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Results for “Randomized Controlled Trial”

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At least 91 records · Page 5Linked to original sources

PubMed1978

Prevention of deep vein thrombosis in neurosurgical patients: a controlled, randomized trial of external pneumatic compression boots.

A prospective, randomized clinical trial in 95 patients undergoing neurosurgical operative procedures was performed to investigate the efficacy of external pneumatic compression (EPC) of the calves as compared with results in a control group that received no specific form of prophylaxis for prevention of deep vein thrombosis (DVT). The diagnosis of DVT was established by the I125 fibrinogen scan and radiographic contrast phlebography. The data indicate that EPC provides significant protection against the development of DVT in comparison with results in the control group (p less than 0.005). There were no known pulmonary emboli in any of the EPC-treated patients. There were no complications of EPC.

Evaluation Studies as Topic↗

PubMed1992

Adenosine during cardiac arrest and cardiopulmonary resuscitation: a placebo-controlled, randomized trial.

UNLABELLED: BACKGROUND AND HYPOTHESIS TESTED: The effects of adenosine (100 micrograms/kg/min; n = 7) were examined during rodent cardiopulmonary resuscitation (CPR). Change in coronary artery perfusion pressure, end-tidal PCO2, and arterial acid-base status of anesthetized, male, Sprague-Dawley rats were compared with CPR controls (0.9% sodium chloride; n = 7) and with sham controls (n = 9). Sustained ventricular fibrillation was induced and precordial chest compression was followed by defibrillation. RESULTS: After 6 mins of cardiac arrest, six (86%) of seven adenosine-treated animals were resuscitated after adenosine infusion and four (57%) of seven control animals were resuscitated after sodium chloride infusion. During chest compression, coronary artery perfusion pressure was 7 +/- 2 mm Hg after adenosine, but was 22 +/- 3 mm Hg in the controls (p less than .01). Parallel decreases were observed in mean aortic pressure. Arterial and end-tidal PCO2 significantly (p less than .01) decreased after adenosine. These changes contrasted with a second control group of nine identically prepared animals which, in the absence of ventricular fibrillation and subsequent chest compression, demonstrated no changes in hemodynamic, respiratory, or blood gas variables. CONCLUSIONS: Adenosine decreased coronary artery perfusion pressure. However, despite marked reductions in coronary artery perfusion pressure, survival was not compromised after adenosine infusion in this rodent model of CPR.

Acid-Base Equilibrium↗

PubMed1988

Meta-analysis of randomized controlled trials as a method of estimating rare complications of non-steroidal anti-inflammatory drug therapy.

The design of randomized controlled trials to assess the efficacy of pharmacological measures for the prevention of the gastrointestinal side-effects of anti-inflammatory drugs requires an accurate estimate of excess risk under controlled conditions. Photocopies of 952 randomized controlled trial publications were obtained after scanning titles and abstracts of a MEDLINE computer search, 427 were excluded for obvious reasons, and 525 were again photocopied after obliterating source and results. Selection criteria were: the presence of a non-anti-inflammatory drug control group; at least 4 days of therapy; at least 3 days without anti-inflammatory drugs before randomization; no complicating background drugs; mention of side-effects; and a clear differentiation of gastrointestinal complications. Observer error, with two independent readings, for inclusion suitability in the study was 19% for Methods and 9% for Results. For the 44 aspirin trials, the mean therapy duration was 357 days; the unweighted rate difference between therapy and control groups ( +/- 1 S.E.M.) for ulcer was 0.006 +/- 0.003, for gross haemorrhage 0.006 +/- 0.002 and for unspecified gastric symptoms 0.03 +/- 0.01. In 123 non-aspirin non-steroidal anti-inflammatory drug (NA-NSAID) trials, the mean duration was 67 days; the unweighted rate difference for ulcer was 0.0005 +/- 0.0003, for gross haemorrhage 0.007 +/- 0.004 and for unspecified gastric symptoms 0.02 +/- 0.005. Risk differences were also pooled using the DerSimonian and Laird method, which weights studies inversely according to variance. Using this method, only the unspecified gastric symptoms for non-aspirin non-steroidal anti-inflammatory drugs (NA-NSAIDs) and the haemorrhage for aspirin were found to be statistically significant. Longer studies have higher risk differences. Randomized control trials to determine prophylactic efficacy against haemorrhage (that is, to demonstrate a reduction of ulcer rate in the therapy group to the rate of controls) would require 190 patients in each group for NA-NSAIDs in studies of 2-6 months; 950 subjects would be needed to detect a 50% reduction. Randomized control trials to determine a reduction in ulcer rate to that of controls in patients on aspirin for more than 6 months would require 700 subjects in each group; 3346 subjects would be needed to detect a 50% reduction. Such studies are feasible.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1988

Comparison of antihypertensive efficacy and perinatal safety of labetalol and methyldopa in the treatment of hypertension in pregnancy: a randomized controlled trial.

