Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “multicenter study”

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 145 records · Page 8Linked to original sources
PubMed1994

Impact of interferon at induction chemotherapy and maintenance treatment for multiple myeloma. Preliminary results of a multicenter study by the Italian non-Hodgkin's Lymphoma Cooperative Study Group (NHLCSG).

In 1990 the Italian Non-Hodgkin's Lymphoma Cooperative Study Group (NHLSG) started a multicenter study on the role of interferon (IFN) in multiple myeloma (MM). The schedule of treatment was based on the assumption that melphalan plus prednisone (MP) would be better for good-prognosis patients, whereas poor-prognosis patients would benefit from polychemotherapy. Accordingly, IFN was included randomly for the induction treatment of good-prognosis patients and randomly as maintenance of the response achieved in both groups. Up to now 78 patients of the 124 enrolled have completed the induction treatment and are evaluable for response and response duration. The overall response rate was 59%. Sixty-two percent of good-prognosis patients obtained objective response, 9/14 (64%) with MP and 9/15 (60%) with MP+IFN. Up to now, with a median follow-up of 9 months from the evaluation of response, no difference has been recorded between the maintenance and no maintenance groups on relapse rate, neither in good- nor in poor-prognosis patients.

Aged↗
PubMed1992

Lomefloxacin versus amoxicillin in the treatment of acute exacerbations of chronic bronchitis: an Italian multicenter study.

Nine centers in Italy participated in a worldwide, multicenter study comparing the effectiveness and safety of lomefloxacin and amoxicillin in patients with acute exacerbations of chronic bronchitis caused mainly by gram-negative pathogens. The 157 enrolled patients received either 400 mg lomefloxacin once daily (n = 78) or 500 mg amoxicillin every 8 hours (n = 79) for 7-10 days. A total of 131 patients were evaluable for bacteriologic efficacy and 154 for clinical efficacy. At 2-4 days after the conclusion of treatment, the bacterial eradication rate was 84.8% for lomefloxacin-treated patients and 64.6% for amoxicillin-treated patients (p = 0.0065); the clinical success rate (cure plus improvement) for lomefloxacin was 94.7% and for amoxicillin was 83.3% (p = 0.0212). The reinfection rate was lower in the lomefloxacin group than in the amoxicillin group (3.0% vs 13.8%, p = 0.0382). Both drug regimens were well tolerated. Once-a-day treatment with 400 mg lomefloxacin was more effective than 500 mg amoxicillin three times daily for the treatment of acute exacerbations of chronic bronchitis caused by gram-negative pathogens.

Acute Disease↗
PubMed1991

Treatment of hypercalcemia of malignancy with intravenous etidronate. A controlled, multicenter study. The Hypercalcemia Study Group.

In a prospective, randomized, double-blind, multicenter study, 202 patients with cancer from 19 medical centers were treated for hypercalcemia of malignancy with daily intravenous infusions of etidronate disodium (136 patients) or saline alone (66 patients) for 3 consecutive days. Patients also received up to 3.25 L of saline daily during the treatment period. Of 157 patients for whom data could be evaluated for efficacy, 63% (72/114) of etidronate-treated and 33% (14/43) of saline-treated patients had a normalization of total serum calcium levels. When serum calcium levels were adjusted for albumin (147 assessable patients), 24% of the etidronate- and 7% of the saline-treated patients responded to treatment. No serious side effects or treatment-related deaths occurred. When accompanied by adequate hydration and diuresis, intravenous etidronate was safe and more effective than hydration and diuresis alone in controlling hypercalcemia of malignancy.

Double-Blind Method↗
PubMedDate not supplied

Short course single daily ceftriaxone monotherapy for acute bacterial meningitis in children: results of a Swiss multicenter study. Part I: Clinical results.

