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Results for “Randomized trial”

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At least 685 records · Page 38Linked to original sources

PubMed1984

Treatment of inoperable non-small cell carcinoma of the lung with radiation therapy, with or without levamisole. A randomized trial of the Southeastern Cancer Study group.

In a randomized trial, 251 patients with inoperable non-small cell lung cancer received radiation therapy (RT) with or without levamisole (2.5 mg/kg twice weekly for 1 year, or until progression). Radiation therapy was delivered to 6000-6500 rad for Stages I and II, and 4000-4500 rad by continuous or split course for Stage III disease. Responses were observed in 40% of patients receiving placebo, and in 29% of patients taking levamisole. Relapse occurred at local sites only in 53% of the placebo- and 75% of the levamisole-treated patients. The frequency of relapse in distant sites was lower (25%) in the levamisole group as compared with the placebo group (47%). No significant difference in survival was observed between the placebo and levamisole-treated groups (median survival, 48.2 and 45 weeks, respectively). Responders to radiotherapy survived significantly longer than nonresponders (median survival, 73 vs. 33.3 weeks, p = 0.001). Among responders, the median survival of patients treated with levamisole was shorter (63.9 weeks) than that of patients receiving placebo (92.7 weeks). Toxicity attributable to levamisole included severe granulocytopenia in five patients and severe nausea and vomiting in nine. It is concluded that levamisole is without significant benefit in this setting.

Adenocarcinoma↗

PubMed2001

Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma.

PURPOSE: A pilot study of 43 patients with potentially resectable esophageal carcinoma treated with an intensive regimen of preoperative chemoradiation with cisplatin, fluorouracil, and vinblastine before surgery showed a median survival of 29 months in comparison with the 12-month median survival of 100 historical controls treated with surgery alone at the same institution. We designed a randomized trial to compare survival for patients treated with this preoperative chemoradiation regimen versus surgery alone. MATERIALS AND METHODS: One hundred patients with esophageal carcinoma were randomized to receive either surgery alone (arm I) or preoperative chemoradiation (arm II) with cisplatin 20 mg/m2/d on days 1 through 5 and 17 through 21, fluorouracil 300 mg/m2/d on days 1 through 21, and vinblastine 1 mg/m2/d on days 1 through 4 and 17 through 20. Radiotherapy consisted of 1.5-Gy fractions twice daily, Monday through Friday over 21 days, to a total dose of 45 Gy. Transhiatal esophagectomy with a cervical esophagogastric anastomosis was performed on approximately day 42. RESULTS: At median follow-up of 8.2 years, there is no significant difference in survival between the treatment arms. Median survival is 17.6 months in arm I and 16.9 months in arm II. Survival at 3 years was 16% in arm I and 30% in arm II (P = .15). This study was statistically powered to detect a relatively large increase in median survival from 1 year to 2.2 years, with at least 80% power. CONCLUSION: This randomized trial of preoperative chemoradiation versus surgery alone for patients with potentially resectable esophageal carcinoma did not demonstrate a statistically significant survival difference.

Adenocarcinoma↗

PubMed1999

Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: results of the FOSIT study. Fosamax International Trial Study Group.

This randomized, double-masked, placebo-controlled trial evaluated the safety, tolerability and effects on bone mineral density (BMD) of alendronate in a large, multinational population of postmenopausal women with low bone mass. At 153 centers in 34 countries, 1908 otherwise healthy, postmenopausal women with lumbar spine BMD 2 standard deviations or more below the premenopausal adult mean were randomly assigned to receive oral alendronate 10 mg (n = 950) or placebo (n = 958) once daily for 1 year. All patients received 500 mg elemental calcium daily. Baseline characteristics of patients in the two treatment groups were similar. At 12 months, mean increases in BMD were significantly (p</=0.001) greater in the alendronate than the placebo group by 4.9% (95% confidence interval 4.6% to 5.2%) at the lumbar spine, 2.4% (2.0% to 2.8%) at the femoral neck, 3.6% (3.2% to 4.1%) at the trochanter and 3.0% (2.6% to 3.4%) for the total hip. The incidence of nonvertebral fractures was significantly lower in the alendronate than the placebo group (19 vs 37 patients with fractures), representing a 47% risk reduction for nonvertebral fracture for alendronate-treated patients (95% confidence interval 10% to 70%; p = 0.021). Incidences of adverse events, including upper gastrointestinal adverse events, were similar in the two groups. Therefore, for postmenopausal women with low bone mass, alendronate is well tolerated and produces significant, progressive increases in BMD at the lumbar spine and hip in addition to significant reduction in the risk of nonvertebral fracture.

