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Results for “Randomized trial”

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At least 127 records · Page 7Linked to original sources

PubMed1985

Plasma exchange and prednisone in Guillain-Barré syndrome: a controlled randomized trial.

A controlled randomized trial of plasma exchange combined with prednisone was compared with supportive care alone in patients with Guillain-Barré syndrome (GBS). There was no significant improvement in the treated group over the controls. The sample size, albeit small (12 treated and 13 controls), had the power (95% chance) to detect a change of 2 British Medical Research Council grades of strength between the groups. The difference in our results and others that indicated a beneficial effect of plasma exchange may reflect an adverse effect of prednisone on recovery in GBS. Failure to find a benefit of plasma exchange in our patients also raises the possibility that GBS may be a heterogeneous disorder with humoral factors playing a role in some but not all patients.

Adolescent↗

PubMed1999

Effect on growth of two different dexamethasone courses for preterm infants at risk of chronic lung disease. A randomized trial.

A randomized study was designed to evaluate the effects of two different dexamethasone courses on the growth of preterm infants. The first phase included 30 preterm infants at high risk for chronic lung disease (CLD). 15 babies (moderately early dexamethasone group) were treated with dexamethasone for 14 days, from the 10th day of life, and received a total dose of 4.75 mg/kg; 15 babies were assigned to the control group. The second phase included 30 preterm infants at high risk for CLD. 15 babies (early dexamethasone group) were treated with dexamethasone for 7 days, from the 4th day of life, and received a total dose of 2.38 mg/kg; 15 babies were assigned to the control group. All the main clinical baseline characteristics were similar between the groups both in the first and in the second phase. Infants given the two dexamethasone courses showed significantly reduced weight gain during the period of treatment when compared to the respective control group, but they had a weight catch-up soon after the end of treatment. At 30 days of life the weight and length gain of each treated group were similar to those of control infants, but the moderately early dexamethasone group showed a significantly poorer head growth. No differences between the groups were observed at discharge. Dexamethasone treatment induces a slower weight gain which is time-limited to the period of treatment and is followed by a body weight catch-up. However, the poorer head growth detected at 30 days of life in the infants who received a higher dose of dexamethasone could indicate important adverse effects, possibly dose-related, on postnatal brain growth and development.

Anti-Inflammatory Agents↗

PubMed1989

Efficacy of ethanolamine and polidocanol in the eradication of esophageal varices. A prospective randomized trial.

A prospective randomized trial has been undertaken to compare the efficacy of two sclerosing agents, Ethanolamine oleate (Et) and Polidocanol (Pl), in the eradication of esophageal varices (EV). Fifty consecutive cirrhotic patients, 22 in the Et and 28 in the Pl group, were included. Clinical data were comparable in both groups. Eradication of the EV was achieved in 81% (18/22) in the Et group and 64.1% (18/28) in the Pl group (p = NS). There was a significant difference in the rate of rebleeding (4 episodes in 3 patients in the Et group and 18 episodes in 13 patients in the Pl group, p less than 0.05). No differences were noted in the number of other complications or mortality. Both sclerosants have proved useful in the eradication of EV, but Et was superior to Pl in the preventation of recurrent bleeding in the course of repeated endoscopic injection sclerotherapy (EIS).

Esophageal and Gastric Varices↗

PubMed1995

The Subcutaneous Heparin and Angioplasty Restenosis Prevention (SHARP) trial. Results of a multicenter randomized trial investigating the effects of high dose unfractionated heparin on angiographic restenosis and clinical outcome.

