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At least 757 records · Page 42Linked to original sources
PubMed1992

Effect of preservation solution on results of cadaveric kidney transplantation. The European Multicentre Study Group.

University of Wisconsin (UW) preservation solution has been reported to be beneficial for canine organ transplants and for human liver and pancreas transplants. To examine whether it affects renal graft survival, a randomised multicentre trial was conducted to compare its effect with that of EuroCollins solution on delayed graft function, renal function, and patient and graft survival in 695 recipients of cadaveric renal transplants. 352 kidneys were preserved with UW and 343 with EuroCollins solution. Delayed graft function occurred in 23% of the UW group and in 33% of the EuroCollins group (p = 0.003). Three factors other than type of preservation fluid were associated with a higher incidence of delayed graft function: older donor age, intracerebral haemorrhage in the donor, and oliguria in the donor. Renal function as indicated by serum creatinine concentration was better in the UW than in the EuroCollins group. Patient survival in the UW and EuroCollins groups after 1 year was 95% and 94%, respectively. In both groups, delayed graft function reduced 1-year graft survival by 15% (p = 0.0001). 1-year graft survival of UW-preserved kidneys was 6% higher than that of controls (88.2% vs 82.5%, p = 0.04). Delayed graft function is significantly associated with a reduction in 1-year graft survival. The preservation solution is the most important factor influencing development of delayed graft function, and UW solution is superior to EuroCollins solution in reducing occurrence of delayed graft function, improving graft function, extending graft survival.

Adolescent↗
PubMed1993

Treatment of active Crohn's disease by exclusion diet: East Anglian multicentre controlled trial.

Elemental diet is as effective in producing remission of Crohn's disease (CD) as is corticosteroid treatment, but most patients relapse soon after resumption of a normal diet. We have investigated the efficacies of dietary modification and oral corticosteroids in maintaining remission achieved with elemental diet. In a multicentre trial, 136 patients with active CD were started on elemental diet and other treatment was withdrawn. 43 (31%) declined to continue elemental diet for 14 days, but 78 (84%) of the remaining 93 achieved remission and were randomly assigned corticosteroids (38) or diet (40). Corticosteroid treatment started at 40 mg prednisolone daily, which was tapered and stopped after 12 weeks; that group received dietary advice on healthy eating. The diet group received "tapered" placebo and were instructed to introduce one new food daily, excluding any that precipitated symptoms. Assessment of progress for up to 2 years was made by physicians unaware of group assignment. Intention-to-treat analysis showed median lengths of remission of 3.8 (interquartile range 5.0) months in the corticosteroid group and 7.5 (15.3) months on diet, and relapse rates at 2 years, adjusted for withdrawals, of 79% and 62%, respectively (p = 0.048). Clinical improvement in the diet group was associated with significant changes in plasma albumin and alpha 1-antichymotrypsin concentrations and erythrocyte sedimentation rate. Food intolerances discovered were predominantly to cereals, dairy products, and yeast. Diet provides a further therapeutic strategy in active Crohn's disease.

Adrenal Cortex Hormones↗
PubMed1982

Multicentre study on intensified remission induction therapy for acute myeloid leukemia.

In a cooperative study at 13 centres in the Federal Republic of Germany, 213 adult patients with AML were treated for remission induction by a 9-day regimen consisting of cytosine arabinoside, daunorubicin and thioguanine (TAD) according to previously described sequencing. Complete remission was achieved in 70% of all patients. Complete remission rate was 57% in the 49 patients 60 years of age and older and 74% in the 164 patients under 60 years. Sixty-eight per cent of all complete remissions and 75% of those in the higher age group were induced by one induction course. Median survival was 10 months for all patients treated and 16 months for responders. Median remission duration was 13 months with 72 patients still in continuous remission for 1-31 months. Remission duration was not significantly different for patients treated either by monthly maintenance therapy or induction type consolidation without further therapy. However, patients completing two consolidation courses had a significantly longer remission duration of 22 months. Compared to similar multicentre studies on AML therapy the intensified induction regimen applied in this study shows an improvement even in older patients.

Adolescent↗
PubMedDate not supplied

Randomized, double-blind, placebo controlled, multicentre study of idebenone in patients suffering from multi-infarct dementia.

