Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Multicentre”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,171 records · Page 65Linked to original sources
PubMed2002

Sulodexide in the treatment of intermittent claudication. Results of a randomized, double-blind, multicentre, placebo-controlled study.

AIMS: Patients with peripheral arterial obstructive disease require treatment to prevent major cardiovascular events and to relieve intermittent claudication. The walking performance of peripheral arterial obstructive disease patients was used to evaluate the usefulness of sulodexide, a glycosaminoglycan containing fast moving heparin and dermatan sulphate. METHODS AND RESULTS: A randomized, multicentre, double-blind, placebo-controlled study was performed in 286 patients with Leriche-Fontaine stage II peripheral arterial obstructive disease. Patients received placebo (n=143) or sulodexide (n=143) for 27 weeks. The primary end-point was the doubling of the pain-free walking distance at the end of treatment, and this was achieved by 23.8% of patients treated with sulodexide and 9.1% of those on placebo (P=0.001). The pain-free walking distance increased on average (+/-SE) by 83.2+/-8.6 m (+64.7% from baseline) with sulodexide and 36.7+/-6.2 m (+29.9% from baseline) with placebo (P=0.001). The maximum walking distance increased by 142.3+/-15.8 m (+76.0% from baseline) and 54.5+/-8.4 m (+27.9% from baseline) (P<0.001), respectively. Results for patients with type II diabetes were similar to those for non-diabetic patients. Plasma fibrinogen decreased with sulodexide, but increased with placebo. CONCLUSION: Sulodexide improved the walking ability of peripheral arterial obstructive disease patients to a significantly greater extent than placebo, with a concurrent significant decrease in fibrinogen. The treatment was well tolerated.

Aged↗
PubMed2002

Exercise-electrocardiography and/or pharmacological stress echocardiography for non-invasive risk stratification early after uncomplicated myocardial infarction. A prospective international large scale multicentre study.

AIMS: The aim of the present study was to assess the relative prognostic value of clinical variables, the exercise electrocardiography test and the pharmacological stress echocardiography test either with dipyridamole or dobutamine early after a first uncomplicated acute myocardial infarction in a large, multicentre, prospective study. METHODS AND RESULTS: Seven hundred and fifty-nine in-hospital patients (age=56+/-10 years) with a recent and first clinical uncomplicated myocardial infarction, with baseline echocardiographic findings of satisfactory quality, an interpretable ECG and able to exercise underwent a resting 2D echocardiogram, a pharmacological stress test with either dipyridamole or dobutamine and an exercise electrocardiography test at a mean of 10 days from the infarction; they were followed-up for a median of 10 months. During the follow-up, there were 13 deaths, 23 non-fatal myocardial infarctions and 59 re-hospitalizations for unstable angina. When all spontaneous events were considered, with multivariate analysis, the difference between the wall motion score index at rest and peak stress (delta wall motion score index), and exercise duration were independent predictors of future spontaneous events (relative risk 7.2; 95% CI=2.73-19.1; P=0.000; relative risk 1.1, 95% CI=1.02-1.18; P=0.008, respectively). Kaplan-Meier survival estimates showed a better outcome for those patients with a negative pharmacological stress echocardiography test compared to patients with low dose positivity (94.7 vs 74.8%, P=0.000). CONCLUSION: Stress echocardiography tests provide stronger information than historical and exercise electrocardiography test variables. Pharmacological echocardiography as well as the exercise ECG is able to predict all spontaneously occurring events when the presence as well as the timing, severity, and extension of stress-induced wall motion abnormalities are considered.

Aged↗
PubMed1999

Antiarrhythmic benefits of dual chamber stimulation with rate-response in patients with paroxysmal atrial fibrillation and chronotropic incompetence: a prospective, multicentre study.

