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 577 records · Page 32Linked to original sources
PubMed1992

Activity and acceptability of piribedil in Parkinson's disease: a multicentre study.

Several controlled trials have shown that the dopamine agonist, Trivastal (piribedil), is active in the treatment of Parkinson's disease, particularly with regard to tremor. To determine its efficacy as monotherapy in patients previously untreated with levodopa, a 3-month multicentre study was conducted with Trivastal 50 mg LP in 113 patients with idiopathic Parkinson's disease. The study population consisted of 66 men and 47 women, aged 63.1, SD 0.6 (43-79) years with a 2.1, SD 0.2 (1-15) year history of Parkinson's disease. Mean disease stage was 1.82 (1-4) by the Hoehn and Yahr classification. Tremor was the predominant clinical feature in 42 patients; the remaining 71 patients displayed the full parkinsonian syndrom. Trivastal 50 mg LP was prescribed stepwise up to doses of 150-250 (207, SD 6.4) mg/day at the end of 3 months. No concomitant anti-parkinsonian medication was given. Patients were clinically assessed at 1, 2 and 3 months on the Webster scale, a specific tremor scale and the HARD depression scale. Mean results were as follows in the 90 patients completing the study. On the Webster scale, tremor fell from 1.7 to 1 (-41%, P less than 0.001), bradykinesia from 1.5 to 0.8 (-47%, P less than 0.001) and rigidity from 1.3 to 0.9 (-31%, P less than 0.001); on the specific scale, rest tremor decreased in daily duration and amplitude from 3.9 to 2.4 (-39%, P less than 0.001) and from 2.9 to 2.1 (-35%, P less than 0.001), respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1996

Technetium-99m tetrofosmin rest/stress myocardial SPET with a same-day 2-hour protocol: comparison with coronary angiography. A Spanish-Portuguese multicentre clinical trial.

Technetium-99m tetrofosmin (Myoview) has unique properties for myocardial perfusion imaging very early after injection of the tracer. We used a very short same-day rest/stress protocol, to be performed within 2 h and evaluated its diagnostic accuracy. The study included 144 patients from seven Spanish and four Portuguese centres with a diagnosis of uncomplicated coronary artery disease (CAD); 78 patients (54%) had no history of prior myocardial infarction. Patients were injected with </=300 MBq 99mTc-tetrofosmin at rest and </=900 MBq approximately 1 h later at peak exercise. Single-photon emission tomographic (SPET) acquisitions were initiated within 5-30 min post injection. The results were compared with those of coronary angiography (CA). The data of 142 patients were completely evaluable (two with non-evaluable images were excluded). The quality of rest images was excellent or good in 86%, regionally problematic in 7%, poor but well interpretable in 5% and non-evaluable in 2%. The overall sensitivity for the detection of CAD was 93%, the specificity 38% and the accuracy 85%. The localization of defects by SPET in relation to the perfusion territories of stenosed vessels (>/=50%) was achieved with a sensitivity of 64% for the left anterior descending artery, 49% for the left circumflex artery and 86% for the right coronary artery, and an accuracy of 71%, 72% and 73% respectively. Concordance of SPET and CA was 62% for single-vessel disease and 68% for multivessel disease. In conclusion, this Spanish-Portuguese multicentre clinical trial confirmed, in a considerable number of patients who underwent coronary angiography, the feasibility of 99mTc tetrofosmin (Myoview) rest/stress myocardial SPET using a very short protocol (2 h).

Coronary Angiography↗
PubMed1989

Long-term follow-up of patients with persistent/recurrent, isolated haematuria: a Hungarian multicentre study.

