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At least 595 records · Page 33Linked to original sources
PubMed1989

Evaluation of the clinical performance of three triphasic oral contraceptives: a multicenter, randomized comparative trial.

Three hundred thirteen women participated in an open, multicenter comparison of the incidence of intermenstrual bleeding (breakthrough bleeding and or spotting) associated with the use of three triphasic oral contraceptives. Triphasil (n = 107), containing levonorgestrel and ethinyl estradiol, and Ortho-Novum 7/7/7 (n = 97) and Tri-Norinyl (n = 109), both of which contain norethindrone and ethinyl estradiol, were administered over four cycles for a total of 1141 cycles. The total incidence of intermenstrual bleeding was significantly lower with Triphasil (17.2%) than with Ortho-Novum 7/7/7 (39.5%) or Tri-Norinyl (49.0%). The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately. The incidence of other side effects was comparable for all regimens. Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use.

Adolescent↗
PubMed1990

The optimal dose of oral norethindrone acetate for addition to transdermal estradiol: a multicenter study.

The effects of adding one of three doses (0.5, 0.75, or 1.0 mg/d) of norethindrone acetate for 12 days each month to continuous, transdermal estradiol (0.05 mg/d) have been determined in a prospective, randomized, multicenter study. Significant symptomatic and psychological improvements were observed and, with one exception, were not opposed by the added progestogen. Distinct redness at the site of last patch application was reported by 10% of patients and faint erythema by 30%. However, less than 5% of patients discontinued treatment because of skin problems. Breakthrough bleeding occurred infrequently and all three doses of norethindrone acetate induced a regular pattern of bleeding with secretory transformation in the endometrium. There was no hyperplasia or carcinoma.

Administration, Cutaneous↗
PubMed1997

Performance of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) in multicenter clinical trials.

The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) is a 10-item functional inventory which was devised for use in therapeutic trials in ALS. Each item is rated on a 0-4 scale by the patient and/or caregiver, yielding a maximum score of 40 points. The ALSFRS assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. Rotated factor analysis of the ALSFRS found that the rating items group logically and consistently into four categories. The ALSFRS has been validated both cross-sectionally and longitudinally against muscle strength testing, the Schwab and England ADL rating scale, the Clinical Global Impression of Change (CGIC) scale, and independent assessments of patient's functional status. In this report, we use the data provided by the placebo patients who participated in the ALS CNTF Treatment Study (ACTS) to demonstrate the robustness, test-retest reliability and consistency of the ALSFRS as employed in a large, multicenter clinical trial.

Amyotrophic Lateral Sclerosis↗
PubMed1990

Comparison of different schedules of cytostatic intravesical instillations in patients with superficial bladder carcinoma: final evaluation of a prospective multicenter study with 419 patients.

In a prospective multicenter study we compared the value of various protocols of mitomycin C and doxorubicin instillation for the prevention of recurrent tumors in patients whose superficial bladder tumors (stages TA and T1) had been removed by transurethral resection. The 3-year and short-term instillation protocols were compared to each other and to a combination of 2 protocols. Evaluation after a mean followup of 28 months confirmed the value of cytostatic bladder instillation in preventing recurrence and progression of tumor in patients with superficial bladder carcinoma. There was no significant difference between the results of long-term and short-term prophylaxis; their combination achieved the best results. Doxorubicin and mitomycin yielded similar results; mitomycin was better tolerated.

Administration, Intravesical↗
PubMed1989

Pneumatic retinopexy. A multicenter randomized controlled clinical trial comparing pneumatic retinopexy with scleral buckling. The Retinal Detachment Study Group.

Pneumatic retinopexy was compared with scleral buckling in a multicenter (7 centers), randomized, controlled, clinical trial with 198 patients. Admission criteria included detachments with retinal break(s) no greater than 1 clock hour in size, within the superior two thirds of the fundus, without significant proliferative vitreoretinopathy (PVR). All patients were followed for at least 6 months. Scleral buckling was compared with pneumatic retinopexy with regard to single-operation reattachment (82 versus 73%), reattachment with one operation and postoperative laser/cryotherapy (84 versus 81%), overall reattachment with reoperations (98 versus 99%), final visual acuity of 20/50 or better in eye with preoperative detachment of the macula for 2 weeks or less (56 versus 80%), PVR (5 versus 3%), and new retinal breaks (13 versus 23%). Complications, including reoperations, as measured by the "score" system, were similar. The anatomic results of the two operations were not significantly different (P greater than 0.05), but pneumatic retinopexy had less morbidity and better postoperative visual acuity (P = 0.01). Pneumatic retinopexy is recommended for cases meeting the admission criteria.

