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PubMed1995

Transvaginal ultrasonography of the endometrium in women with postmenopausal bleeding--a Nordic multicenter study.

OBJECTIVE: The purpose of this study was to use transvaginal ultrasonographic measurements to find the thickness of the endometrium below which the risk of endometrial abnormality in women with postmenopausal bleeding is low. STUDY DESIGN: This multicenter study was carried out at eight clinics in four Nordic countries. The study included 1168 women with postmenopausal bleeding scheduled for curettage Before the curettage was performed, the thickness of the endometrium was measured with transvaginal ultrasonography. The measurement included both endometrial layers (double-layer technique). The transvaginal ultrasonographic measurement was compared with the histopathologic diagnosis of the curettage specimens. RESULTS: In women with atrophic endometrium the mean endometrial thickness (+/- SD) was 3.9 +/- 2.5 mm. The corresponding figures for women with endometrial cancer were 21.1 +/- 11.8 mm. No malignant endometrium was thinner than 5 mm. In 30 women (2.8%) it was not possible to measure the thickness of the endometrium; one of these women had endometrial cancer. The 95% confidence limit for the probability of excluding endometrial abnormality was 5.5% when the endometrial thickness was < or = 4 mm as measured by transvaginal ultrasonography. CONCLUSION: The risk of finding pathologic endometrium at curettage when the endometrium is < or = 4 mm as measured by transvaginal ultrasonography is 5.5%. Thus in women with postmenopausal bleeding and an endometrium < or = 4 mm it would seem justified to refrain from curettage.

Adult↗
PubMed1993

Multicenter study of single-dose and multiple-dose fleroxacin versus ciprofloxacin in the treatment of uncomplicated urinary tract infections.

The clinical efficacy and safety of single-dose and multiple-dose fleroxacin were assessed and compared with those of ciprofloxacin in women with uncomplicated urinary tract infection (UTI) in this clinical study. This multicenter, randomized, double-blind, prospective study compared single-dose therapy with fleroxacin, 400 mg, with 7-day courses of fleroxacin, 200 mg once a day, and ciprofloxacin, 250 mg twice a day, in the treatment of uncomplicated symptomatic UTI in women at 18 centers in the United States. Of 961 patients enrolled, 316 were in the fleroxacin single-dose group, 321 in the fleroxacin 7-day group, and 324 in the ciprofloxacin group. Of these patients, 943 met the criteria for inclusion in the safety analysis and 556 met those for inclusion in the efficacy analysis. Bacteriologic cure rates at 5-9 days after therapy in patients evaluable for efficacy were 88%, 96%, and 96% in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group, respectively (p < 0.05). Clinical cures occurred in 93.6%, 97.2%, and 98% of the groups, respectively (difference not significant). At 4-6 weeks after therapy, the rates of bacteriologic cure in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group were 91%, 89%, and 93%, respectively (difference not significant). Adverse events were similar to those with other new quinolones and comparable among the treatment groups. Insomnia was more frequent in patients who received fleroxacin. Fleroxacin and ciprofloxacin as multidose regimens are similarly safe and effective in the treatment of uncomplicated UTI in women. Single-dose fleroxacin achieved a clinical response rate comparable to that achieved by the multiple-dose regimens, whereas its bacteriologic eradication rate was inferior.

Adolescent↗
PubMed1999

Identification of sentinel lymph nodes in vulvar carcinoma patients with the aid of a patent blue V injection: a multicenter study.

BACKGROUND: The aim of this multicenter study was to investigate the feasibility and negative predictive value of sentinel lymph node detection with blue dye in vulvar carcinoma patients. METHODS: In patients with squamous cell carcinoma of the vulva without suspicious groin lymph nodes, patent blue V was injected intradermally shortly before surgery. Routine groin lymph node dissection and radical vulvectomy were performed. During the surgery, blue lymph vessels and lymph nodes were identified, and the blue lymph nodes were sent separately for histologic examination. The negative predictive value of the blue lymph nodes for the absence of metastases was assessed by histologic examination of the groin lymph node specimens. RESULTS: Fifty-one patients in whom 93 groin lymph node dissections were performed were entered. One or more blue lymph nodes were detected in only 52 groins (56%). Nine (17%) of these were tumor positive, and 6 blue lymph nodes were the only tumor positive lymph nodes in the specimen in which they were found. There were two false-negative blue lymph nodes. The negative predictive value was 0.953. CONCLUSIONS: It was shown in this multicenter study that sentinel lymph node detection in vulvar carcinoma patients with blue dye only is not feasible because its negative predictive value is too low. Further studies involving the use of a combination of radioactive labeled technetium and blue dye are warranted.

