--- a +++ b/clusters/9knumclustersv2/clust_1340.txt @@ -0,0 +1,53 @@ +PHASE IB: Transaminases (AST and/or ALT) =< . x ULN +Transaminases =< . x ULN, except in known hepatic disease, wherein may be =< x ULN +ARM I&II: Transaminases =< times above the upper limits of the institutional normal +Transaminases < x normal at the time of transplant. +Research participant serum total bilirubin or transaminases does not exceed x normal limit +Transaminases < x normal at the time of transplant +Transaminases =< times above the upper limits of the institutional normal +Transaminases =< x upper limit of normal (ULN) or if liver metastases were present, =< x ULN +Transaminases (serum glutamate pyruvatetransaminase [SGPT]) =< . x upper limit of normal (ULN) +Serum total bilirubin > . and/or serum transaminases > X the upper limits of normal +Documented bilirubin and hepatic transaminases of =< . x upper limit of normal (ULN) +Serum transaminases =< x ULN +PART : Transaminases must be < x the upper limit of normal +Research participant transaminases does not exceed x normal limit +Transaminases > x upper limit of normal for age +The patient has a history of liver disease (excluding Gilberts disease and non-active hepatitis C) and/or elevation of transaminases or bilirubin above the normal limit +Transaminases less than or equal x upper limit of normal unless related to the disease +Liver: transaminases < x upper limit of normal and bilirubin < x upper limit of normal +Bilirubin < . x ULN; transaminases < x ULN +Serum transaminases =< X ULN.\r\n* Note: Transaminases can be up to X ULN in the setting of liver metastases. +Transaminases must be < x the upper limit of normal per reference values of treating institution +Patients must have serum direct bilirubin =< . mg/dl and transaminases =< x institution upper limit of normal +Transaminases < . x upper limit of normal +Transaminases < . x upper limit of normal (ULN) +Transaminases < . x upper limit of normal (up to x upper limit of normal [ULN] in patients with liver metastases) +Transaminases < x upper limit of normal +Liver transaminases within . times ULN +Liver transaminases > -times the upper limit of normal +Serum transaminases activity =< . x ULN, with the exception of serum transaminases (< x ULN) if the patient has liver metastases +Transaminases < x ULN +Hepatic dysfunction as evidenced by elevated transaminases +Transaminases must be < x the upper limit of normal per reference values of referring institution +Transaminases < times the upper limit of normal +Transaminases =< x the upper limit of normal for age appropriate indices +Serum transaminases activity =< x ULN +Subject with liver failure as defined by a serum total bilirubin > . and/or serum transaminases > x the upper limits of normal +DONOR: Hepatic transaminases =< . x ULN +Transaminases > times upper normal limit +Transaminases =< x ULN, except in known hepatic disease, wherein may be =< x ULN +Transaminases =< x ULN +Active liver disease with elevated transaminases > x ULN +Hepatic dysfunction (elevated transaminases or bilirubin > times normal), drawn within days of consent +Documented liver disease with marked elevation of transaminases > x ULN or, +Unexplained persistent elevation of transaminases (> times upper limits of normal) +History of, or current, active or chronic liver disease even if transaminases have normalized +Transaminases =< . x institutional upper limit of normal (IULN) +Transaminases =< . x institutional upper limit of normal (IULN) +SUB-STUDY I: Liver transaminases > times the upper limit of normal +SUB-STUDY II: Liver transaminases > times the upper limit of normal +SUB-STUDY III: Liver transaminases > times the upper limit of normal +Liver transaminases > times the upper limit of normal +Transaminases =< IULN +Elevated LDH levels are permissible if transaminases are =< IULN