OBJECTIVES: We sought to determine whether 12,500 IU of unfractionated heparin given subcutaneously twice daily for 4 months after percutaneous transluminal coronary angioplasty beneficially influences the subsequent rate of angiographic restenosis and the incidence of clinical events. BACKGROUND: Heparin has been shown to exhibit powerful antiproliferative effects against smooth muscle cells in several animal models. METHODS: A randomized trial with blinded data analysis was undertaken to assess the effect of unfractionated subcutaneous heparin on angiographic restenosis after coronary angioplasty. After successful angioplasty, patients were randomized to receive no heparin or 12,500 IU of heparin given subcutaneously twice daily for 4 months. Quantitative coronary angiography was performed before angioplasty, immediately after angioplasty and at follow-up ("early" [before 4 months] or electively [at 4 months]). RESULTS: The study group comprised 339 patients, 167 randomly assigned to receive heparin, 172 to receive no heparin. Repeat cardiac catheterization was performed in 90% of randomized patients. At early and elective restudy (mean 4.2 months), the mean +/- SD difference in minimal lumen diameter between the postangioplasty and follow-up measurement was -0.55 +/- 0.58 mm for the no heparin group and -0.43 +/- 0.59 mm for the heparin group (p = NS). Clinical events during the follow-up period did not differ significantly between groups: fatal myocardial infarction (1 patient in each group), coronary bypass grafting (5 patients in each group), repeat angioplasty (12 in the no heparin, 6 in the heparin group), angina at 4-month assessment (33% in the no heparin, 32% in the heparin group). CONCLUSIONS: Long-term treatment with high dose subcutaneous heparin (12,500 IU twice daily) for 4 months did not favorably influence angiographic or clinical outcome after coronary angioplasty.

Angioplasty, Balloon, Coronary↗

PubMed1985

Femoral neck fracture: sliding screw plate versus sliding nail plate--a randomized trial.

In a randomized trial 49 patients with fracture of the neck of the femur and an age of less than 70 years or a high level of physical activity were allocated to treatment with a sliding screw plate or a sliding nail plate fixation. The patients were followed for 2-5 years. At follow-up the union rate was found to be 86.2 per cent of the fractures in the screw plate group and 73.7 per cent in the nail plate group (P less than 0.3). Necrosis of the femoral head was encountered in respectively 10 and 21 per cent. Hip replacement was necessary in respectively 23.3 and 31.6 per cent. The nail slid out of the femoral head, resulting in recurrence of the fracture's displacement in three fractures with a sliding nail plate, and in none with a sliding screw plate (P = 0.053). Secondary loss of the femoral neck's angle was more frequently seen in the sliding nail plate group (P less than 0.01). In conclusion, the sliding screw plate gives better fixation of fractures of the neck of the femur and was followed by a lower frequency of reoperation than after an unthreaded device.

Adult↗

PubMed1993

Oesophagectomy by a transhiatal approach or thoracotomy: a prospective randomized trial.

A prospective randomized trial of 67 patients undergoing oesophagectomy by either a transhiatal approach or right-sided thoracotomy was conducted over a 40-month period. In 32 patients the approach was transhiatal and 35 had a thoracotomy; the groups were well matched before operation. There were two hospital deaths in patients having the transhiatal oesophagectomy and three in those undergoing thoracotomy. Blood transfusion, intensive care stay and overall time of hospitalization were not significantly different between the two groups. There was no difference in the postoperative morbidity rate and, in particular, the incidences of pulmonary complications were similar (19 per cent for transhiatal oesophagectomy, 20 per cent for thoracotomy) with anastomotic fistula in 6 and 9 per cent respectively. The median (range) operating time was significantly longer in patients having thoracotomy (6 (3.5-9.5) versus 4 (3-8) h). Long-term survival was unaffected by the type of operation performed or addition of preoperative chemotherapy or radiotherapy. Nodal status was a significant prognostic factor within but not between the two groups. It is concluded that oesophagectomy by a transhiatal route or right thoracotomy are equally effective surgical options for treatment of squamous cell oesophageal cancer.

Aged↗

PubMed1993

Treatment of perforated sigmoid diverticulitis: a prospective randomized trial.

