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Results for “Randomized trial”

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PubMed1978

Randomized trial of emergency mesocaval and portacaval shunts for bleeding esophageal varices.

A randomized trial of emergency portacaval or mesocaval shunting was conducted in twenty-four cirrhotic patients bleeding from esophageal varices. The group of eleven patients having mesocaval shunts was comparable to the group having portacaval shunts in age distribution, sex, and preoperative physical condition. Postoperative fatality rates were 46% after portacaval shunting and 73% after mesocaval shunting. Results favor portacaval shunts for the emergency control of bleeding varices in the spectrum of patients seen in an urban hospital.

Adult↗

PubMed1995

High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial.

PURPOSE: The aims of this study were to compare in a randomized trial the results of high-dose versus conventional-dose chemotherapy as first-line treatment for metastatic breast cancer. The comparison included complete response (CR) rate, duration of response, and duration of survival. PATIENTS AND METHODS: Ninety patients were entered onto a study to compare two cycles of high-dose cyclophosphamide 2.4 g/m2, mitoxantrone 35 to 45 mg/m2, and etoposide (VP16) 2.5 g/m2 (HD-CNV) versus six to eight cycles of conventional-dose cyclophosphamide 600 mg/m2, mitoxantrone 12 mg/m2, and vincristine 1.4 mg/m2 (CNV) as first-line treatment for metastatic breast cancer. The high-dose regimen included either autologous bone marrow or peripheral-blood stem-cell rescue. All 90 patients are assessable. RESULTS: The response rates were significantly different. The overall response rate for HD-CNV was 43 of 45 (95%), with 23 of 45 patients (51%) achieving CR. Twenty-four of 45 patients (53%) who received conventional CNV have responded, with only two patients achieving CR. Both duration of response and duration of survival were significantly longer for patients, who received HD-CNV. Toxicity of the high-dose therapy was moderate in most patients. Grade 2 to 3 mucositis and hematologic suppression that required supportive treatment was universal, but hematologic recovery to a neutrophil count more than 500/microL and platelet count more than 40,000/microL occurred at day 18 (median) after therapy. CONCLUSION: HD-CNV appears to be a promising schedule that results in a significant proportion of CRs and increased survival in patients with metastatic breast cancer.

Adult↗

PubMed1980

Cimetidine in acute gastric mucosal bleeding: results of a double-blind randomized trial.

The hemostatic effect of cimetidine has been investigated in a double-blind, randomized trial in patients bleeding from acute mucosal lesions. During a 48-hr period, hemostasis was achieved in 5 of 15 patients (33%) treated with intravenous cimetidine administered with antacid therapy and in four of 12 patients (33%) treated with antacids alone. In a second stage of the trial, the effect of oral cimetidine in preventing further bleeding was investigated. Bleeding did not recur in 18 patients receiving cimetidine and antacids while 6 out of 20 patients who were given antacids alone suffered further hemorrhage during the 14-day period of the study. It is concluded that intravenous cimetidine administered with antacids was not found more effective in obtaining hemostasis than antacids alone. When given orally to patients who had been bleeding from acute lesions but were not doing so at the beginning of treatment, cimetidine with antacids is more effective than antacids alone in the prevention of further bleeding.

Adult↗

PubMed1993

The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial.

After intubation for advanced, inoperable squamous carcinoma of the oesophagus, a prospectively controlled randomized trial was done to investigate the effect of radiotherapy (41 patients) or mono-chemotherapy (40 patients) or no further treatment (46 patients). Treatment had no significant effect on either palliation or survival (p < or = 0.7) and did not alter the natural history of the disease.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

An inhalation bolus of sevoflurane versus an intravenous bolus of remifentanil for controlling hemodynamic responses to surgical stress during major surgery: a prospective randomized trial.