In a prospective Swiss multicenter study, 119 children (aged three weeks to 15.5 years) with acute bacterial meningitis were treated with single daily doses of ceftriaxone (100 mg/kg on days one and two and 60 mg/kg thereafter). All patients were randomly assigned to either short course (four, six, seven days) or full course (eight, 12, 14 days) therapy depending on whether they had contracted meningococcal, Haemophilus influenzae type b or pneumococcal meningitis. Bacteriological cure was obtained in 92 children who fully completed the study and in all the 20 culture-positive of the 27 children secondarily excluded from the study for failure to meet all bacteriological and initial safety criteria for continuation in protocol (secondary exclusions). Complete clinical recovery was noted in 105 of 119 patients (88%) and was as frequent in the short course (91%) as in the full course (89%), and as in the secondary exclusion (81%) group. All patients survived. At follow-up examination three to six months after hospital discharge only seven infants and seven children (11.8%), mostly those with poor presentation on admission (p = 0.0012), showed residual neurological sequelae. Side effects of antibiotic therapy were minor but more frequent, albeit not statistically significant (p = 0.065), in children receiving the full course therapy. The results of this study suggest that short course treatment of acute bacterial meningitis in children with single daily ceftriaxone monotherapy is as efficacious as full course therapy and at least as well tolerated.

Adolescent↗
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

[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↗
PubMed1978

[Treatment of general psychovegetative disorders with a single night dose of dipotassium-clorazepate within a multicenter study (author's transl)].

The therapeutical effect of Tranxilium was studied in an open multicenter study by 66 general practitioners and 26 specialists. 1.027 patients were treated with Tranxilium 20, given in a single dose at night, for a period of three weeks. During this time, the patient's psychic status and functional organic disorders were assessed by means of rating scales. A complete medical assessment followed at the end of the study. States of anxiety, restlessness, depressive mood, irritation and insomnia as well as functional organic disorders improved significantly (p is less than 0.001) already after the first week of treatment. At the end of treatment, with the majority of patients the above symptoms had either completely disappeared or were found only to a small extent. In 85% of the patients, all investigators rated the stabilization and brightening effect on psychic conditions as well as the harmonizing effect on disturbed organic functions as "very good" to "good". In 89% of the patients, the overall therapeutic success was judged as "very good" to "good". The overall tolerance was excellent in 96% of the cases.

Anti-Anxiety Agents↗
PubMed1988

Primary pulmonary hypertension: an Italian multicenter study. A retrospective epidemiological survey in the period 1975-1985.

An epidemiological retrospective survey on primary pulmonary hypertension was undertaken in Italy in 1985-6. The aim of the study was to obtain clinical and laboratory data on patients observed in the major cardiological Institutions, both Universities and Hospital Clinical Centers, in the period 1975-85. Forms were sent to 67 centers and twenty-three of them communicated their data on 124 cases of primary pulmonary hypertension. The diagnosis was considered certain or probable in 91 patients by the referring center. The mean age of patients was 38.5 years, with an overall female-to-male ratio of 2:1. Data were subjected to statistical analysis which confirmed the poor prognosis of the disease particularly for patients with high pulmonary resistances, low cardiac output and in class 3-4 of the NYHA. Half of the 124 cases were treated with calcium antagonists after 1980, but the results of therapy in modifying the clinical course of the disease could not be assessed by the study. Like all retrospective studies even the Italian Multicenter Study is biased but it can be considered as an useful preliminary investigation which can form the basis for a prospective registry of primary pulmonary hypertension cases.

Age Factors↗
PubMed1989

Effects of simvastatin and probucol in hypercholesterolemia (Simvastatin Multicenter Study Group II).

This 12-week, randomized, double-blind, multicenter study compared the efficacy, tolerability and safety of simvastatin (a potent HMG-CoA reductase inhibitor) and probucol. Two doses of simvastatin, 20 or 40 mg once daily, were compared to probucol, 500 mg twice daily. Both simvastatin doses were significantly more effective than probucol in improving the plasma lipid profile. Mean reduction in low density lipoprotein (LDL) cholesterol was 34% with 20-mg simvastatin and 40% with the 40-mg dosage, compared to a mean reduction of 8% with probucol. Simvastatin significantly decreased total cholesterol, triglycerides and apolipo-protein B, and increased high density lipoprotein (HDL) cholesterol and apolipoprotein A-I. Probucol caused some reduction in LDL cholesterol but significantly decreased HDL cholesterol. Both simvastatin and probucol were well tolerated and no serious drug-related events occurred. Simvastatin appears to be a well-tolerated and effective new agent used once-a-day as an adjunct to diet in the management of patients with hypercholesterolemia.

