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Results for “Randomized trial”

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At least 55 records · Page 3Linked to original sources

PubMed1991

Role of gastric colonization in the development of pneumonia in critically ill trauma patients: results of a prospective randomized trial.

Critically ill trauma patients were entered in a prospective, randomized trial to determine the role of gastric colonization in the development of pneumonia. Trauma patients admitted to the SICU were randomized to receive antacids (n = 27), continuous IV cimetidine (n = 32), or sucralfate (n = 30). Quantitative nasogastric tube (NGT) cultures were obtained biweekly and correlated with gastric pH, the incidence of pneumonia, and the incidence of pneumonia caused by an organism previously isolated from the stomach (percentage of gastric source of pneumonia--% GSP). Patients receiving antacids had a significantly greater pH than those receiving cimetidine (5.6 +/- 1.03 vs. 4.7 +/- 1.03; p = 0.006). However, there was no significant difference between the overall incidence of pneumonia, the percentage of NGT isolates greater than 10(6)/ml, or the % GSP. The gastric bacteriology of the three subgroups was nearly identical, with Candida albicans, Enterococci, and beta-hemolytic Streptococci being the most frequently isolated organisms. Gastric growth of organisms preceding their appearance in the blood occurred in 5 of 89 (5.6%) patients. These results suggest that 1) in trauma patients, the incidence of pneumonia is not increased by the use of stress ulcer prophylactic agents that elevate gastric pH; 2) increases in gastric pH progressively increased the number of intragastric bacteria but this did not correlate with an increased incidence of % GSP; and 3) while organisms in the upper intestinal tract may be pathogens for pneumonia, they are uncommonly a source of bacteremia in seriously injured patients.

Adolescent↗

PubMed1991

Total peripheral artery occlusions: conventional versus laser thermal recanalization with a hybrid probe in percutaneous angioplasty--results of a randomized trial.

Increasing the primary success rate in recanalization of peripheral vascular occlusions is one aim of using laser techniques in the treatment of peripheral vascular disease. Although reports of lasers enabling recanalization after failure of guide wires have been numerous, direct comparisons of the success of the two techniques in a randomized trial have been few. The results of a randomized trial showed no statistical difference in recanalization of femoropopliteal occlusions between the conventional guide wire and hybrid laser probe. The number of patients with iliac occlusions was small and comparisons are difficult to make, but the findings suggest that the hybrid laser probe has little to offer. Immediate crossover to the alternative method allowed investigation of the relationship between the two methods in practice. Combining the two methods improved the primary success rate from 82% to 91% for femoropopliteal occlusions randomized to laser thermal recanalization and from 74% to 91% for those randomized to conventional recanalization.

Angioplasty, Balloon↗

PubMed1991

Aztreonam therapy in children with febrile neutropenia: a randomized trial of aztreonam plus flucloxacillin versus piperacillin plus gentamicin.

In a prospective, randomized trial in 100 febrile neutropenic children, aztreonam plus flucloxacillin was compared with piperacillin plus gentamicin. At the 72 h clinical assessment there was no statistically significant difference between the two groups. However, in microbiologically documented infections there was a higher response rate in the piperacillin/gentamicin group (57%) than in the aztreonam/flucoxacillin group (41%). This was contributed to by the poorer Gram-positive cover of the aztreonam/flucloxacillin combination. In clinically documented infections and unexplained fevers the response rate of the two antibiotic regimens was identical. There were two deaths; one early death (in the piperacillin/gentamicin arm) and one late death. At the final assessment a successful outcome was obtained in the remaining patients. In the aztreonam/flucloxacillin group 75% of the episodes required modification compared with 59% in the piperacillin/gentamicin group.

Adolescent↗

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↗

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↗

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↗

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↗

PubMed1990

A randomized trial of two occlusive dressings in the treatment of leg ulcers.

