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At least 127 records · Page 7Linked to original sources
PubMed1991

[Randomized, double-blind comparison of isosorbide-5-mononitrate and delayed-action nifedipine in patients with stable exertional angina. Multicenter Study Group].

The therapeutic effects of IS-5-MN and s.r. nifedipine were investigated in this double-blind, randomized, group-comparative, multicenter study over 2 weeks, in 251 patients with stable reproducible exercise-induced angina. After 2 weeks' treatment with IS-5-MN 20 mg b.i.d. or t.i.d., 61% of the patients were responders who showed an increase in total exercise time (to moderately severe angina) of greater than or equal to 20% in comparison with placebo in the run-in phase. The corresponding responder rate after s.r. nifedipine 20 mg b.i.d. or 40 mg b.i.d. was 53%. Both IS-5-MN and s.r. nifedipine significantly increased the total exercise time, the time to angina onset and to greater than or equal to 1 mm ST-depression, and significantly reduced the rate pressure product and the ST-segment depression at peak exercise in comparison with placebo in the run-in phase. The improvement in quality of life as indicated by the reduction in anginal episodes and intake of short-acting nitrates was comparable with both drugs. The pattern and incidence of all AEs were as expected in the two active treatment groups. The daily treatment costs for a 20 mg b.i.d. dosing regimen for both drugs in the Federal Republic of Germany was 64% higher for s.r. nifedipine than with IS-5-MN.

Angina Pectoris↗
PubMed1990

Office versus ambulatory recordings of blood pressure (OvA): a European multicenter study. The Steering Committee.

The long-term prognostic value of ambulatory blood pressure recordings in essential hypertension is poorly documented. A European Multicenter study has been set up to evaluate office versus ambulatory (OvA) recordings during a follow-up period of 5 years in a minimum of 2000 patients. The end-point of the study is the question of whether ambulatory blood pressure measurements are better correlated with patient morbidity and mortality than office recordings. In a specific substudy, short-term evolution (6 months) of left ventricular hypertrophy will be followed in untreated hypertensives with randomly allocated treatment. A number of readaptations of the primary protocol are discussed.

Blood Pressure Determination↗
PubMed1985

Acebutolol in essential hypertension: results of two multicenter studies against placebo and propranolol.

Two double-blind multicenter studies compared acebutolol with placebo (acebutolol, N = 121; placebo, N = 116) and with propranolol (acebutolol, N = 186; propranolol, N = 190) in essential hypertension. Acebutolol significantly reduced mean sitting diastolic blood pressure from 99.2 +/- 0.3 mm Hg at baseline to 89.1 +/- 0.9 mm Hg at the end of dose titration (p = 0.001). Significantly more acebutolol patients (65%) achieved therapeutic goal than did placebo patients (28%, p less than 0.01). The reduction in heart rate in acebutolol-treated patients (9.2 bpm) was greater than in placebo-treated patients (1.2 bpm, p = 0.001). The incidence of side effects and the number of patients discontinued because of side effects did not significantly differ between acebutolol and placebo. Acebutolol and propranolol produced comparable reductions in diastolic, systolic, and mean arterial blood pressures (p less than 0.001). At equipotent doses the 13% decrease in heart rate in patients receiving acebutolol was significantly less than the 17% decrease in propranolol patients (p = 0.02). The number of patients experiencing central nervous system (CNS) side effects while receiving acebutolol (N = 50) was significantly less than with propranolol (N = 75, p = 0.001), and significantly fewer acebutolol patients (N = 11) were discontinued because of side effects compared with propranolol patients (N = 29, p less than 0.01). Laboratory, ECG, or chest X-ray results did not differ for acebutolol, placebo, or propranolol. Acebutolol appears to be safe and effective in the management of mild to moderately severe essential hypertension and is better tolerated than propranolol in terms of CNS side effects, with a significantly lesser effect on heart rate.

Acebutolol↗
PubMed1991

Prospective multicenter study on isolation of human immunodeficiency virus type 1 from homosexual men after seroconversion.

A prospective multicenter study was undertaken to isolate human immunodeficiency virus type 1 (HIV-1) from 45 homosexual men for a period of 30 months after seroconversion. Efficiency of HIV-1 isolation from peripheral blood mononuclear cells was relatively stable over time, ranging from 64% at the time of seroconversion to more than 82% after 18 months of seroconversion. However, Kaplan-Meier analysis of HIV-1 culture data indicates that the cumulative proportion of HIV-1 culture positivity at 3, 6, 12, and 18 months after seroconversion was 62, 65, 84, and 92%, respectively. No significant correlation was observed between the presence of HIV-1 p24 antigen in serum, or numbers of CD4+ and CD8+ blood lymphocytes, and HIV-1 isolation within this period of time. These data suggest that HIV-1 viremia in homosexual men gradually increases to almost 100% culture positivity by 18 months after seroconversion.

