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At least 703 records · Page 39Linked to original sources
PubMed1990

Tumor immunoscintigraphy by means of radiolabeled monoclonal antibodies: multicenter studies of the Italian National Research Council--Special Project "Biomedical Engineering".

Four radioimmunopharmaceuticals (99mTc- and 111In-labeled anti-melanoma and 111In- and 131I-labeled anti-carcinoembryonic antigen F(ab')2 fragments derived from monoclonal antibodies 225.28S and F023C5) were developed by means of a collaborative effort coordinated by the Italian National Research Council, Special Project "Biomedical Engineering." After appropriate pilot studies, the radioimmunopharmaceuticals, prepared by Sorin Biomedica (Saluggia, Italy), were distributed to 31 Nuclear Medicine departments in Italy and in 10 other European countries within the framework of three immunoscintigraphy multicenter studies. A total of 1245 patients were studied, 898 of whom carried 1725 documented tumor lesions; 1596 of 2193 tumor lesions (468 of which were previously unknown) were imaged by immunoscintigraphy in 785 of 990 lesion-bearing patients. Among the occult lesions, 173 were imaged in 92 patients admitted to the study as lesion-free patients. The results have been analyzed in terms of the reliability, reproducibility, and diagnostic usefulness of the method and of each immunoradiopharmaceutical.

Adenocarcinoma↗
PubMed1990

Multicenter evaluation of triamcinolone acetonide nasal aerosol in the treatment of adult patients with seasonal allergic rhinitis.

Triamcinolone acetonide aerosol inhalation therapy is effective for the prophylactic treatment of asthma. Recently, the delivery system for this preparation has been modified for use in allergic rhinitis. A total of 180 adult patients with symptomatic seasonal allergic rhinitis participated in this double-blind, placebo-controlled, multicenter trial. Patients received either placebo or approximately 25 mg per actuation of triamcinolone acetonide aerosol per nostril, qid, for 4 weeks. Each patient kept a daily diary rating rhinitis symptoms. Both the patient and the physician also gave global evaluations of drug efficacy. Of 168 evaluable patients, significant reductions were seen at week 1, week 2, and in the overall study evaluation of ratings for intensity (P less than .001) and duration (P less than .05) of various rhinitis symptoms such as nasal stuffiness, discharge, and sneezing in the group given triamcinolone acetonide. Superiority to placebo group was evident as early as day 1 and maintained throughout the study. Both patients and physicians rated triamcinolone acetonide as significantly more effective than placebo for the duration of the study (P less than .001). There was a marked reduction in nasal smear eosinophils in the triamcinolone acetonide group. There was no difference between groups in safety evaluations including no evidence of suppression of the adrenal axis and no evidence of fungal infection. This study demonstrates that triamcinolone acetonide in a dose of 25 micrograms per nostril, qid, is effective, well tolerated, and safe in reducing symptoms in adult patients with seasonal allergic rhinitis.

Administration, Intranasal↗
PubMed1990

Effects of simvastatin and cholestyramine in familial and nonfamilial hypercholesterolemia. Multicenter Group I.

Simvastatin, a potent inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, was compared with cholestyramine resin in a randomized open-label 12-week multicenter study of 251 high-risk patients with familial or nonfamilial hypercholesterolemia. Simvastatin, 20 mg and 40 mg daily, produced mean reductions in total cholesterol of 26% and 33%, respectively, and reductions in low-density lipoprotein cholesterol level of 32% and 40%. Cholestyramine resin, 4 to 12 g twice daily, reduced total cholesterol and low-density lipoprotein cholesterol levels 15% and 21%, respectively. High-density lipoprotein cholesterol levels were increased 8% to 10% by all treatments. Plasma triglyceride levels were moderately decreased by simvastatin treatment, while triglyceride levels increased with cholestyramine treatment. Simvastatin was better tolerated than cholestyramine, which had numerous gastrointestinal tract side effects. No patient had a serious drug-related adverse event.

Adult↗
PubMed1990

Incidental white matter hyperintensities on magnetic resonance imaging in HIV-1 infection. Multicenter AIDS Cohort Study.