Cataract Extraction↗
PubMed1989

Comparative multicenter studies with TRUE Test and Finn Chambers in eight Swedish hospitals. TRUE Test Study Group.

A multicenter study with the TRUE Test standard panel and the same allergens in petrolatum applied with the Finn Chamber technique indicated 167 positive reactions with both test methods. Thirty-eight positive reactions were indicated with TRUE Test alone and 28 positive reactions were indicated with the Finn Chamber method only. Irritant reactions were equally frequent with both tests. Quality, as scored by surface distribution and adherence of the tape, tended to be slightly better with TRUE Test. Less than 50% of the positive test results were predicted by history, whereas more than 75% of them had past or present relevance.

Allergens↗
PubMedDate not supplied

[Blood pressure control and quality of life: a comparative multicenter double-blind and cross-over trial of labetalol and captopril].

The purpose of this multicenter randomised, double-blind and cross-over study was to compare the antihypertensive effects of labetalol (L) and captopril (C) in 42 moderate hypertensive patients (mean age: 52 years). The drugs were given during two 4-weeks periods at the end of which the systolic (SBP) and diastolic blood pressures (DBP) were measured at rest in supine and standing positions. The assessment of the quality of life was realized with 4 scales completed by the practitioner [anxiety, depression, well-being, visual analog scale (VAS)] and 4 scales of auto-assessment completed by the patient [2 VAS, well-being, sub-scale of pleasure]. At the end of the first treatment's period (D28), both drugs had decreased significantly supine SBP and DBP (p less than 0.001), standing DBP (L = p less than 0.01; C = p less than 0.05), while only L lowered supine SBP (p less than 0.01). The cross-over analysis was unable to conclude, due to the number of patients and a significant interaction which reduced its power. Thus the effect of the first treatment's period seemed to influence the efficacy of the second one. The percentages of patients with a controlled BP were respectively: after 4 weeks of treatment, L = 61 p. 100 vs C = 42 p. 100 and at the end of study (D56), L = 67 p. 100 vs C = 64 p. 100. The cross-over analysis didn't show any difference between the effects of L and C on the quality of life.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1989

Multicenter follow-up study of the transmandibular implant.

The purpose of this multicenter study was to review the results of treatment and identify complications in edentulous patients who were treated with the transmandibular implant. A total of 190 patients were treated in four university departments. These patients presented for treatment with mandibular bone heights that ranged from 4 to 18 mm (mean, 10 mm). After postoperative periods that ranged from 3 months to 5 years, 182 of the 190 implants (95.8%) were stable and functional. Three implants were removed due to perioperative fractures in mandibles with 4 to 6 mm of bone height. Five were removed due to infection which occurred within the first 3 months after surgery. Reversible complications that developed in 22.2% of the patients were treated successfully. The 182 implants in function demonstrated no mobility and no infrabony pockets around any of the transmucosal posts. The results of this study demonstrate that the transmandibular implant has acceptable predictability and reliability for reconstruction of patients with severe atrophy of the mandibular alveolar process.

Bone Resorption↗
PubMed1989

Data processing and analysis in the Multicenter Morphometric Mammary Carcinoma Project (MMMCP).

In the Multicenter Morphometric Mammary Carcinoma Project (MMMCP), the prognostic value and reproducibility of routinely assessed quantitative pathological parameters in breast cancer is prospectively studied in approximately 3000 patients. Considering the high number of patients and the fact that many laboratories and hospitals throughout the Netherlands participate in this project, data acquisition, processing and analysis is an important component of the project. The data collection scheme, the structure of the database and the processing of data are described.

Breast Neoplasms↗
PubMed1989

The Multicenter Morphometric Mammary Carcinoma Project (MMMCP). A nationwide prospective study on reproducibility and prognostic power of routine quantitative assessments in The Netherlands.