A prospective randomized trial was carried out on 62 patients with diffuse peritonitis from perforated diverticulitis of the left colon, comparing acute transverse colostomy, suture and omental covering of a visible perforation with acute resection without primary anastomosis. For purulent peritonitis the postoperative mortality rate was significantly higher after acute resection (six of 25) than after colostomy (none of 21). In those treated by acute resection, the mortality rate was not significantly higher after Hartmann's procedure (five of 15) than after exteriorization of both lumens (one of ten). The postoperative mortality rate in patients with faecal peritonitis did not differ significantly between colostomy (six of ten) and acute resection (two of six). Stomas became permanent in four of 25 patients with diverticulitis surviving acute colostomy and in seven of 22 surviving acute resection. Suture and transverse colostomy is superior to resection for purulent peritonitis because of the lower postoperative mortality rate and in spite of the shorter hospital stay in those surviving acute resection.

Adult↗

PubMed1995

Iridium-192 versus cobalt-60 boost in 3-7 cm breast cancer treated by irradiation alone: final results of a randomized trial.

This prospective randomized trial compared an iridium-192 implant boost with a cobalt-60 external irradiation boost to the primary tumor site, in 255 patients with breast cancers 3-7 cm in diameter. All patients had a partial (> 50%) or complete response following primary external beam irradiation of 58 Gy to the whole breast, as well as irradiation to the axillary, supraclavicular and internal mammary nodes. Patients with clinically positive axillary nodes also received a cobalt-60 10-15 Gy boost to the inferior axilla. All patients had core biopsy only. Both groups were comparable in age, tumor size, node involvement, grade, and progesterone receptor levels. The boost dose was 20 Gy in both groups. At the median 8-year follow-up, the breast recurrence risk was 24% in the iridium group and 39% in the cobalt group (p = 0.02). When adjusted to other prognostic and treatment factors, the brachytherapy boost decreased the breast recurrence risk by 60%. The 8-year breast preservation rates were 81% and 67%, respectively (p = 0.024). Cosmetic outcome in both groups was evaluated in 120 patients with a minimum 3-year follow-up and was comparable in both groups. This study demonstrates that in selected patients with large tumors treated with irradiation alone, local control and breast preservation rates are improved by the use of brachytherapy to boost the primary tumor.

Adult↗

PubMed1992

Topical anesthesia with eutetic mixture of local anesthetics cream in vasectomy: 2 randomized trials.

Two paired randomized trials testing topical anesthesia with a eutetic mixture of local anesthetics (EMLA cream*) in vasectomy were performed. In 1 trial EMLA cream was applied on 1 side of the scrotum, while infiltration anesthesia into the skin and subcutaneous tissue with mepivacaine was used on the contralateral side. All but 1 of the 13 patients (p less than 0.05) preferred infiltration anesthesia because of pain as the incision reached the subcutaneous tissue. In the other trial 29 patients received EMLA cream on 1 side of the scrotum before bilateral mepivacaine infiltration. There was significantly less pain on the sides with the anesthetic cream (p less than 0.001). Many patients would pay the price of the cream. In conclusion, EMLA cream cannot replace but it can supplement infiltration anesthesia during vasectomy.

Adult↗

PubMed1997

Amoxycillin/clavulanic acid prophylaxis in elective colorectal surgery: a prospective randomized trial.

In a randomized trial of 440 patients undergoing elective colorectal surgery, the prophylactic efficacy and the safety of amoxycillin/clavulanic acid were compared with that of a control regimen of clindamycin and gentamicin. Surgical wound healing was assessed by the ASEPSIS points scale; it was normal in 86% of patients and the scores for both groups were not statistically different (amoxycillin/clavulanic acid: 11.1; clindamycin + gentamicin: 10.9). Intra-abdominal infections were more frequent in the clindamycin + gentamicin arm of the study (Fisher's exact test, P = 0.035). It is concluded that amoxycillin/clavulanic acid is as effective and safe as clindamycin + gentamicin in the prevention of wound infection and may provide better protection against intra-abdominal infections.