Two occlusive dressings--one zinc oxide medicated (Mezinc) and one hydrocolloid (Duoderm)--were compared in a prospective, randomized trial over a period of 8 weeks to determine their healing ability and effect on pain for venous and arterial leg ulcers. All patients were patch-tested before the study and colophony allergy was an exclusion criterion. Of the 43 outpatients included, 31 completed the trial and 6 patients randomized to each treatment group were withdrawn. The initial ulcer areas decreased after 8 weeks of treatment with Mezinc by 64% and by 48% after treatment with Duoderm. Ulcer pain was relieved in 50% of the patients--with a similar analgesic effect for the two dressings. Mezinc treatment was discontinued in 2 cases due to sensitization to colophony (one ingredient of Mezinc) which indicated a risk of contact allergy to colophony due to Mezinc treatment. 1103 consecutive eczema patients were patch-tested on the back with Mezinc and colophony 20% in petrolatum simultaneously. It was found that 42 (4%) of the patients showed allergic skin reactions to colophony and 19 (2%) to Mezinc. Both dressings were well tolerated by leg ulcer patients and there appeared to be no major differences in the efficacy of the two occlusive dressings.

Aged↗

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↗

PubMed1992

Hepatic arterial infusion of floxuridine in patients with liver metastases from colorectal carcinoma: long-term results of a prospective randomized trial.

PURPOSE: A multicentric randomized study that compared patients who received intrahepatic arterial infusion (HAI) to a group of patients who did not receive HAI (control group) was performed for unresectable hepatic metastases from primary colorectal carcinoma. PATIENTS AND METHODS: One hundred sixty-six patients were assigned randomly to HAI of floxuridine (5 fluoro-2'deoxyuridine [FUDR]) 0.3 mg/kg/d for 14 days every 4 weeks or to the control group; this latter group, depending on the investigator's choice, was either under observation or received systemic fluorouracil (5-FU). The same regimen of systemic 5-FU also was administered to the HAI group in the event of extrahepatic progression. No crossover from the control group to the HAI group was permitted. The mean duration of follow-up was 54 months (range, 31 to 72), and 163 patients were analyzed. RESULTS: A significant improvement was observed in the survival rate for the 81 patients assigned to HAI group (P less than .02) with a 1-year survival rate of 64% versus 44% in the control group (82 patients). The 2-year survival rate was 23% versus 13%. The median survival was 15 months versus 11 months for the HAI group and the control group, respectively. Survival was better for patients with a less than 30% liver involvement, and for those treated in more specialized centers. The hepatotoxic effects of HAI were observed in 47 patients (chemical hepatitis [n = 28], and biliary sclerosis [n = 19]). The 1-year rate of sclerosing cholangitis was equal to 25%. Gastrointestinal toxicity was infrequent and consisted of gastritis or diarrhea. CONCLUSIONS: Therapy with HAI of FUDR improves the survival of patients with liver metastases over colorectal carcinoma. However, the methods that are used to diminish the toxicity of HAI and efficient systemic chemotherapy, such as a combination of 5-FU and leucovorin, are required to prevent extrahepatic metastases.

Colorectal Neoplasms↗

PubMed1991

[Comparison of three different fractionations in radiotherapy for esophageal carcinoma--a prospective randomized trial on 80 patients].

A prospective randomized clinical trial on three different kinds of fractionation in radiotherapy for 80 patients with esophageal carcinoma was carried out from March 1987 to September 1987. The fractionation schemes were: Group A- routine fractionation; Group B- accelerated hyperfractionation with twice-a-day irradiation; and Group C- accelerated hyperfractionation with three-times-a-day irradiation. The 2-year survival rates of the respective groups were: Group A- 18.5% (5/27); Group B- 44.4% (12/27); and Group C- 26.9% (7/26). The difference in survivals was statistically significant between Groups B and C (P less than 0.05) but not between Groups A and C (P greater than 0.05). Though with limited duration of follow-up, the authors prefer the twice-a-day accelerated hyperfractionation scheme for esophageal carcinoma.

Adult↗

PubMed1991

Weight loss in women participating in a randomized trial of low-fat diets.