The Multicenter Morphometric Mammary Carcinoma Project (MMMCP) has been set up to investigate prospectively the prognostic value and reproducibility of routine assessments of the morphometric Multivariate Prognostic Index (MPI) and other quantitative parameters in comparison with classical prognosticators and steroid receptors in breast cancer patients. In this project, 34 hospitals participate, divided over six geographically different regions. Of each patient entering in the study, multiple clinical and classical pathological parameters (including tumor size and lymph node status) as well as several quantitative parameters such as mean nuclear area, DNA index and mitotic activity index will be evaluated. Of all patients, the MPI will be assessed with tumour size, lymph node status and mitotic activity index. The quantitative assessments are performed in all consecutive breast cancers which enter the participating pathology laboratories, and all measurements are controlled in Amsterdam. The patient intake time will be from January 1, 1988 until January 1, 1990. It is expected that 3000 patients will enter in this study. Follow up data will be gathered up to 10 years. However, two to five years after the initiation of the Project, a first evaluation of the reproducibility and prognostic significance of routine MPI and other assessments in breast cancer patients will be possible. A detailed description of this project is given.

Breast Neoplasms↗
PubMed1988

Percutaneous transvenous caval interruption with the "LGM" filter: early results of a multicenter trial.

From September 1985 to December 1986, 100 patients undergoing percutaneous placement of a transvenous "LGM" caval filter were included in a multicenter prospective trial. Peripheral venograms completed by pulmonary arteriography or scintigraphy were obtained for all patients. Eighty-five patients had experienced pulmonary embolism, 59 had iliocaval thrombosis, while 40 had venous thrombosis confined to the lower limbs. In two instances, insertion or passage of the catheter was impossible. Ninety-eight "LGM" filters were placed percutaneously through the internal jugular vein, 82 of which were correctly positioned in the infrarenal inferior vena cava. Eight filters were positioned with a tilt of more than 15 degrees with respect to the vertical axis, five failed to open correctly, and three were incompletely open and tilted. No postoperative deaths were observed; there were two recurrent embolisms, and seven caval thromboses occurred during the year that followed insertion of the filter. The "user-friendliness" and efficacy of this percutaneous filter makes it a treatment of choice in the partial interruption of the inferior vena cava.

Aged↗
PubMed2002

Multicenter evaluation of an enzyme immunoassay (Platelia Aspergillus) for the detection of Aspergillus antigen in serum.

Invasive aspergillosis is a serious problem for immunocompromised patients, especially if neutropenic. The diagnosis of this infection is complicated, since clinical symptoms are often similar to those of other fungal diseases. The chance of detecting the presence of a specific antigen in the serum could confirm the suspected clinical diagnosis and. perhaps, be useful for the follow-up of the patient. The Medical Mycology Committee of the Associazione Microbiologi Clinici Italiani (AMCLI) decided to evaluate in a multicenter prospective study (from I November 1998 to 28 February 1999) the performance of the Platelia Aspergillus Kit (Bio-Rad) for the detection of Aspergillus galactomannan in human serum. The enrolled patients included various groups of immunosuppressed patients (mostly neutropenic). Blood samples were drawn at the time of enrollment. This decision was based upon a clinical diagnosis of probable aspergillosis (antibiotic non-responsive fever for at least 96 hours, cough, hemophthosis and positive chest X-ray). Additional blood samples were drawn on days 3, 6, 9, 12, 15 and 21. Culture and histopathologic examinations were performed according to the individual laboratory workflow. For each patient the laboratory filled a form with all the available clinical information, to create a database on which to evaluate the results of the test. During the study, 187 patients with various kinds of immunosuppression were enrolled. A total of 256 sera were tested: for 117 patients (62.6%) only the basal sample was tested, whereas for the 70 symptomatic patients (37.4%) multiple specimens (range: 1-6) were tested. The results allowed the laboratories to exclude (68.6%) or confirm (31.5%: confirmed and/or probable) the clinical diagnosis of invasive aspergillosis; 4 cases remained undetermined. Based on the results of this study, it seems that the use of this test should be limited to those patients with clinical symptoms of aspergillosis.

Antigens, Fungal↗
PubMed1993

Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.

The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.

Administration, Intravaginal↗
PubMed2003

Evaluation of the CD14 C-159 T polymorphism in the German Multicenter Allergy Study cohort.