HIV Seropositivity↗
PubMed1988

[Chemotherapy of chronic myelocytic leukemia. Status of the German Multicenter Study on busulfan versus hydroxyurea versus alpha interferon, October 1897].

For palliative therapy during the chronic phase of CML busulfan has proved to be the drug of choice. During the past years hydroxyurea and also interferon-alpha have gained increasing significance since they might prolong the duration of the chronic phase. In a multicenter study it is being determined, whether the use of hydroxyurea or of interferon-alpha instead of busulfan prolongs the duration of the chronic phase of Philadelphia-positive CML. Additional goals are the examination, whether the types of disease evolution and the terminal phases differ between the treatment groups, and the prospective recognition of prognostic criteria for the duration of the chronic phase of CML. By November 26, 1987, 321 CML-patients had been randomized, 147 for busulfan, 149 for hydroxyurea and 25 for interferon-alpha. The average age is about 50 years. 59 patients reached the end of the chronic phase, 55 died. The mean observation time of all patients is 1.34 years. At present no significant difference in survival is recognizable between the busulfan and hydroxyurea groups. Fewer adverse effects have been observed in the hydroxyurea group. Philadelphia chromosome-negative patients show a higher average age and tend to have lower white blood cell and platelet counts. The number of patients having received interferon-alpha is still too small to allow evaluation. This report intends to document organization and progress of this study which to our knowledge is, at present, the largest ongoing prospective multicenter study on the therapy of CML.

Busulfan↗
PubMed1992

Prospective evaluation of ultrasonic surgical dissectors in hepatic resection: a cooperative multicenter study.

Blood loss is the major cause of postoperative mortality and morbidity associated with hepatic resection. A prospective multicenter study was conducted to determine if ultrasonic dissectors (USD) were useful in hepatic resection and could reduce this hemorrhagic risk. Forty-seven hepatic resections were performed in 42 consecutive patients during a two month period in 11 public, surgical centers. Twenty-one patients had primary or secondary malignancies, six had benign tumors, two had biliary cysts, one had cholangiocarcinoma, one had Caroli's disease, and 11 had hydatid cysts of the liver. Two different USD devices were evaluated (CUSA System-Lasersonics and NIIC-DX 101 T). The hepatic resections tested included a wide range of procedures. Each surgeon had the possibility of choosing between the USD and his own usual technique for each operative step and according to local conditions. The average volume of blood infused, irrespective of the underlying pathology or the procedure performed, was 1.0 L (range 0-4.8 L). Fourteen patients required no transfusions. No operative or immediate postoperative deaths were recorded. Five major complications, all unrelated to the use of the USD, developed in three patients. Access to intra and extraparenchymal arterial and venous tributaries and particularly the control of the hepatic veins were facilitated by USD. While transection of hepatic parenchyma was neither easier nor faster than with conventional techniques, it was found to be less hemorrhagic. Overall appraisal was expressed on an analog scale; the USD was found to be helpful or very helpful in 75 percent of all resections. With regard to the pathology being treated, total or partial excision of hydatid cysts was greatly enhanced by the use of the USD while this benefit was not found for wedge resections of other hepatic lesions. With regard to user friendliness and maintenance, the NIIC-DX 101 T device was preferred. We conclude that the USD facilitates formal hepatic resections. Converging opinions emerging from various surgical centers reinforce this conclusion.

Adult↗
PubMed1990

[Multicenter study of long-term management of HIV exposed and HIV infected children. Study organization and aims].

In order ot improve and standardize medical and psychosocial care for infants born to HIV-positive mothers, a prospective multicenter study has been initiated at 6 university hospitals in West-Germany in 1987. Aims of the study are: 1) determination of the rate of vertical HIV-transmission, relevant maternal risk factors and the clinical symptomatology of pre-or perinatally acquired HIV-infections, 2) identification of immunological and virological laboratory markers important for the verification and staging of HIV-infections in infants, 3) elaboration of an interdisciplinary approach to the care of HIV-infected children and their families, integrating medical care, social and psychological attendance.

