[c09aa8]: / clusters / 9knumclustersv2 / clust_296.txt

Download this file

101 lines (100 with data), 19.2 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
The patient has known and active alcohol or drug dependency
Ongoing alcohol or drug addiction
Ongoing alcohol or drug addiction
History of or ongoing alcohol abuse that, in the opinion of the investigator, would compromise compliance or impart excess risks associated with study participation
Known or suspected active drug or alcohol use
Alcohol dependency within months before study entry
Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol, including patients with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol. Patients planning to take a vacation for or more consecutive days during the course of the study are ineligible.
Participant is an active alcoholic or consumes excessive amounts of alcohol per the following definitions:\r\n* Female: More than drinks on any day or a total of more than seven drinks in a week\r\n* Male: More than drinks on any day or a total of more than drinks in a week\r\n** drink = \r\n*** Beer: oz. ( standard size can or bottle)\r\n*** Wine: oz. (one standard glass)\r\n*** Spirits: oz. (one mixed drink or one . fluid oz. shot)
Regular and excessive use of alcohol within the months prior to study entry defined as alcohol intake > drinks per week in a man or > drinks per week in a woman. Approximately g of alcohol equals one \drink\ unit. One unit equals ounce of distilled spirits, one -ounce beer, or one -ounce glass of wine.
Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigators opinion will prevent completion of the protocol therapy or follow-up
Ability to comply with dietary and tobacco/alcohol abstinence requirements.
Active alcohol use disorder or hazardous drinking; this will be screened with the Alcohol Use Disorders Identification Test (AUDIT-C), and positive scores ( or greater for men and or greater for women) will result in study clinician assessment and discretion
Patients with a current history (in the past days) of heavy drinking which is defined in accordance with Center for Disease Control and Prevention (CDC) definition as more than drinks per week for women and more than drinks per week for men; a standard drink contains . ounces of pure alcohol; generally, this amount of pure alcohol is found in -ounces of beer, -ounces of malt liquor, -ounces of wine, .-ounces or a shot of -proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey); while on study, patients should limit their alcohol consumption to no more than drinks per week for women and no more than drinks per week for men
Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements
Patients in active alcohol withdrawal
Willingness to abstain from alcohol or any alcohol-containing fluids for the duration of the study
Patients with a current history (in the past days) of heavy drinking which is defined in accordance with Centers for Disease Control and Prevention (CDC) definition as more than drinks per week for women and more than drinks per week for men; a standard drink contains . ounces of pure alcohol; generally, this amount of pure alcohol is found in -ounces of beer, -ounces of malt liquor, -ounces of wine, .-ounces or a shot of -proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey); while on study, patients should limit their alcohol consumption to no more than drinks per week for women and no more than drinks per week for men; patients who feel they cannot comply with this recommendation are not eligible
Willing to limit daily alcohol intake to the following: one -oz glass of beer, one -oz glass of wine, or one .-oz portion of -proof alcohol
Subject is a chronic alcoholic (intake > units of alcohol (> bottles of wine weekly)) or drug abuser
Subjects with a known hypersensitivity to fulvestrant or any of its formulation components including castor oil, alcohol, benzyl alcohol, and benzyl benzoate.
or above for men OR or above for women on the Alcohol Use Disorders Identification Test (AUDIT-C) are considered a positive screen and will require additional clinician assessment to determine if an alcohol use disorder is present
Use of alcohol or drug use that may interfere with the patient's ability to participate in the study.
Ongoing alcohol use or abuse defined as > an average of alcoholic beverages daily
History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the months preceding diagnosis
Willingness to reduce alcohol consumption during study to or fewer standard drinks/day ( oz. of alcohol or two beers ( oz.), or two oz. glasses of wine).
Evidence of problem alcohol consumption based on AUDIT.
Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigators opinion will prevent completion of protocol therapy or follow-up
Unable to abstain from alcohol for the duration of the study
Excessive alcohol intake should be avoided (occasional use is permitted)
Ongoing alcohol or drug addiction
Patients with any medical condition, including alcohol or drug abuse or mental incapacity / hypersensitive to the study drug, which in judgment of the investigator will interfere with the patient's participation in the study or evaluation of study results
Regular alcohol consumption averaging more than seven drinks/week for women and drinks/week for men within months of screening.