UNLABELLED: We studied 120 patients scheduled for elective major thoracic or abdominal surgery, randomized into 2 groups: a Sevoflurane group (n = 63) and a Remifentanil group (n = 57). Heart rate (HR) and mean arterial pressure (MAP) are indicative of sympathetic response to surgical stress. A positive response was defined as a 15% increase in the HR and MAP above baseline measurements. When a positive response occurred, in the Sevoflurane group we administered a bolus dose of 8% sevoflurane (fresh gas flow 6 L/min) and in the Remifentanil group, an IV bolus dose of remifentanil 1 microg x kg(-1) x min(-1), which was maintained until MAP and HR returned to baseline measurements (effective bolus). If, after a bolus dose, a decrease in MAP and/or HR of >15% occurred with respect to baseline values, the response was considered to be excessive. The bolus dose was ineffective in 4.8% of the responses in the Sevoflurane group and in 17.8% of the responses in the Remifentanil group (P < 0.05). In the Sevoflurane group, an excessive effect occurred in 12% of responses, and in 26.7% in the Remifentanil group (P < 0.05). An inhalation bolus of sevoflurane seems to be more effective than an IV remifentanil bolus during maintenance, with more effective control of hemodynamic responses to surgical stress. IMPLICATIONS: We compared an inhalation bolus of sevoflurane with remifentanil for managing hemodynamic responses to major abdominal or thoracic surgery. This prospective, randomized trial demonstrated better results with sevoflurane.

Administration, Inhalation↗

PubMed2004

Randomized trial of yoga as a complementary therapy for pulmonary tuberculosis.

OBJECTIVE: The present prospective, randomized trial compared the efficacy of anti-tuberculosis treatment (ATT) with two separate programs (yoga and breath awareness), on lung capacities and bacteriological status in pulmonary tuberculosis patients. METHODOLOGY: A total of 1009 pulmonary tuberculosis patients were screened and 73 were alternately allocated, to yoga (n = 36) or breath awareness (n = 37) groups, with 48 patients completing the 2-month trial. Patients aged between 20 and 55 years, who were sputum-positive on three consecutive examinations, had no prior ATT, and no comorbidities or extrapulmonary tuberculosis were included. In addition to ATT, one group practised yoga (n = 25) and the other practised breath awareness (n = 23) for 6 h per week, each session being 60 min. The main outcome measures were: symptom scores, bodyweight, FVC, FEV(1), FEV(1)/FVC%, sputum microscopy, sputum culture, and postero-anterior view of the CXR. RESULTS: At the end of 2 months, the yoga group showed a significant reduction in symptom scores (88.1%), and an increase in weight (10.9%), FVC (64.7%) and FEV(1) (83.6%) (P = 0.001, in all comparisons, paired t-test). The breath awareness group also showed a significant (paired t-test) reduction in symptom scores (16.3%, P= 0.02), and an increase in weight (2.1%, P= 0.003) and FEV(1) (63.8%, P= 0.04). Significantly more patients in the yoga group showed sputum conversion based on microscopy on days 30 and 45 compared to the breath awareness group (P = 0.045 and P= 0.002, respectively, chi(2) test). Ten of 13 in the yoga group had negative sputum culture after 60 days compared with four of 19 in the breath awareness group (P = 0.005, chi(2) test). Improvement in the radiographic picture occurred in 16/25 in the yoga group compared to 3/22 in the breath awareness group on day 60 (P = 0.001, chi(2) test). CONCLUSIONS: The improved level of infection, radiographic picture, FVC, weight gain and reduced symptoms in the yoga group suggest a complementary role for yoga in the management of pulmonary tuberculosis.

Adult↗

PubMed1989

A prospective randomized trial of schedules for sclerosing esophageal varices. 1-versus 2-week intervals.

A prospective randomized trial was performed to compare the efficacy and complications of 1-week (20 patients) and 2-week (20 patients) interval schedules of endoscopic injection sclerotherapy for patients with esophageal varices; 6 were acute, 3 were elective and 31 were prophylactic cases. There were no significant differences between the 1-week and 2-week interval groups with regard to total number of sclerotherapy sessions, total volume of the sclerosant used (5% ethanolamine oleate) or rate of complications such as pyrexia, stricture and pleural effusion. The incidence of ulcer and/or slough formation after EIS was the same in the two groups. Neither early nor recurrent bleeding occurred in any patient in the two groups. Eradication of varices in the 2-week interval group was achieved significantly earlier (p less than 0.05) than in the 1-week interval group.

