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At least 739 records · Page 41Linked to original sources
PubMed1989

[Intravenous nimodipine in the treatment of cerebral vasospasm following subarachnoid hemorrhage caused by aneurysm rupture: a comparative multicenter study].

The efficacy of intravenous Nimodipine (used at the rate of 2 mg.h-1) was investigated in the treatment of delayed ischemic deterioration or angiographic vasospasm after subarachnoid haemorrhage caused by a ruptured aneurysm in a randomized, double-blind, placebo-controlled multicenter study. A total of 127 case reports was validated: 73 patients received Nimodipine, 54 received placebo. The two groups were comparable in demographic and clinical status data. Analysis of number of deaths and of patients with severe deficit related to vasospasm alone showed a significant statistical difference (Nimodipine = 19%; Placebo = 49%; p = 0.01). The risk of mortality connected with vasospasm was reduced by 82% in the treated group. Side effects were equally frequent in the two groups. The only difference noted was the increase in heart rate in group Nimodipine. The results of this study demonstrate the efficacy of intravenous Nimodipine in the treatment of consequences of cerebral vasospasm after a subarachnoid haemorrhage caused by a ruptured aneurysm.

Adult↗
PubMed1989

[A multicenter study of IgG and IgM toxo-test enzymun].

A multicenter study was performed to evaluate Boehringer Mannheim Enzymun test toxo IgG and IgM in comparison with others IgG Elisa tests (Biotrol, Biomerieux, Abbott) or IgM Elisa test (Abbott) or in comparison with other methods (direct agglutination, indirect immunofluorescence, dye test or ISAGA). The IgG study of 700 sera and IgM study of 430 sera lead to conclude to a good sensibility and specificity of IgG and a lower specificity for IgM kit to detect toxoplasmosis.

Antibodies, Protozoan↗
PubMed1989

Oral ciprofloxacin vs parenteral cefotaxime in the treatment of difficult skin and skin structure infections. A multicenter trial.

A prospective, randomized, double-blind, multicenter study was conducted of hospitalized patients to compare the efficacy and safety of oral ciprofloxacin (dosage, 750 mg every 12 hours) with intravenous cefotaxime (dosage, 2.0 g every 8 hours) as monotherapy for difficult skin and skin structure infections requiring hospitalization. Five hundred seventy patients were assessed for an analysis of safety and 461 patients were assessed for an analysis of efficacy. The most common infections were infected ulcers and abscesses. At the end of therapy, there was a higher incidence of recurrent or persistent organisms in the cefotaxime group compared with ciprofloxacin. Adverse reactions related to either therapy were rare. By pathogens, there were no differences in activity, except the higher rate of recurrent or persistent Pseudomonas aeruginosa infection in the cefotaxime group. By diagnosis, the two drugs had comparable efficacy, except for the higher incidence of bacteriologic failure in patients with polymicrobial infected ulcers in the cefotaxime group. Larger studies are needed to evaluate emergence of resistance to ciprofloxacin. Oral ciprofloxacin therapy is as safe and effective as parenteral cefotaxime in the treatment of difficult infections of the skin and skin structure, and affords the prospect of early discharge from the hospital and significant cost savings.

Administration, Oral↗
PubMed1989

Multicenter clinical trials and their value in assessing total joint arthroplasty.

Multicenter clinical trials (MCT) have an important role in the assessment of total joint arthroplasty. The primary reason for such MCT is the need to have access to a large number of patients. In Sweden, failure after total hip arthroplasty has been recorded prospectively since 1979. Medical records from every reoperation are documented and computer analyzed. This MCT has shown that patient-related, surgical, and implant-related parameters are of importance to rates of failure. There were an increasing number of revisions after total hip arthroplasty in Sweden between 1979 and 1986. Male gender and young age increase the risk of revision. The primary diagnosis is very important for type of failure. The risk of deep infection is small but increases with the number of previous operations. Aseptic loosening has emerged as the main problem and is the cause for 74% of all revisions. Prosthetic design is of utmost importance for the rate of failure, and significant differences exist among different prosthesis types with respect to long-term survival. Finally, this MCT has shown that revisions for total hip arthroplasty in patients younger than 70 years of age eventually have failed in Sweden whenever the cemented technique has been used.

Aged↗
PubMed1989

Multicenter controlled study of Sinemet CR vs Sinemet (25/100) in advanced Parkinson's disease.