A retrospective multicentre study of 341 children with persistent/recurrent, isolated haematuria is described. The haematuria was isolated for at least 6 months at the beginning of observation. The duration of follow-up was 2-5 years in 201, 5-10 years in 119, 10-15 years in 19, and over 15 years in 2 cases. Of these patients 47.8% became symptom-free. In 18.4% the haematuria remained isolated; in 13.8% it was combined with proteinuria over 250 mg/day more than 2 years later. The occurrence of associated proteinuria increased progressively with time. It was 8.6% between the 3rd and 5th years, and 37.0% after the 5th year. Renal biopsy was performed because of the symptoms of glomerular disease in 47 cases at an average time of 12 months following the appearance of proteinuria. Proteinuria appeared after a 2-5, 5-10, 10-15 and more than 15 years follow-up period in 16, 23, 6, and 2 patients respectively; 14 of them had Alport's nephropathy. The percentage of more serious azotaemia was 1.7 (creatinine clearance: 10-50 ml/min per 1.73 m2) and 0.3 (creatinine clearance: less than 10 ml/min per 1.73 m2). Mortality was 0.58%. Most of the patients who developed severe azotaemia had persistent microscopic haematuria at the beginning. The prevalence of hypertension was only 1.2%. The time of its appearance was above 5 years in 2 and below 5 years in 2 cases. All these patients had chronic glomerulonephritis. The haematuria was associated with hypercalciuria in 19.9%. In 14.3% of the overall group of patients urolithiasis developed 2-15 years after onset. All of these had hypercalciuria.(ABSTRACT TRUNCATED AT 250 WORDS)

Child↗
PubMed1983

Synchronous multicentric osteosarcoma.

A case of synchronous multicentric osteosarcoma is reported in an 11-year-old boy. This very rare condition is characterized by simultaneous involvement of multiple skeletal sites, and the prognosis is generally poor.

Bone Neoplasms↗
PubMed1994

Multicentric extraabdominal desmoid tumour: a case report.

The very rare condition of multicentric desmoid tumours involving two distant and apparently independent sites is reported in a 17-year-old man. The tumours grew simultaneously and reached approximately equal size. No evidence of familiar polyposis or any other feature of Gardner's syndrome were noted. The proximal desmoid tumour developed from the left hip region and extended into the femoral bone, whereas the distal mass was attached to the left popliteal fossa infiltrating the flexor muscles, the nerves and vessels. On the basis of the good results published recently in the literature and our own earlier experiences, the intralesional resection of the desmoid tumours was completed with postoperative fractionated radiotherapy.

Adolescent↗
PubMed1998

A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets.

A Danish multicentre study was undertaken of the manifestations, infections, thrombotic events, survival and predictive factors of survival in 513 Danish patients with systemic lupus erythematosus (SLE) according to the 1982 classification criteria of the American College of Rheumatology. The mean duration of follow-up was 8.2 years from diagnosis and 12.8 years from first symptom. This paper describes the most common clinical and laboratory manifestations and their relationship to sex and age at the time of onset and diagnosis. Cluster analysis revealed three clinically defined clusters at the time of disease onset. Cluster 1 (57% of patients) consisted of relatively elderly patients without nephropathy or malar rash, but with a high prevalence of discoid lesions. Cluster 2 (18%) consisted of patients with nephropathy, a third of whom also developed serositis and lymphopenia. The patients of the third cluster (25%) all had malar rash and half were photosensitive. Follow-up showed that the patients of cluster 2 developed azotaemia, large proteinuria, arterial hypertension and myositis significantly more often than did the rest of the patients, but the mortality was not increased. The risk of developing renal end-stage disease was highest in men with early-onset disease.

Adolescent↗
PubMed1998

A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value.

In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91%, 76% and 64% after 1, 5, 10 and 15 years, respectively. The direct causes of death included SLE (n = 35), infections (n = 25), malignancy (n = 9), cardiovascular disease (n = 32) and other causes (n = 21). Uni- and multivariate analyses of survival and mortality were performed for all deaths and for SLE-related deaths. Azotaemia (one-fifth of the patients) was a strong predictor of increased overall and SLE-related mortality, but nephropathy per se (one-half of the patients) and large proteinuria (one-sixth of the patients) were unrelated to survival. Haemolytic anaemia had a significant negative influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival. Since 1980 the mortality caused by SLE manifestations has decreased significantly.