Acute Disease↗

PubMed2005

Does off-pump coronary artery bypass reduce mortality, morbidity, and resource utilization when compared with conventional coronary artery bypass? A meta-analysis of randomized trials.

The authors undertook a meta-analysis of 37 randomized trials (3369 patients) of off-pump coronary artery bypass surgery versus conventional coronary artery bypass surgery. No significant differences were found for 30-day mortality (odds ratio [OR], 1.02; 95% confidence interval [CI], 0.58-1.80), myocardial infarction (OR, 0.77; 95%CI, 0.48-1.26), stroke (OR, 0.68; 95%CI, 0.33-1.40), renal dysfunction, intraaortic balloon pump, wound infection, rethoracotomy, or reintervention. However, off-pump coronary artery bypass surgery significantly decreased atrial fibrillation (OR, 0.58; 95%CI, 0.44-0.77), transfusion (OR, 0.43; 95%CI, 0.29-0.65), inotrope requirements (OR, 0.48; 95%CI, 0.32-0.73), respiratory infections (OR, 0.41; 95%CI, 0.23-0.74), ventilation time (weighted mean difference, -3.4 h; 95%CI, -5.1 to -1.7 h), intensive care unit stay (weighted mean difference, -0.3 days; 95%CI -0.6 to -0.1 days), and hospital stay (weighted mean difference, -1.0 days; 95%CI -1.5 to -0.5 days). Patency and neurocognitive function results were inconclusive. In-hospital and 1-yr direct costs were generally higher for conventional coronary artery bypass surgery versus off-pump coronary artery bypass surgery. Therefore, this meta-analysis demonstrates that mortality, stroke, myocardial infarction, and renal failure were not reduced in off-pump coronary artery bypass surgery surgery; however, selected short-term and mid-term clinical and resource outcomes were improved compared with conventional coronary artery bypass surgery.

Coronary Artery Bypass↗

PubMed1991

Prospective, randomized trial of the biofragmentable anastomosis ring. The BAR Investigational Group.

A randomized trial was undertaken to compare the biofragmental anastomotic ring (BAR) with conventional intraperitoneal colorectal anastomotic techniques. Patients were randomized into one of two schemes: BAR versus sutured or BAR versus stapled anastomosis. There were 782 patients entered into the study and 283 patients (36%) had a sutured anastomosis, 104 patients (13%) had a stapled anastomosis, and 395 (51%) had the BAR. Comparison of the BAR with combined suture and stapled controls revealed no significant differences in wound complication, abscess rate, bleeding, anastomotic leaks, ileus, obstruction, or deaths. There were no differences in return of bowel function, return to normal diet, or hospital stay. Intraoperative difficulties occurred in 46 BAR patients (17%), and this was significantly higher (p less than 0.001) than for sutured (3%) but not for stapled anastomoses (11%). The occurrence of these problems did not adversely effect the outcome. The data suggest that the BAR is a safe, satisfactory alternative to sutured or stapled colorectal anastomoses.

Adolescent↗

PubMed2001

Increased mortality with oral platelet glycoprotein IIb/IIIa antagonists: a meta-analysis of phase III multicenter randomized trials.