Adolescent↗

PubMed1992

Treatment with alpha-interferon versus alpha-interferon in combination with streptozocin and doxorubicin in patients with malignant carcinoid tumors: a randomized trial.

An open randomized trial was performed to compare the effect of recombinant interferon-alpha 2a (rIFN-alpha 2a) (group A, n = 12) versus rIFN-alpha 2a in combination with chemotherapy (group B, n = 11) in patients with malignant carcinoid tumors. Both groups received rIFN-alpha 2a at a dose of 3 MU/m2 s.c. three times weekly during the first 6 months. IFN was discontinued every third week in group B, followed by an i.v. injection of 2 g streptozocin and 40 mg/m2 doxorubicin. After 6 months group A showed one complete biochemical response (CR), 9 patients with stable disease (SD) and 2 who progressed (PD). Two patients had a partial reduction (PR) of tumor size, 9 showed SD and one PD. All patients in group B demonstrated SD. Chemotherapy was withdrawn after 6 months and all patients continued with rIFN-alpha 2a at an increased dose of 3 MU/m2 five days/week for a further 6 months. After 12 months 6 patients showed PR, 12 SD and one PD biochemically. Tumor size showed SD in 18 patients and PD in one. One patient died from cardiomyopathy, probably induced by doxorubicin. Antibodies against rIFN-alpha 2a developed in 41% of the patients. In conclusion, we detected no difference in response rates between the two treatment groups. Adverse reactions from the combination were considerable. The frequent development of IFN antibodies might have interfered with the therapeutic results.

Aged↗

PubMedDate not supplied

The relative effectiveness of educational and behavioral instruction programs for patients with NIDDM: a randomized trial.

In this randomized trial patients with non-insulin-dependent diabetes were allocated to one of four programs: a minimal instruction program (n = 59), and education program of individual visits (n = 57), an education program incorporating a group education course (n = 66), and a behavioral program (n = 59). Individual and group education programs had higher attrition rates than the behavioral and minimal programs. The four programs, which involved different amounts of patient contact time, delivery format, and instructional strategies, all produced reductions in HbA1 and BMI, with no significant differences between the programs. There were no differences between groups over three time periods in total cholesterol, HDL cholesterol, systolic blood pressure, or proportion of patients consulting an ophthalmologist. The behavioral program produced a greater reduction in diastolic blood pressure over 12 months than the education programs and a greater reduction in the cholesterol risk ratio over 3 months than the other programs. The behavioral program patients were more likely to have visited a podiatrist after 6 months and reported higher satisfaction.

Adolescent↗

PubMed1993

Use of a tourniquet in the internal fixation of fractures of the distal part of the fibula. A prospective, randomized trial.

A prospective, randomized trial was undertaken to determine the rate of complications after the use of a tourniquet during open reduction and internal fixation of simple, closed fractures of the distal part of the fibula. Forty patients were operated on with use of a tourniquet (Group 1) and forty patients, without use of a tourniquet (Group 2). The average duration of the operation was significantly different between the two groups (41 +/- 9 minutes for Group 1 compared with 53 +/- 12 minutes for Group 2 [p = 0.026]). There were more complications in the patients in Group 1, two of whom had an isolated deep-vein thrombosis of the calf. The wound was possibly infected in eleven patients (seven in Group 1 and four in Group 2 [p < 0.05]) and frankly infected in three patients, all in Group 1 (p < 0.05). The plaster-of-Paris cast needed to be changed in three patients from Group 1. The patients in Group 1 returned to work an average of one week later than those in Group 2. The mean duration of follow-up was eighteen months (range, nine to thirty-two months). Given the lower prevalence of postoperative complications and the shorter time to recovery for the patients in Group 2, we believe that it is justified not to use a tourniquet in the operative treatment of simple, isolated fibular fractures.

Adult↗

PubMed1985

Cisplatin combination chemotherapy versus chlorambucil in advanced ovarian carcinoma: mature results of a randomized trial.