BACKGROUND: While the haemodynamic benefits of DDDR pacing compared with DDD pacing in patients with brady-tachy syndrome and chronotropic incompetence (CI) are well demonstrated, the antiarrhythmic advantage is controversial and so far not clearly demonstrated. AIM: We have performed a prospective, randomized, multicentre study to evaluate the efficacy of DDDR and DDD pacing modes in preventing paroxysmal atrial fibrillation (PAF) episodes in patients with brady-tachy syndrome and CI. METHODS AND RESULTS: Seventy-eight patients were included in the study. All patients had a dual chamber pacemaker implanted and were randomly programmed to DDD or DDDR with a cross over (DDD --> DDDR or vice versa) at 3 months. The final evaluation was performed at 6 months by means of two self-administered symptom questionnaires to evaluate activity. Symptoms of palpitations were analysed and scored. The patients were less symptomatic with the DDDR mode. The number of mode-switch activations compared with symptomatic episodes of PAF confirmed the high rate of asymptomatic PAF episodes in patients with brady-tachy syndrome. We conclude that in a small but well defined population of patients affected by sick sinus syndrome with CI and severely symptomatic PAF, DDDR pacing compared with DDD pacing may offer an additional antiarrhythmic benefit and should be considered the primary mode of pacing.

Aged↗
PubMed2001

Colocalization of the viral interleukin-6 with latent nuclear antigen-1 of human herpesvirus-8 in endothelial spindle cells of Kaposi's sarcoma and lymphoid cells of multicentric Castleman's disease.

Human herpesvirus-8 (HHV-8) also called Kaposi's sarcoma-associated herpesvirus infects spindle cells in Kaposi's sarcoma (KS) and lymphoid cells in multicentric Castleman's disease (MCD). In KS cells, HHV-8 is mainly latent with the expression of latent nuclear antigen-1 (LNA-1), whereas in MCD both lytic and latent antigens are produced by lymphoid cells. We show by immunohistochemical labeling that in KS viral interleukin-6 (vIL-6) is expressed in rare spindle cells, whereas in MCD, vIL-6 is detectable in lymphoid cells around lymphoid follicles but also within the follicular dendritic reticulum cell network. The staining of apoptotic bodies with anti IL-6 antibody suggests the achievement of a complete lytic cycle in a subset of lymphoid cells. Interestingly, in MCD, some areas contained vascular spindle cells latently infected by HHV-8 on the basis of LNA-1 expression. This finding might imply that in MCD, both vascular and lymphoid cells proliferate in response to the viral infection. Double immunostaining with anti LNA-1 and anti vIL-6 in MCD and KS identifies 2 subsets of HHV-8 infected (vascular and lymphoid) cells, some with exclusive expression of LNA-1 and some with coexpression of vIL-6 and LNA-1. This suggests that in vivo the regulation of the expression vIL-6 and LNA-1 protein varies with the cell type. In addition, the detection of infected endothelial cells in MCD may indicate that these cells belong to the reservoir for HHV-8.

Apoptosis↗
PubMed2004

Multicentric Castleman's disease associated with glomerular microangiopathy and MPGN-like lesion: does vascular endothelial cell-derived growth factor play causative or protective roles in renal injury?

A 52-year-old Japanese man presented with fever spikes, generalized fatigue, anorexia, and anasarca. The patient was referred for the evaluation of fever of unknown origin in association with swelling of cervical, axillary, and inguinal lymph nodes. He also manifested nephrotic syndrome, acute renal failure, hepatosplenomegaly, massive pleural effusion, ascites, disseminated intravascular coagulation, and hypergammaglobulinemia. C-reactive protein was positive and plasma vascular endothelial cell-derived growth factor (VEGF) and serum interleukin-6 levels were markedly elevated. Lymph node biopsy results showed that findings were compatible with Castleman's disease of hyaline vascular type associated with interfollicular plasmacytosis. In conjunction with the clinical findings, a diagnosis of multicentric Castleman's disease was made. The patient underwent renal biopsy because of nephrotic syndrome, and the results showed proliferation of mesangial cells, lobulation of glomeruli, and tram track pattern of the capillary wall without immune complex deposition. Electron microscopy showed widening of the subendothelial space. No electron-dense deposits were present in both mesangial and subendothelial regions. Pathologic features were compatible with glomerular microangiopathy and membranoproliferative glomerulonephritis-like lesions. With corticosteroid therapy, systemic symptoms disappeared; both VEGF and interleukin-6 levels were normalized, and he went into complete remission of nephrotic syndrome. In this article, the role VEGF plays in the pathogenesis of nephrotic syndrome and glomerular microangiopathy is discussed.