BACKGROUND: Numerous clinical trials have established the benefits of intravenous glycoprotein IIb/IIIa inhibition in the management of coronary artery disease. In contrast, the recent large-scale, placebo-controlled, randomized trials of the oral glycoprotein IIb/IIIa antagonists have failed to provide commensurate reductions in late composite ischemic end points despite potent inhibition of platelet aggregation. METHODS AND RESULTS: The ORs for death, myocardial infarction, urgent revascularization, and major bleeding from the 4 large-scale, placebo-controlled, randomized trials with oral glycoprotein IIb/IIIa inhibitors were calculated and combined. Stratification by low-dose or high-dose therapy and the use of concurrent aspirin was also undertaken. In 33 326 patients followed for >30 days, a consistent and statistically significant increase in mortality was observed with oral glycoprotein IIb/IIIa therapy (OR, 1.37; 95% CI, 1.13 to 1.66; P:=0.001). This effect was evident regardless of aspirin coadministration and treatment with either low-dose or high-dose therapy. Although a reduction in urgent revascularization was observed with oral glycoprotein IIb/IIIa inhibition, pooled analysis favored an increase in myocardial infarction that did not demonstrate statistical significance. CONCLUSIONS: Although we found a highly significant excess in mortality consistent across 4 trials with 3 different oral glycoprotein IIb/IIIa inhibitor agents, this was associated with a reduction in the need for urgent revascularization and no increase in myocardial infarction. These findings suggest the potential for a direct toxic effect with these agents and argue against a prothrombotic mechanism. Further investigation to elucidate the cause of this increased fatality risk is warranted.

Administration, Oral↗

PubMed2002

Cardiac function after orthotopic liver transplantation and the effects of immunosuppression: a prospective randomized trial comparing cyclosporin (Neoral) and tacrolimus.

There are several case reports in the literature that describe cardiac complications in the first few weeks after orthotopic liver transplantation (OLT) in patients receiving tacrolimus as their primary immunosuppressive therapy. In this study, we investigated the cardiac function of patients on tacrolimus (T) compared with those on cyclosporin (C) (Neoral; Novartis, Basel, Switzerland) immunosuppression, after OLT, in a prospective randomized trial. We randomized 40 adult patients with cirrhosis to either T or C with azathioprine and prednisolone immunosuppression and followed up on them for 3 months after OLT. All had detailed clinical, biochemical, electrocardiographic and echocardiographic assessments at regular intervals. Abnormalities in cardiac function were common after OLT and significant deterioration in left ventricular diastolic function was demonstrable up to 3 months in both patient groups. Cardiac function was similar in the T and C arms and no significant electrocardiographic differences were observed, although reduced heart rate variability (HRV) and higher mean serum brain natriuretic peptide (BNP) levels were identified in the T group. The percentage increase in posterior wall thickness was higher in the T group. Cardiac dysfunction as shown by worsening echocardiographic measures of left ventricular diastolic function and by clinical cardiac events is common in the first 3 months after OLT in patients with cirrhosis. HRV and BNP values in the T group were worse than in the C group, but this was not translated to an increase in cardiac clinical events in this study.

Administration, Oral↗

PubMed1990

Comparison of balloon angioplasty and laser thermal angioplasty in the treatment of femoropopliteal atherosclerotic disease: initial results of a prospective randomized trial. Work in progress.

The authors recently initiated a prospective randomized trial in which results of standard balloon angioplasty were compared with those of laser thermal angioplasty in the treatment of patients with symptoms of femoropopliteal occlusive disease. The data regarding their initial technical success are reported herein. Twenty-five patients with moderate to severe claudication have thus far undergone 27 procedures. The type of lesions treated varied from short focal stenoses to occlusions up to 10 cm in length; 12 stenoses and 15 occlusions were treated. Fourteen procedures were randomized to laser therapy and 13 to standard balloon angioplasty. If the primary randomized treatment failed, the alternative procedure was then attempted. Of the 14 laser procedures, five were initial failures; three of these failures were subsequently treated successfully with the balloon technique. Three of 13 balloon procedures were failures; none were subsequently successful with use of the laser. While these data are limited, initial experience indicates that technical success is directly related to the ability to pass an angiographic wire through the lesion and the length and type of lesions. It does not appear to depend on whether the laser or the balloon is used.

Aged↗

PubMed1989

Ten-year results of a randomized trial comparing a conservative treatment to mastectomy in early breast cancer.

