PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Randomized trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 73 records · Page 4Linked to original sources
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↗
PubMed1981

Multi-drug chemotherapy with and without radiation for carcinoma of the stomach and pancreas: a prospective randomized trial.

A prospectively randomized trial in advanced gastric and pancreatic carcinoma compared multi-drug chemotherapy, with and without radiotherapy to the local lesion, in terms of median survival and toxicity. Of 29 patients with gastric adenocarcinoma, 14 were randomized to receive 5-FU and Methyl-CCNU, and 15 to receive 5-FU and local radiotherapy to a dose of 4600 rad, and then Methyl-CCNU. Thirty patients with advanced adenocarcinoma of the pancreas were similarly randomized. There was no significant difference between the two arms of the gastric or pancreatic adenocarcinoma groups, with a median survival of 13 months and 11.5 months respectively in gastric carcinoma, and 7.8 months and 7.3 months in pancreatic carcinoma. Complications were minimal in both groups. There was more hematopoietic depression in the radiation-treated patients, but none had radiotherapy discontinued because of toxicity.

Adenocarcinoma↗
PubMed1995

Combination therapy using adrenaline and heater probe to reduce rebleeding in patients with peptic ulcer haemorrhage: a prospective randomized trial.

A prospective randomized trial was performed to assess the efficacy of the combined therapy of endoscopic injection of adrenaline and heater probe application in the management of patients with major peptic ulcer haemorrhage. Some 153 consecutive patients were randomized to receive either local injection of adrenaline (1:10,000) followed by heater probe thermocoagulation (74 patients) or no endoscopic treatment (79 patients). The two groups were well matched with regard to age, haemoglobin concentration on admission, non-steroidal anti-inflammatory drug usage and endoscopic findings. More patients in the treatment group were in shock on admission (21 versus 13). Initial haemostasis was achieved in all patients randomized to endoscopic therapy. Rebleeding occurred in fewer treated than control patients (five versus 16, P = 0.01). The treated group also had fewer deaths (zero versus two) and requirement for operation (two versus six). The results show that the combination of sclerotherapy with adrenaline and subsequent thermocoagulation reduces the rate of rebleeding in peptic ulcer haemorrhage.

Adult↗
PubMed1989

Metaphylactic effect of mitomycin C with and without hyaluronidase after transurethral resection of bladder cancer: randomized trial.

In a randomized trial 2 groups of 28 patients who had undergone transurethral resection of bladder tumors were treated with 20 mg. mitomycin C alone or with 200,000 units hyaluronidase to determine whether adjuvant hyaluronidase would improve tumor recurrence rates. Patient groups were comparable statistically. In the group receiving additive hyaluronidase the percentage of tumor recurrences was decreased significantly (p less than 0.05). Side effects were not increased. Thus, adjuvant hyaluronidase appears to have a role in the metaphylaxis of bladder tumors. The potential reduction of the hyaluronidase dose without loss of protective action and the role of additive hyaluronidase in the systemic treatment of metastatic urothelial tumors remain to be investigated.

Adult↗
PubMed1998

Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial.

A prospective randomized trial was carried out to evaluate the efficacy of fibrin glue in preventing lymphorrhea after axillary lymphadenectomy in breast cancer. One hundred and eight breast cancer patients, operated on by two senior surgeons, were randomized into two groups: group 1 (n = 58) without fibrin glue and group 2 (n = 50) with 2 ml of fibrin glue applied to the axillary dissection area at the end of the lymphadenectomy procedure. Early postoperative morbidity was 2/58 and 0/50 in groups 1 and 2, respectively. Mean daily postoperative drainage was significantly greater in group 1. The mean cumulative drainage quantity 6 days after the operation was 407.8 ml and 214.4 ml in groups 1 and 2, respectively (p = 0.001). The mean postoperative hospital stay was 10.1 days and 8.0 days in groups 1 and 2, respectively (p = 0.006). One delayed seroma was observed in each group. Fibrin glue seems to reduce daily postoperative drainage and hospital stay, but did not affect delayed seroma formation after axillary lymphadenectomy for breast cancer.