Acute Kidney Injury↗
PubMed2006

Renal involvement in multicentric Castleman disease with glomeruloid hemangioma of skin and plasmacytoma.

A 47-year-old man presented with fever of unknown origin, generalized weakness, edema, and renal failure. He had left-sided pleural effusion, generalized lymphadenopathy, multiple nontender cutaneous nodules, hepatomegaly, renal failure, and hypergammaglobulinemia. Axillary lymph node biopsy showed findings consistent with Castleman disease of the hyaline vascular type associated with interfollicular plasmacytosis. A renal biopsy performed in view of proteinuria and acute renal failure showed hypercellular glomeruli with capillary loop thickening and double contours consistent with membranoproliferative glomerulonephritis. Skin nodule biopsy showed a glomeruloid hemangioma characterized by dermal proliferation of capillary loops in a nodular manner resembling a glomerulus. He experienced clinical and biochemical remission with steroids. Discontinuation of steroid therapy was associated with recurrence of renal failure, reappearance of nodules, lymphadenopathy, and appearance of bony lytic lesions. Biopsy of bony lytic lesions showed plasmacytoma. The patient achieved complete remission on treatment with steroids and cyclophosphamide and is free of symptoms at the end of 40 months of follow-up. To our knowledge, this is the first case report of the occurrence of membranoproliferative glomerulonephritis, glomeruloid hemangioma of the skin, and plasmacytoma in a patient with multicentric Castleman disease without human immunodeficiency virus infection.

Biopsy↗
PubMed2005

Multicentric contiguous variant of epithelioid angiosarcoma of the bone. A rare variant showing angiotropic spread.

Epithelioid angiosarcoma of the bone is a rare tumor and is a diagnostic challenge. Here we present an autopsy case of a 62-year-old man with multifocal osteolytic lesions in the extremities and the pelvis. The initial diagnosis of a tibial biopsy was poorly differentiated adenocarcinoma. On the occasion of autopsy, a fungating thrombotic nodule was found at the anterior wall of the right atrium, and small hemorrhagic infarcts with tumor thrombi were found in the lung. Histologically, the above lesions were identical to the former tibial biopsy and they showed large eosinophilic epithelioid cells with irregular ovoid nuclei and prominent eosinophilic nucleoli. Rare intracytoplasmic lumina were identified. Immunohistochemically, the tumor cells were positive for cytokeratins (CAM5.2 and AE1/AE3), CD31, factor VIII-related antigen, and vimentin. This case showed angiotropic spread of the tumor only to the right atrium and the lung, with no solid mass in other organs. Multicentric epithelioid angiosarcoma of the bone is a pitfall in pathological diagnoses, especially if a strong radiological impression of metastatic carcinoma is provided. Therefore, pathologists should be aware of this rare variant.

Adenocarcinoma↗
PubMed1999

Immune-mediated haemolytic anaemia in two sibling cats associated with multicentric lymphoblastic infiltration.

Immune-mediated haemolytic anaemia associated with multicentric lymphoblastic infiltration is reported in two sibling cats. Both cats presented at under 16 months of age with clinical signs of acute anaemia. In each case there was autoagglutination, a positive Coombs' test and the anaemia was regenerative. At presentation, both cats were negative for FeLV antigen. In each case, the disease proved fatal within 2 months of the initial diagnosis. In both cases, T-lymphoblastic infiltration of bone marrow, liver and spleen was found at post-mortem examination.

Anemia, Hemolytic, Autoimmune↗
PubMed2002

Surveillance of methicillin-resistant Staphylococcus aureus (MRSA) and Enterobacteriaceae producing extended-spectrum beta-lactamase (ESBLE) in Northern France: a five-year multicentre incidence study.