Adult↗
PubMed1999

Probucol for treatment of hyperlipidemia in persistent childhood nephrotic syndrome. Report of a prospective uncontrolled multicenter study.

In a prospective, uncontrolled multicenter study, we have evaluated the effects of probucol on hyperlipidemia, proteinuria, and glomerular filtration rate (GFR) in hyperlipidemic children with persistent nephrotic syndrome. Probucol was started for a total of 12 weeks in 8 children and for 24 weeks in 14 children. Lipoprotein profiles, serum malondialdehyde (MDA) levels, proteinuria, renal function, and electrocardiogram were monitored every 4 weeks. Side effects were recorded by questionnaire. Treatment was completed by 7 of 8 patients for 12 weeks and by 7 of 14 children for 24 weeks. After 12 weeks, the mean serum concentrations of triglycerides (-15%), total cholesterol (-25%), very low-density lipoprotein-cholesterol (-27%), low-density lipoprotein-cholesterol (-23%), and high-density lipoprotein-cholesterol (-24%), as well as apolipoprotein (apo) A-I (-19%), apo B (-21%), and MDA (-32%) were reduced. The positive effects of probucol on the lipoprotein profile persisted over 24 weeks; however, there was no significant effect on either proteinuria or GFR. In conclusion, probucol had beneficial effects on lipoproteins and lipid peroxidation, but improved neither proteinuria nor GFR. The drug was generally tolerated well, but had to be discontinued because of a prolonged QT interval in 4 of 22 patients.

Adolescent↗
PubMed2000

Endovascular-assisted versus conventional in situ saphenous vein bypass grafting: cumulative patency, limb salvage, and cost results in a 39-month multicenter study.

OBJECTIVE: In this retrospective multicenter study, the results of a minimally invasive method of endovascular-assisted in situ bypass grafting (EISB) versus "open" conventional in situ bypass grafting (CISB) were evaluated with a comparison of primary and secondary patency, limb salvage, and cost. METHODS: Enrolled in this study were 273 patients: 117 underwent CISB (42 femoropopliteal, 75 femorocrural) and 156 underwent EISB (41 femoropopliteal, 115 femorocrural). EISB was performed with an angioscopic Side Branch Occlusion system and an angioscopically guided valvulotome. All the patients underwent follow-up examination with serial color-flow ultrasound scanning. RESULTS: Both groups had similar comorbid risk factors for diabetes mellitus, coronary artery heart disease, hypertension, and cigarette smoking. The primary patency rates (CISB, 78.2% +/- 5% [SE]; EISB, 70.5% +/- 5%; P =.156), the secondary patency rates (CISB, 84.1% +/- 4%; EISB, 82.9% +/- 5%; P =.26), and the limb salvage rates (CISB, 85.8%; EISB, 88.4%; P =.127) were statistically similar, with a follow-up period that extended to 39 months (mean, 16.6 months; range, 1 to 40 months). In veins that were less than 2.5 to 3.0 mm in diameter, the EISB grafts fared poorly, with an increased incidence of early (12-month) graft thromboses (CISB, 10 grafts, 8.5%; EISB, 24 grafts, 15.3%). However, wound complications (CISB, 23%; EISB, 4%; P =.003), mean hospital length of stay (CISB, 6.5 days +/- 4.83; EISB, 3.2 days +/- 3.19; P =.001), and mean hospital charges (CISB, $25,349 +/- $19,476; EISB, $18,096 +/- $14,573; P =.001) were all significantly reduced in the EISB group. CONCLUSION: The CISB and EISB midterm primary and secondary patency and limb salvage rates were statistically similar. In smaller veins (< 2.5 to 3.0 mm in diameter), however, EISB is not appropriate because overly aggressive instrumentation may cause intimal trauma, with resultant early graft failure. With the avoidance of a long leg incision in the EISB group, wound complications and hospital length of stay were significantly reduced, which lowered hospital charges and justified the additional cost of the endovascular instruments. When in situ bypass grafting is contemplated, EISB in appropriate patients is a safe, minimally invasive, and cost-effective alternative to CISB.

Aged↗
PubMed1989

Clinical experience with ciprofloxacin: analysis of a multicenter study.

The authors report a multicenter study of 19 patients treated with ciprofloxacin (mean daily dosage, 972 mg per day; mean duration of treatment, 8.5 days) for a variety of infections, ten microbiologically proven. Of these, bacteriologic cure equaled 70%, and improvement 30%. Overall, clinical cure equaled 73.7%, while improvement was 15.8%. No infections were classified as chronic. One adverse reaction was noted; a case of severe vomiting classified as related definitely to ciprofloxacin therapy. The patient discontinued therapy.