We examined weight changes over 1 and 2 y in 303 women enrolled in a low-fat dietary-intervention trial. Participants were randomly assigned to an intervention group that received intensive instruction in maintaining a low-fat diet or to a control group. After 1 y intervention-group women had decreased fat intake by 45.3 g (from 39.2% to 21.6% energy from fat) and weight by 3.1 kg (all P less than 0.0001); control-group women decreased fat intake by 8.8 g (from 38.9% to 37.3% energy from fat) and weight by 0.4 kg. In both univariate analyses and multivariate models, weight loss was more strongly associated with change in percent energy from fat than with change in total energy intake. These data, which are consistent with both epidemiologic and clinical studies, suggest that body adiposity is a function both of energy balance and the proportion of energy derived from fat.

Aged↗

PubMed1991

Prevention of alloimmunization in patients with acute leukemia by use of white cell-reduced blood components--a randomized trial.

Platelet refractoriness arising from HLA alloimmunization is a serious complication of transfusion therapy. In a prospective randomized trial, white cell (WBC)-reduced blood components were compared to standard platelet and red cell concentrates with respect to alloimmunization, refractoriness, and platelet increments after transfusion. Sixteen of 31 adult acute leukemia patients received only WBC-reduced platelet concentrates (PCs) and red cells (RBCs), with fewer than 10(6) WBCs per unit. Fifteen control patients received standard blood components with a mean of 0.1 x 10(9) (PCs) and 1 x 10(9) (RBCs) WBCs per unit. Platelet loss during cotton-wool filtration averaged 14 percent (range, 3-32%) from fresh PCs and 24 percent (range, 9-62%) from stored PCs. Filtration did not change corrected increments (CI) measured after transfusion of fresh PCs. The Cl 1 hour after filtration of stored PCs diminished by 27 percent, but the difference was smaller after 18 hours, which suggests better survival of WBC-reduced platelets. The number of platelet units transfused did not differ in the two groups. No patient in the WBC-reduced group developed permanent platelet refractoriness; transient HLA antibodies of low titer developed in two patients. In the control group, one patient became refractory because of immunization and two developed transient HLA antibodies. It can be concluded that the reduction of WBCs in blood components can effectively prevent alloimmunization.

Adolescent↗

PubMed2026

Impact of oxytocin discontinuation on fetal heart rate and uterine contractility: A pre-specified ancillary analysis embedded within a randomized trial.

INTRODUCTION: Oxytocin is widely used to augment uterine contractions during labor. However, its use has been associated with fetal heart rate (FHR) abnormalities and neonatal morbidity, which may be reduced by discontinuing oxytocin during labor. We aimed to assess the impact of oxytocin discontinuation at the onset of the active phase of labor on FHR patterns and uterine contractility. MATERIAL AND METHODS: This study is a pre-specified ancillary analysis of the STOPOXY trial, a multicenter, randomized, open-label, controlled superiority trial conducted in 21 French maternity units between January 2020 and January 2022, which aimed to assess the impact of oxytocin discontinuation during active labor on neonatal morbidity. Participants who received oxytocin before 4 cm dilation were randomly assigned (1:1) to either oxytocin discontinuation or oxytocin continuation. For the present analysis, we included women from the per-protocol discontinuation group of the parent trial. Inclusion was restricted to the six centers with electronic cardiotocography storage where valid cardiotocography recordings were available for at least 1 h before and 1 h after oxytocin discontinuation. Using a paired before-and-after design, FHR parameters (classified according to FIGO criteria) and uterine activity were compared during the 60 min preceding versus the 60 min following oxytocin discontinuation by independent obstetricians blinded to neonatal outcomes. Changes in FHR pattern were categorized as no change, improvement, or deterioration. RESULTS: 284 women fulfilled the eligibility criteria. Following oxytocin discontinuation, mean FHR increased (135 vs. 137.5 bpm; p < 0.002) and FHR variability significantly changed (p = 0.010), with a lower rate of reduced variability (3.9% vs. 2.5%) and a higher rate of normal variability (48.2% vs. 53.3%). The proportion of tracings with decelerations significantly decreased (64.1% vs. 48.6%; p < 0.001). Uterine activity decreased, with fewer uterine contractions (4.0 vs. 3.5 contractions per 10 min; p < 0.001). CONCLUSIONS: Among women receiving oxytocin during early labor, discontinuation at the onset of the active phase was associated with improved FHR patterns and reduced uterine activity, suggesting a lower fetal stress and tachysystole. Further studies are needed to assess whether these changes affect labor management or maternal experience.