Adult↗

PubMed1990

Randomized trial of laser-assisted passage through occluded femoro-popliteal arteries.

A randomized trial was carried out in patients with occlusions of the femoro-popliteal artery to compare the passage of metal-tipped optical fibres with guide wires and catheters through the occlusions, prior to balloon angioplasty. The study was in a provincial English teaching hospital providing a vascular service for the area. Fifty patients were entered; 25 into the "laser" group and 25 into the "control" group. End points were (a) the success in passage through the occlusion and (b) the outcome 1 month after passage. Comparison of the groups showed no appreciable difference between the two methods with regard to age, sex, symptoms, incidence of diabetes, or previous myocardial infarctions. Successful passage through the occlusion followed by dilatation was achieved in 18 (72%) patients in the laser group and 20 (80%) in the control group. After 1 month, 13 (52%) arteries in the laser group were patent compared to 13 (57%) in the control group. Confidence limits for the difference in success of passage are -15% to +31%, and -24% to +33% for patency after 1 month. Since these limits include zero, it is unlikely that a longer trial would alter the difference between the two methods. The results suggest that the laser system currently in use is no better than conventional methods.

Adult↗

PubMedDate not supplied

Triangular test and randomized trials: practical problems in a small cell lung cancer trial.

The triangular test has been used to monitor survival data from a randomized trial in patients with small cell lung cancer. The results of consecutive interim analyses and the problems met by the data monitoring committee and the co-ordinators are described. The methods as well as the consequences of the early stopping on the analysis and the results of this trial are discussed. From this experience, we believe that statistical stopping rules--only one of the factors to be taken into account when deciding to stop a trial--should be used with caution. Independent data monitoring committees may be useful in helping to review the ongoing results and advise the participants in the trial.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1988

Split-course versus continuous radiotherapy. Analysis of a randomized trial from 1964 to 1967.

A randomized clinical trial was performed from 1964 to 1967 to compare the therapeutic results of split-course external beam radiotherapy with those of continuously fractionated treatment. Altogether 439 consecutive patients with carcinoma of larynx, nasopharynx, hypopharynx, oropharynx, oral cavity, oesophagus and urinary bladder were included in the series. 227 patients received split-course treatment and 212 were treated by the continuous-course method. In the split-course treatment there was a 2-3 weeks' interruption after 25-30 Gy. This break was compensated by a 10% increase in the total dose. For each tumour site local control and failure rates for the 2 treatment techniques were similar. No significant differences in 5- and 10-year survival were noted. Acute side effects were milder in all patients treated with split-course. The occurrence of late reactions was similar in both treatment groups. However, severe late reactions in the urinary bladder were somewhat more frequent in patients treated with split-course technique; the difference was not statistically significant. We conclude that there were no significant differences in local control, long-term survival and late normal tissue reactions between the treatment groups. The acute normal tissue reactions were milder in the split-course treated groups. We still regard split-course as a useful treatment modality provided the interruption is compensated with about 10% increase in total dose. However, more studies are needed to show which tumours proliferate during prolonged radiotherapy.

Cell Division↗

PubMed2003

Twenty-year results of the Naples GUN randomized trial: predictive factors of adjuvant tamoxifen efficacy in early breast cancer.

PURPOSE: Tamoxifen (TAM) is increasingly administered to new early breast cancer patients. Because it is not devoid of toxic effects, we studied factors potentially predictive of its efficacy. EXPERIMENTAL DESIGN: From 1978 to 1983, 433 patients were enrolled in the GUN randomized trial: 206 were assigned to TAM versus 227 controls (no-TAM). Premenopausal patients with axillary lymph node involvement (60 TAM versus 65 no-TAM) also received nine CMF cycles. Eight biological markers were retrospectively assayed for most patients: estrogen; progesterone; prolactin receptors (PrlRs); microvessel count (MVC); S-phase fraction; tumor ploidy; epidermal growth factor receptor (EGFR); and HER2. We performed a multivariate test of the TAM/covariate interactions to establish whether these variables predicted for TAM efficacy. Estimates of the TAM effect were expressed as hazard ratio (HR) of death of TAM over no-TAM patients with 95% confidence intervals (95% CIs). RESULTS: At a median follow-up of 15 years, PrlRs, MVC, S-phase fraction, ploidy, and EGFR did not influence TAM efficacy. Differently, HER2 had an overall significant predictive effect: HR = 0.59 (95% CI: 0.40-0.87) in HER2-negative subjects versus HR = 1.09 (95% CI: 0.63-1.87) in HER2-positive subjects (interaction test: P = 0.04). The predictive effect of HER2 was also evident in the subgroup of patients with steroid receptor-positive tumors (HER2 positive: HR = 1.33, 95% CI: 0.70-2.51; HER2 negative: HR = 0.73, 95% CI: 0.47-1.14). CONCLUSIONS: With the statistical power of the present randomized trial, S-phase, ploidy, EGFR, PrlR, and MVC do not seem to predict for TAM efficacy. Conversely, our data support the hypothesis that tumors overexpressing HER2 might not benefit from adjuvant TAM.