Adolescent↗
PubMed1994

Increased interleukin-6 (IL-6) production in a young child with clinical and pathologic features of multicentric Castleman's disease.

A 21-month-old boy presented with a papular rash, lymphoadenopathy, and splenomegaly. He developed symmetric polyarthritis, fever, and progressive glomerulonephritis. Serologies for viral agents including HIV were negative. Antinuclear antibody was transiently positive, but no anti-DNA antibodies were present. CH50 and serum C3 values were low. Biopsies of skin, kidney, bone marrow, and lymph node were obtained. There was a perivascular and periadnexal lymphocytic infiltrate in the skin, with a normal epidermis. Renal biopsy showed proliferative mesangial glomerulonephritis. Bone marrow showed an increased number of plasma cells. Lymph node showed histologic changes described in multicentric Castleman's disease including marked follicular hyperplasia, vascular proliferation, and interfollicular expansion with numerous plasma cells. IL-6 mRNA was demonstrated in cells in the marginal zone and interfollicular regions of the node by in situ hybridization. Likewise, the serum IL-6 level was elevated during a clinical exacerbation of the patient's nephritis. These data suggest an underlying lymphoproliferative disorder, such as Castleman's disease, with overproduction of IL-6 resulting in systemic features of the disease, including glomerulonephritis.

Castleman Disease↗
PubMedDate not supplied

Teicoplanin in the treatment of skin and soft tissue infections: results of a multicentre study.

The clinical efficacy and safety of teicoplanin was studied in hospitalized patients with skin and soft tissue infections. In an open multicentre study 64 patients were treated with teicoplanin i.v. and/or i.m. Predisposing or complicating factors for infection were present in almost 80% of the patients. Teicoplanin was usually given as an initial loading dose of 400 mg (87.1%), or 800 mg (6.5%) or various doses (6.5%). During the course of the study, the mean daily dose of teicoplanin was 261.3 mg. Sixty of the 62 evaluable patients responded to treatment. 58 gram-positive pathogens were isolated, consisting of Staphylococcus aureus (n = 41), coagulase-negative staphylococci (n = 6) and streptococci (n = 11). Elimination of pathogens was seen in 37/47 of all microbiologically evaluable cases. Persistence, recurrence or reinfection occurred in 7/47, 2/47 and 1/47, respectively. Adverse reactions were reported in only three patients with allergic reaction, local reaction and rise in transaminases in one case each. Therapy failed only in two patients.

Adolescent↗
PubMedDate not supplied

Total pancreatectomy for ductal adenocarcinoma of the pancreas with special reference to resection of the portal vein and multicentric cancer.

Between March 1, 1968 and March 1, 1986, 323 patients underwent surgery for cancer of the pancreas or the periampullary region. Extirpative procedures were performed in 91 patients, of whom 51 had ductal carcinoma of the pancreas. Forty-seven patients had total pancreatectomy, 9 associated with resection of the portal vein and 1 with total gastrectomy. Operative mortality was 15% but fell to zero for the 19 total pancreatectomies performed after 1981. With the introduction of total pancreatectomy, the resectability rate increased from 15% to 32%. Overall mean survival was 14.4 months. Actuarial survival was 42.4% at 1 year, 25.6% at 2 years, 11.9% at 3 years, and 8% at 5 years. Six patients are alive 7, 11, 14, 30, 30, and 73 months, respectively, after operation. Survival was calculated according to the classifications of Hermreck, Tryka and Brooks, and the TNM system. Ductal carcinoma was multifocal in 32% of patients, and 25% had epithelial dysplasia of the pancreatic duct. When portal vein resection was necessary, mean survival was 6.1 months, compared with 18.25 months when it was not performed. We conclude that total pancreatectomy has increased our resectability rate, mainly in patients with tumor spread beyond the usual margins of division for Whipple's procedure. However, the procedure does not appear worthwhile when portal vein resection is necessary or when multicentric cancer or neoplastic emboli are observed in the operative specimen.