Magnetic resonance (MR) scans were performed as part of a prospective neuropsychological study within the Multicenter AIDS Cohort Study. Fifty HIV-1-seronegative men, 85 HIV-1-seropositive men without constitutional symptoms, and 14 with symptomatic HIV disease underwent MR imaging using a uniform protocol. Scans were rated by neuroradiologists blinded to all clinical details except age. The majority of MR scans were normal in all of the clinical groups and no covert mass lesions or diffuse white matter abnormalities were identified. Focal hyperintensities in the white matter were observed in 24% of the HIV-1 seronegatives, 26% of HIV-1 asymptomatic seropositives (CDC II/III), and 17% of those with ARC/AIDS. No significant associations were noted between the white matter hyperintensities and HIV-1 serostatus, neurological abnormalities, CD4 count, alcohol or drug use, hypertension, or smoking. In one individual classified with early HIV-1 dementia, MR demonstrated several hyperintensities in the deep parietal white matter, but at autopsy no microscopic abnormalities corresponding to the MR findings were identified. Our studies imply that focal white matter hyperintensities identified on MR are not specific for HIV-1 infection and are probably incidental and of no clinical significance.

AIDS-Related Complex↗
PubMed1990

An assessment of diltiazem and hydrochlorothiazide in hypertension. Application of factorial trial design to a multicenter clinical trial of combination therapy.

This multicenter, factorial-design trial assessed the safety and additive antihypertensive efficacy of a slow-release (SR) formulation of diltiazem hydrochloride given alone or in combination with hydrochlorothiazide for treatment of mild to moderate hypertension. After a 4- to 6-week placebo run-in period, 297 qualifying patients were randomized to receive placebo, 1 of 4 doses of diltiazem SR monotherapy, 1 of 3 doses of hydrochlorothiazide monotherapy, or 1 of 12 possible combinations of diltiazem SR and hydrochlorothiazide for 6 weeks. A dose-related reduction in blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination. Absolute blood pressures of patients who received combination therapy were lower by an overall mean of 3.0 mm Hg diastolic and 8.0 mm Hg systolic vs diltiazem SR used alone and 3.5 mm Hg diastolic and 4.0 mm Hg systolic vs hydrochlorothiazide used alone. At the largest doses used, 50% of patients achieved goal blood pressure while taking hydrochlorothiazide, 57% while taking diltiazem SR, and 75% while taking combination therapy. Combination therapy was well tolerated. This trial clearly demonstrates that diltiazem SR and hydrochlorothiazide have additive antihypertensive effects.

Adult↗
PubMed1989

The long-term efficacy of ibopamine in treating patients with severe heart failure: a multicenter investigation.

This randomized, double-blind, placebo-controlled, multicenter trial compared the effects of treatment with ibopamine with those of placebo in patients with severe heart failure who still showed symptoms although they were receiving standard therapy with digitalis and diuretics. The results showed a significant and sustained improvement in exercise tolerance (+70% about in average), clinical condition, and NYHA functional class and a decrease in cardiothoracic ratio and left ventricular end-systolic wall stress in patients treated with ibopamine, digitalis, and diuretics (group 1) compared with patients treated with digitalis, diuretics, and placebo (group 2).

Adult↗
PubMed1989

Long-term therapy of chronic congestive heart failure with ibopamine: a multicenter trial.

The present multicenter open investigation was designed to provide information on the adverse reaction rate, drug interaction, and survival in a group of 544 cardiac patients treated for 1 year with ibopamine either alone or in association with digitalis, diuretics, and other drugs. Some efficacy parameters were also considered. Heart failure was due to idiopathic dilated cardiomyopathy (21%), ischemic heart disease (32%), hypertensive heart disease (31%), and others (16%). Ibopamine was given alone to 39 patients; the others were given the drug in association with digitalis, diuretics, and vasodilators. One hundred forty patients did not complete the trial (25.7%). The most common causes of discontinuation were death (12.5%), noncompliance with the protocol (5%), and adverse events (3.9%). The clinical conditions and NYHA functional class improved in most patients. The cardiothoracic ratio decreased on average. The 1-year mortality rates associated with NYHA class II, III, and IV were 4.4, 13.8, and 37.2%, respectively. Survival tended to be shorter in a small group of 22 patients with hyponatremia, thus confirming some previous reports. Adverse experiences were mainly related to cardiovascular and gastrointestinal systems; the symptoms were considered severe only in 1 of 544 patients enrolled. Ibopamine seems not to induce dangerous arrhythmias. Blood pressure and heart rate did not change over time during ibopamine treatment. Laboratory tests were not significantly affected; fluctuations observed in some tests were related to concomitant variations in the severity of the primary disease. No tolerance to ibopamine seems to be observed during this long-term therapeutic trial.