Adult↗
PubMed1990

[NMR studies of the whole body--results of a multicenter study for evaluating nuclear magnetic resonance tomography].

Within the framework of a national multi-centre study the spectrum of application and the ranking of magnetic resonance tomography were investigated. Although scans of the brain and vertebral column still dominate the scene, it has become evident that whole body scanning via MR can be very accurate for certain indications. This is particularly true for examinations of gynaecological diseases (95%) and for lesions of the liver (97%). However, the number of problems in which MR can provide answers to diseases in the whole body range is still limited, and hence it would be most desirable to achieve further instrumental and methodical improvements.

Brain Diseases↗
PubMed1990

[Roxithromycin versus doxycycline in the treatment of cervicitis. Prospective randomized multicenter study under practice-related conditions].

In a prospective randomized multicenter study Roxithromycin 150 mg or Doxycycline 100 mg was given b.i.d. p.o. for ten days to women with clinically diagnosed cervicitis. All women were seen as outpatients by one of eight licensed gynecologists in their private office in the Essen city area. With a cure and improvement rate of 100% in those women who completed therapy, Roxithromycin (n = 106) was as effective as Doxycycline (n = 104; 98%). At 90% Roxithromycin was as well tolerated as Doxycycline at 93%. Both drugs were clinically and microbiologically effective in eradicating Chlamydia trachomatis.

Adult↗
PubMed1993

Comparison of diltiazem standard formulation and diltiazem controlled release in patients with stable angina pectoris: a randomized, double-blind, cross-over, multicenter study.

In a randomized, double-blind, cross-over, multicenter study with a placebo run-in phase, the efficacy and safety of two oral formulations of diltiazem, standard three or four times daily (t.i.d. or q.i.d.) and controlled release twice daily (b.i.d.), were compared in 49 patients with stable angina pectoris. ST-segment depression at maximum exercise 12 h after tablet intake was less frequently observed with diltiazem controlled release than with standard diltiazem (34 of 49, 69% vs. 43 of 49, 88%, p = 0.007). In patients with ST-segment depression after both treatments (n = 33), the average time to 1-mm ST-segment depression was 55.4 +/- 19.9 s longer with diltiazem controlled release than with standard diltiazem [476 +/- 195 vs. 422 +/- 163 s, p = 0.009; 95% confidence interval (CI) 14.8-96 s]. Reduction in mean number of anginal attacks and nitroglycerin (NTG) intake was not significantly different between treatment with standard diltiazem and diltiazem controlled release. The incidence of side effects was low and not different between the two treatments. Both formulations are equally effective in reducing the number of anginal attacks and are well tolerated. Diltiazem controlled release is more effective than standard diltiazem in preventing myocardial ischemia 12 h after tablet intake. Thus, diltiazem controlled release allows twice-daily intake frequency and may therefore be preferable to standard diltiazem in treatment of stable angina pectoris.

Adult↗
PubMedDate not supplied

A multicenter study of colorectal adenomas. Rationale, objectives, methods and characteristics of the study cohort. The Multicentric Study of Colorectal Adenomas (SMAC) Workgroup.