Aged↗
PubMed1995

Maintenance of serum albumin levels in pediatric burn patients: a prospective, randomized trial.

A prospective, randomized trial was performed to determine whether maintaining serum albumin levels in burned pediatric patients had any effect on morbidity and mortality. Patients < 19 years of age with burns > 20% total body surface area were randomized to receive supplemental albumin to maintain levels 2.5 to 3.5 g/dL ("High Albumin") or were given albumin only if levels dropped < 1.5 g/dL ("Low Albumin") after completing burn shock resuscitation. The 36 patients in the Low Albumin group were well matched for age, burn size, depth of injury, and inhalation injury when compared with the High Albumin group (34 patients). As expected, serum albumin levels were significantly lower in the Low Albumin group when compared with the High Albumin group. No differences between groups were noted for resuscitation needs, maintenance fluid requirements, urine output, tube feedings received, days of antibiotic treatment, or ventilatory requirements. No differences in hematology, electrolytes, or nutritional laboratories were found. Finally, length of stay, complication rate, and mortality were not affected by albumin treatment. Albumin supplementation to maintain normal serum levels does not seem to be warranted in previously healthy children who suffer severe burns and who receive adequate nutrition.

Adolescent↗
PubMed1993

Air and liquid contrast agents in the management of intussusception: a controlled, randomized trial.

A randomized study comparing air and liquid contrast agents for diagnosis and reduction of intussusception involved 101 patients. Fifty received liquid contrast material and 51 received air. Rates of diagnosis were 49% (25 of 51) for air and 54% (27 of 50) for liquid contrast material (P = .62). Rates of reduction were 76% (19 of 25) for air and 63% (17 of 27) for liquid contrast material (P = .31). Air enemas resulted in shorter fluoroscopic times in patients without an intussusception and for examinations by radiologists who had performed four or more air enemas. Air enemas were found to be accurate in demonstration of intussusception and at least as effective as liquid contrast medium for reduction of intussusception. In experienced hands, the shorter fluoroscopic time with resultant lower radiation exposure associated with air is an important benefit. There still may be clinical situations, however, in which a liquid contrast agent is preferred.

Air↗
PubMed1991

Prevention of central venous catheter sepsis: a prospective randomized trial.

A prospective randomized trial was undertaken to evaluate the influence of routine 72-hour catheter exchange and the use of an implantable collagen cuff in preventing central venous catheter infection in critically ill patients requiring multiple lumen central venous access. Patients were randomized to one of four groups, which determined whether the central venous catheter placed would be removed at 3 or 7 days and whether an implantable collagen cuff would be used or not. Upon removal, cultures of the central line tip, the insertion site, and peripheral blood were obtained. One hundred and fifty-nine catheters were studied in 85 patients during a 14-month period. There were 26 (16.4%) episodes of catheter colonization and four (2.5%) episodes of catheter infection in the entire population. Catheter colonization rates (same organisms cultured from catheter tip and skin site) were 14.5 per cent at 3 days and 18.4 per cent at 7 days. Infection rates (same organism cultured from catheter tip and peripheral blood culture) were 2.4 per cent at 3 days and 2.6 per cent at 7 days. With regard to the use of the collagen cuff, colonization rates were 14.5 per cent with the use of the cuff and 18.1 per cent without the use of the cuff. Infection rates were 5.3 per cent with the use of the cuff and 0 per cent without the use of the cuff. None of these differences reached statistical significance.(ABSTRACT TRUNCATED AT 250 WORDS)

Bacterial Infections↗
PubMed1991

Conservative treatment of postmastectomy lymphedema: a controlled, randomized trial.