A randomized study to compare the efficacy of combination chemotherapy (cisplatin, doxorubicin, cyclophosphamide: PACe) with chlorambucil (CB) in International Federation of Gynecology and Obstetrics (FIGO) stage III and IV ovarian carcinoma was conducted between May 1979 and October 1983. Patients failing initial CB were subsequently eligible for treatment with PACe. Eighty-nine patients were randomized and 85 were eligible for analysis; as of date, 72 of these patients have died. The majority of patients in this study had bulky residual disease after their initial laparotomy (76%). Complete response (CR) was documented by a second laparotomy after five cycles of combination therapy or 6 to 12 months alkylating agent therapy. The overall response rate (CR plus partial response [PR]) for the combination (PACe, 68%) was significantly higher (P = .0004) than that for the chlorambucil (CB, 26%). However, the median survival was not improved (PACe, 13 months; CB, 11 months) and the survival curves were not significantly different (log rank test P = .25). The results of this study are comparable to preliminary data reported from other similar randomized studies. PACe, as administered in this study, is not indicated as routine therapy in patients with bulky residual ovarian carcinoma.

Actuarial Analysis↗

PubMed1985

The effect of intravenous hyperalimentation on the dietary intake of patients with small cell lung cancer. A randomized trial.

In a randomized trial of 119 patients with small cell cancer of the lung, the effects of a 30-day course of central intravenous hyperalimentation (IVH) on dietary intake were evaluated. All patients underwent the same aggressive chemotherapy and radiation therapy; 57 patients received IVH and 62 served as controls. Median caloric intake prior to antineoplastic therapy was less than 1.2 times basal energy expenditure, below the maximum necessary to maintain weight. While receiving IVH, patients had increased caloric and protein intake. Once the IVH was stopped, oral intake was transiently depressed and thereafter similar to control patients. Baseline nutritional parameters, age, sex, and immediate toxicity from chemotherapy did not predict subsequent caloric insufficiency. Direct estimation of dietary intake is likely the most valuable measure in selecting patients who will need adjunctive nutritional support.

Adult↗

PubMed1983

[Secretin versus somatostatin in acute hemorrhage of gastroduodenal ulcers and erosions: a randomized trial].

In a randomized trial the efficiency of synthetic secretin (0,25 clinical units/kg bw/h; 15 patients) was compared with that of synthetic somatostatin (250 micrograms/h, 15 patients) in treatment of severe acute non arterial bleeding from peptic ulcers or stress lesions in the upper digestive tract. In all patients the presence of hemorrhage at beginning of the therapy was established by endoscopic examination. Both test preparations were given as continuous infusions over 48 h and had identical effects on the hemorrhage: in 12 patients (80%) out of each group bleeding stopped during the infusion of secretin or somatostatin, 6 patients (20%) had to be operated on for persistant bleeding or severe recurrence.

Acute Disease↗

PubMed2003

Durability of treatment effects after endometrial cryoablation versus rollerball electroablation for abnormal uterine bleeding: two-year results of a multicenter randomized trial.

In a randomized trial, 93% of cryoablation patients who were evaluated at both 12 and 24 months and not retreated were free of abnormal uterine bleeding at 12 months and 94% at 24 months versus 92% of electroablation patients at both times. The retreatment rate was similar after cryoablation (12.9%) and electroablation (14.0%).

Cryosurgery↗

PubMed1991

Is follicular flushing necessary for oocyte retrieval? A randomized trial.

A prospective randomized trial was performed to evaluate the necessity of follicular flushing during transvaginal, ultrasonically guided oocyte recovery under mild sedation. Patients with tubal damage as the sole cause of their infertility were randomized into one of two groups. Group one had their follicles aspirated only. Follicles of patients in Group 2 were aspirated and flushed with a total of 10 ml of flushing medium. There was no significant difference in the number of oocytes retrieved, fertilization rate or pregnancy rate in each group. There was, however, a significant shortening of operating time in the aspiration only group.

Adult↗