BACKGROUND AND AIMS: The Multicenter Study of Colorectal Adenomas (SMAC) is a retrospective-prospective cohort study involving four Gastrointestinal Endoscopy Units in Italy. The main aim of the study is to evaluate the relationship between clinical and pathologic information at index colonoscopy and subsequent incidence of adenoma and colorectal carcinoma. We report the rationale, objectives and methods of the study, including patient characteristics at initial presentation. METHODS: All patients were consecutively identified from the endoscopy registries of the four Centres from January 1, 1985 to December 31, 1992. Inclusion criteria were: age 18-69 years, endoscopy performed with adequate toilette at least up to the rectosigmoid junction, and removal of all detectable polyps. Exclusion criteria were: familial adenomatous polyposis, inflammatory bowel diseases, adenocarcinoma in adenoma with infiltrated margins, previous invasive cancer at any site, colon resection and geographic inaccessibility. RESULTS: Out of 20,071 patients who underwent endoscopy at the four Centres, 11,959 fulfilled the eligibility criteria (5,892 males and 6,067 females, mean age = 51.1 +/- 11.6 years). The main reasons for exclusion were age (n = 4,020) and previous or present colorectal cancer (n = 2,389). Symptoms were the most common reason for referral (72.3%), while post-polypectomy follow-up and positive fecal occult blood accounted for most of the remaining cases. A pancolonoscopy was performed in 3,088 patients (25.8%), while a left-sided endoscopy was performed in 7,887 (66%). A total number of 4,810 polyps were removed from 2,699 patients (2,994 adenomas, 1,580 hyperplastic polyps and 236 polyps lost after resection). A significant association (p < 0.001) between age and the endoscopic findings was observed. The subjects without polyps (n = 9,198) had the lowest age (mean = 49.9; 95%CL = 49.6-50.1) followed by the patients with hyperplastic polyps (n = 661; mean age = 52.3; 95%CL = 51.5-53.1), and the patients with adenomas (n = 1,732; mean age = 56.2; 95%CL = 55.8-56.6), and the patients with hyperplastic polyps and adenomas (n = 306; mean age = 57.2; 95%CL = 56.3-58.2). Polyps were diagnosed more frequently in males than in females (28.6% versus 17.0%; p < 0.0001). CONCLUSION: This study provides some insights in the natural history of colorectal cancer and stresses the need to develop adequate strategies in the follow-up of subjects after either positive or negative colonoscopy.

Adenoma↗
PubMed1987

Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study.

A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic improvement was good and was comparable in both groups. We saw side-effects in only three patients, two on sucralfate and one on cimetidine, and these did not necessitate withdrawal from the study. Endoscopy showed improvement of esophagitis in 53% and healing in 31% of patients after sucralfate treatment. With cimetidine, improvement was seen in 67% and healing in 14%. One patient on cimetidine developed a stricture during treatment. We conclude that treatment with sucralfate improves symptoms and lessens severity of reflux esophagitis and that the results with sucralfate appear to be comparable to those obtained with cimetidine. Sucralfate is a valid alternative to H2-receptor antagonist therapy.

Adult↗
PubMed1984

Naftidrofuryl in chronic arterial disease. Results of a controlled multicenter study.

In a double blind, randomized multicenter study naftidrofuryl, a vasoactive substance, was compared with placebo in the treatment of 104 patients with chronic arterial occlusive disease. After a run-in period of four weeks the patients received either naftidrofuryl (600 mg daily) or placebo over 12 weeks. The pain-free and the total walking distances improved significantly in both groups. However, the difference in the improvement of the pain-free walking distance was significant (p less than 0.02) in favour of naftidrofuryl. There also was a difference in the improvement of the total walking distance in favour of naftidrofuryl which was not significant. The results indicate that naftidrofuryl has a beneficial effect on the symptoms and lengthens the painfree walking distance in patients with arterial occlusive disease.

Adult↗
PubMed1987

The treatment of angina pectoris with nitroglycerin plasters. A multicenter study involving 6,986 patients.