A controlled, randomized trial was carried out to evaluate the effectiveness of a new conservative treatment for postmastectomy lymphedema. Seventy-four patients were randomized to wear only an elastic sleeve for six months (group A) or to receive additionally an induction treatment with electrically stimulated lymphatic drainage (group B). The evaluation of results was focused not only on the mean variations in limb measurements in the two groups, but also on the frequency of clinically significant reductions of lymphedema (i.e., at least 25% compared to the initial values). A mean reduction of limb girth of about 17% was obtained in both groups, without significant differences between the two treatments. An 'objective response', however, was not achieved by the majority of patients. On the other hand, compliance to therapy was good and a significant result could be obtained simply and economically also in the group of patients treated only with the elastic sleeve.

Aged↗
PubMed1988

Postoperative radiation as adjuvant treatment for carcinoma of the oral cavity, larynx, and pharynx: preliminary report of a prospective randomized trial.

A prospective randomized trial was performed in patients with advanced squamous cell carcinomas (SCC) of the oral cavity, larynx, and pharynx to examine the effect of adjuvant postoperative radiation therapy on locoregional recurrence and survival following "curative" resection. Fifty-one patients with stage III or IV SCC treated from 1981 through 1984 were randomized to receive either surgery alone (n = 27) or surgery with postoperative radiation (n = 24). Five patients were excluded from the study after randomization because of ineligibility or protocol violations. Overall recurrence rates of 55.6% and 36.8% were noted in the surgery and surgery with adjuvant radiotherapy arms, respectively (p = NS). This trend towards a higher recurrence rate in the surgery only arm was in part due to the development of lymph node metastases in the contralateral, nonoperated neck. Thus far, no significant differences in either locoregional or overall survival have been noted between the two treatment arms. In this preliminary analysis, adjuvant postoperative radiotherapy does not appear to improve disease-free or overall survival.

Adult↗
PubMed1996

Laparoscopic versus open appendectomy: prospective randomized trial.

A prospective randomized trial comparing laparoscopic appendectomy with open appendectomy in patients with a diagnosis of acute appendicitis was conducted between October 1992 and April 1994. Of the 158 patients randomized, 7 patients were excluded because of protocol violations (conversion to laparotomy in 4, appendix not removed in 3). The 151 patients randomized to either a laparoscopic (n = 79) or an open appendectomy (n = 72) showed no difference in sex, age, American Society of Anesthesiology (ASA) rating, or previous abdominal surgery. The histologic classification of normal, catarrhal, inflamed, suppurative, and gangrenous appendicitis was not different between the two groups. Conversion from laparoscopic to open appendectomy was necessary in seven patients (9%) who had advanced forms of appendiceal inflammation. When compared to open appendectomy the laparoscopic group had a longer median operating time (63 minutes versus 40 minutes), fewer wound infections (2% versus 11%), less requirement for narcotic analgesia, and an earlier return to normal activity (median 7 days versus 14 days). There was no difference in morbidity, and both groups had a median time to discharge of 3 days. Laparoscopic appendectomy is as safe as open appendectomy; and despite the longer operating time, the advantages such as fewer wound infections and earlier return to normal activity make it a worthwhile alternative for patients with a clinical diagnosis of acute appendicitis.

Adolescent↗
PubMed1998

Vaginal misoprostol compared with vaginal gemeprost in termination of second trimester pregnancy. A randomized trial.

A prospective randomized trial was conducted in 140 women to compare the efficacy of vaginal gemeprost with vaginal misoprostol for termination of second trimester pregnancy. Women requesting termination of second trimester pregnancy were randomized into two groups. Group A women were given 1 mg vaginal gemeprost every 3 h for a maximum of five doses in the first 24 h, whereas group B women were given 400 micrograms vaginal misoprostol every 3 h for a maximum of five doses in 24 h. The median induction-abortion interval in the vaginal misoprostol group (14.1 h) was significantly shorter than that in the gemeprost group (19.5 h). The percentage of women who achieved successful abortion within 24 h in the misoprostol group (80.0%) was significantly higher than that in the gemeprost group (58.6%). There was no significant difference in the incidence of side effects between the two groups except for diarrhea, which was more common in the gemeprost group. The incidence of fever was more common in the misoprostol group. It is concluded that vaginal misoprostol is more effective than gemeprost in termination of second trimester pregnancy.