In this randomized double-blind, placebo controlled, multicentre study on 108 elderly patients with mild to moderate mental deterioration of vascular origin, idebenone - a benzoquinone derivative with a hydroxyalkyl side chain - proved to be therapeutically effective in the treatment of multi-infarct dementia. The oral administration of idebenone 45 mg/day b.i.d. for 120 days significantly improved the scores of the following test in comparison with placebo: Mini Mental State, Randt Memory Test, Gottfries Rating Scale, Token Test, Toulouse Piéron Test, indicating improvements in memory attention and cognitivity. The drug was well tolerated and effective in patients with multi-infarct dementia. No changes in laboratory parameters were observed either before or after treatment.

Clinical Trial↗
PubMedDate not supplied

Idebenone in senile dementia of Alzheimer type: a multicentre study.

Idebenone is a new cerebro-active drug, effective in dementia disorders, particularly indicated in primary degenerative dementias, i.e. Alzheimer's disease. This new molecule acts as an electron trapper and a free radical scavenger protecting mitochondrial membranes from lipid peroxidation. A multicentric, double-blind trial of idebenone (45 mg twice daily orally) vs. placebo was carried out on 102 elderly patients affected by Alzheimer-type dementia of mild or moderate severity. Idebenone was administered for 4 consecutive months, 45 mg twice daily. Clinical evaluations were performed at the time of enrollment (t0) and monthly thereafter (t30, t60, t90 and t120) and at follow-up (t150 ). Tolerability to idebenone treatment was good and was associated with a statistically significant improvement of memory, attention and behaviour. It is worthwhile noting that these cognitive and behavioral findings were observed after the first month of treatment with enhancement evident in the following period.

Clinical Trial↗
PubMedDate not supplied

Idebenone in the treatment of multi-infarct dementia: a randomised, double-blind, placebo controlled multicentre trial.

A controlled double blind randomised open multicentre study was carried out on 104 patients with multi-infarct dementia (MID) from a mild to a moderate degree. The patients were randomly assigned to balanced blocks in each center and treated for 90 days either with idebenone (CV-2619) 90 mg/daily or placebo, after a 2-week turn-in period. The Gottfries Rating Scale, SCAG, Rey's A Figure Test, Rey's 15 Words Test, Token Test, Verbal Fluidity Test and the Blessed Dementia Test were used for assessment. The data were statistically analyzed using parametric and non-parametric tests. Seven patients were excluded (5 idebenone + 2 placebo) after a few days treatment, for reasons not related to drug administration; therefore, 97 patients were assessed for efficacy and 104 for tolerability. A certain placebo effect was found in the examination results but it never achieved the efficacy levels of idebenone. The latter is particularly effective for improving recent and remote memory, attention, orientation, vigilance and verbal comprehension and the effects continued even after a month of placebo treatment. There were no important adverse reactions and neither laboratory parameters nor clinical vital signs were significantly altered.

Clinical Trial↗
PubMedDate not supplied

Effects of idebenone in elderly subjects with cognitive decline. Results of a multicentre clinical trial.

A randomized, multicentre study on idebenone vs. oxiracetam was carried out in order to evaluate the therapeutic efficacy of idebenone in subjects with senile cognitive decline. Seventy-nine patients were enrolled: 39 treated with idebenone 45 mg twice daily p.o. and 40 treated with oxiracetam 800 mg twice daily p.o. Idebenone proved to be more effective and was shown to be statistically significant in the following test: SCAG, Rey's 15 Words, Gottfries Rating Scale. The greater efficacy of idebenone was confirmed by the efficacy judgement given by the investigators. The tolerability of both treatments can be said to be most satisfactory: none of the patients left the study because of side-effects. No significant variations were observed in the vital signs.

Clinical Trial↗
PubMed1994

Outcome of patients with diabetes and unstable angina. A subgroup analysis in the Spanish Multicentre Trial of trifusal in unstable angina. Grupo de Estudio del Trifusal en la Angina Inestable.

We analyzed the clinical characteristics of the 58 diabetic and 218 nondiabetic patients enrolled in the Spanish multicentre trial of trifusal in unstable angina. After 6 months of follow-up, 25 suffered from myocardial infarction or death, 10 of which were diabetics (17.2%) and 15 nondiabetics (6.9%) (P = 0.0146). This difference remained significant after multivariate analysis. We conclude that diabetes is an independent predictor of adverse outcome in patients with medically treated unstable angina.