A randomized trial was conducted at the Institut Gustave-Roussy (IGR) between 1972 and 1980 comparing tumorectomy and breast irradiation with modified radical mastectomy. One hundred and seventy-nine patients with an infiltrating breast carcinoma up to 20 mm in diameter at macroscopic examination were included: 88 had conservative management, and 91 a mastectomy. All patients had a low-axillary dissection with immediate histological examination. For the patients with positive axillary nodes, a complete axillary dissection was undertaken. Overall survival, distant metastasis, contralateral breast cancer and locoregional recurrence rates were not significantly different between the two treatment groups.

Adenocarcinoma↗

PubMed2006

Comparison of standard-dose and low-dose gemcitabine regimens in pancreatic adenocarcinoma patients: a prospective randomized trial.

BACKGROUND: A prospective, randomized study was performed to determine whether gemcitabine infusion at a low dose (250 mg/m2) is comparable or superior to the standard-dose infusion (1000 mg/m2) in terms of the survival period, clinical benefit, and frequency of adverse effects in patients with advanced pancreatic adenocarcinoma. METHODS: Twenty-five patients who were histologically proven to have locally advanced pancreatic cancer or pancreatic cancer with distant metastases were initially enrolled in the present study. They were treated with gemcitabine infusion at either a dose of 1000 mg/m2 over 30 min (the standard regimen) on days 1, 8, and 15 of every 4-week cycle or at a dose of 250 mg/m2 over 30 min every week. Survival time, response rate, time to treatment failure, clinical benefit response, and adverse effects were compared between the two groups. RESULTS: Twenty-one patients received gemcitabine for more than 1 month. The median survival period was 7.2 months for patients who received the low-dose infusion regimen, in contrast to 5.2 months for patients administered the standard-dose infusion regimen. The time to treatment failure was 5.6 months for patients in the low-dose infusion regimen, in contrast to 3.4 months for patients in the standard-dose infusion regimen. There were no significant differences in either survival time to time to treatment failure or clinical benefits between the two groups, but the incidence of adverse reactions in patients administered the low-dose therapy was significantly lower than that in patients receiving the standard-dose therapy (P<0.05). In particular, patients in the standard infusion regimen group experienced more hematologic toxicity than those in the low-dose regimen. CONCLUSIONS: These findings suggest that the low-dose gemcitabine infusion regimen can be continuously administered to patients with locally advanced and systemically spreading pancreatic cancer because of its reduced toxicity, resulting in better quality of life and an improved safety profile as compared to the standard infusion treatment regimen.

Adenocarcinoma↗

PubMed2005

Androgen suppression plus radiation versus radiation alone for patients with stage D1/pathologic node-positive adenocarcinoma of the prostate: updated results based on national prospective randomized trial Radiation Therapy Oncology Group 85-31.

PURPOSE: To update the effect of immediate androgen suppression in conjunction with standard external-beam irradiation versus radiation alone on a group of histologically lymph node-positive patients with adenocarcinoma of the prostate. MATERIALS AND METHODS: A national prospective randomized trial (Radiation Therapy Oncology Group 85-31) of standard external-beam irradiation plus immediate androgen suppression versus external-beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy-three patients in this trial had histologically involved lymph nodes. Ninety-eight patients received radiation plus immediate androgen suppression (luteinizing hormone-releasing hormone [LHRH] agonist), whereas 75 patients received radiation alone with hormonal manipulation instituted at the time of relapse. RESULTS: With a median follow-up of 6.5 years for all patients and 9.5 years for living patients, estimated progression-free survival with prostate-specific antigen (PSA) level less than 1.5 ng/mL at 5 and 9 years was 54% and 33%, respectively, for patients who received immediate LHRH agonist versus 10% [corrected] and 4% for patients who received radiation alone with hormonal manipulation instituted at time of relapse (P < .0001). Multivariate analysis revealed radiation therapy and immediate hormonal manipulation as having a statistically significant impact on all end points analyzed: absolute survival, disease-specific failure, metastatic failure, and biochemical control with PSA less than 4 ng/mL and less than 1.5 ng/mL. CONCLUSION: Pending the results of randomized trials, patients with adenocarcinoma of the prostate who have pathologically involved pelvic lymph nodes (pathologic node-positive or clinical stage D1) should be considered for external-beam irradiation plus immediate hormonal manipulation rather than radiation alone with hormone manipulation at the time of relapse.