Controlled-release carbidopa/levodopa 50/200 (Sinemet CR) and standard carbidopa/levodopa (Sinemet 25/100) were compared in a multicenter double-blind trial involving 202 patients with advanced Parkinson's disease and motor response fluctuations. Treatment with Sinemet CR significantly reduced daily "off" time. According to both physician and patient global ratings, patients showed significant improvements with Sinemet CR compared to treatment with standard Sinemet. Patients preferred Sinemet CR treatment by a ratio of approximately 2 to 1. Daily dosing frequency was 33% less with Sinemet CR, while daily intake of levodopa required was increased by 25%. The safety profiles of the 2 formulations were similar. We conclude that Sinemet CR is superior to standard Sinemet for many patients with advanced Parkinson's disease, although it does not solve the problem of fluctuating motor performance.

Aged↗
PubMedDate not supplied

[Perphenazine enanthate. Results of a 1-year open multicenter study].

The results of a one-year, open multicenter trial of perphenazine enanthate, a sustained-release neuroleptic drug, are reported. 240 patients (62% suffering from schizophrenia) were included in the study and 144 were followed during the 12-month period. The usual adverse reactions associated with sustained-release neuroleptic drugs were observed. Total and partial BPRS ratings showed that improvement (expressed as a percentage) after 12 months' treatment was similar for systematized chronic delusions, paranoid schizophrenia and hebephrenia. However, the onset of therapeutic activity was different in these three groups of patients. Maximum therapeutic activity, as defined by the BPRS rating, was obtained within 4 months in chronic delusions whereas schizophrenia improved more progressively. Such patients therefore require prolonged treatment before the therapeutic activity of a sustained-release neuroleptic drug can be assessed.

Adult↗
PubMed1989

Intravenous nicardipine for the treatment of severe hypertension. A double-blind, placebo-controlled multicenter trial.

A placebo-controlled, double-blind multicenter trial was conducted in 123 patients with severe hypertension to examine the efficacy and safety of intravenously administered nicardipine hydrochloride in controlling blood pressure. Seventy-three patients were initially randomized to receive nicardipine treatment. This group had an initial blood pressure of 213 +/- 3/126 +/- 2 mm Hg. Sixty-seven patients achieved the therapeutic goal (diastolic blood pressure less than or equal to 95 mm Hg; systolic blood pressure less than or equal to 160 mm Hg). Fifty patients were randomized to receive placebo solution. Blood pressure in these patients was 216 +/- 3/125 +/- 2 mm Hg. No patient in this group achieved the therapeutic goal during the "blinded" portion of the study. Forty-four of 49 patients who did not respond to placebo administration responded to subsequent treatment with nicardipine. Patients with end-organ damage were included in the study. These included patients with left ventricular hypertrophy, retinopathy, and renal insufficiency. Patients with and without end-organ damage responded equally well to nicardipine treatment. Serious adverse experiences were infrequent, the most common adverse reaction being headache in 24% of the patients studied.

Dose-Response Relationship, Drug↗
PubMed1989

Value of perindopril in the treatment of chronic congestive heart failure. Multicenter double-blind placebo-controlled study.

Right cardiac catheterization studies have demonstrated an improvement in cardiac hemodynamics in patients with heart failure following the administration of perindopril (per): reduction in ventricular filling pressures (pulmonary capillary wedge pressure, right atrial pressure) and systemic resistance and an increase in cardiac output. The intensity and duration of these modifications were frequently insufficient after 2 mg, but were significant over 24 hours after 4 mg. A randomized, double-blind multicenter study versus placebo (pla) was conducted for 3 months, following a preinclusion period of 15 days, in 103 heart failure patients (stages II and III of the NYHA classification) treated with diuretic +/- digitalis. The following parameters were evaluated before (be), after 1 month (1m) and after 3 months (3 m) treatment: duration of stress test (DST) (sec), clinical severity score (SS), cardiothoracic ratio (CTR), serum creatinine (Cr) (mumol/l), systolic blood pressure (SBP) (mm Hg) in the supine (s) and erect (e) positions. 50 patients received per and 53 received pla; 46 patients in each group completed the double-blind period. Perindopril was administered at doses of 2 mg (n = 6) and 4 mg (n = 40). The following results were obtained: (table; see text) Three cases of acute heart failure occurred in the placebo group compared with none in the peridopril group. The efficacy of perindopril in heart failure was demonstrated by the improvement in effort capacity and severity score and by the reduction in cardiothoracic ratio. The variation in SBP and serum creatinine, in particular, reflected the good safety.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1989

[Lisuride for the prevention of migraine. Results of a multicenter study].

In an open multicenter study involving 420 patients lisuride proved to be an effective and well-tolerated migraine prophylactic. In 61.4% of the patients the frequency of migraine attacks was reduced by more than 50% during the 3 month treatment period; the severity and duration of remaining attacks were markedly reduced. In the overall assessment, the effect was regarded as good to excellent in 69.7% of the patients and tolerance was good to excellent in 94.2%. The most common side effects were nausea (4.0%), vertigo (3.1%), drowsiness (1.4%). Prognostic criteria for the response to lisuride could not be identified.

