***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: This r and omized , prospect i ve , multicenter trial compared the safety and efficacy of steroid-free immunosuppression ( IS ) to the safety and efficacy of 2 st and ard IS regimens in patients undergoing transplantation for hepatitis C virus ( HCV ) infection . The outcome measures were acute cellular rejection ( ACR ) , severe HCV recurrence , and survival .  The patients were r and omized ( 1:1:2 ) to tacrolimus ( TAC ) and corticosteroids ( arm 1 ; n = 77 ) , mycophenolate mofetil ( MMF ) , TAC , and corticosteroids ( arm 2 ; n = 72 ) , or  MMF , TAC , and daclizumab induction with no corticosteroids  ( arm 3 ; n = 146 ) . In all , 295 HCV RNA-positive subjects were enrolled . At 2 years , there were no differences in ACR , HCV recurrence ( biochemical evidence ) , patient survival , or graft survival rates . The side effects of IS did not differ , although there was a trend toward less diabetes in the steroid-free group . Liver biopsy sample s revealed no significant differences in the proportions of patients in arms 1 , 2 , and 3 with advanced HCV recurrence ( ie , an inflammation grade ≥ 3 and /or a fibrosis stage ≥ 2 ) in years 1 ( 48.2 % , 50.4 % , and 43.0 % , respectively ) and 2 ( 69.5 % , 75.9 % , and 68.1 % , respectively ) . Although we have found that steroid-free IS is safe and effective for liver transplant recipients with chronic HCV , steroid sparing has no clear advantage in comparison with traditional IS The immunosuppressive effect of a monoclonal antibody ( moAb ) , BT563 , directed to the alpha-chain of the IL-2R ( CD25 ) , was analyzed in a prospect i ve nonr and omized trial and a prospect i ve r and omized trial . Primary objectives were evaluation of the incidence of acute rejections and infections ; secondary objectives were safety and tolerability of the moAb . A total of 28 patients were enrolled ( phase II ) to receive 10 mg/day of BT563 ( 12 days ) as immunoprophylaxis in combination with cyclosporine , azathioprine , and low-dose steroids .  Subsequently 32 patients were r and omly assigned ( phase III ) to receive BT563 ( 10 mg/day ) for 12 days or ATG ( 5 mg/kg/day ) for 7 days in addition to cyclosporine and low-dose steroids . No side effects of the BT563 treatment were noted . The actuarial survival was 82 % at 12 months in the phase II trial and 92 % at 12 months in both arms of the phase III trial . There was one acute rejection in the phase II trial . No acute rejections were noted in the BT arm of the phase III trial and 5 acute rejections were treated in the ATG arm . In the phase II trial 7 infectious episodes were observed , while one infection was seen in the BT arm and 7 in the ATG arm of the triple immunosuppression phase III trial . In all patients circulation of coated CD25 + lymphocytes was observed during BT563 treatment ; there was no evidence of depletion or modulation of CD25 + cells . Mean serum levels of BT563 ranged from 1.6 to 7.6 microgram/ml throughout the therapy . An antimurine response was seen in 82 % ( phase II ) and 100 % ( phase III ) of the patients . Antirabbit antibodies were found in 56 % of the patients treated with ATG . Analysis of the antimurine response specificity revealed in 56 % blocking anti-isotypic antibodies and only in 3 % of the patients an anti-idiotypic response . The data of the study presented suggest that therapy with an anti IL-2R moAb is at least equal to ATG application according to the incidence of acute rejections and infections Basiliximab , a high-affinity chimeric monoclonal antibody , is effective in reducing acute rejection episodes in renal allograft recipients . We assessed the ability of this antibody to similarly improve the outcome in liver transplant recipients . Adult recipients of a primary cadaveric liver transplant were r and omized to treatment , stratified by hepatitis C virus ( HCV ) seropositivity . Patients were administered 40 mg of basiliximab  ( n = 188 ) or placebo ( n = 193 ) as two 20-mg bolus injections days 0 and 4 , plus cyclosporine and steroids . Primary efficacy variables were biopsy-confirmed acute rejection and its composite end point , including death or graft loss , and were assessed at 6 and 12 months and by HCV cohort . Because of differential efficacy responses between HCV-positive and HCV-negative cohorts , an additional analysis incorporating HCV recurrence as a component of treatment failure , termed problem-free transplant , was introduced . Safety and tolerability were monitored over the 12 months of the study . All 381 patients were assessable , and no meaningful differences in background characteristics were apparent between treatment groups . Biopsy-confirmed acute rejection rates 6 months after transplantation were 35.1 % in the basiliximab group versus 43.5 % in the placebo group . For death , graft loss , or first biopsy-confirmed acute rejection , rates were 44.1 % versus 52.8 % , respectively . The reduction in rejection episodes was concentrated in the HCV-negative cohort ( 14.5 % relative to placebo ; P = .034 ) , with a much smaller difference ( 2.9 % ) in the HCV-positive cohort . For HCV-positive patients , problem-free transplant was shown at 12 months in 26.6 % of the basiliximab group versus 11.6 % in the placebo group ( P = .020 ) and for all patients at 12 months in 39.7 % of the basiliximab group versus 30.1 % in the placebo group ( P = .035 ) . The incidence of infection and other adverse events was similar across the two treatment groups . There were 56 deaths ( 25 deaths , basiliximab group ; 31 deaths , placebo group ) over the 12-month study . The intravenous bolus injection was well tolerated . Immunoprophylaxis with 40 mg of basiliximab , in combination with cyclosporine and steroids , reduces the incidence of acute rejection episodes with no clinical ly relevant safety or tolerability concerns . The influence of HCV recurrence on efficacy results can be accounted for in future trials by using the concept of problem-free transplant , incorporating recurrence as a component of treatment failure Background . Calcineurin inhibitor-induced renal dysfunction is a major problem in liver transplantation . Interleukin-2 receptor antagonist induction followed by delayed tacrolimus ( Tac ) administration may minimize the renal insult without compromising immunoprotection . Methods . This open , r and omized , multicenter trial evaluated the benefit of daclizumab induction with delayed Tac on renal function at 6 months ; an observational study was continued for 18 months . Liver transplant patients with a 12-hr serum creatinine ( SrC ) level less than 180 & mgr;mol/L received either delayed Tac with daclizumab induction ( n=98 ) or st and ard Tac ( n=101 ) both combined with mycophenolate mofetil and steroids . The primary endpoint was the incidence of SrC level more than 130 & mgr;mmol/L at 6 months . Results . The incidence was 22.4 % with delayed Tac and 29.7 % with st and ard Tac ( P = ns ) , which remained unchanged at 12 months ( 21.6 % and 23.9 % ) but increasing slightly at 24 months ( 29.0 % and 32.9 % ) , respectively . A post hoc analysis of renal function was done based on patients stratification by SrC at 12 hr ( ≤100&mgr;mol/L or > 100 & mgr;mol/L ) showing no difference in SrC values at 6 months regardless of the 12-hr values despite a trend toward better estimated glomerular filtration rate for patients with 12-hr value less than 100 & mgr;mol/L in the delayed Tac group . Biopsy-proven acute rejection was similar at 6 months ( 17.5 % and 18.75 % ) , 12 months ( 23.5 % and 23.8 % ) , and 24 months ( 24.5 % and 25.7 % ) , respectively . Patient and graft survival in both groups were comparable and good . Similar types and incidences of adverse events were reported in both groups at all time . Conclusions . Delay of Tac does not benefit renal function in liver transplant recipients with a good renal function at baseline OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials We report the results of a prospect i ve r and omized controlled trial in liver transplantation assessing the efficacy and safety of antithymocyte globulin ( ATG‐Fresenius ) plus tacrolimus monotherapy at gradually decreasing doses . Patients were r and omized to either : ( a ) st and ard‐dose tacrolimus plus steroids;or ( b ) peritransplant ATG‐Fresenius plus reduced‐dose tacrolimus monotherapy followed by weaning of tacrolimus starting 3 months after transplantation . The primary end‐point was the achievement of very low‐dose tacrolimus ( every‐other‐day or once daily dose with < 5 ng/mL trough levels ) at 12 months after transplantation . Acute rejection occurring during the first 3 months after transplantation was more frequent in the ATG group ( 52.4 % vs. 25 % ) . Moreover , late acute rejection episodes occurred in all recipients in whom weaning was attempted and no recipients reached the primary end‐point . This motivated the premature termination of the trial  . Tacrolimus trough levels were lower in the ATG‐Fresenius group but no benefits in terms of improved renal function , lower metabolic complications or increased prevalence of tolerance‐related biomarkers were observed . In conclusion , the use of ATG‐Fresenius and tacrolimus at gradually decreasing doses was associated with a high rate of rejection , did not allow for the administration of very low doses of tacrolimus and failed to provide detectable clinical benefits . Clinical Trials.gov identifier : NCT00436722 BACKGROUND Calcineurin inhibitors are the most commonly used immunosuppressive drugs in liver transplantation , but the optimum initial immunosuppression regimen is not known . The aim of our study was to compare tacrolimus with microemulsified ciclosporin , in a regimen with st and ardised concomitant immunosuppressive therapy . METHODS In all liver transplant centres in the UK and Republic of Irel and , 606 patients undergoing a first orthotopic liver transplantation were r and omly assigned open-label tacrolimus or microemulsified ciclosporin . Primary outcome was the combined frequency ( whichever occurred first ) of death , retransplantation , or treatment failure for immunological reasons , analysed by intention to treat . FINDINGS 96 % of patients received the treatment allocated to them . The primary outcome was reached in 62 ( 21 % ) of 301 patients in the tacrolimus group versus 99 ( 32 % ) of 305 allocated microemulsified ciclosporin ( relative risk 0.63 [ 95 % CI 0.48 - 0.84 ] , p=0.001 ; time-to-event analysis log-rank test p=0.002 ) : deaths ( 50 
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Overall , no difference in mortality ( RR 0.91 ; 95 % CI 0.64 to 1.28 ; low- quality of evidence ) , graft loss including death ( RR 0.92 ; 95 % CI 0.71 to 1.19 ; low- quality of evidence ) , and adverse events ( ( RR 0.97 ; 95 % CI 0.93 to 1.02 ; low- quality evidence ) outcomes was observed between any kind of T-cell specific antibody induction compared with no induction when the T-cell specific antibody induction agents were analysed together or separately .
T-cell specific antibody induction seems to reduce acute rejection when compared with no induction .
No other clear benefits or harms were associated with the use of any kind of T-cell specific antibody induction compared with no induction , or when compared with another type of T-cell specific antibody .