Labetalol was compared with methyldopa in a randomized controlled trial involving 176 pregnant women with mild to moderate hypertension. Diastolic blood pressure below 86 mmHg was obtained in a similar proportion of women given labetalol or methyldopa. Intrauterine death occurred in four women treated with methyldopa, and the one neonatal death on day 1 occurred in the labetalol group. The average birthweight and the proportion of preterm or small-for-gestational-age babies were similar in both groups. Heart rate, blood pressure, blood glucose, respiratory rate, and Silverman score of the babies did not differ between the two treatment groups, whether the comparison was made for all the infants, or only for those that were preterm or small-for-gestational-age. These data indicate that maternal beta-blockade with labetalol is as safe as methyldopa for the fetus and the newborn.

Adult↗

PubMed1992

Randomized, controlled trial of compression gloves in rheumatoid arthritis.

A randomized, controlled trial was conducted to determine efficacy of the Isotoner and the Futuro compression gloves in 39 patients with hand synovitis secondary to rheumatoid arthritis. After 7 days of nighttime treatment, both brands of gloves were found to decrease subjective symptoms of pain and stiffness (p < 0.05). In addition, swelling of the proximal interphalangeal joints decreased, while range of motion, rate of finger motion, and grip strength all increased (p < 0.05). Compression gloves should be used with caution in patients with bilateral carpal tunnel syndrome, because 12 of 13 such patients experienced worsening of their symptoms following one nighttime wearing of compression gloves. While both gloves were found to be efficacious in improving the signs and symptoms of hand synovitis, neither glove was found to be superior to the other. Patient preferences related to glove composition and fit may ultimately determine which glove to prescribe.

Adult↗

PubMed1991

Recombinant human alpha-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France.

We have conducted a multicenter randomized controlled trial comparing two doses of recombinant human alpha-interferon for efficacy in 60 patients with chronic non-A, non-B hepatitis. The source of infection appeared to be transfusion in 30 patients, intravenous drug abuse in 16 patients and was unknown in 14 patients. Patients were randomly assigned to no treatment or to treatment with either 1 or 3 MU of alpha-interferon given three times a week for 24 wk. Forty-five patients (75%) were positive for antibody to hepatitis C virus. During the 24-wk treatment period, mean serum ALT levels decreased in both treatment groups, but the decrease was statistically significant only in the 3 MU group. However, at 24 wk, the proportion of patients with normal ALT levels was similar in the 3 MU group (39%) and the 1 MU group (45%), and both were significantly higher than in controls (0%). Repeat liver biopsy specimens showed a significant decrease in the severity of histological changes in the 3 MU group but not in the 1 MU group or in controls. Responses to alpha-interferon did not correlate with patient's age, gender, source of infection, pretreatment serum ALT, presence of anti-hepatitis C virus or cirrhosis. After treatment, the mean ALT levels rose in both treated groups. The proportion of patients with normal ALT levels at wk 48 was 28% in the 3 MU group and 20% in the 1 MU group. In conclusion, a dose of 3 MU was superior to 1 MU of alpha-interferon given three times weekly for 24 wk in inducing improvements in serum ALT levels and liver histological examinations.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed1992

Geriatric follow-up by home visits after discharge from hospital: a randomized controlled trial.

The aim of this prospective, randomized and controlled trial was to carry out and evaluate a model for follow-up by home visits after discharge from hospital of persons aged 75 years or more. The trial was a feasibility study in which hospital staff, district nurses, and general practitioners already working within the hospital and the primary health sector participated, with changes in the usual organization. On the day after their discharge from hospital, 163 patients were visited in their homes by the district nurse. Two weeks later, they were evaluated at home by their general practitioner. For 181 control patients, discharge took place according to the usual procedures. Endpoints were evaluated one year after discharge. Significantly more patients from the control group had been admitted to nursing homes as compared with the trial group (25/10, p < 0.05); the control patients stayed 2700 days at institutions, the trial group 1950 days. It is proposed that this simple and practicable follow-up routine be introduced in connection with discharge of elderly persons from hospital.

Aged↗

PubMed1989

Succinylcholine and atropine for premedication of the newborn infant before nasotracheal intubation: a randomized, controlled trial.