Adult↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 90 patients treated with ciprofloxacin (mean daily dosage, 936 mg per day; mean duration of treatment, 9.7 days) for a variety of infections, 42 were microbiologically proven. For one case the outcome of therapy was unknown. Of the 41 reported outcomes bacteriologic cure resulted in 92.7%, improvement in 7.3% of cases. Clinical cure equaled 88.4%, while improvement was 9.3%. Failure was reported in 2.3% of cases. A total of 14 infections were classified as chronic. Overall, there were 9/90 (10%) adverse reactions. Six were classified as definitely related to therapy. Therapy with ciprofloxacin was discontinued in four (4.4%) patients because of adverse effects.

Adolescent↗
PubMed1989

Intravenous prostaglandin E1 versus pentoxifylline therapy in chronic arterial occlusive disease--a controlled randomised multicenter study.

In a controlled multicenter study 70 patients with chronic arterial occlusive disease stage IV according to Fontaine's classification were randomised to treatment with prostaglandin E1 (PGE1) or pentoxifylline (PX), administered over 4 weeks. Parameters of effectiveness were the reduction of analgesics, the relief of rest pain according to an analogue scale, the improvement of the ulceration according to an ulcer score and the healing of necrotic area. The results show that both forms of treatment produced a significant reduction in analgesic consumption and rest pain. Moreover in both groups a significant reduction of the ulcer score and healing of the necrotic area were observed. Side effects occurred in six patients of the PGE1-group and in ten patients of the PX-group, which required premature discontinuation of treatment in four patients of the PX-group. The study also demonstrated that PGE1 is more effective in the treatment of severe arterial occlusive disease than PX. With respect to the analgesic consumption, the reduction of ulcer score and the healing of necrotic area a significant difference was found in favour of PGE1. In accordance the six months follow-up examinations showed a marked deterioration in the PX-group opposed to the PGE1-group. The intravenous application of PGE1 over a period of 4 weeks in patients with severe arterial occlusive disease seems to be an effective therapeutical principle.

Aged↗
PubMed1989

[Swiss simvastatin multicenter study: 1. Efficacy of 10 mg simvastatin daily in patients with primary hypercholesterolemia].

In a Swiss multicenter study with determination of lipid and lipoprotein parameters in a central laboratory, the efficacy of simvastatin, MSD, was evaluated in patients with primary hypercholesterolemia. Lipid and lipoprotein values were determined in 109 patients before and after 6 weeks' therapy with 10 mg simvastatin per day. A significant decrease in total cholesterol, LDL-cholesterol and apo B, of 21.1, 25.8 and 24.1% respectively, was observed. No influence of simvastatin on apo A-II was found, but HDL-cholesterol and apo A-I were slightly increased (+6.1 and 4.4% respectively). The data show that HMG-CoA reductase inhibitors constitute a new class of effective drugs for the treatment of hypercholesterolemia.

Adult↗
PubMed1989

[Perforated sigmoiditis. Experiences with 805 cases. A multicenter study].

This was a multicenter study corresponding to 40 services. For each patient, a card containing 90 questions was filled out. At the same time we sent a personal survey card with 11 criteria questions. Our cases corresponded to 805 patients, 457 males and 348 females. The highest frequency was between 50-80 years. The therapeutic methods most often used were: drainage plus Hartmann, 37.1%; drainage plus colostomy, 24.9%; resection and anastomosis without colostomy, 12.45%, and with colostomy, 5.11%; drainage plus exteriorization, 5.98%, and conservative, 4.6%. We studied the morbimortality correlation according to different anatomoclinical groups and techniques used. The results were nonsignificant for mortality and statistically significant for evisceration, eventration, diffuse peritonitis, upper gastrointestinal bleeding, anastomotic dehiscence and type of anastomosis, manual or instrumental.

Adult↗
PubMed1989

Ensuring data quality in a multicenter clinical trial: remote site data entry, central coordination and feedback.

In an ongoing multicenter clinical trial, "Treatment Strategies in Schizophrenia," the five participating sites have the capacity to perform a variety of tasks or study functions independently. These tasks include (a) verification of diagnostic eligibility through the use of computerized decision algorithms; (b) assignment of patients to treatment based on prognostic indicators using a computerized randomization algorithm; (c) entry of data into a microcomputer using a clinical trial data management system that performs simple range and missing data item checks; and (d) regular transfer of all data to the central coordinating team. The clinical trial data management system employed allows for both independent site functioning and assurance of consistency across sites. The integration of a variety of software outside the main data management system provides the central coordinators with the tools to monitor critical data as it is collected, as well as the capacity to assess the flow, quality, and uniformity of the ongoing trial.