Adolescent↗

PubMed1992

[Analgesic effect of transcutaneous cranial electrostimulation in patients treated by Nd:YAG laser for cancer of the rectum. A double-blind randomized trial].

The aim of this double blind cross-over randomized trial was to assess if transcutaneous cranial electrical stimulation by Limoge current could decrease the dose of fentanyl required in patients with rectal cancer treated by Nd:YAG laser. Fifty patients, 29 women, 21 men, 78 +/- 10 years old (range: 53-96 years), were treated by 2 laser sessions with an interval of 48 hours between each session. Active and sham electrostimulation were given in random order for the 2 laser sessions. The major end point was the quantity of fentanyl injected when the score of pain was greater than or equal to 5 according to a visual analgesic scale. Age, sex, body weight, tumor location and length, tumor circumferential extent and luminal patency, duration of laser session, amount of energy delivered per session (watt-seconds), and number of patients with deep sedation did not differ between the 2 groups. There was no interaction between the order of treatments and the treatments. The mean quantity of fentanyl was 29 micrograms and 42 micrograms when sham electrostimulation was given. There was a decrease of 31 percent in the quantity of fentanyl with active electrostimulation (P less than 0.05). Results were not affected either by the treatment order nor by tumor location. There were no side effects in either group.

Aged↗

PubMed1995

A randomized trial comparing fluconazole with clotrimazole troches for the prevention of fungal infections in patients with advanced human immunodeficiency virus infection. NIAID AIDS Clinical Trials Group.

BACKGROUND: Cryptococcal meningitis and other serious fungal infections are common complications in patients infected with the human immunodeficiency virus (HIV). Fluconazole is effective for long-term suppression of many fungal infections, but its effectiveness as primary prophylaxis had not been adequately evaluated. METHODS: We conducted a prospective, randomized trial that compared fluconazole (200 mg per day) with clotrimazole troches (10 mg taken five times daily) in patients who were also participating in a randomized trial of primary prophylaxis for Pneumocystis carinii pneumonia. RESULTS: After a median follow-up of 35 months, invasive fungal infections had developed in 4.1 percent of the patients in the fluconazole group (9 of 217) and in 10.9 percent of those in the clotrimazole group (23 of 211; relative hazard, as adjusted for the CD4+ count, 3.3; 95 percent confidence interval, 1.5 to 7.6). Of the 32 invasive fungal infections, 17 were cryptococcosis (2 in the fluconazole group and 15 in the clotrimazole group; adjusted relative hazard, 8.5; 95 percent confidence interval, 1.9 to 37.6). The benefit of fluconazole was greater for the patients with 50 or fewer CD4+ cells per cubic millimeter than for the patients with higher counts. Fluconazole was also effective in preventing esophageal candidiasis (adjusted relative hazard, 5.8; 95 percent confidence interval, 1.7 to 20.0; P = 0.004) and confirmed and presumed oropharyngeal candidiasis (5.7 and 38.1 cases per 100 years of follow-up in the fluconazole and clotrimazole groups, respectively; P < 0.001). Survival was similar in the two groups. CONCLUSIONS: Fluconazole taken prophylactically reduces the frequency of cryptococcosis, esophageal candidiasis, and superficial fungal infections in HIV-infected patients, especially those with 50 or fewer CD4+ lymphocytes per cubic millimeter, but the drug does not reduce overall mortality.

AIDS-Related Opportunistic Infections↗

PubMed2003

[Chemotherapy for advanced or metastatic pancreatic cancer: analysis of 43 randomized trials in 3 decades (1974-2002)].