AIDS Serodiagnosis↗
PubMed1990

Use of monoclonal antibodies to human breast-tumor-associated antigens in the diagnosis of fine-needle aspirates of breast nodules: results of a multicenter study.

Fine-needle aspiration (FNA) cytology is being increasingly employed in conjunction with physical examination and mammography in the pre-surgical diagnosis of breast nodules. In the present study, we have submitted to multicenter validation an immunocytochemical test which employs monoclonal antibodies (MAbs) to breast-tumor-associated antigens (BTAA) for the diagnosis of breast cancer. The results of this analysis, which has evaluated 846 FNAs, show that the immunological test has a sensitivity of 88.62%, a specificity of 97.9% and an accuracy of 92.4%. The predictive value of a positive and a negative finding were 98.4% and 85.57% respectively. Comparison between the cytological and immunocytochemical diagnosis displayed a higher sensitivity, accuracy and predictive value of a negative result with the latter method (p less than 0.01). Our findings clearly indicate that immunocytochemical methods can complement and improve the diagnostic accuracy of FNA cytology of breast nodules.

Antibodies, Monoclonal↗
PubMed1991

National cooperative rHu erythropoietin study in patients with chronic renal failure: a phase IV multicenter study. Report of National Cooperative rHu Erythropoietin Study Group.

Initial experience with recombinant human erythropoietin (rHuEPO, epoetin alfa) was gained through research protocols in which patient selection and management were tightly controlled. When epoetin alfa was approved for use by the Food and Drug Administration (FDA) these constraints were removed. The present study was designed to examine the medical and social impact of epoetin alfa therapy, as well as to document its safety and efficacy as it is used in clinical practice. From 1,000 to 2,000 patients at 100 to 200 centers will be enrolled and monitored for 1 year. Two groups of patients are being studied--those already receiving epoetin alfa at study entry and those new to epoetin alfa therapy. Demographic data are collected initially and detailed outcome data are collected monthly. This interim report presents data from 68 participating dialysis centers on 447 enrolled patients. To date, 89% of the patients are on in-center hemodialysis, while 9% are on home dialysis (79% continuous ambulatory peritoneal dialysis [CAPD], 14% continuous cyclic peritoneal dialysis [CCPD]). Preliminary analyses suggest this population is similar in age and cause of chronic renal failure to the overall US dialysis population, although whites and males are somewhat underrepresented. Of those already on epoetin alfa at study entry, 62% were receiving 3,000 to 9,000 U/wk. In addition, those already on epoetin alfa had better self-rated general health than those new to therapy. Outcomes and epoetin alfa usage patterns are currently being fully analyzed. Three-month follow-up data on a cohort of patients new to epoetin alfa indicate that the average dose in these patients is less than 100 U/kg/wk; two thirds of the doses were administered intravenously. Hematocrit levels increased over the 3 months from a level of 25.1% at entry to 30.6% by month 3. The percentage of cohort patients who were transfusion-independent increased from 85.1% at study entry to 95.7% by month 3. No increases in the incidence of adverse events occurred in the cohort group and no changes in the safety profile were indicated. These preliminary findings suggest that low doses of rHuEPO are being used in general, with a resultant low mean hematocrit. Thus, patients do not seem to be realizing the full potential beneficial effects of this remarkable agent.

Adolescent↗
PubMed1990

Aldactazine/captopril combination, safe and effective in mild to moderate systemic hypertension: report on a multicenter study of 967 patients.

The safety and efficacy of a thiazide/potassium-sparing diuretic and an angiotensin-converting enzyme inhibitor used concomitantly was evaluated in a large, multicenter study. Aldactazine was administered alone for 2 months, after which time captopril was added in those whose blood pressure had not normalized (332 patients). At the end of the 6-month study, control of blood pressure was achieved in 88% of the patients with one or the other regimen. No clinically significant changes were recorded for a number of biologic parameters. Specifically, there was 1 case of hyperkalemia (6 mmol/liter), a very low incidence of hypotension (1.6%), and a low rate of adverse effects. Therefore, such a combination could provide important therapeutic benefits in hypertensive patients.

Adolescent↗
PubMed1990

[A Sicilian multicenter study of the clinical effectiveness and tolerability of nimesulide in gynecologic inflammatory diseases].

Hundred-eighty patients, aged between 18 and 58 years, participated in a multicenter study, in order to assay the efficacy and tolerability of nimesulide in gynaecological inflammatory diseases. Thirty patients were affected by adnexitis, 41 patients by cervicitis, 6 by endometritis, 13 by myometritis and 90 patients presented more pathologies associated. Al the patients were treated with nimesulide 100 mg granular (sachets) bid for a mean period of 19 days. Treatment with nimesulide produced good results in all pathologies, significantly reducing the intensity of symptomatology. The tolerability of the drug was always good.