Adult↗
PubMed1989

[A multicenter comparative study in patients with liver metastasis to compare tegafur in new forms with existing drugs. SF-RC.SF-SP Comparative Study Group].

A multicenter comparative study was carried out in 101 patients with liver metastasis to compare tegafur in a new oral form (Sunfural S) and tegafur in a new soft-capsule suppository form (Sunfural Rectal Capsules) with existing drugs. Sunfural S showed a tendency toward high plasma and tissue levels as compared to existing drugs, and clinically, Sunfural S produced survival times that surpassed those of existing drugs. Liver metastasis at the present time has few effective treatments, but we expect that anticancer effects will be obtained through the administration of new drugs with improved bioavailability.

Administration, Oral↗
PubMed1989

Efficacy and safety of flecainide in patients with stable ventricular ectopic beats. Multicenter trial of the Italian Study Group on the Electrophysiology of Arrhythmias.

The aim of this multicentre study, carried out by the Italian Study Group on the Electrophysiology of Arrhythmias (GISEA) in 60 Italian Cardiology Centres on 260 patients, was to assess the efficacy and the safety of flecainide in the treatment of stable hyperkinetic ventricular arrhythmias (greater than 100 ventricular ectopic beats/hour per day). The stability of the arrhythmia was verified using 24 hour Holter recordings allowing for a spontaneous variability of less than 20%. All the patients belonged to class NYHA I or II. Flecainide was administered in 2 x 100 mg/day doses and if the efficacy criteria, checked by the Holter on the 6th day, were not met the dose was increased to 2 x 150 mg/day. After a further Holter recording on the 11th day, therapy continued until the 31st day when the final recordings were carried out. The study protocol was completed by 249/260 pts. (95.7%). Due to violation of the protocol which included lack of basal stability of the arrhythmia 69/249 pts. (28%) were excluded. The 69 excluded patients were not considered for the efficacy evaluation, but entered for safety considerations. Only 16/180 (8%) of the qualified pts. were drop-outs. In the remaining 164 patients considered in the final evaluation, flecainide proved to be effective in 122 patients (74%) with a greater than 80% reduction of ventricular ectopic beats. In 118/131 patients (90%) there was a greater than 75% reduction in the couples and suppression of non-sustained ventricular tachycardia. The flecainide plasma levels were, on average, within the therapeutic range and could be correlated to dose level. The total incidence of adverse effects was 15% and the most frequent extracardiac ones were of a neurologic type. Proarrhythmic effects were observed in only 3/249 patients. This multicenter study in pts. with greater than 2400 ventricular ectopic beats/day confirms that flecainide is effective in the treatment of hyperkinetic ventricular arrhythmias including complex ones and that it is well tolerated in patients in a good NYHA functional class. Moreover this study emphasizes the serious problem of the individual variability of ventricular ectopic beats which requires the application of rigorous selection criteria for the correct execution of the trial as was done in this study.

Adolescent↗
PubMedDate not supplied

A multicenter comparison of adhesion, preference, tolerability, and safety characteristics of two transdermal nitroglycerin delivery systems: Transderm-Nitro and Deponit.

One hundred forty-two patients with stable angina were enrolled in a four-week, multicenter, office-based study to compare the adhesion properties, patient preference, and tolerability of two commercially available transdermal nitroglycerin patches. Data from 139 patients were analyzed. Each patient simultaneously wore one 5-mg Transderm-Nitro (TDN) patch and one 5-mg Deponit (DPT) patch. Patients daily recorded the following information in a diary format: number of angina attacks, frequency of sublingual nitroglycerin use, patch adhesion, and problems at the adhesion site or other medical problems. At the end of the study, patients rated their patch preferences based on ease of application and removal, ease of removing backing, overall adhesion, and adhesion under specific conditions, such as showering, swimming, exercise, hot weather, high humidity, and perspiration. They also specified which patch they would choose for their next prescription. Differences in adhesion properties (P less than 0.0001) and tolerability at the site of application favored TDN over DPT. In addition, significantly more patients (P less than 0.0001) specified TDN as their next prescription choice (83% vs 11%).