Adult↗
PubMed1997

A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy.

The potent serotonin receptor (5-HT3) antagonists are new highly selective agents for the prevention and control of chemotherapy-induced nausea and vomiting that have been shown to be comparable to or more effective than traditional metoclopramide regimens. This study was designed to compare the antiemetic efficacy of dolasetron and metoclopramide in chemotherapy-naive and non-naive cancer patients receiving high-dose cisplatin-containing chemotherapy. This multicentre, double-blind, randomized trial compared the efficacy and safety of single i.v. doses of dolasetron mesilate salt (1.2 or 1.8 mg/kg) and metoclopramide (7 mg/kg) in 226 patients for the prevention of acute emesis and nausea associated with the administration of high-dose (> or = 80 mg/m2) cisplatin. Efficacy and safety were evaluated for 24 h. Complete responses were achieved by 57%, 48%, and 35% of patients given dolasetron mesilate 1.8 mg/kg (P = 0.0009 vs metoclopramide), dolasetron mesilate 1.2 mg/kg (P = 0.0058 vs metoclopramide), and metoclopramide, respectively. Overall, dolasetron was significantly more effective than metoclopramide for time to first emetic episode, nausea, patient satisfaction, and investigator global assessment of efficacy. Males, chemotherapy-naive patients, and alcoholics had higher response rates. Dolasetron was well tolerated, with mild-to-moderate headache most commonly reported. Twelve percent of patients receiving metoclopramide reported extrapyramidal symptoms compared with 0% of patients receiving dolasetron. In conclusion, dolasetron mesilate was effective for the prevention of CINV with high-dose cisplatin. Single i.v. doses of dolasetron mesilate were more effective than 7 mg/kg metoclopramide in preventing nausea and vomiting induced by highly emetogenic cisplatin-containing chemotherapy. In addition, 1.8 mg/kg dolasetron mesilate consistently produced the highest response rates and appears to be the most effective dose for further clinical development.

Acute Disease↗
PubMed1995

Multicentre comparative study of the efficacy and safety of azithromycin compared with amoxicillin/clavulanic acid in the treatment of paediatric patients with otitis media.

An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy, the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid (CA) given for ten days. A satisfactory response (cure plus improvement) was noted 10 to 14 days after the start of treatment in 199 of 215 (92.6%) azithromycin-treated children and in 186 of 198 (93.9%) amoxicillin/CA-treated children. The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum. Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin. Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4.5%) azithromycin-treated patients and in 20 of 240 (8.3%) treated with amoxicillin/CA. No patients in the azithromycin treatment group were withdrawn from treatment, but six amoxicillin/CA patients, including two < 2 years of age, discontinued treatment prematurely because of adverse events; the difference between treatment groups was statistically significant (p = 0.0146). It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media.

Amoxicillin↗
PubMed1998

Treatment of acute exacerbations of chronic bronchitis: comparison of trovafloxacin and amoxicillin in a multicentre, double-blind, double-dummy study. Trovafloxacin Bronchitis Study Group.

The efficacy and safety of trovafloxacin and amoxicillin were compared in a double-blind, double-dummy multicentre trial involving 412 patients (> or = 40 years of age) with acute exacerbations of chronic bronchitis (AECBs). Patients were randomized to 5 days' oral treatment with 200 or 100 mg trovafloxacin administered once daily, or 500 mg amoxicillin given three times daily. Overall clinical efficacy at the end of therapy was similar in each treatment group, with clinical success (cure+improvement) achieved in 88% and 91% of clinically evaluable patients receiving trovafloxacin 200 mg and 100 mg, respectively, and in 89% of amoxicillin-treated patients. Corresponding rates at follow-up were 77%, 85% and 79%, respectively. Similar responses were noted at the end of treatment and end of study in the intent-to-treat patients. Although all three treatments produced similar bacteriological efficacy, there was a trend towards higher eradication rates for Haemophilus influenzae among patients (both clinically evaluable and intent-to-treat populations) treated with trovafloxacin 200 mg compared with those treated with amoxicillin. Both drugs were well tolerated, with treatment-related adverse events, of which headache and gastrointestinal disturbances were the most common, occurring in 12% and 6% of patients in the trovafloxacin 200 mg and 100 mg groups, respectively, and in 9% of amoxicillin-treated patients.