Adolescent↗
PubMed1987

Efficacy of nifedipine gastrointestinal therapeutic system in combination with beta blockers in the management of exertional angina. A multicenter study of 54 patients.

This multicenter study assessed the efficacy of a new formulation of nifedipine in 54 patients with stable angina pectoris receiving beta-blocker therapy. This once-daily preparation of nifedipine was administered in double-blind fashion in doses of 30, 60, and 90 mg. All patients experienced pain-limited exercise at placebo baseline treadmill testing. Eight hours post-dose exercise testing resulted in a significant increase in time to onset of angina for all three dose levels of nifedipine but not for placebo. Exercise testing 24 hours after dosing showed significant improvement in time to angina and total exercise time for patients receiving 60-mg and 90-mg doses but not for the 30-mg or placebo categories. These preliminary results suggest that this new formulation of nifedipine is beneficial when added to stable doses of a beta blocker in patients in whom angina is still exhibited during exercise testing.

Adrenergic beta-Antagonists↗
PubMed1986

The prognosis of transient global amnesia. Results of a multicenter study.

In a Danish multicenter study, 74 patients 20 to 75 years of age (mean age, 58.8 years) with transient global amnesia (TGA) without accompanying major neurological signs were studied. Over a follow-up period ranging from seven to 210 months (mean, 66.6 months) the observed rates of death and cerebrovascular morbidity were similar to those expected in the Danish population, matched for age and sex. Sixteen patients (22%) had further TGAs occurring one month to nine years after the original episode; the mean annual recurrence rate was 4.7%. We concluded that TGA without associated major neurological deficits is a benign clinical phenomenon, probably caused by a functional cerebral disturbance unrelated to cerebrovascular disease in general. Furthermore, the observed temporal pattern of recurrence suggests that, although TGA is in principle a recurrent disorder, the annual risk of recurrence is so low that most of the elderly patients are likely to experience only one attack.

Adult↗
PubMed1988

Intravenous immunoglobulin (i.v. IgG) for previously treated acute or for chronic idiopathic thrombocytopenic purpura (ITP) in childhood: a prospective multicenter study.

In a prospective multicenter study 42 thrombocytopenic (less than 30 X 10(9) platelets/l) children with chronic idiopathic thrombocytopenic purpura (ITP) or with acute ITP, dependent on or refractory to corticosteroids, were given 0.4 g i.v. IgG/kg body weight/day on 5 consecutive days and thereafter once a week if the platelet count fell to less than 20 X 10(9)/l or if the patient bled. After the initial 5 days of i.v. IgG the platelets rose within a mean of 7-8 days to greater than 30 X 10(9)/l in all and to greater than 150 X 10(9)/l in 33 of 42 patients (79%). After a mean observation time of 26.6 months 26 of 42 patients (62%) showed a satisfactory long-term effect, i.e. no need for treatment for at least 6 months without bleeding and with no platelet counts below 20 X 10(9)/l. No difference in response rate was found between children with chronic and those with previously treated acute ITP. These results indicate that i.v. IgG could be used to control emergency situations, e.g. to stop bleeding or to prepare a patient for surgery. I.v. IgG also represents a good alternative to treatment modalities, such as splenectomy and/or the administration of cytostatic immunosuppressants with potentially serious side effects. In addition to the expected transient rise in serum IgG levels, i.v. IgG induced a more prolonged elevation of serum IgM. Platelet associated IgG, elevated before therapy, was correlated with the clinical long-term outcome.

Acute Disease↗
PubMed1996

Trajectories and profiles of adaptive behavior in males with fragile X syndrome: multicenter studies.

We conducted two multicenter studies on adaptive trajectories and profiles in males with fragile X syndrome. Study 1 longitudinally assessed 29 males ages 1-20 years using age-equivalent scores from the Vineland Adaptive Behavior Scales. Fragile X boys ages 1-10 years showed significant gains in adaptive skills from first to second testing; males ages 11-20 years were stable in their adaptive development. Study 2 cross-sectionally examined 132 males ages 1-20 years. Significant age-related gains were found in boys ages 1-10, particularly in preschool children. Subjects ages 11-20 showed increased variability and nonsignificant relations between age and adaptive skills. Preliminary findings from 26 young adults with fragile X syndrome ages 21-40 years showed stable age-equivalent adaptive scores during these years. Relative strengths in daily living skills and weaknesses in communication were only evident among older subjects. Significant relations were found between adaptive behavior standard scores and IQ; these two scores also showed age-related declines that likely parallel one another. Findings are related to adaptive features in other genetic syndromes, and to directions for future adaptive behavior research.