Pancreatic cancer represents a major challenge to oncologists because of its high chemoresistant nature and dismal outcomes, especially in advanced diseases. Clinical trials on the effects of systemic chemotherapy for patients with advanced pancreatic cancer have not been shown to have consistent benefits. A systematic review and meta-analysis was therefore conducted to examine this issue. All randomized trials on chemotherapy treatment for advanced pancreatic cancer published since the 1970's were identified by means of Medline and other major oncology databases. Systematic review of all trials was carefully conducted and data from trials with similar designs and regimens were pooled and grouped together in the benefit outcome analyses. Data for 5,365 patients from 43 randomized controlled trials were identified. Survival benefit over best supportive care was demonstrated in 5-FU-based chemotherapy in 9 randomized trials. However, trials that comparing 5-FU or other cytotoxic agent alone versus 5-FU-based combinations did not show any statistical differences, nor were various 5-FU-combinations comparing among themselves. On the other hand, gemcitabine was shown to improve survival and clinical benefit responses better than 5-FU and other new agents. Overall, these results were encouraging and future research to explore means to optimize drug treatment (especially gemcitabine-based regimens) for advanced pancreatic cancer is warranted.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1993

A diagnostic and therapeutic N-of-1 randomized trial.

The objective of this paper is to study the effect of amitriptyline on a young woman with symptoms of lightheadedness, palpitations, somnolence and fatigue. We conducted a single case (N-of-1) randomized trial including three pairs of treatment periods. Each pair included one four-week period when the patient was receiving amitriptyline and one four-week period when the patient was receiving placebo. The clinical setting was a secondary care internal medicine practice. During active treatment periods, amitriptyline was given in a dose of 100 mg each evening. Efficacy symptoms included lightheadedness, headaches and somnolence/fatigue. Side-effects of dry mouth and constipation were also monitored. Each symptom was rated on a seven point scale in which higher numbers denoted fewer symptoms. For the combined efficacy score, the mean difference in scores and the associated standard error was in favour of amitriptyline. The most profound effect was on sleepiness. These differences represent clinically important treatment effects. Dry mouth and constipation were worse on the active drug, but differences did not reach statistical significance. Our experience suggests the usefulness of N-of-1 randomized trials in outpatient medical practice, including psychiatric practice.

Adult↗

PubMed2001

Putting theory into practice: a cluster randomized trial with a small number of clusters.

Many of the difficulties encountered in the design, organization and analysis of cluster randomized trials arise from the dual nature of such trials; that is, they focus on both the cluster and the individual. A trial now in progress to compare three methods of promoting secondary prevention of coronary heart disease in primary care includes only 21 general practices, but 2142 patients, and thus contains the problems of both small and large samples. With only seven practices in each arm, the trial demanded carefully restricted randomization, may be difficult to analyse, and risks loss of power if one practice should drop out. At the same time, the large number of patients makes for an expensive and administratively complex study. The simultaneous demands of clarity and thoroughness point to an analysis at both cluster and individual level. With two different approaches, however, there may be difficulties of presentation, even if the results agree, and additional problems of interpretation if they do not. Finally, practical considerations may conflict with theoretical demands. Since the trial contained a service element, all patients with heart disease had to be included, even though it would have been more efficient to take only a sample of patients from some practices.

Aged↗

PubMed2000

A randomized trial of hierarchical counseling in a short, clinic-based intervention to reduce the risk of sexually transmitted diseases in women.

INTRODUCTION: Effective public health interventions to reduce the incidence of sexually transmitted disease (STD), including HIV, among women are urgently needed. METHODS: A randomized trial among STD clinic patients of two types of counseling regarding methods to reduce disease transmission: a 'hierarchical' message (HP), with counseling on male condoms, female condoms, diaphragms, cervical caps, and spermicides (three formulations) and a single method message (SM) covering male condoms only or female condoms only. For this analysis, 1591 subjects received one of three educational messages at the central public STD clinic in Philadelphia. Disease incidence data for up to 6 months following the index visit were extracted from the clinic's electronic database. The primary outcome was STD reinfection: laboratory-confirmed trichomonas infection and/or clinical diagnoses of at least one of four STD. Rates were based on the full sample of randomized women (full sample) and on the subset who spontaneously returned between 22 days and 183 days following their initial visit (returners). RESULTS: Rates of trichomonas infection (SM 2.5% full sample and 12.9% returners versus HP 2.4% full sample and 11.5% returners) and clinical diagnoses (SM 6.3% full sample and 39.7% returners versus HP 6.9% full sample and 41.2% returners) did not differ across the two arms of the randomized trial, both as a straight percentage and in survival analysis (P = .81). CONCLUSION: At least in this single-session intervention trial, increasing choices in protection for women did not produce a change in disease risk compared with single-method approaches.