Acute Disease↗
PubMed1997

Prospective, randomised, multicentre study of meropenem versus imipenem/cilastatin as empiric monotherapy in severe nosocomial infections.

The clinical and bacteriological efficacy and the tolerability of meropenem versus imipenem/cilastatin (both 1 g t.i.d.) in severe nosocomial infections were compared in a multicentre, randomised, nonblinded study. A total of 151 patients were recruited; 133 (66 meropenem, 67 imipenem/cilastatin) were clinically evaluable and 84 (42 meropenem, 42 imipenem/cilastatin) bacteriologically evaluable. Most clinically evaluable patients (90%) were in intensive care units, required mechanical ventilation (72%), and had received previous antibiotic therapy (62%). The mean (+/- SD) APACHE II score was 15.2 (+/- 6.6) in the meropenem group and 17.8 (+/- 6.8) in the imipenem/cilastatin group. The primary infections were nosocomial lower respiratory tract infections (56% of patients), intra-abdominal infections (15%), septicaemia (21%), skin/skin structure infections (5%), and complicated urinary tract infections (3%); 35% of the patients had two or more infections. There was no significant difference between the meropenem and imipenem/cilastatin groups in the rates of satisfactory clinical (weighted percentage 87% vs. 74%) or bacteriological (weighted percentage 79% vs. 71%) response. There was a slightly higher rate of clinical success with meropenem against primary or secondary lower respiratory tract infection (89% vs. 76%). Drug-related adverse events occurred in 17% and 15% of meropenem and imipenem/cilastatin patients, respectively. Meropenem (1 g t.i.d.) was as efficacious as the same dose of imipenem/cilastatin in this setting, and both drugs were well tolerated.

Adolescent↗
PubMed1997

Italian multicentre study of didanosine compassionate use in advanced HIV infection. Italian BMS-906 Study Group.

The aim of the present study, a multicentre trial of didanosine (ddI) compassionate use, was to identify factors associated with a better outcome in patients given ddI monotherapy. Enrolled were 1047 HIV-positive patients intolerant of and/or unresponsive to zidovudine (ZDV) therapy, with CD4+ cell counts of < 200/microliter or AIDS. Didanosine was given at a dose of 250 mg b.i.d. (patients > or = 60 kg) or 167 mg b.i.d. (patients < 60 kg). Clinical examinations and laboratory tests were performed every two months. Endpoints included death, the occurrence of a new AIDS-defining disease, or permanent discontinuation of ddI for a severe adverse event. At entry, the median CD41 cell count was 47/microliter and the median duration of prior ZDV treatment 19 months; 446 patients (43%) were classified as having AIDS. Severe toxicity occurred in 143 subjects (14%); the frequency of pancreatitis was very low (0.2%). The benefit in terms of CD4+ cell counts was greater for patients whose counts exceeded 100/microliter at entry and remained at this level until month 12 in those patients still receiving treatment. Death and/or new AIDS-defining events were observed in 374 cases (36%) over a median follow-up of eight months. AIDS dementia was observed in 11 patients (1%). Multivariate analysis of survival without disease progression showed that the factors associated with a worse outcome include the severity of immunodepression, a diagnosis of AIDS at entry, and a history of both intolerance of and clinical resistance to ZDV. Surprisingly, the patients who had received previous prolonged treatment with ZDV had a better outcome. In conclusion, severely immunodepressed patients previously administered long-term monotherapy may receive a short-term benefit from being switched to another antiretroviral drug.