Aged↗
PubMed1995

Interstitial brachytherapy for penile carcinoma: a multicentric survey (259 patients).

Although cancer of the penis is a rare disease, we have collected 506 cases through a multicentric study. In the present study we analyse the results obtained from 259 patients treated by interstitial brachytherapy from 1959 to 1989. Among the 259 patients, 184 males had exclusive brachytherapy (group A) while 75 received a combination of surgery and brachytherapy and/or external beam irradiation (EBI) (group B). Five- and 10-year survival rates are, respectively: overall survival, 66 and 52%; cause-specific survival, 88 and 88%; disease-free survival, 78 and 67%. One hundred and forty-three patients in group A (78%) and 48 (64%) in group B avoided mutilation of the penis while late side effects occurred in 137/259 patients (53%). Survival depends on the volume of the tumor and the presence of involved nodes; systematic groin dissection does not however seem advisable.

Adult↗
PubMed1996

Multicentre dosimetry study of mantle treatment in Australia and New Zealand.

PURPOSE: To determine the difference between expected and measured dose for patients prescribed a mantle treatment for Hodgkin's disease and estimate the range of dose at critical sites and between different treatment centres. METHODS AND MATERIALS: Twenty three radiotherapy centres were surveyed with regard to the accuracy of dose delivery to a custom-built upper-torso phantom. Thermoluminescent dosimeters were used to monitor the delivered dose at sites such as mid-plane, spinal cord, neck, axilla and lung. RESULTS: The intended dose to the phantom at each centre was 1 Gy to central axis mid-plane. Of the centres surveyed, the median measured dose to this region was 0.96 Gy with a minimum of 0.92 and a maximum of 1.00 Gy. Median dose to the axilla region was low (0.90 Gy) whereas median dose to the blocked lung and neck region were higher than expected, 0.18 Gy and 1.25 Gy, respectively. The 95% confidence interval on the reported relative dose using the 4000 thermoluminescence dosimetry readings in this study was +/- 1.5% CONCLUSION: In this controlled experiment, using conventional methods to calculate dose, there was a surprising variability in the dose delivered at the central axis mid-plane position. This was traced to lack of uniformity in the use of equivalent squares to calculate the output factor. The measured doses to axilla and lung are explained by photon and electron scattering effects. Centres, where dose compensation was included, had a superior dose homogeneity in the neck. The off-axis dose calculations depend on computer planning software but the magnitude of these differences is secondary to that of central axis mid-point dose differences. Improved consistency of dose calculation techniques between centres would enable more reliable dose response evaluation from multicentre clinical studies of Hodgkin's disease.

Australia↗
PubMed1989

Prevalence of retinopathy in diabetic subjects from out-patient clinics in Lombardy (Italy), and associated risk factors. A multicentre epidemiologic study.

There is little information on the prevalence of diabetic complications in Italy. For this reason, a multicentre population-based study was carried out in 1983-1985 in 12 representative out-patient clinics for the treatment of diabetes in the Lombardy region. Out of a total population of 17,704 patients 1160 diabetic subjects were randomly selected within strata based on their duration of disease (less than or equal to 5; 6-10; 11-20; greater than 20 years). Eight hundred and thirty-eight responders were examined using standardised protocols. The estimated prevalences (adjusted for duration of disease) for the total population involved in the study were 29.7% and 7.6% for background and proliferative retinopathy respectively. The overall standardised rates were higher in insulin-dependent diabetes mellitus (IDDM) (53.6%) than in non-insulin-dependent diabetes mellitus (NIDDM) (34.7%) for both background (41.1%, 28.4% respectively) and proliferative (12.5%, 6.2% respectively) retinopathy, and increased with the duration of disease. The analysis of the relationship between diabetic retinopathy and the calculated risk factors did not show any association with hypertension or metabolic control, except for post-prandial blood glucose in subjects with durations 6-10 and greater than 20 years; an association with azotaemia was found in subjects with durations less than or equal to 5 and 11-20 years. Diabetic retinopathy appeared to be independently associated with the type of treatment and not with the type of diabetes, metabolic control, or hypertension.

Diabetic Retinopathy↗
PubMed1990

Problems in the management of chronic hepatitis B with interferon: experience in a randomized, multicentre study.