Adult↗

PubMedDate not supplied

Mitomycin C for metastatic prostate cancer: final analysis of a randomized trial.

BACKGROUND: Almost all patients that undergo hormonal manipulation for metastatic prostate cancer will ultimately progress because of hormone resistance. Therefore we assessed the effect of early addition of intravenous Mitomycin C to orchiectomy in patients with newly diagnosed metastatic prostate cancer. PATIENTS AND METHODS: 178 patients with histologically proven and previously untreated metastatic prostate cancer were included in a prospective, randomized multicenter trial. Randomization was done centrally between orchiectomy alone and orchiectomy with Mitomycin C. 148 patients were evaluable. RESULTS: At the final analysis 139 patients have deceased. The remaining 9 patients are still alive, but all present progression. There was no statistically significant difference in the real time to progression, or in the estimated cancer related and overall survival between both groups. Mean time to progression was 29 months in group 1 (orchiectomy alone), and 26 months in group 2 (orchiectomy and Mitomycin C) (p = 0.64). Mean time to cancer related death was 32 months and mean overall survival was 31 months in both groups. CONCLUSIONS: Mitomycin C has no beneficial effect when used in conjunction to orchiectomy in patients with newly diagnosed metastatic prostate cancer.

Aged↗

PubMed1987

A prospective, randomized trial of abdominal wound drainage in gastric bypass surgery.

A prospective, randomized trial was conducted in 194 morbidly obese patients who had gastric bypass to determine the effect of subcutaneous closed suction drainage on wound infection rates. There was no difference in the incidence of postoperative wound infection with the use of drains compared with simple abdominal closure. Organisms isolated from infected wounds were predominantly skin flora and did not differ between the two groups. Patients with wound infections had significantly prolonged hospitalizations compared with those without infections, but in the subgroup with wound infections there was no difference in hospitalization time between the drainage or control groups.

Abdomen↗

PubMed2004

Randomized trials of rate vs. rhythm control for atrial fibrillation.

Recent randomized trials have not demonstrated mortality or stroke risk reduction benefits from a rhythm-control compared to rate-control strategy in the treatment of atrial fibrillation. These studies reinforce the need for continued anticoagulation in both strategies for patients with atrial fibrillation and risk factors for stroke. Although rate control can be rationalized as a first line approach, rhythm control strategies may be justified for patients who are younger, who remain symptomatic or functionally impaired, or who have a first episode of atrial fibrillation.

Anti-Arrhythmia Agents↗

PubMed1982

Prophylactic endoscopic sclerosing treatment of the esophageal wall in varices -- a prospective controlled randomized trial.

From January 1, 1978 to January 1, 1980 a controlled randomized trial comparing conservative treatment with prophylactic sclerotherapy of esophageal varices prior to hemorrhage was carried out. In all 71 patients liver cirrhosis was histologically confirmed. The two randomly assigned groups were comparable. Indications of endoscopic treatment were the existence of varices III-IV bearing erosions, varices II-IV without erosions but coagulation factors below 30%, or both. Six patients left the trial. In group Ia -- treatment by conservative means -- a high rate of variceal bleeding and death was observed. Comparing these results with those of group Ib treated by sclerotherapy, bleeding and death rates were found to be highly significantly lower. -- Thus the investigated criteria for predicting a recent variceal hemorrhage are confirmed. Prophylactic sclerotherapy in esophageal varices with erosions and/or poor coagulation reserve of the liver can largely prevent an esophageal hemorrhage from varices, and prolongs the life of these chronically ill patients.

Clinical Trials as Topic↗

PubMed2004

Design and analysis of group-randomized trials: a review of recent practices.

We reviewed group-randomized trials (GRTs) published in the American Journal of Public Health and Preventive Medicine from 1998 through 2002 and estimated the proportion of GRTs that employ appropriate methods for design and analysis. Of 60 articles, 9 (15.0%) reported evidence of using appropriate methods for sample size estimation. Of 59 articles in the analytic review, 27 (45.8%) reported at least 1 inappropriate analysis and 12 (20.3%) reported only inappropriate analyses. Nineteen (32.2%) reported analyses at an individual or subgroup level, ignoring group, or included group as a fixed effect. Hence increased vigilance is needed to ensure that appropriate methods for GRTs are employed and that results based on inappropriate methods are not published.

Bibliometrics↗