AIDS Dementia Complex↗
PubMed1994

Antibiotic treatment of burned patients: an Italian multicentre study.

Antibiotic therapy in burn centres with highly specialized ICUs has reduced the mortality and morbidity in burn and trauma but, in spite of constantly improving supportive surgical and resuscitation methods, infection remains a major problem. Indeed, the clinical experience, as recorded in Europe and the USA, using different antimicrobial drugs and regimens, emphasizes a constantly evolving pattern of pathogenic microorganisms in the wound and in the rest of the patient's body, and their increasing chemoresistance. We report the preliminary results of 559 patients in a large controlled multicentre clinical study (mean age 41.4 +/- 17.8 years and burns covering a mean body surface area of 35.7%), with the collaboration of 13 of the 15 major Italian burn centres. The antibiotic treatment consisted of prophylactic administration of pefloxacin (800 mg i.v. OD for 4 days) for all patients as a first treatment while waiting for an antibiogram, and chemotherapy with teicoplanin (800 mg i.v. OD) together with netilmicin (300 mg i.m. OD) in one or more cycles. At random, half of the patients received thymostimulin (70 mg i.m. OD pro die for the first month and every other day thereafter until discharge from hospital). Of the bacterial pathogens involved in septic complications, 63.3% were Gram-positive (Staphylococcus spp. and Streptococcus spp.). The mortality rate was 15.5%. Pefloxacin chemoprophylaxis was successful in 19.4% of patients and cure or improvement was seen with combination chemotherapy in 66.7% of patients, mainly with only one treatment cycle. The incidence of mortality and sepsis was not significantly influenced by treatment with thymostimulin.

Adolescent↗
PubMed1991

Nosocomial pneumonia: comparative multicentre trial between monotherapy with cefotaxime and treatment with antibiotic combinations.

In a multicentre clinical trial involving 32 hospitals, 588 adult patients diagnosed with nosocomial pneumonia and not receiving mechanical ventilation were treated randomly with monotherapy with cefotaxime or the antibiotic combination routinely used in each particular hospital. Both groups of patients were similar regarding demographic data, concurrent diseases, additional therapies and causative organism. Protocol violations were recorded in 40 patients, and these patients were excluded from the evaluation of treatment efficacy. The cure rate was 79% in the cefotaxime group and 71% in the group receiving antibiotic combinations; this difference is statistically significant (p = 0.03, Fisher's two-tailed test). In the patients receiving combinations of cephalosporins having activity predominantly against gram-positive organisms plus aminoglycosides, the cure rate obtained was very low. The frequency of serious adverse reactions was significantly higher in the group treated with antibiotic combinations. It is concluded that monotherapy with cefotaxime is the regimen that offers better results for the empirical treatment of nosocomial pneumonia.

Adolescent↗
PubMed1982

[Steroid-free treatment of renal transplant patients with cyclosporin A. A European multicentre study].

In a multicentre trial conducted in eight European centres, 232 recipients of cadaveric renal allografts were randomly allocated to receive either cyclosporin A (CyA, 117 patients) or azathioprine and steroids (control, 115 patients) for immunosuppression. After a follow-up period of up to eleven months, graft survival probability estimates are 73% in the CyA group and 53% in the control group. Two deaths have occurred In the CyA group and seven in the control group. 82% of the CyA group with functioning grafts are receiving CyA alone, 17% have been changed to azathioprine and steroids and one patient is receiving prednisolone in addition to CyA; 27% have never received steroids. At six months post-transplant renal function is similar in patients receiving CyA and in those receiving azathioprine and steroids. On the basis of these preliminary results CyA appears to be more effective than conventional immunosuppression and avoids the necessity of long-term steroid therapy.

Adult↗