Twenty preterm newborn infants were randomized to receive either atropine alone (20 micrograms/kg) or atropine plus succinylcholine (2 mg/kg) before nasotracheal intubation. Heart rate, BP, transcutaneous PO2, and intracranial pressure were monitored continuously before, during, and after intubation. No infants developed bradycardia or hypoxia. Intracranial hypertension developed during intubation in the infants receiving atropine alone, but was prevented by premedication with succinylcholine and atropine (p less than .01). A 41% increase in systemic BP occurred immediately after the administration of succinylcholine (p less than .01). BP increased during intubation in both groups, and the overall peak BP was not significantly different between the groups. Intubation was significantly shorter in the infants receiving succinylcholine. Premedication with succinylcholine and atropine will facilitate intubation of neonates, and ameliorate the adverse physiologic consequences of this procedure.

Atropine↗

PubMed1990

Randomized, controlled trial of a 10-day course of amifloxacin versus trimethoprim-sulfamethoxazole in the treatment of acute, uncomplicated urinary tract infection. Amifloxacin Multi-Center Trial Group.

We conducted a randomized controlled trial of orally administered amifloxacin versus trimethoprimsulfamethoxazole (TMP-SMX) as treatments of acute uncomplicated urinary tract infection in women. Amifloxacin at a dosage of 200 mg twice a day appeared as safe and effective as TMP-SMX, but amifloxacin at 400 mg twice a day tended to cause adverse events more frequently than did TMP-SMX.

Administration, Oral↗

PubMed1983

Randomized controlled trial of physiotherapy for postoperative pulmonary complications.

A prospective randomized controlled trial was conducted in patients undergoing elective cholecystectomy to assess the value of routine chest physiotherapy. One hundred and two patients entered the study: 47 patients developed no pulmonary complications, 29 had pulmonary atelectasis and a further 26 developed chest infection. The pattern of changes in arterial oxygen tension in the period after operation supported the clinical allocation of the patients. Of 51 patients not receiving physiotherapy, 11 developed atelectasis and 19 chest infection. Of 51 treated patients, 18 developed atelectasis and seven chest infection. Routine prophylactic postoperative chest physiotherapy decreased significantly the frequency of chest infection (P less than 0.02).

Adult↗

PubMed1979

Randomized controlled trial of cefuroxime for established postoperative respiratory infection.

A randomized controlled trial has investigated the value of cefuroxime (a new antibiotic resistant to beta-lactamase) in 80 patients with established postoperative respiratory infection. Although the majority of respiratory isolates were sensitive to cefuroxime, there was no significant advantage in the antibiotic group compared with the controls with respect to duration of fever, radiological abnormality or infected sputum. We conclude that antibiotics are rarely necessary for the majority of patients who develop postoperative respiratory infections.

Cephalosporins↗

PubMed1985

The Dublin randomized controlled trial of intrapartum fetal heart rate monitoring.

In a randomized controlled trial involving 12,964 women, a policy of continuous electronic intrapartum fetal heart monitoring was compared with an alternative policy of intermittent auscultation, both policies including an option to measure fetal scalp blood pH. Women allocated to electronic fetal heart monitoring had shorter labors and received less analgesia. The caesarean delivery rates were 2.4% for electronic fetal heart monitoring and 2.2% for intermittent auscultation but this small difference arose from the identification of nearly twice as many fetuses with low scalp pH (less than 7.20) in the electronic fetal heart monitoring group. The forceps delivery rate was 8.2% in the electronic fetal heart monitoring group compared with 6.3% in the intermittent auscultation group, and this excess was explained by more instrumental deliveries prompted by fetal heart rate abnormalities. There were 14 stillbirths and neonatal deaths in each group, with a similar distribution of causes. There were no apparent differences in the rates of low Apgar scores, need for resuscitation, or transfer to the special care nursery. Cases of neonatal seizures and persistent abnormal neurological signs followed by survival were twice as frequent in the intermittent auscultation group, and this differential effect was related to duration of labor. Follow-up at 1 year of babies who survived neonatal seizures revealed three clearly abnormal infants in each group. The implications of these findings for both theory and practice are discussed.

Adult↗

PubMed1978

Results of a controlled randomized trial of proximal gastric vagotomy with and without pyloroplasty.

The 1--5 year results of a prospective randomized trial of proximal gastric vagotomy (PGV) with and without pyloroplasty in 64 men operated upon electively for chronic duodenal ulcer are reported. The effects of the operation on gastric secretion, as tested at 6 months with pentagastrin and isulin, were the same in both groups. There was no statistically significant difference in the clinical results between the two groups. The authors conclude that the addition of pyloroplasty makes little, if any, difference to the results of PGV. Pyloroplasty is thus better omitted as it adds nothing of value and may increase the risk of the procedure.

Adult↗

PubMed1978

Adjuvant chemotherapy in large-bowel cancer: demonstration of effectiveness of single agent chemotherapy in a prospectively controlled,, randomized trial.