BACKGROUND: Multiple genetic studies have shown linkage of atopy-related phenotypes to chromosome 5q31. In this region several candidate genes for atopy are localized such as the Th2 cytokines IL-4, IL-5 and IL-13, but also CD14, a receptor for LPS. Recently, a functional CD14 promoter polymorphism was related to total and specific IgE responsiveness. OBJECTIVE: The aim of our study was to evaluate the role of this single nucleotide polymorphism (SNP) in a large German birth cohort. METHODS: Atopy-related phenotypes were longitudinally carefully evaluated in over 800 children from birth to the age of 10 years. Yearly visits included standardized interviews, physical examinations and determination of total and specific IgE antibodies. Pulmonary function tests and histamine provocations were performed at the age of seven. Eight-hundred and seventy-two children of the Multicenter Allergy Study (MAS) cohort were genotyped using melting curve and restriction digest analyses. RESULTS: CD14-159 allele frequencies were consistent with previous reports, however, no association of the SNP with asthma, atopic dermatitis, allergic rhinitis, total or specific IgE levels could be observed. CONCLUSION: The CD14-159 SNP might not play a major role in the development of atopy in German children.

Follow-Up Studies↗
PubMed2001

A multicenter, double-blind study on triple therapy with lansoprazole, amoxicillin and clarithromycin for eradication of Helicobacter pylori in Japanese peptic ulcer patients.

BACKGROUND: Two triple therapies with lansoprazole (LPZ)/amoxicillin (AMPC)/clarithromycin (CAM) for eradication of Helicobacter pylori were studied in multicenter, double-blind fashion to evaluate the eradication rate of H. pylori and safety of eradiation treatment in Japanese patients with H. pylori-positive active gastric ulcers or duodenal ulcers. METHODS: Patients were randomly chosen for the control treatment of LPZ 30 mg twice a day (b.i.d.; Group A-LPZ-only) or the test treatments of LPZ 30 mg plus AMPC 750 mg and CAM 200 mg b.i.d. (Group B-LAC200) and LPZ 30 mg, AMPC 750 mg and CAM 400 mg b.i.d. (Group C-LAC400). All eradication treatments lasted for a period of 7 days. Successful eradication was assessed by culture and gastric histology 1 month after completion of the ulcer treatment. RESULTS: The eradication rates of H. pylori in the full analysis set were 0% in Group A-LPZ-only, 87.5% in Group B-LAC200 and 89.2% in Group C-LAC400 for gastric ulcer and, 4.4% in Group A-LPZ-only, 91.1% in Group B-LAC200 and 83.7% in Group C-LAC400 for duodenal ulcer. The eradication rates of Group B-LAC200 and Group C-LAC400 were 89.2% (95% CI: 84.8-93.7%) and 86.4% (95%CI: 81.5-91.3%) in total in the full analysis set, 89% (95% CI: 84.3-93.7%) and 85.3% (95%CI: 80.1-90.5%) in the per protocol set. The eradication rates in Groups B-LAC200 and group C-LAC400 were statistically significantly higher than the rate in Group A-LPZ-only for both gastric ulcer and duodenal ulcer patients (p <.0001 for both). CONCLUSION: A satisfactorily high H. pylori eradication rate was obtained in Japanese ulcer patients with the triple therapy regimen consisting of LPZ 30 mg, AMPC 750 mg, and CAM 200 mg b.i.d.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

Efficacy of adjuvant fluorouracil and leucovorin in stage B2 and C colon cancer. International Multicenter Pooled Analysis of Colon Cancer Trials Investigators.

The International Multicenter Pooled Analysis of Colon Cancer Trials (IMPACT) investigators have now completed two large systematic reviews of adjuvant therapy trials in colon cancer. The IMPACT 1 study pooled data from three separate trials each comparing the efficacy of 5-fluorouracil (5-FU)/leucovorin with observation alone as adjuvant treatment for 1,526 patients with Dukes' B or C colon cancer. The results showed that treatment with 5-FU/leucovorin significantly reduced mortality by 22% (P = .029) and events such as relapse, second tumor, or death by 35% (P < .0001) after 3 years of follow-up. The side effects associated with 5-FU/leucovorin were clinically acceptable. The IMPACT 1 study also showed a clear benefit of adjuvant treatment for patients with Dukes' C colon cancer, but not for stage-B patients. After up to 10 years of follow-up, 5-FU/leucovorin significantly reduced mortality by 30% for patients with Dukes' C disease (P = .003), but only reduced mortality by 8% in patients with Dukes' B colon cancer (P = .658). The aim of the IMPACT 2 study was to determine whether 5-FU/leucovorin is an effective adjuvant treatment for patients with Dukes' B2 colon cancer. Results were pooled from five separate trials that randomized 1,016 patients. After a median of 5.75 years of follow-up, B2 patients receiving 5-FU/leucovorin did not have a significant increase in overall survival or event-free survival. At 5 years, the hazard ratio for overall survival was 0.86 (90% confidence interval, 0.68 to 1.07) and for event-free survival was 0.83 (90% confidence interval, 0.72 to 1.07). 5-Fluorouracil/leucovorin was not recommended as a standard adjuvant treatment for all patients with Dukes' B2 colon cancer.