Adult↗
PubMed1988

[Clinical efficacy of long-term treatment with LH-RH analogue, ICI 118630 (Zoladex), in prostatic cancer patients. The Zoladex Multicenter Study Group].

The Zoladex (ICI 118,630) multicenter trial included 149 patients with stage B +o D prostatic cancer recruited from 1984 to date. Of them 53 clinical responders on the treatment for 40 weeks or longer were subjected to assessment of antitumour response, overall subjective response, endocrinological response, safety and usefulness. The responders consistently showed a clinical response as evidenced by antitumour response in 32 of 50 patients (64.0%) at week 12 and in 35 of 51 (68.6%) at week 40, and overall subjective response in 42 out of 47 patients (89.4%) at both week 12 and week 40. Endocrinologically, all of the 47 eligible patients maintained a 40-week or longer response. Adverse reactions were observed in 19 out of 73 patients (26.0%), subdivided by the time of occurrence as 15/73 (20.5%) up to week 12, 3/71 (4.6%) between week 12 and week 40, and 5/53 (9.4%) in and after week 40. No patient required the discontinuance of treatment. Usefulness of the drug was observed in 51 out of 52 patients (98.1%). The results indicated that Zoladex in a once monthly regimen may be of great advantage to elderly patients with prostatic cancer, and allow an improved patient compliance: Zoladex may not only produce clinical remission but also improve the quality of life.

Buserelin↗
PubMed1985

Six-year follow-up of the Norwegian Multicenter Study on Timolol after Acute Myocardial Infarction.

The original Norwegian Multicenter Study on Timolol after Myocardial Infarction was a double-blind, randomized study comparing the effect of timolol with that of placebo for up to 33 months after acute myocardial infarction. The initial results showed that the cumulated mortality rate was 39.4 per cent lower among 945 patients randomly assigned to timolol treatment than among 939 patients randomly assigned to placebo (P = 0.0003). After the end of the double-blind period the majority of participating patients in the timolol group continued to receive beta-adrenergic blockade, whereas the majority of placebo-treated patients continued without such blockade. During an extended follow-up of participating patients up to 72 months after randomization, the mortality curves of the two groups continued to rise in parallel. Cumulated mortality rates were 32.3 per cent in the placebo group and 26.4 per cent in the timolol group (P = 0.0028). We conclude that the previously observed early beneficial effect of beta-adrenergic blocking therapy is maintained for at least six years after infarction.

Adrenergic beta-Antagonists↗
PubMed1989

[Clinical results with sulbactam/ampicillin in a multicenter study of 425 patients].

In an open, non-comparative multicenter study, efficacy and toleration of sulbactam/ampicillin for therapy of various infections were investigated. 42 centers in the Federal Republic of Germany and West-Berlin participated in this study. In total, 425 patients were included, 112 of whom suffered from renal/urinary tract infections, 103 from respiratory tract infections, 84 from intraabdominal infections, and 73 from skin/soft tissue infections. Moreover, 43 female patients had gynecological infections. More than 95% of the patients received three daily dosages of 3 g sulbactam/ampicillin via intravenous short-infusion. Mean duration of therapy was 7.3 days. In 280 patients, in total, pathogens were initially identified, among them were 87 patients with mixed infections. At study onset, 393 pathogens were identified, after completion of the trial 63 germs could still be made evident. In 234 cases (= 83.6%) pathogens were eradicated by therapy, in 19 patients superinfection occurred, and in 27 patients pathogenic organisms persisted. 419 patients were included into evaluation of clinical efficacy of sulbactam/ampicillin therapy. In 391 cases (= 93.3%) therapy was successful with 293 patients cured and 98 improved. Therapy failed in 28 patients (= 6.7%) which, in 23 cases, led to discontinuation of treatment. Sulbactam/ampicillin was well tolerated. In total, 55 adverse drug reactions were observed, 22 of which were exanthemas (= 5.2% of all patients). In seven patients (= 1.6%) therapy had to be discontinued due to adverse events. The combination of sulbactam, a beta-lactamase inhibitor, with the reliable antibiotic agent ampicillin has proved to be successful in therapy of infections of different localizations with excellent toleration.

Bacteria↗
PubMed1987

[Astemizole in urticaria--a multicenter study by 412 established dermatologists].