Activities of Daily Living↗
PubMed1986

Cardiovascular complications of estrogen therapy for nondisseminated prostatic carcinoma. A preliminary report from a randomized multicenter study.

In a prospective multicenter study, 244 men with highly or moderately differentiated prostatic cancer in stage I, II or III (VACURG) were consecutively randomized to three groups of treatment: Group A (77 patients) received polyestradiol phosphate (Estradurin, Leo) 80 mg i.m. every fourth week + ethinyl estradiol (Etivex, Leo) 150 micrograms daily, group B (72 patients) estramustine phosphate (Estracyt, Leo) 280 mg twice daily, and group C (76 patients) no therapy. Only men without current or previous other malignancy and without cardiovascular disease were admitted to the study. After 4 1/2 years 125 of the 244 patients had left the study, 9 because of cancer progression (stage IV, VACURG). The most serious complications were cardiovascular, including ischemic heart disease, cardiac decompensation, cerebral ischemia and venous thromboembolism, which occurred in 24 patients from group A and 9 from group B as compared to only one patient in group C. The subgroup superficial or deep venous thrombosis comprised 11 group A and 2 group B patients. Estrogens (E + e) offered as palliative treatment to patients with non-generalized prostatic carcinoma is burdened with a high incidence of serious cardiovascular complications.

Aged↗
PubMed1995

[Postoperative complications and fatalities in surgical therapy of colon carcinoma. Results of the German multicenter study by the Colorectal Carcinoma Study Group].

In a prospective multicenter study an analysis of postoperative morbidity and mortality of 1224 patients with colon carcinoma treated in 7 departments of surgery was performed. The postoperative morbidity rate was 23.2% in elective surgery and 39.1% in emergency surgery. Postoperative mortality was 3.4% in elective cases and 11.6% in emergency cases. Preoperative associated diseases, which are more frequent in higher age, advanced tumor stage, and postoperative non-surgical complications rise operative mortality. However, surgical complications increase postoperative mortality only in cases of anastomotic leaks. The rates of postoperative complications depended on different surgical departments. Departments performing a delayed tumor resection in emergency surgery had better results. In elective cases the standard of oncological resections should be observed. In emergency cases operative procedure and extension of the resection should be planed in consideration of preoperative risk factors of the individual patient.

Adult↗
PubMed1995

Frequency of hereditary nonpolyposis colorectal cancer. A prospective multicenter study in Finland.

PURPOSE: Hereditary nonpolyposis colorectal cancer (HNPCC) is an autosomal dominant cancer syndrome characterized by early onset of colorectal carcinomas (CRC). Recently, two HNPCC genes have been mapped and cloned, one in the short arm of chromosome 2 and another in the short arm of chromosome 3. There has been a major controversy about the frequency of HNPCC. The few estimates available have been based on series selected by age or series representing local area. The purpose of the present study was to design a nonselected, prospective, multicenter study, taking into account the family background and other risk factors of CRC. METHODS: The proportion of HNPCC of all (N = 406) CRC cases was evaluated in a prospective multicenter study. Family history and other risk factors were investigated over a 12-month period for all new CRC patients in ten hospitals. These cases constituted 23 percent of all CRCs diagnosed in Finland during the study period. RESULTS: Three (0.7 percent) cases of verified and seven (1.7 percent) cases of suspected HNPCC were identified, following the evaluation of all families with features indicative of susceptibility to cancer. The proportion of identifiable risk factors of CRC was 5.8-7.5 percent (HNPCC, 0.7-2.4 percent; previous CRC, 3.4 percent; ulcerative colitis, 1.0 percent; familial adenomatous polyposis coli, 0.7 percent). CONCLUSION. This prospective multicenter study revealed that the frequency of hereditary colorectal cancer is lower than in some previous studies, when diagnosis is based on extensive pedigree analysis. This result with recent findings of common ancestral founding mutation in Finnish HNPCC families indicates that there may be geographic differences in the occurrence of HNPCC. However, this does not change the fact that identification of HNPCC--perhaps one of the most common inherited diseases identified in humans--has become a question of vital importance now when diagnosis of the syndrome and large-scale screening of gene carriers using specific tests are on the horizon.

Adult↗
PubMed1984

Left ventricular dysfunction after acute myocardial infarction: results of a prospective multicenter study.