Clinical Trials as Topic↗
PubMedDate not supplied

[Retrospective multicenter study on carcinomas of the lips and oral cavity. The role of multiple malignancies].

In a retrospective multicenter study the role of multiple cancer has been assessed in 2481 patients with carcinomas of the lips and oral cavity. In 3.2% of the cases the malignancies developed outside the maxillofacial area. In the majority of cases two malignant neoplasms were found. Most of them were histologically carcinomas. The bronchi and stomach were common localizations in patients with lip carcinomas, whereas patients with oral carcinomas exhibited mainly cancers of the breast, stomach and uterus. Sex-limited multiple cancers associated with oral carcinoma occurred predominantly in women. Surgery is the most common form of treatment. The prognosis for patients with lip carcinomas is significantly poorer when multiple cancers are present.

Adolescent↗
PubMed1989

[Minipress in the treatment of arterial hypertension in light of results from a multicenter study. I. 3-month treatment: monotherapy versus combination treatment].

Multicenter study of the effectiveness and safety of prazosin (Minipress) in patients with arterial hypertension was carried out in 15 medical centers. Of 366 patients who entered the study, 328 persons satisfying all the protocol conditions were included into the final analysis. The treatment lasted 3 months. Highly significant decrease of systolic and diastolic blood pressure was obtained in all periods of observation. In about two-thirds of patients Minipress was effective as a single drug and in the remaining persons the decrease of blood pressure was achieved using prazosin in combination with other antihypertensive drugs. Patients requiring combination therapy were almost 2 years older (however, the difference was not significant), had higher initial blood pressure and greater body mass. Mean daily doses of Minipress in the monotherapy and combination treatment were 5.6 and 10 mg, respectively. Side effects were observed in 27% of patients, but only in 5% they were the cause of drug withdrawal.

Adult↗
PubMed1988

Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Collaborative European Multicenter Study Group.

In a randomized multicenter trial, involving the collaboration of eight European neonatal intensive care units, the efficacy of replacement therapy with a new surfactant preparation (Curosurf) was tested in 146 patients with severe neonatal respiratory distress syndrome. Criteria for entry included birth weight 700 to 2,000 g, age when treated two to 15 hours, and requirement of artificial ventilation with FiO2 greater than or equal to 0.6. The babies were treated with a single large dose of surfactant (200 mg/kg) at a median age of nine hours (range two to 15 hours). Average FiO2 before treatment was the same (0.80) for both surfactant-treated patients and control patients. Babies receiving surfactant showed, within five minutes, a dramatic improvement of oxygenation as reflected by a nearly threefold increase of the PaO2/FiO2 ratio. Six hours after randomization, the PaO2/FiO2 ratio still showed a 98% improvement in surfactant-treated patients compared with controls (P less than .001), and statistically significant differences in favor of the treated babies persisted until 48 hours after randomization, when surviving control infants began to recover. Treatment with surfactant decreased neonatal (less than or equal to 28 days) mortality from 51% to 31% (P less than .05). Compared with control babies, the surfactant-treated group also had a decreased incidence of pulmonary interstitial emphysema (23% v 39%; P less than .05) and pneumothorax (18% v 35%; P less than .05). The percentage of survivors without bronchopulmonary dysplasia in the treated group was more than twice that of the control group (55% v 26%; P less than .001).(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗
PubMed1987

Oral contraception with a triphasic combination of gestodene and ethinyl estradiol: results of a multicenter clinical study.

The clinical effects of a low-dose triphasic oral contraceptive containing the new progestogen gestodene and ethinyl estradiol were investigated in phase II and III multicenter studies. The phase II study compared the clinical effects in 377 women taking this new compound during 2123 cycles with the effects of a low-dose triphasic combination of levonorgestrel and ethinyl estradiol in 362 women treated in 2088 cycles. The discontinuation rates after 6 months were similar in the two groups, and no major differences in side effects were observed. Cycle control was better during intake of the gestodene-containing preparation, since spotting occurred less frequently (P less than .05). The phase III investigation comprised 1921 women representing a total of 27,308 cycles. The Pearl index was 0.05. During the 24-month trial, 243 women (12.7%) dropped out of the study because of side effects, mainly bleeding disturbances (6.0%), headache (2.2%), and breast tension (2.0%). The results of these studies indicate that the triphasic combination of gestodene and ethinyl estradiol is well tolerated and provides high contraceptive efficacy and good cycle control.

Clinical Trials as Topic↗