In a multicentre trial, 82 patients known to be hepatitis B e antigen and hepatitis B virus DNA positive for at least 1 year, with elevated serum alanine aminotransferase levels and chronic liver lesions on biopsy, were randomized to receive either recombinant interferon alfa-2a at a dose of 4.5 million units thrice weekly for 4 months or no treatment. At the end of therapy, viral DNA clearance and aminotransferase normalization were significantly (p less than 0.05) more frequent in treated patients than in controls. After 16 months' follow up, the difference was still significant for hepatitis B e antigen clearance and transaminase normalization. Hepatitis B virus DNA reactivation was observed during follow up in 43% of treated patients and 50% of controls. Improvements in liver inflammation were observed in patients on interferon. High pre-treatment serum aminotransferase levels, female sex and a low score for fibrosis in the initial biopsy were predictive factors significantly (p less than 0.05) associated with termination of hepatitis B virus replication in treated cases. These results indicate that interferon is effective in inducing clearance of HBV from serum and improvement of biochemical and histological parameters of liver disease. However, a more prolonged regimen of therapy may be required to obtain stable suppression of hepatitis B virus replication.

Adult↗
PubMed1990

Ursodeoxycholic acid for the treatment of primary biliary cirrhosis. Interim analysis of a double-blind multicentre randomized trial. The UDCA-PBC Study Group.

Based on uncontrolled observations, we have proposed ursodeoxycholic acid (UDCA) as a novel therapeutic approach in primary biliary cirrhosis (PBC). To confirm and extend our original findings, we have designed a double-blind multicentre randomized clinical trial. An interim analysis was planned at 6 months, involving all subjects included in the trial, with a final analysis at 2 years. The UDCA-PBC trial began in June 1987 and will be completed in March 1990. Seventy patients were randomized to receive UDCA and 68 a placebo. The two groups were well matched with respect to age, sex, duration and prevalence of symptoms and histologic severity (50% of the UDCA group had stage III-IV disease vs. 37% of the placebo group). During the first 6 months of follow-up, six patients withdrew from the trial. At 6 months, the proportion of patients with jaundice was significantly lower (p less than 0.01) in UDCA recipients than in the placebo group. There was a similar decrease in the proportion of patients with pruritus and fatigue in both groups. The following laboratory test values were significantly lower in UDCA recipients than in the placebo group after 6 months of therapy: serum bilirubin, alkaline phosphatase, alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyltranspeptidase activities (p less than 0.001), cholesterol (p less than 0.003) and IgM levels (p less than 0.03). The results of this interim analysis confirm and extend the biochemical data provided by our previous pilot study. However the final analysis of the trial is necessary for a definitive assessment of the safety and efficacy of UDCA therapy in PBC.

Adult↗
PubMed1988

A multicentre study to compare piperacillin with the combination of netilmicin and metronidazole for prophylaxis in elective colorectal surgery undertaken in district general hospitals.

We have conducted a multicentre randomized study to compare piperacillin with the combination of netilmicin and metronidazole in patients undergoing elective colorectal surgery. There was no significant difference in the incidence of operation-related infection, chest or urinary tract infection. Major life-threatening sepsis occurred in 6% and the overall incidence of operation-related infection was 24%. Organisms which normally inhabit the bowel lumen were cultured from most of the postoperative infections; however, Staphylococcus aureus was isolated as a causative organism in nine patients in the piperacillin group compared with none in the netilmicin and metronidazole group. We are concerned at the high incidence of infection in both groups, and we believe that other factors in addition to prophylactic antibiotics need to be evaluated if the incidence of infection is to be reduced further.

Adult↗
PubMed1989

Home parenteral nutrition in adults: a multicentre survey in Europe.

This registry describes a multicentre experience of Home Parenteral Nutrition (HPN) in nine European countries covering 27 centres and 194 patients. The main purpose of this study was to evaluate the quality of life and prognosis of patients on HPN. Patients started HPN at 44 +/- 1 years old (mean +/- SEM), and received 200 courses of HPN for a mean of 12 +/- 1 months representing a cumulative duration of 207 years. The four commonest indications for HPN were inflammatory bowel disease (30%), mesenteric vascular disease (21%), malignancy (17%) and radiation enteritis (13%). The nutritional status during HPN was clinically normal or subnormal in 93% of cases. The yearly incidence of catheter related complications leading to a catheter change was 0.74, sepsis accounting for half of this. The duration of hospital readmission for HPN complications was 4 +/- 1% of time spent at home, which represents 2 weeks per year and 41% of the total readmission time. Mortality was mainly influenced by the underlying disease since only 3% of patients died of HPN complications. A good social rehabilitation was observed in 52% of patients who during treatment recovered their pre-HPN occupational status. The poorest social rehabilitation was observed in patients over 65 years of age, and patients with malignancies and radiation enteritis, who also had the poorest prognosis. Caution seems necessary before recommending HPN in these patients.