Antimetabolites, Antineoplastic↗
PubMed2004

[Cardiological and psychosocial status of patients with malignant ventricular arrhythmias before implantation of a cardioverter defibrillator. First results from the German Austrian ICD Multicenter Study (GAIMS)].

In a prospective multicenter study of coping, subjective well-being and objective course of the disease we recruited patients with life-threatening cardiac arrhythmias awaiting the implantation of a cardioverter defibrillator. All patients received a semistructured interview and a number of well validated self-assessment questionnaires. In addition, detailed cardiological findings were documented. The present paper describes the study rationale and design as well as the main study hypotheses. In addition, we present representativity data for the inclusion sample and cross-sectional psychometric findings obtained before implantation of the device. The study sample consists of 286 patients with severe ventricular arrhythmias and is almost representative for all ICD recipients in the participating centers and ICD recipients in general. Despite their severe physical impairment, patients only showed moderate levels of psychological abnormalities. Only patients with severe heart failure or a history of repeated resuscitations showed elevated rates of anxiety or depression. However, there were relevant associations among the self-rating scales: Patients with abnormal anxiety or depression scores reported significantly elevated levels of physical complaints and depressive coping. They also showed low social support and an impaired quality of life. These cross-sectional findings add to the international literature on coping and well-being of patients with malignant cardiac arrhythmias. On the background of earlier research findings and clinical experience our results show high plausibility. Prospective changes over time in the different dimensions of psychosocial adjustment and their prognostic power for future quality of life and arrhythmic events will be reported separately.

Adaptation, Psychological↗
PubMed1989

A multicenter randomized, placebo-controlled trial of surfactant therapy for respiratory distress syndrome.

We carried out a multicenter randomized, placebo-controlled trial to evaluate the efficacy and safety of surfactant in the treatment of respiratory distress syndrome. The study population was made up of newborn infants weighing 750 to 1750 g who were receiving assisted ventilation with 40 percent or more oxygen. The eligible infants received a single dose of either surfactant (100 mg of phospholipid per kilogram of body weight [4 ml per kilogram]) or an air placebo (4 ml per kilogram), administered into the trachea within eight hours of birth by an investigator not involved in the clinical care of the infant. When compared with the infants who received the placebo (n = 81), the infants who were treated with surfactant (n = 78) had a 0.12 greater average increase in the ratio of arterial to alveolar oxygen tension (P less than 0.0001), a 0.20 greater average decrease in the fractional inspiratory oxygen concentration (P less than 0.0001), and a 0.26-kPa greater average decrease in the mean airway pressure (P less than 0.0001) during the 72 hours after treatment. Pneumothorax was less frequent among the infants treated with surfactant than in the control group (13 percent vs. 37 percent; P = 0.0005). There were no statistically significant differences between the groups in the proportion of infants in each of five ordered clinical-status categories on day 7 (P = 0.08) or day 28 (P = 0.75) after treatment. There were also no significant differences between the groups in the frequency of bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or periventricular-intraventricular hemorrhage. In each group, 17 percent of the infants died by day 28. We conclude that treatment with the single-dose surfactant regimen used in this study reduces the severity of respiratory distress during the 72 hours after treatment and decreases the frequency of pneumothorax, but that it does not significantly improve clinical status later in the neonatal period and does not reduce neonatal mortality. Further study of different surfactant regimens and patient-selection criteria will be required to determine whether this initial improvement can be translated into reductions in mortality or serious morbidity.

Bronchopulmonary Dysplasia↗