Adhesiveness↗
PubMed1989

OKT3 prophylaxis versus conventional drug therapy: single-center perspective, part of a multicenter trial.

As part of a collaborative study, Orthoclone OKT3 (Ortho Pharmaceutical Corporation, Raritan, NJ) monoclonal anti-T-cell antibody was used prophylactically for 14 days following cadaveric renal transplantation. Patients were randomized before treatment and compared with a control group treated with triple-drug immunosuppressant therapy consisting of cyclosporine, azathioprine, and prednisone. The OKT3 group (also treated with prednisone and azathioprine) had significantly fewer patients with acute rejection during the first year (27% v 60%), significantly delayed onset of acute rejection (median number of days to rejection, 56 v 10), and shortened duration of delayed initial graft function (median number of days on nonfunction, 5.5 v 9.0). OKT3 was safely administered intraoperatively. The study group included diabetics and patients over the age of 50 years. There was an increased incidence of benign fungal infection in patients treated with OKT3. The outcome data of both the prophylactic and control groups in this single-center trial was different from the multicenter experience in that patient and graft survival was 100% in both groups. The only difference in the immunosuppressive protocol was the use of 2 g intravenous methylprednisolone intraoperatively. The combination of intraoperative OKT3 with 2 g methylprednisolone may merit further study. It was concluded that OKT3 prophylaxis reduces the incidence of rejection episodes, delays the occurrence of rejection, and may reduce the duration of delayed initial graft function. It is not associated with an increase in serious infection and can be administered safely to a variety of cadaver transplant recipients.

Antibodies, Monoclonal↗
PubMed1989

Prevention of postsurgical adhesions by INTERCEED(TC7), an absorbable adhesion barrier: a prospective randomized multicenter clinical study. INTERCEED(TC7) Adhesion Barrier Study Group.

INTERCEED(TC7) (Johnson & Johnson Patient Care Inc., New Brunswick, NJ) is an absorbable fabric specially designed to reduce postsurgical adhesions. The authors report on a prospective, randomized, multicenter, clinical trial that evaluated the efficacy of Interceed in reducing adhesions in humans. Infertility patients (n = 74) with bilateral pelvic sidewall adhesions were studied at treatment laparotomy and "second-look" laparoscopy to determine Interceed's effectiveness. After removal of adhesions at laparotomy, the deperitonealized area of one pelvic sidewall was covered with Interceed. The contralateral untreated sidewall served as the control. Pelvic sidewalls covered with Interceed had a 90% improvement over control sidewalls in preventing adhesion formation. Additionally, Interceed treatment was associated with a 57% reduction of the extent of adhesion formation over that obtained by microsurgical techniques alone. Interceed also provided a significant benefit in reducing the severity of those adhesions that did form, and significantly reduced the number of adhesions between the ovary and pelvic sidewall. In conclusion, Interceed significantly reduced the incidence, extent, and severity of postsurgical pelvic adhesions.

Cellulose↗
PubMed1989

No evidence for a role of alcohol or other psychoactive drugs in accelerating immunodeficiency in HIV-1-positive individuals. A report from the Multicenter AIDS Cohort Study.

In a multicenter cohort study of homosexual men, the proportion of seropositives at enrollment who developed the acquired immunodeficiency syndrome (AIDS) during the following 18 months ranged from 5.5% to 8.2% in 1597 alcohol drinkers vs 9.2% in 109 nondrinkers with no clear trend according to use, and from 6.3% to 9.6% for 1662 users vs 7.2% for 83 nonusers of psychoactive drugs prior to enrollment. Among seropositive men with low initial T helper lymphocyte counts, those who continued to use drugs showed no significantly higher 18-month risk of AIDS than nonusers (13% vs 10%); the corresponding risks were 13% and 15%, respectively, for continued heavier vs continued lighter consumption of alcohol. No other manifestations of immunodeficiency were positively associated with substance use prior to enrollment. Prior use was not associated with low mean T helper cell counts at enrollment, and continued drug or alcohol use after enrollment was not associated with greater subsequent decline in counts. As used in a large cohort of homosexual men, psychoactive substances did not enhance the progression of human immunodeficiency virus infection.