Humans↗

PubMed1991

Follow-up of conventional angioplasty versus laser thermal angioplasty for total femoropopliteal artery occlusions: results of a randomized trial.

Sixty-eight patients with 68 femoropopliteal occlusions were entered into a randomized trial of conventional guide-wire and catheter percutaneous angioplasty versus laser thermal angioplasty. Thirty-four occlusions were randomized to conventional angioplasty and 34 to laser thermal angioplasty. After successful recanalization and balloon dilation, the patients were followed up for 1 year. Follow-up consisted of obtaining measurements of the ankle-arm indexes at 1, 3, 6, and 12 months. The increase in the mean resting ankle-arm index 1 year after conventional angioplasty (0.26) was greater than that after laser angioplasty (0.12). At 1-year follow-up, the cumulative success rate was 47% for patients treated with conventional angioplasty versus 39% for those treated with laser angioplasty. Statistical analysis showed no significant difference in clinical success between the two treatment groups.

Angioplasty, Balloon↗

PubMed1992

Effect of chloroquine chemoprophylaxis during pregnancy on birth weight: results of a randomized trial.

To determine the effect of chloroquine chemoprophylaxis during pregnancy on birth weights, a randomized trial was carried out in 1987 and 1988 in Banfora, Burkina Faso (West Africa). Seven hundred forty-five randomly selected women treated with chloroquine sulfate were compared to with 719 controls who received no treatment. In spite of an unquestionable effect of chloroquine in preventing placental infection (4.1% infected placentas in the treated group versus 19.0% in the controls), the mean difference in birth weights between the two groups (6 g) was not significant. The difference in the proportion of low birth weight (LBW) newborn babies in two groups (16.3% versus 16.4%) was also not significant. However, there was a strong relationship between placental infection and birth weight (the mean birth weight difference between infected and uninfected placentas was 113 g, and the proportion of LBW babies was 26.0% in infected placentas versus 14.8% in uninfected placentas). The small difference in birth weights observed between the two groups may be due to the fact that the prevalence rate of placental infection is low and that prophylaxis is effective only on a portion of the subjects in the treated group. It may also indicate that malaria is only one of several risk factors responsible for LBW. The relatively small increase in birth weight, the expected poor acceptance of mass prophylaxis, and the spreading of chloroquine-resistant Plasmodium strains should be considered before extending malaria chemoprophylaxis to all pregnant women. It might be worth considering to limit prophylaxis to primigravidae.

Adult↗

PubMed1992

The natural history of lung cancer estimated from the results of a randomized trial of screening.

The results from a randomized controlled trial of screening for lung cancer in Czechoslovakia have been used to estimate parameters of the natural history, using a model to simulate the disease process and the effects of screening. The results suggest that the period before clinical presentation during which lesions can be detected by screening is very short (seven to eight months). This implies that to detect three-quarters of all lung cancers by screening, two examinations per year are necessary, and that such a program would advance diagnosis by six months if there were complete participation. The results of the trial itself suggest that the benefit, in terms of a reduction in mortality from lung cancer, is likely to be very small.

Adult↗

PubMed1990

A randomized trial of terlipressin plus nitroglycerin vs. balloon tamponade in the control of acute variceal hemorrhage.

A randomized trial was undertaken to determine the efficacy of nitroglycerin in addition to terlipressin infusion to improve the control of acute variceal hemorrhage compared with balloon tamponade. Forty-seven bleeding episodes in 34 cirrhotic patients were included, with terlipressin plus sublingual nitroglycerin in 23 episodes (group I) and balloon tamponade in 24 episodes (group II). At the end of the 12-hr period, hemorrhage had been equally controlled in both groups (18 of 23; 78% in group I and 19 of 24; 79% in group II). When attempted, balloon tamponade appeared more efficient in the failures of group I (4 of 4) than did terlipressin plus nitroglycerin in the failures of group II (0 of 3), although this difference was not significant. Major complications were rare (one in each group) and never required cessation of therapy. Thus terlipressin and nitroglycerin were as effective as balloon tamponade in controlling variceal hemorrhage and were associated with few minor complications.

Adult↗