In order to measure the incidence of methicillin-resistant Staphylococcus aureus (MRSA) and of Enterobacteriaceae producing extended-spectrum beta-lactamase (ESBLE), and to evaluate the impact of the national guidelines for multidrug-resistant bacteria (MDRB) prevention in hospitals of Northern France, a multicentre study was conducted for three months every year starting in 1996, in volunteer hospital laboratories. All clinical specimens positive for MRSA and ESBLE were prospectively surveyed. During the five-year surveillance period, the overall proportion of MRSA was 38.4% in the 28,534 strains of S. aureus, and that of ESBLE was 11.4% in the 6121 strains of Klebsiella pneumoniae and 47.7% in the 2353 strains of Enterobacter aerogenes. The overall incidence rates of clinical specimens positive for MRSA, ESBL-K. pneumoniae and E. aerogenes were 0.84. 0.05 and 0.12/1000 hospital-days (HD), respectively. In the 23 hospitals that participated in the survey every year, the proportion and incidence of ESBLE decreased. Hence, despite recommendations as for isolation precautions, MRSA remains poorly controlled and requires more effective measures.

Anti-Bacterial Agents↗
PubMed2002

Efficacy and safety of oxitropium bromide, theophylline and their combination in COPD patients: a double-blind, randomized, multicentre study (BREATH Trial).

We compare the efficacy including spirometry, peak expiratory flow (PEFR) and quality of life and safety of an 8-week treatment with inhaled oxitropium, theophylline or their combination in patients with mild-to-severe chronic obstructive pulmonary disease (COPD). We conducted a multicentre, double-blind, double-dummy randomized, parallel-group study at 29 Italian outpatients clinics. A group of 236 patients with mild-to-severe COPD (baseline FEV1 < or = 70% of predicted value) were recruited. Treatments were as follows: Inhaled oxitropium bromide 200 microg (N=75), sustained-release oral theophylline 300 mg (N=81) or their combination (N=80), taken twice daily. Spirometry (FEV1 and FVC) was evaluated every 4 weeks, and morning and evening PEFR (before and 2-4 h after drug intake) was measured daily. Symptoms, cough and dysponea, were recorded daily. Health status was evaluated at baseline and week 8 using the disease specific St George' Respiratory Questionnaire (SGRQ). Any adverse event occurring during the treatment period was recorded on a diary card. FEV1 and FVC improved in all the groups at 4 and 8 weeks, but the difference between treatment groups did not reach statistically significant levels. Differences between groups in pre-dosing morning and evening PEFR were not significant. Post-dosing morning and evening PEFR were increased and the largest increase was seen in patients treated with both drugs. However, differences between groups was significant only for evening values (P=0.008). The proportion of patients who experienced a decrease in symptoms was high in all groups but no differences among groups were observed. SGRQ total scores decreased in all treatment groups after 8 weeks, particularly in the oxitropium and combination groups. Clinically significant change (> or = 4 units) was only observed in patients treated with oxitropium bromide whether with or without theophylline. Adverse events related to treatments were higher in the group treated with theophylline alone (P < 0.02). We conclude that inhaled oxitropium bromide alone was associated with an improvement in FEV1, PEFR and symptoms in patients with COPD that was not statistically different from that of oral theophylline alone or of the combination of both drugs. Oxitropium bromide in combination with theophylline provided a greater improvement in evening post-dosing PEFR. Oxitropium bromide alone or in combination with theophylline improved the quality of life better than theophylline alone.

Aged↗
PubMed2000

Long-term open multicentre, add-on trial of vigabatrin in adult resistant partial epilepsy. The Canadian Vigabatrin Study Group.

