6 months prior to the screening visit (day 0) when the consent form is signed
Psychiatric disorders or conditions that, in the opinion of the investigator, would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder).
With current substance abuse and/or history of substance abuse, as per medical records or patient report
Individuals with known or suspected substance abuse, obtained by self-reporting.
History of substance abuse
History of alcoholism or other substance abuse
Substance abuse within the past 2 years
Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.
Has a known psychiatric and/or substance abuse disorder that would make it difficult for the participant to cooperate with the requirements of the trial
Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, etc.)
History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator.
Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.
Has history of bipolar disorder or major depression
History of idiopathic seizure disorder, psychosis, or schizophrenia
Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, anxiety; this is determined by clinical assessment
Known diagnosis of bipolar depression or psychosis
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others); ), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]- IV) are not eligible; patients who have a history of major depression that is controlled with chronic oral therapy are eligible provided they have no history of inpatient hospitalization, history of documented suicide attempt or ideations, and are managed with one anti-depressant which has not required dose adjustment in 6 weeks; patients with a history of depression who would otherwise be eligible should be evaluated by a mental health professional prior to enrollment if there is any uncertainty regarding the status of their mental health; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
History of psychiatric disorder (e.g. depression; suicidal ideation; psychosis)
Any other condition which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment, the safety of the individual subject or the outcome of the trial. (including but not limited to: history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, suicidal attempt or ideation, homicidal ideation, or >= Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 anxiety)
Severe psychological illness such as major psychosis (e.g. schizophrenia), major bipolar depression, or suicidal situational depression
Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment may not participate in this study without discussion with and agreement of the study principal investigator (PI)
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, homicidal ideation (e.g. risk of doing harm to self or others)
Current major depression or another major psychiatric disorder as described in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (use of central nervous system [CNS] active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months)
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
History of idiopathic seizure disorder, psychosis or schizophrenia
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV).
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others).
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
Uncontrolled depression or other major psychiatric disorder
Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
Diagnosis of depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses
No active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)
Major psychiatric disorder, such as schizophrenia, bipolar disorder, or untreated depression (treatment for depression is defined as current therapy with antidepressant medication or cognitive behavioral therapy [CBT])
Have an active serious mental illness (e.g., schizophrenia, bipolar disorder) as indicated by medical records
Major mental illness (e.g., schizophrenia, psychotic disorder)
Current diagnosis of a major psychiatric disorder (e.g., schizophrenia, bipolar disorder)
Meet Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis that could be exacerbated by the administration of cannabis
Psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions)
Serious mental illness (e.g., schizophrenia), which may interfere with engagement in the intervention
Any of the following: diagnosis of schizophrenia or bipolar disorder made by a physician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, or the presence of other known current untreated causes of fatigue such as anemia (defined as hemoglobin [Hgb] < 10 g/dL within 3 months of study enrollment) or untreated hypothyroidism
Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self-report and review of medical history
As per self report or as documented in the medical record, current untreated (e.g. no medication, no therapy) major psychiatric disorder (schizophrenia, major depression); patients diagnosed with a major psychiatric disorder will be reviewed by the study principal investigator (PI) to determine eligibility prior to consent
Major mental illness (e.g., schizophrenia, major depressive disorder)
Patient has serious psychiatric condition (e.g., bipolar disorder, schizophrenia or other psychosis, bulimia or anorexia nervosa, suicide attempt within 6 months or current active suicidal ideation) that would compromise the patient’s ability to complete the study, at the discretion of the investigator
As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
Individuals with the following characteristics will be excluded: male breast cancer survivors, non-ambulatory, unable to provide informed consent; have a major mental illness (i.e., schizophrenia); have a mental illness that is not being treated/controlled (i.e., bipolar disorder); and reside > 100 miles from the research site
Patients who have ever been diagnosed with bipolar disorder or schizophrenia
Major mental illness (e.g., schizophrenia, major depressive disorder)
Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia)
Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder
Has a Diagnostic and Statistical Manual (DSM) IV diagnosis of Major Depressive Disorder
Patients who have ever been diagnosed with bipolar disorder or schizophrenia.
Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia; (defined per medical history)
Have schizophrenia or any other psychotic disorder
Diagnosis of a formal thought disorder (e.g., schizophrenia)
Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression
Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:\r\n* Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder\r\n* History of alcohol or other substance abuse or dependence within 365 days prior to registration\r\n* Chronic liver disease\r\n* End-stage renal disease\r\n* Uncontrolled narrow-angle glaucoma\r\n* Clinically significant coagulation disorder
Received treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months
Major mental illness (e.g, schizophrenia, major depressive disorder)
Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder)
Diagnosis of a major depressive episode, an acute anxiety disorder, psychosis, post-traumatic stress disorder (PTSD), or schizophrenia as listed in the patient’s medical history per Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria in the chart and/or by self-report; assessing the concomitant medications will provide some insight into whether this needs further evaluation
Documented history of mental incapacitation or significant emotional or psychiatric disorder (i.e. bipolar, schizophrenia) that, in the opinion of the investigator, precludes study entry as these patients may not be able to cooperate with this slightly invasive procedure or with the data collection process
Diagnosis of a formal thought disorder (e.g., schizophrenia)
PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Diagnosis of a formal thought disorder (e.g. schizophrenia)
Current or past diagnosis of a major psychiatric disorder precluding adequate outcome responses such as schizophrenia, dementia, delirium etc. as recorded in the pre-operative record
Participant has current major psychiatric illness (i.e. schizophrenia, bipolar disorder)
Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)
Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia
Having untreated clinical depression and other psychotic mental disorders (e.g., bipolar, schizophrenia) (>= 27 on the Center for Epidemiological Studies Depression Scale [CES-D])
Major mental illness (e.g., schizophrenia, psychotic disorder)
Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder
Educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions)
Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa)
Does not have schizophrenia
Any major thought disorder (e.g., schizophrenia, dementia)
Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis
With current diagnosis of major axis I psychiatric disorder (Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with electroconvulsive therapy (ECT) (mild depression that is well treated with stable dose of selective serotonin reuptake inhibitor [SSRI] antidepressants may be allowed)
Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, or substance abuse within two years)
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse follow-up evaluation.
Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
Serious psychiatric illness, alcoholism, or drug addiction