In a prospectively randomized study, the effect of adjuvant chemotherapy with 5-FU on survival and recurrence rates was analyzed in 299 evaluable patients with colorectal carcinoma who either underwent a curative or a palliative resection. In the treatment group, chemotherapy consisted of the intravenous administration of 12 mg/kg daily of 5-FU for 4 consecutive days, then 6 mg/kg on alternate days, to the point of toxicity, or to a maximum of five doses, followed by 12mg/kg weekly for 1 year. Some degree of drug toxicity was seen in the majority of patients, was rarely severe, and there have been no drug-related deaths. Analysis of the survival curves and disease-free interval curves reveal definite evidence of drug benefit in two unfavorable subgroups, namely patients with Dukes C tumors and in patients whose tumor was located in the rectum. In the chemotherapy groups, patients who were treated to toxicity (WBC less than 4000 mm3), the disease-free interval was significantly longer than the nonleukopenic patients. We conclude that the addition of 5-FU to the surgical treatment of colorectal carcinoma provides a small, but significant benefit in patients with colorectal cancer in certain unfavorable subgroups, namely patients with Dukes C lesions and patients with rectal carcinoma.

Clinical Trials as Topic↗

PubMed1986

Percutaneous transluminal coronary angioplasty after thrombolytic therapy: a prospective controlled randomized trial.

In 162 patients with acute transmural myocardial infarction, combined intravenous and intracoronary thrombolytic therapy with streptokinase was initiated. In vessels that remained occluded, mechanical recanalization was performed with a 3F recanalization catheter (group I, n = 79) or a 4F Grüntzig balloon catheter (group II, n = 83). After reperfusion, intracoronary streptokinase was administered superselectively. After termination of streptokinase infusion, angioplasty was performed only in patients in group II. There was no difference between the groups in relation to sex, age, infarct location, creatine kinase levels and time between onset of symptoms and start of treatment. Initial coronary angiography showed an open vessel in 27 (34%) of 79 patients in group I and 21 (25%) of 83 patients in group II. The final reperfusion rate was 90% (71 of 79) in group I and 86% (71 of 83) in group II. Angioplasty was attempted in 69 of the 71 patients in group II with a success rate of 65% and an occlusion rate of 3%. During the hospital stay, reocclusion occurred in 14 (20%) of 71 patients in group I. After thrombolytic therapy, coronary luminal narrowing in group I was 75 +/- 17% in patients without and 87 +/- 6% in patients with reocclusion (p less than 0.05). In group II, reocclusion was found in 10 (14%) of 71 patients. After angioplasty, the degree of coronary stenosis in group II was reduced from 82 +/- 12 to 51 +/- 30% (p less than 0.001). Reocclusion was found in 3 (7%) of the 45 patients with successful angioplasty and in 7 (32%) of the 22 patients with unsuccessful angioplasty (p less than 0.01). Improvement in regional left ventricular function was observed only in patients from group II with anterior myocardial infarction. In conclusion, by combined medical and mechanical recanalization, the rate of coronary reperfusion can be increased and infarct time shortened, providing the possibility of full revascularization by angioplasty, with improvement of regional wall motion and reduction of the rate of reocclusion.

Adult↗

PubMed1975

Chemotherapy of advanced breast cancer: a controlled randomized trial of cyclophosphamide versus a four-drug combination.

Ninety-nine patients with advanced breast cancer were randomized to receive either cyclophosphamide continuously or a combination of cyclophosphamide, methotrexate, 5-fluorouracil and vinblastine given intermittently. The number and duration of objective responses were greater in patients receiving the combination but the differences between the two treatments did not achieve formal significance. The combination was logistically easier to manage and produced less toxicity.

Adult↗

PubMed1987

Psychological group counseling for the prevention of ulcer relapses. A controlled randomized trial in duodenal and prepyloric ulcer disease.

The effect of psychological counseling on 1-year ulcer relapse rate of recurrent duodenal and prepyloric ulcer disease was evaluated in 148 patients randomly allocated into three treatment groups; psychological counseling group, maintenance cimetidine (400 mg at bedtime), and placebo cimetidine at bedtime. Ulcer relapses were monitored by endoscopy at 6 and 12 months after inclusion and at symptomatic recurrence. The estimated proportion of relapse-free patients after 12 months follow-up in the psychological counseling group (0.43 +/- 0.08) did not differ significantly from the placebo group (0.47 +/- 0.07), whereas the corresponding value for the cimetidine group (0.70 +/- 0.07) was significantly higher (p less than 0.01). The effect of cimetidine on ulcer recurrence, however, was confined to smokers; relapse risk among nonsmokers did not differ significantly between the treatment groups. The negative outcome of psychological counseling raises doubts as to whether duodenal or prepyloric ulcer recurrences can be prevented by such a therapeutic approach.

Adolescent↗

PubMed2026

Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 ± 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

Bias↗