Vigabatrin (VGB) has been shown in a number of clinical trials with varying designs to be effective and well-tolerated as both add-on therapy and monotherapy in epilepsy with partial seizures with or without secondary generalization as well as in infantile spasms. The present study is an open, long-term (1 year) extension of a randomized double-blind placebo-controlled multicentre Canadian trial of VGB in resistant partial adult epilepsy. The present study was designed to examine the safety and long-term efficacy of VGB. Completers of the preceding double-blind study had their dose of VGB titrated to 4 g/day over 3 weeks. Patients were evaluated every 2-4 weeks and at week 14 were allowed to continue only if they achieved a 50% seizure reduction compared with pre-VGB baseline. In addition to neurological and physical examinations, safety was assessed by a cognitive psychosocial test battery, visual and somatosensory evoked potentials and MRI scans. Ninety-seven of 100 eligible patients entered the study, 53 of whom completed the 52 weeks. Fifty-eight percent of the patients had a greater than 50% seizure reduction in seizures vs. pre-VGB baseline. Seizure reductions of 56% and 45%, respectively, were seen in the VGB and placebo groups from the preceding study. Fifty-four percent of patients were judged by the investigators to have experienced at least a moderate therapeutic effect. Discontinuations were 29% for lack of efficacy and 12% for adverse effects. There was a mean weight gain of 3.7 +/- 0.2 kg by end of study. Neurologica/psychiatric side effects were the most common reason for withdrawal including three behavioral reactions attributed to the drug which required temporary hospitalization. There were no abnormalities on laboratory or special tests and there was a tendency for improvement on most tests of cognitive function and mood. Vigabatrin, as an add-on agent, is well-tolerated and can be of long-term benefit in a substantial proportion of patients with intractable partial epilepsy.

Adolescent↗
PubMed2002

Low dose and slow titration of topiramate as adjunctive therapy in refractory partial epilepsies: a multicentre open clinical trial.

PURPOSE: A multicentre open clinical trial was conducted to evaluate the clinical usefulness of a slower titration of topiramate (TPM) to 300 mg /day as adjunctive therapy for medically intractable partial epilepsies. METHODS: Nineteen centres participated in the trial. Study patients had to have had two or more seizures per 4 weeks whilst taking maximum tolerated doses of one but not more than two anti-epileptic drugs. The starting dose of TPM was 25 mg /day and the dose was increased weekly by 25 mg /day until 100 mg /day was reached. Thereafter TPM was increased by 50 mg /day weekly up to the target dose of 300 mg /day, which was followed by an 8 week maintenance phase. Seizure outcomes were measured by intention-to-treat analysis (ITTA). RESULTS: Two hundred and thirteen patients entered the study. Median seizure frequency reduction rate was 44.8%, responder rate was 47.6%, and seizure free rate was 9.0%. These results were comparable to that of TPM 600 mg /day in our previous controlled trial. In subgroup analysis, seizure free rate was higher in those patients with a lower baseline seizure frequency rate. Seventeen patients (8.0%) were prematurely withdrawn from the study due to adverse events (AE) or lack of effect. One or more AEs were reported in 22% of patients, with dizziness being the most frequent AE. Other AEs occurred in less than 5% of patients. CONCLUSION: TPM 300 mg /day was effective and in conjunction with a slower dose-titration, markedly reduced the incidence of AEs, compared with previous study.

Adolescent↗
PubMed2001

Carboplatin plus paclitaxel in extensive small cell lung cancer: a multicentre phase 2 study.

A multicentre phase 2 trial (single-stage design) was undertaken to test the efficacy and toxicity of carboplatin (AUC 6 according to Calvert) plus paclitaxel (175 mg/m(2)3-h infusion) every 4 weeks in the first line treatment of patients affected by extensive small cell lung cancer. The primary end-point of the trial was the objective response rate. 31 objective responses among 50 patients were considered necessary to proceed to a phase 3 trial. 48 patients were enrolled (median age 59 years). Treatment was very well tolerated. 3 patients (6.2%) had a complete response and 23 (47.9%) a partial response, for an overall response rate of 54.2% (95% CI: 39.2-68.6). Median time to progression was 5.7 months (95% CI: 5.2-6.2). Median survival was 9.6 months (95% CI: 7.2-14.6), with a median follow-up time of alive patients of 12 months. At 1 year, the probability of being progression-free or alive was 0.16 and 0.43, respectively. In conclusion, carboplatin plus paclitaxel as given in the present study is very well tolerated but not sufficiently active to warrant phase 3 comparison with standard chemotherapy regimens.