Acquired Immunodeficiency Syndrome↗
PubMed1989

[Cefotetan in the therapy of respiratory infections. Multicenter research].

In a controlled multicenter trial 291 patients have been treated with cefotetan. They suffered from acute or chronic exacerbated bronchopulmonary disorders. In 110 patients it was possible to identify the etiological agent: enterobacteria (62), non-fermentative gram-negative bacilli (10), Haemophilus influenzae (8), Branhamella catarrhalis (1), Streptococcus pneumoniae (19), Staphylococcus aureus (12), Streptococcus pyogenes (4). In the exacerbations of chronic bronchitis (203), cefotetan was generally administered at the dose of 1 g/12 h i.m., whereas it was administered at the dose of 2 g/12 h i.v. in acute infection. The mean duration of therapy was 8.8 days. Positive clinical results were obtained in 251 patients (86.2%) with eradication of the pathogen initially isolated in 90.5% of cases. Cefotetan showed good local and general tolerance. The results obtained confirm those of studies concerning limited numbers of patients and show the efficacy of cefotetan both in acute and chronic pathologies, also in patients with serious involvement of their general conditions (concomitant pathologies, high mean age).

Acute Disease↗
PubMed1989

Experience of a German multicenter study group with ifosfamide in small cell lung cancer.

In three German multicenter randomized trials, which included 718 patients, the activity of ifosfamide in small cell lung cancer (SCLC) was tested. In study 1, IE (ifosfamide, 1.5 g/m2, days 1 through 5; etoposide, 120 mg/m2, days 3 through 5) alternating with CAV (cyclophosphamide, 600 mg/m2, days 1 and 2; doxorubicin, 50 mg/m2, day 1; vincristine, 2 mg, day 1) was compared with a response-oriented treatment with IE therapy up to maximum response and subsequently an immediate switch to CAV. After chemotherapy, patients with limited disease received chest irradiation with 45 Gy. Prophylactic cranial irradiation (30 Gy) was given to all patients who achieved complete response (CR). A total of 324 patients were evaluable. Total response rate (CR + partial response [PR]) was 75% v 78% for the two treatment groups; the CR rate was 29% for both groups. Survival was nearly identical in both arms, with a median survival of 10.0 months for all patients, 12.0 months for those with limited disease (LD), and 7.5 months for those with extensive disease (ED). The 2-year survival rate was 11%. In study 2, IE was compared with PE (cisplatin, 90 mg/m2, day 1; etoposide, 150 mg/m2, days 3 through 5). A total of 141 patients were evaluable. Total response (CR + PR) rate was 65% for PE and 68% for IE; the CR rate for PE was 32% v 20% for IE. Survival favored PE with a median survival of 11.6 months v 9.4 months for all patients, 14.8 months v 11.0 months for LD, and 8.9 months v 7.5 months for ED. Two-year survival rates were 12% v 9% for all patients, 23% v 10% for those with LD, and 5% v 9% for those with ED. From these trials, we conclude that IE is an active and well-tolerated regimen for SCLC, and that PE may be superior to IE in limited-stage disease. Taking these results into account, we modified our chemotherapy protocols in study 3 and compared IAV (ifosfamide, 2 g/m2, days 1 to 5; doxorubicin, 25 mg/m2, days 1 and 2; vincristine, 2 mg, day 1) alternating with either PE or JE (carboplatin, 300 mg/m2, day 1; etoposide, 120 mg/m2, days 1 to 3). Interim results of 253 evaluable patients are as follows: CR + PR rate after 4 cycles was 68%; the CR rate was 28%; median survival was 11.6 months for all patients, 14.8 months for LD, and 10.2 months for ED.(ABSTRACT TRUNCATED AT 400 WORDS)

Aged↗
PubMedDate not supplied

[Treatment of deep venous thrombosis. Comparative study of a low molecular weight heparin fragment (Fragmin) by the subcutaneous route and standard heparin by the continuous intravenous route. A multicenter study].