In a multicenter prospective study of 866 patients who survived the coronary care unit phase of an acute myocardial infarction, variables reflecting left ventricular function were examined to assess their impact on 2 year survival. Single variables that reflected left ventricular dysfunction before infarction and in the acute and recovery phases were, respectively, history of prior myocardial infarction, rales in the coronary care unit dichotomized at greater than bibasilar and predischarge radionuclide ejection fraction dichotomized at less than 0.40. When combined in a stepwise fashion, patients lacking these three risk characteristics had a 2 year 4.2% mortality rate, whereas patients possessing all three characteristics had a 45% mortality rate. Rales in the coronary care unit and predischarge ejection fraction act independently, and each contributes to mortality. Fifty-two patients with advanced rales but an ejection fraction of 0.40 or greater had a 21% mortality rate. Similarly, 208 patients with few rales but an ejection fraction of less than 0.40 had a 15% mortality rate. These data suggest that the mortality risk imposed by those factors that assess permanent left ventricular damage is independent of and additive to the mortality risk contributed by dynamic, acute phase dysfunction. These data fit the hypothesis that acute phase dysfunction is, in part, due to transient ischemia that, on reversal, can restore function toward normal. The results suggest 1) that assessment of left ventricular function during the acute and recovery phases of myocardial infarction is necessary to define prognostic characteristics of an individual patient, and 2) that of particular importance is the identification of patients whose postinfarction course is consistent with reversible ischemia.

Cardiac Output↗
PubMed1993

[An evaluation of the hypolipidemic effects of lovastatin in primary hypercholesterolemia. A multicenter study].

In the multicenter trial, the hypolipidemic efficacy and adverse event profile of lovastatin were estimated in 294 patients with primary hypercholesterolemia. The mean baseline (on placebo) lipid and lipoprotein values were: total serum cholesterol (TC) 313 mg/dl, triglycerides (TG) 168 mg/dl, low density lipoprotein cholesterol (LDL-C) 235 mg/dl, high density lipoprotein cholesterol (HDL-C) 44.9 mg/dl. Lovastatin was begun with 20 mg/day, the dose being doubled after 4 and 8 weeks if the target reduction of TC < 200 mg/dl was not reached at those moments. At the end of the treatment the mean TC decreased by 29.5% (p) as compared with the baseline level, TG by 14% (p). The normal target level of TC was reached in 106 patients (36%), the borderline levels (200-240 mg/dl) in 123 (42%), high TC (240 mg/dl) remained in 65 patients (22%). LDL-C decreased by 38% (p), HDL-C increased by 7.8% (p), whereas LDL-C/HDL-C ratio decreased by 40% (p). The treatment was well tolerated by patients: mild clinical side effects were noticed in 2.7% of patients and asymptomatic transient deviations of laboratory tests in 8.2%. The authors conclude about high hypolipidemic efficacy and low adverse event profile of lovastatin in patients with primary hypercholesterolemia.

Adult↗
PubMed1991

Angiographically assessed coronary arterial patency and reocclusion in patients with acute myocardial infarction treated with anistreplase: results of the anistreplase reocclusion multicenter study (ARMS).

In this open multicenter study, 156 patients with acute myocardial infarction received 30 U of anistreplase intravenously over 5 minutes within 4 hours of the onset of chest pain. The patency of the infarct-related vessel was determined by coronary angiography 90 minutes after anistreplase treatment, and also 24 hours after treatment, in patients with a patent infarct-related vessel at 90 minutes, to assess the reocclusion rate. The investigators categorized the infarct-related vessel as patent or occluded, and 2 independent cardiologists graded the infarct-related vessel according to the Thrombolysis in Myocardial Infarction (TIMI) perfusion criteria. At the 90-minute assessment, 106 of 145 evaluable patients (73%) had patent infarct-related vessels, and 39 of 145 (27%) had occluded infarct-related vessels. Of the 139 independently assessed patients, 98 (71%) had TIMI grades 2 or 3 and 41 (29%) had TIMI grades 0 or 1. At the 24-hour assessment, 98 of 102 patients (96%) had a patent infarct-related vessel, and reocclusion had occurred in 4 of 102 patients (4%). Of the 94 independently assessed patients 90 (96%) had TIMI grades 2 or 3, and 4 (4%) had TIMI grades 0 or 1. The reliability of noninvasive parameters as indicators of achieved patency of the infarct-related vessel was estimated by means of correlation with patency assessed by coronary angiography. A significant correlation of 0.62 was found. The patency rate of 71 to 73% after use of anistreplase in patients with acute myocardial infarction corresponds with findings in earlier studies. The low reocclusion rate of 4% after use of anistreplase probably reflects the prolonged action of anistreplase.

Adult↗