Adenocarcinoma↗

PubMed1997

Short-term safety of live attenuated Japanese encephalitis vaccine (SA14-14-2): results of a randomized trial with 26,239 subjects.

The short-term safety of an effective and inexpensive new live attenuated Japanese encephalitis vaccine (SA14-14-2) was studied in a randomized trial, using block randomization. Of 26,239 children who were enrolled, half received the vaccine and half served as controls. Subjects were prospectively followed for 30 days for severe adverse events, such as encephalitis, meningitis, and "all-cause" hospitalization. No cases of encephalitis or meningitis occurred in either group. The upper 95% confidence limit for adverse events not occurring among subjects receiving their first dose was 4.1/10,000. Risk ratios and 95% confidence intervals for other adverse events were 0.70 (0.43-1.15) for all-cause hospitalization, 0.91 (0.37-2.22) for seizure, and 0.79 (0.56-1.11) for fever lasting > or = 3 days. These data attest to the short-term safety of the SA14-14-2 virus strain and the hamster kidney cell substrate.

Animals↗

PubMed1984

Levamisole as adjuvant to chemotherapy of ovarian cancer. Results of a randomized trial and 4-year follow-up.

The results of a randomized trial, stratified according to age and stage of disease, in 140 patients with ovarian cancer are presented. The drug, levamisole, or a placebo was given as adjuvant to cytotoxic chemotherapy for 12 months after maximal surgical reduction of tumor. Because of severe side effects, levamisole treatment was discontinued in 8 of 69 patients (marked neutropenia in 5, severe skin rashes in 3). There were no significant differences in the survival curve and mean duration of survival between levamisole-treated and placebo-treated groups during the 4 years of follow-up, except for patients with Stage II disease. Among these latter patients, the survival rate became progressively much lower in the levamisole-treated group and the difference reached statistical significance after the second year of follow-up (P less than 0.01). In view of the inconclusive evidence that levamisole provides a beneficial effect (in fact, there is concern of a deleterious effect) and the serious side effects, the drug should not be used in patients with ovarian cancer.

Adjuvants, Immunologic↗

PubMed2004

A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.

BACKGROUND: Incidence rates for many types of cancer are higher among African American men than in the general population, yet African American men are less likely to participate in cancer screening trials. This paper describes the outcomes of a randomized trial (the AAMEN Project) designed to recruit African American men aged 55-74 years to a prostate, lung and colorectal cancer screening trial. METHODS: The recruitment interventions address four types of barriers to clinical trial participation: sociocultural barriers, economic barriers, individual barriers and barriers inherent in study design. Subjects were randomized to a control group or one of three increasingly intensive intervention arms, which used different combinations of mail, phone and in person church-based recruitment. RESULTS: Of the 39,432 African American men residing in the geographically defined study population (southeastern Michigan and northern Ohio), 17,770 men (45%) could be contacted, and 12,400 (31% of 39,432) were found to be eligible to participate. No statistically significant differences in age, education or income level were found among participants in the four study arms. A significantly greater enrollment yield (3.9%) was seen in the most intensive, church-based intervention arm, compared to the enrollment yields in the other two intervention arms (2.5 and 2.8%) or the control group (2.9%) (P < 0.01). CONCLUSIONS: The intervention that involved the highest rate of face-to-face contact with the study participants produced the highest enrollment yield, but several strategies that were thought could improve yield had no effect. These findings, which are consistent with current literature on population-based recruitment, should facilitate the development of future recruitment efforts involving older African American men.

Black or African American↗