This open, randomised multicenter trial compares the efficacy and safety of Fragmin administered subcutaneously twice daily with standard heparin administered by continuous infusion in the treatment of deep vein thrombosis (DVT). The initial dose of Fragmin is 100 U anti-Xa/kg/12 h and the further doses are adjusted according to the anti-Xa activity between 0.5 and 0.8 U/ml, 3 hours after the morning injection. The initial dose of standard heparin is 240 UI/kg/12 h. The dose adjustments are based on the daily results of APTT (1.5 - 3 times the control). Treatments efficacy are appreciated when comparing the venography performed before and after 10 days of treatment. The safety is evaluated on clinical parameters and iterative biological tests. Sixty-six patients have been included in this study. Efficacy of the two treatments is equivalent with a phlebographic improvement in respectively 79.3 p. 100 (Heparin Group) and 71.0 p. 100 (Fragmin Group) of the cases and an aggravation in 3.4 p. 100 and 6.4 p. 100 (NS) respectively. The frequency of dosage adjustments is lower and the stability of biological tests is better in the Fragmin group. In conclusion, the administration of Fragmin twice daily by subcutaneous route seems to be equivalent at least to standard heparin continuous infusion in the treatment of recent DVT. The better convenience and safety of Fragmin have to be verified on a larger panel of patients.

Adult↗
PubMed1989

Comparison of nizatidine and cimetidine as once-nightly treatment of acute duodenal ulcer. Nizatidine Multicenter Duodenal Ulcer Study Group.

Nizatidine, a new H2-receptor antagonist for the treatment of duodenal ulcer disease, was compared with cimetidine in an 8-wk, randomized, double-blind, multicenter clinical trial. Patients were randomly allocated to receive either nizatidine 300 mg h.s. or cimetidine 800 mg h.s. Patients were treated for 8 wk, regardless of the healing status of their ulcers. An endoscopy was performed at Wk 2, 4, and 8. Healing rates with nizatidine 300 mg h.s. were numerically, but not statistically significantly, superior to those with cimetidine 800 mg h.s. at each treatment period. Ulcer healing rates at Wk 2, 4, and 8 were 41% (78/191), 73% (130/179), and 81% (145/179) for nizatidine and 33% (60/184), 67% (116/174), and 75% (126/168) for cimetidine, respectively. Symptoms of peptic ulcer disease were similarly reduced at each treatment period by nizatidine and cimetidine. Patients with healed ulcers at either Wk 2 or Wk 4 were continued on therapy and an endoscopy was performed at Wk 8. Ulcer recurrence occurred in 10% of nizatidine-treated and 19% of cimetidine-treated patients at Wk 8 (p = 0.085). The observation of recurrence of duodenal ulcer while patients were receiving full-dose H2-receptor antagonist therapy has not been reported previously.

Acute Disease↗
PubMed1989

A multicenter clinical evaluation of a new monophasic combination: Minulet (gestodene and ethinyl estradiol).

The safety and efficacy of a low-dose monophasic oral contraceptive (OC) containing a new progestogen, gestodene (GTD), combined with ethinyl estradiol (EE) is being investigated in two ongoing multicenter trails. In this interim analysis, the formulation was found to be effective and well tolerated. Subject compliance was excellent; no pills were missed in 91.2% of the cycles. The number of women who withdrew from the study was low (15%), indicating good subject acceptance. GTD + EE provided optimal cycle control. Of the total number of OC cycles analyzed, spotting occurred in 8.1%, breakthrough bleeding in 1.8%, and both spotting and breakthrough bleeding in 3.3%. The incidence of spotting decreased fairly steadily during OC administration. Amenorrhea occurred in 0.5% of the cycles. There were no unexpected or serious side effects. The incidence of side effects was low and declined with increased duration of OC use. There were no clinically significant changes in weight or blood pressure. Virtually all of the systolic and diastolic blood pressure readings were in the normal range. The results of this interim analysis indicate that the GTD + EE formulation is a safe and reliable contraceptive.

Adolescent↗