Journal Article↗
PubMed1987

A randomized, prospective, comparative, multicentre trial of a single combination versus alternating combinations of antitumour drugs in advanced breast cancer.

A prospective, multicentre trial was conducted in 262 patients with advanced breast cancer randomized to receive every 3 weeks either: (i) a single five-drug combination of adriamycin (50 mg), vincristine (1.5 mg) and 5-fluorouracil (750 mg) given intravenously; with methotrexate (50 mg) intramuscularly and chlorambucil (10 mg) orally all at time zero, followed by three further doses of chlorambucil (10 mg) at 6-h intervals, or (ii) one course of two alternating three-drug combinations consisting of regimen A--vincristine (1.5 mg), adriamycin (70 mg) and methotrexate (50 mg) and regimen B--5-fluorouracil (750 mg) and vindesine (5 mg) intravenously with cyclophosphamide (50 mg) orally at time zero, followed by three further doses of cyclophosphamide (50 mg) at 6-h intervals. Results show that overall response rates to chemotherapy were comparable in the two arms of this study being 63% (83 of 131 patients) for the single combination and 64% (84 of 131 patients) for the alternating combinations. Response rates according to menopausal status indicate no significant difference for the two arms of this study. However overall, combining all patients treated with either the single or the alternating combinations, post-menopausal patients had a significantly lower response rate (57%) compared with pre-menopausal patients (76%), P less than 0.05. Overall serious side-effects were minimal and were similar in both treatment groups. Response durations and overall survival data, which are essentially similar for the two treatment groups, proved disappointing with a median response duration of only approx. 6 months and overall median survival only slightly in excess of 1 year. Alternative treatment approaches are needed to maintain the remissions initially achieved in metastatic breast cancer.

Adult↗
PubMed1987

Late deaths and second primary malignancies among long-term survivors of childhood cancer: an Italian multicentre study.

A multicentre registry of children who had been successfully removed from therapy for some common childhood cancers (Hodgkin's disease, non-Hodgkin's lymphoma, neuroblastoma, nephroblastoma, acute lymphatic leukaemia and other leukaemias) was established in Italy in 1981. The present study describes mortality and occurrence of second primary malignancies (SPMs) among 1467 children who were alive when the registry was established. Follow-up ended on December 31, 1983 for mortality and 1 year later for the occurrence of SPMs. Sixty-seven deaths were recorded, 11 of which were due to causes other than progression of the original disease. Eleven incident SPMs were identified (i.e. 3 acute myeloid leukaemias, 3 thyroid carcinomas, 1 bilateral breast carcinoma, 1 liver malignant mesenchymoma, 1 astrocytoma, 1 chondrosarcoma and 1 osteosarcoma) corresponding to an incidence rate of 2.1/1000 patient-years at risk. Anecdotal reports were collected regarding 2 further SPMs (a thyroid carcinoma and a myeloid leukaemia) as well as several benign tumours, including 2 mammary fibroadenomas.

Child↗
PubMed1988

Tamoxifen plus bromocriptine versus tamoxifen plus placebo in advanced breast cancer: results of a double blind multicentre clinical trial.

We carried out a double blind multicentre clinical trial in which 171 patients with advanced breast cancer were randomized to receive tamoxifen (30 mg/day) + bromocriptine (5 mg/day) or tamoxifen + placebo. No difference was found in the overall response rates in the two groups (37.5% for placebo; 38% for bromocriptine) or in subgroups (breast tumours, lymph nodes, lung, bone, skin metastases). Tolerability was good in both groups. Within the limits of the statistical power of the test (80%), our results do not show any benefit when bromocriptine was added to tamoxifen.

Antineoplastic Combined Chemotherapy Protocols↗