A multicenter study was carried out in order to evaluate the efficacy and tolerability of 2 doses of a nitroglycerin transdermal system (TTS-NG 5 mg/24 h and TTS-NG 10 mg/24 h) on a large population of patients affected by angina pectoris. Nine hundred and seventy three cardiologists enrolled a total of 6,986 patients, 4,290 males and 2,696 females, mean age 61.7 years (range 26-95), 3,283 with effort-angina, 2,062 with mixed angina and 1,641 with angina at rest. Patients whose angina was not satisfactorily controlled by their previous therapy, were given TTS-NG 5 for 1 week in the morning, while continuing their antianginal treatment, with the exception of nitrates which were gradually withdrawn. At the end of this period, patients who responded to the treatment continued taking the same dose for a further 6 weeks, while poor responders were given a double dose of the study medication over the same period. Six thousand two hundred and sixty patients (90%) completed the study. TTS-NG 5 proved to be effective in 2,091 patients (33%) with a reduction in weekly anginal attacks after only 1 week of treatment (from 5.8 +/- 2.9 to 2.4 +/- 2.3). This reduction improved in the following 2 weeks (from 2.4 +/- 2.3 to 1.2 +/- 1.6) and subsequently remained virtually unchanged. Four thousand one hundred and sixty-nine patients (67%), whose angina was not sufficiently controlled by TTS-NG 5 (from 5.0 +/- 2.4 to 4.3 +/- 2.8), received double the dose at the end of the first week. TTS-NG 10 brought about a reduction in weekly anginal symptoms during the 2nd and the 3rd week (from 4.3 +/- 2.8 to 2.0 +/- 2.2), with a further decrease during the following 2 weeks (from 2.0 +/- 2.2 to 1.1 +/- 1.7). The reduction in anginal attacks was of the same extent both during the day and the night, thus suggesting that the drug is effective throughout 24 hours. A similar pattern was observed in the reduction of the number of anginal attacks weighted by their severity, the severity of attacks weighted by their number and the number of trinitrine pills taken. Tolerability was good in the majority of cases. In conclusion, this study confirms the efficacy of TTS-NG in the treatment of angina pectoris, thus supporting some recently published data obtained by using more standardized protocols and rigorous evaluation criteria.

Administration, Cutaneous↗
PubMed1993

German multicenter studies on plateletpheresis from healthy donors. German Hemapheresis Study Group.

It is reported on two German Multicenter Plateletpheresis Studies with the Fresenius AS 104 cell separator accompanied by a Multicenter Counting Study. 15 centers participated, a total of 1884 separations were evaluated. It could be shown that multicenter studies help to give a more objective opinion about a cell separator and the separation protocol used if it is possible to improve the counting methods and to eliminate individual center effects by an accompanying Multicenter Counting Study. The AS 104 proved to be a good cell separator for platelet collection regarding platelet yields (3.1 x 11" from 3.5 I citrated blood), separation efficiency (about 45%), yield prediction (SD = not equal to 15%) and leukocyte contamination (median WBC 47 x 10(6)).

Blood Donors↗
PubMed1994

A multicenter study on HLA and autoimmunity in Japanese patients with early-onset insulin-dependent diabetes mellitus (IDDM): the JDS Study.

The Japan Diabetes Society (JDS) conducted a multicenter study on HLA and autoimmunity in Japanese patients with early-onset insulin-dependent diabetes mellitus (IDDM). HLA, immunoglobulin heavy-chain complex (Gm), properdin factor B (BF), and glyoxalase of erythrocytes (GLO) were typed, and organ-specific autoantibodies including islet cell antibodies (ICA) were assayed in 159 IDDM patients and their relatives and in 258 healthy Japanese subjects. The HLA-DRw9 phenotype and HLA-Bw61/DRw9 haplotype were significantly increased among the patients with autoantibodies other than ICA, whereas the DR4 phenotype and Bw54/DR4 haplotype were significantly increased in those without the autoantibodies. The DR4 phenotype was significantly increased in the patients with autoimmune thyroid diseases. The relative risk of the HLA-DRw9/DR4 genotype was highest among all DR genotypes. The Gm phenotype of g and gft were significantly increased in the patients with the autoantibodies. The BF-F phenotype was significantly decreased in the patients either with or without the autoantibodies. There was no association of GLO types with IDDM. The prevalence of ICA among IDDM patients was decreased with duration of IDDM. No significant association was found between the prevalence of ICA and sex, age at onset, or HLA type. On the other hand, the prevalence of the autoantibodies was not significantly changed with duration of the disease, and was significantly higher in females than in males.

Adolescent↗