Adult↗
PubMed2001

Depression, anxiety and quality of life among scheduled cosmetic surgery patients: multicentre prospective study.

Objective: To measure cosmetic surgery patients' state of psychological vulnerability. Method: A multicentre prospective study was carried out in three hospital departments. One hundred and three patients scheduled for cosmetic surgery were examined using a structured interview and using three assessment scales: the MADRS (Montgomery and Asberg Depression Rating Scale), the SISST (Social Interaction Self Statement Test) and the EQ-5D (EuroQol) which measures quality of life. Results: The MADRS index was higher than that of the control group (p<0.01) with 20% depressive patients. SISST: the social anxiety was greater than that of the control group (p<0.001). The EQ-5D visual analogue scale average was 77.39% indicating that there was no significant difference when compared with the control group, but the descriptive EQ-5D revealed an over-representation of the anxiety/depression category (p<0.01); 50% had already taken psychotropic treatment of which 27% were an antidepressant. Conclusion: The cosmetic surgery population presents a significant state of psychological vulnerability. Copyright 2001 European Association for Cranio-Maxillofacial Surgery.

Journal Article↗
PubMed1999

Italian multicentre study of carpal tunnel syndrome. Differences in the clinical and neurophysiological features between male and female patients.

The Italian Carpal Tunnel Syndrome Study Group has carried out a multicentre study on 1123 hands with idiopathic carpal tunnel syndrome. We have compared the findings on clinical examination, the neurophysiological data and a patient-oriented assessment in men and women. The patient-oriented assessment showed that men complain of less discomfort than women; clinical examination was similar in the two populations and neurophysiological investigations showed greater changes in men.

Adult↗
PubMed1977

Multicentric early gastric carcinoma mimicking type I (10 years after B-I-surgery).

10 YEARS AFTER B-I-partial gastrectomy for a proven benign gastric ulcer a multicentric early gastric carcinoma type II b, c was detected by endoscopy and histology. This early carcinoma differed from published cases in respect of its macroscopic classification, localization and expansion. The carcinoma situated next to the anastomosis invaded the duodenal mucosa. It also invaded a polypoid fold caused by the previous surgery, thus imitating an early gastric carcinoma type I.

Adenocarcinoma, Mucinous↗
PubMed2002

Local treatment of vaginal infections of varying etiology with dequalinium chloride or povidone iodine. A randomised, double-blind, active-controlled, multicentric clinical study.

This randomised, double-blind, multicentric clinical study compared the efficacy and tolerability of the two vaginal antiseptics, 10 mg dequalinium chloride (CAS 522-51-0, Fluomycin N) and 200 mg povidone iodine (CAS 25655-41-8), in a parallel-group design. A total of 180 patients with vaginal infections of varying etiology participated in this study (bacterial vaginosis, fluor vaginalis, vulvo-vaginal candidiasis, trichomoniasis). Patients were randomly allocated to one of the two treatment groups and were treated once per day for 6 days. Control examinations took place 5 to 7 days after the end of treatment, and 3 to 4 weeks after the first control examination. The total symptoms score, a summary score for the clinical symptoms, discharge, burning, pruritus, redness of vulva/vagina, was defined as primary efficacy parameter. The treatments at the first control examination were compared in the full analysis set using the Wilcoxon-Mann-Whitney U-test, 2-sided, thereby proving equivalence of both treatments at the 5% level. Both treatments strongly improved the symptoms of vaginal infections both on short-term and long-term follow-up. Descriptive analysis of the secondary parameters, vaginal pH, degree of purity of the vaginal flora, and number of lactobacilli in the wet mounts, supported the comparable efficacy of both therapies to restore the vaginal milieu. Analysis of the diagnostic subgroups indicated that irrespective of the diagnosis, both treatments improved the efficacy criteria as observed for the entire population. The global assessment of the therapeutic efficacy by investigators and patients supported the results of the efficacy analysis with good to very good ratings in 70-90% of the cases. A good tolerability of both preparations was observed in this study with a low number of adverse events in the test group (5.8%).

Adolescent↗