In the course of a multicenter study on 2122 patients treated by 412 dermatologists in general practice, we investigated the effect of astemizole (Hismanal) on urticaria. During 2 weeks of treatment with astemizole 10 mg daily, the percentage of the patients with severe or moderate affection dropped from 82.4% to 9.1%, while the figure of the patients with severe or moderate pruritus decreased from 83.9% to 7.8%. In 74% of the patients, the onset of action occurred during the first 24 hours. The peak of effect was reached within the first day in 36.6% of the patients, and within 2 days in 57.5% of the patients. The physicians observed an excellent outcome in 44.4% and good results in 31.9% of the patients. The therapeutic success was considered moderate in 12.0% and unsatisfactory in 9.6% of the cases. The incidence of side effects was very low, i.e., 5.4%. Slight sedation was observed in 1.9% of the cases.

Administration, Oral↗
PubMed1990

[Multicenter study in the Campania region on the clinical effectiveness and tolerance of nimesulide in gynecologic inflammatory diseases].

Two-hundred and twenty patients, aged between 18 and 71 years, participated in a multicenter study in order to assay the efficacy and tolerability of nimesulide in gynecological inflammatory diseases. Forty and two patients were affected by adnexitis, 37 by cervicitis, 12 by endometritis, 9 by myometritis and 120 patients presented more pathologies associated. All the patients were treated with nimesulide 100 mg granular (sachets) b.i.d. for a mean period of 19.5 days. The treatment with nimesulide produced good results in all pathologies, significantly reducing the intensity of symptomatology. The tolerability of the drug resulted to be good.

Adolescent↗
PubMed1992

Transcervical cannulation of the fallopian tube for the management of ectopic pregnancy: prospective multicenter study.

OBJECTIVE: To determine the efficacy of transcervical tubal cannulation and intraluminal methotrexate injection for the management of tubal ectopic pregnancy (EP). DESIGN: Prospective multicenter study of 33 patients with tubal pregnancies. SETTING: Four university-based gynecology and radiology departments in three different countries: France, England, and Germany. PATIENTS: Thirty-three patients who presented with a clinical diagnosis of EP. INTERVENTIONS: Patients underwent transcervical tubal cannulation under fluoroscopic or ultrasound control and local injection of methotrexate (up to 50 mg). MAIN OUTCOME MEASURES: We evaluate the feasibility of transcervical tubal cannulation for the management of tubal pregnancy. RESULTS: Two patients elected to withdraw from the protocol. In the remaining 31 patients there was complete resolution of the EP in 27 (87%). Surgery was performed in 4 patients. Seventeen patients, 14 of whom desired pregnancies, were available for follow-up to assess the return of reproductive potential. Seven of 7 patients who subsequently underwent hysterosalpingography had patency of the affected tube. Five patients later had an intrauterine pregnancy. One patient had an early miscarriage, two have given birth, and two singleton pregnancies are still ongoing. The remaining patients are symptom free. CONCLUSIONS: This study demonstrates that transcervical tubal catheterization in patients with tubal pregnancies is feasible and can be performed without anesthesia or analgesia in most cases. Intraluminal methotrexate per se is capable of causing regression of the EP. This approach offers a new alternative for the treatment of selected patients with tubal EP.

Adult↗
PubMed1989

Effect of methylprednisolone sodium succinate on quality of life in preterminal cancer patients: a placebo-controlled, multicenter study. The Methylprednisolone Preterminal Cancer Study Group.

The effectiveness of an 8-week, 125 mg/day intravenous course of methylprednisolone sodium succinate (MPSS) for improving quality of life in patients with preterminal cancer was investigated in a double-blind, placebo-controlled, multicenter study. Quality of life was assessed using the Nurses' Observational Scale for Inpatient Evaluation (NOSIE), the Linear Analog Self-Assessment Scale (LASA), and the Physicians' Global Evaluation. A total of 403 patients were enrolled: 207 were treated with MPSS and 196 were treated with placebo. MPSS was significantly more effective than placebo in improving quality of life as judged by the changes from baseline in the NOSIE and LASA total scores. (P less than 0.05) and by the Physicians' Global Evaluation (P less than 0.001). The mortality rate was similar between MPSS-treated males (40.2%), placebo-treated males (35.5%), and MPSS-treated females (40.0%). However, the mortality rate of 27.7% for female placebo-treated females was significantly lower than for their MPSS-treated counterparts. The reason for lower mortality among placebo-treated females is unknown and warrants further study.

Adolescent↗