History of any hepatitis (e.g. alcohol or non-alcohol steatohepatitis (NASH), drug- related, autoimmune)
The following agents are not permitted while patients are taking MLN, and should be discontinued at prior to registration if patients are taking them:\r\n* Patients must stop using the proton pump inhibitor (PPI) for at least days prior to the first dose of MLN; administration of PPI while on study is not permitted\r\n* Histamine- (H) receptor antagonists are not permitted from the day prior through to the end of MLN dosing, except as required for premedication for rituximab; constant dosing of H blockers is not permitted\r\n* Antacid preparations are not permitted for hours before or hours after administration of MLN\r\n* Administration of pancreatic enzymes is not permitted at any time while on study\r\n* Co-administration of enzyme-inducing antiepileptic drugs, rifampin, rifabutin, rifapentine or St. John's wort is not permitted\r\n* Concurrent bisphosphonate therapy is allowed if it was started before study entry and is maintained at recommended dosing intervals; if bisphosphonate therapy is initiated after study entry, bone lesions will not be considered evaluable for disease response\r\n* Patients must be willing not drive, operate dangerous tools or machinery, or engage in any other potentially hazardous activity that requires full alertness and coordination if they experience excessive sedation; if a patient experiences excessive sedation believed to be related to MLN, treatment with MLN should be interrupted\r\n* Patients must be willing to limit alcohol consumption to no more than standard unit of alcohol ( oz beer [ mL], . oz [ mL] of -proof alcohol, or one -oz [ mL] glass of wine) per day during the study and for days from the last dose of MLN; minimize the use of agents with central nervous system (CNS) effects\r\n* Benzodiazepine use is discouraged but not prohibited
Chronic or planned acute alcohol use of or more drinks per day
History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis [NASH], auto immune, or grade - drug-related hepatitis)
Daily consumption of alcohol exceeding standard drinks a day (defined as grams of alcohol, which is equivalent to mL of beer, mL of light beer, mL of wine or mL of liquor)
Current alcohol or chemical abuse, or mental or psychiatric condition precluding protocol compliance
Phase b subject is unable to avoid alcohol or tobacco consumption for the duration of the study.
Excessive alcohol intake (more than alcoholic beverages per day) should be avoided (occasional use is permitted)
History of excessive alcohol consumption
Have an active chemical or alcohol dependency as assessed by the investigator
Subjects who are known to be actively abusing alcohol or drugs
Ongoing alcohol or drug addiction
Patient agrees to consume no more than standard unit of alcohol per day during the study and for days from the last dose of alisertib; a standard unit of alcohol is defined as a oz beer ( mL), . oz ( mL) of -proof alcohol, or one -oz ( mL) glass of wine
Subject must be willing to limit alcohol to moderate use which is defined as: up to one drink a day for women or two drinks a day for men; examples of one drink include:\r\n* Beer: fluid ounces ( milliliters)\r\n* Wine: fluid ounces ( milliliters)\r\n* Distilled spirits ( proof): . fluid ounces ( milliliters)
Patients with a history of excessive alcohol intake which is defined in accordance with Centers for Disease Control and Prevention (CDC) definitions as more than drink per day for women and more than drinks per day for men
Ongoing alcohol or drug addiction
Ongoing alcohol or drug addiction
Patients with a history of alcohol abuse, or patients unwilling or unable to remain completely abstinent of alcohol during the study period
PART I: Participants who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one of the following per day: mL distilled spirits, mL beer, or mL wine) will not be allowed
PART II: Those who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one of the following per day: mL distilled spirits, mL beer, or mL wine) will not be allowed
Alcohol abuse problems make patients INELIGIBLE; patients need to be consuming less than or equal to units of alcohol weekly
History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis (NASH), drug-related, auto-immune)
Alcohol consumption within days of first study treatment, or refusing to abstain from alcohol for the duration of study treatment
Evidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigators opinion will prevent completion of the protocol therapy or follow-up
History of any hepatitis (e.g., alcohol or non-alcohol steatohepatitis [NASH], auto immune, or grade - drug-related hepatitis)
Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individuals sleep
Other exclusion criteria include: illicit drug use, shift work, current dieting, excessive regular use of alcohol (more than two ounce glasses of wine or equivalents/day) or a history of binge drinking (more than drinks/ hour period) within the last months
Self-reported consumption of > alcoholic drinks per week or positive screening on the CAGE questionnaire in relation to the past year; NOTE: A single, standard alcoholic drink is defined as grams of alcohol, which is equivalent to mL of beer, mL of light beer, mL of wine or mL of liquor
Patients with a current history (in the past days) of heavy drinking which is defined in accordance with Centers for Disease Control and Prevention (CDC) definition as more than drinks per week for women and more than drinks per week for men. A standard drink contains . ounces of pure alcohol. Generally, this amount of pure alcohol is found in -ounces of beer, -ounces of malt liquor, -ounces of wine, .-ounces or a shot of -proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey). While on study, patients should limit their alcohol consumption to no more than drinks
Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individuals sleep
Patients with suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the investigator to be likely to affect their ability to sign the informed consent, or undergo study procedures will be excluded
Alcohol intake > oz/day
Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements
Current alcohol over-use as defined by currently consuming drinks or more per day or binge drinking ( or more drinks in one night) within the past week
Patients with a current history (in the past days) of heaving drinking which is defined in accordance with Centers for Disease Control and Prevention (CDC) definition as more than drinks per week for women and more than drinks per week for men; a standard drink contains . ounces of pure alcohol; generally, this amount of pure alcohol is found in -ounces of beer, -ounces of malt liquor, -ounces of wine, .-ounces or a shot of -proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey); while on study, patients should limit their alcohol consumption to no more than drinks per week for women and no more than drinks per week for men; patients who feel they cannot comply with this recommendation are not eligible
Consume excessive amounts of alcohol (> drinks/week)
Caregivers: Alcohol consumption less than drinks/day
Other exclusion criteria include: illicit drug use, shift work, current dieting, excessive regular use of alcohol (more than two ounce glasses of wine or equivalents/day) or a history of binge drinking (more than drinks/ hour period) within the last months
Chronic alcohol abuse (> alcoholic beverages daily)
Concurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol consumption of more than drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the data
Willingness to avoid excessive use of alcohol during the study; note: excessive use is defined as drinking >= alcoholic drinks per week on average
Concurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol consumption of more than drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the data
Not willing or are unable to limit alcohol consumption to =< alcoholic beverages a day during the study period
Current excessive alcohol consumption (average alcohol consumption of more than drinks per day)
Intake of alcohol, food or beverages (e.g., grapefruit, cranberry, pomegranate and aloe vera juices, German chamomile) known to interfere with either CYPA or CYPD metabolic enzymes within week prior to Day and during the overall study period.
Blood alcohol level > . (one re-screen allowed)
Binge alcohol drinking (/ [female/male] drinks per day more than days in the past month)
Patients with a current dependence on alcohol (characterized by a physical addiction to alcohol that interferes with physical or mental health, and social, family or job responsibilities)
Are alcohol consumers (defined as an average consumption of greater than drink/day over one week [wk] [one drink = oz. liquor, oz. beer])
Current heavy alcohol consumption (greater than or equal to drinks/day, days/week)
For Zyban:\r\n* Pregnant or breast feeding or planning to become pregnant in the next months\r\n* History of seizure disorder or head trauma\r\n* History of severe allergic reaction to Zyban (also known as Wellbutrin, Bupropion)\r\n* History of eating disorder, such as anorexia or bulimia, which is overeating and throwing up\r\n* Currently taking Wellbutrin, Zyban or any other medications that contain bupropion\r\n* History of alcohol or substance abuse in the past year\r\n* Current excessive alcohol consumption defined as or more alcoholic drinks per week and/or binge drinking ( or more drinks on one occasion) or more times in the past month\r\n* Use of monoamine oxidase (MAO) inhibitors, such as Nardil, tranylcypromine, phenelzine, or Parnate\r\n* Reported use of illegal drugs (opiates, cocaine, narcotics, or other stimulants such as diet pills)\r\n* Use of psychoactive medications, such as fluoxetine, doxepin, clonidine, or buspirone\r\n* Use of benzodiazepines, such as Xanax, Valium, Ativan, Klonopin in the past weeks
Concurrent excessive alcohol consumption (average alcohol consumption of more than drinks per day)
History of chronic alcohol use or abuse defined as any one of the following: a) average consumption of or more alcohol containing beverages daily in the past months; b) consumption of or more alcoholic beverages within a hour (hr) period in the past months
Willing to use alcohol in moderation while taking study agent
Patients with history of chronic alcohol use
Chronic alcohol use defined as > standard drinks per day (more than beers, glasses of wine, or shots of liquor per day)
Participants with bleeding diathesis, history of gastric/duodenal ulcers in the last years, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol consumption to i.e. =< alcohol drinks a day
Have a history of alcoholism or high alcohol consumption (average of > standard drinks/day)
Patients who are on disulfiram, metronidazole or are dependent on alcohol
Not willing or are unable to limit alcohol consumption to =< alcoholic beverages a day during the study period
History of alcohol or drug dependency in the past year
Current or recent (within three months) alcohol or drug abuse problems, including marijuana use within prior year, assessed via the Drug Use Questionniare- month
Current or recent (within the past months) alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention)
History of ongoing alcohol abuse or binge drinking; alcohol abuse will be defined as a pattern of drinking that results in harm to ones health, interpersonal relationships, and ability to work; binge drinking will be defined as at least one episode of consuming more than five units in men and four units in women during the previous month; one unit of alcohol can generally said to be a half pint of beer, a single measure (shot glass) of a spirit or a small glass of table wine
Patients with a history of excessive alcohol intake which is defined in accordance with Centers for Disease Control and Prevention (CDC) definitions as more than drink per day for women and more than drinks per day for men; this definition is referring to the amount consumed on any single day and is not intended as an average over several days; a standard drink is equal to . grams (. ounces) of pure alcohol; generally, this amount of pure alcohol is found in -ounces of beer, -ounces of malt liquor, -ounces of wine, .-ounces or a shot of -proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey)
Ability and willingness to completely abstain from alcohol consumption for days prior to kava administration, continuing until a minimum of days after kava administration