Abortifacient Agents, Nonsteroidal↗
PubMed1995

Failure of orally administered dipyridamole to enhance the antineoplastic activity of fluorouracil in combination with leucovorin in patients with advanced colorectal cancer: a prospective randomized trial.

PURPOSE: A randomized trial was performed to investigate the ability of the nucleoside transport inhibitor dipyridamole (DP) to enhance the antitumor activity of fluorouracil (5-FU)/leucovorin (folinic acid [FA]). PATIENTS AND METHODS: One hundred eighty-one untreated patients with advanced colorectal cancer were randomized to receive 5-FU 600 mg/m2 plus FA 300 mg/m2 on days 2 to 4 with or without DP 75 mg orally three times daily on days 1 to 5. Cycles were repeated every 3 weeks. Only patients with documented tumor progression before therapy were eligible. 5-FU pharmacokinetics using high-performance liquid chromatography (HPLC) were assessed in 11 nonrandomized patients receiving paired cycles with or without DP. RESULTS: One hundred seventy-four patients were assessable for toxicity and response. There was no significant difference in toxicity, except DP-related headache in 24% of patients. An objective response rate of 15% (one complete response [CR] and 13 partial responses [PRs]) for 5-FU/FA and 13% (two CRs and nine PRs) for 5-FU/FA/DP was observed. The dose-intensity of 5-FU delivered was significantly higher (1.09- to 1.16-fold) for the DP-containing arm. Pharmacokinetic parameters of 5-FU did not differ significantly, except for a prolonged half-life (t1/2) induced by DP. The median time to progression (P = .8) and the median survival time (11.6 months for 5-FU/FA v 9.3 months for 5-FU/FA/DP; P = .14, log-rank test) were not different between treatment arms. CONCLUSION: Orally administered DP did not improve the antineoplastic activity of 5-FU/FA in patients with advanced colorectal cancer when used at this dose and schedule. The observed increase in 5-FU dose-intensity for FU/FA/DP was not clinically relevant.

Administration, Oral↗
PubMed1994

Randomized trial comparing weekly versus 3-week chemotherapy in small-cell lung cancer: a Cancer Research Campaign trial.

PURPOSE: A randomized trial of chemotherapy, given on either a 1-week or a 3-week schedule, was performed in small-cell lung cancer (SCLC) patients. The aim was to determine if weekly scheduling produced survival superior to conventional treatment. PATIENTS AND METHODS: Four hundred thirty-eight patients with SCLC with either limited disease (LD; 276 patients) or good-prognosis extensive disease (ED; 162 patients) were randomized. Weekly chemotherapy was 12 alternating cycles of ifosfamide/doxorubicin and cis-platin/etoposide (PE), while 3-week treatment was six alternating cycles of cyclophosphamide/doxorubicin/vincristine (CAV) and PE. Thoracic irradiation was administered 3 weeks after completion of chemotherapy to LD patients who attained a complete response (CR) or partial response (PR). Patients were well matched for clinical characteristics and prognostic factors. RESULTS: Overall response was the same in both arms: 82.3% (39.4% CR) with weekly and 81.1% (36.9% CR) with 3-week treatment. The median survival (MS) durations were 10.8 and 10.6 months for weekly and 3-week chemotherapy, respectively. The 2-year survival rates were 11.8% and 11.7% in the weekly and 3-week arms, respectively. Received dose-intensity (DI) was 73.9% of projected for weekly treatment and 92.7% for 3-week treatment. Hematologic toxicity was the major dose-limiting toxicity for the weekly treatment. CONCLUSION: This trial excludes at 90% power a benefit of greater than 10% for 2-year survival for weekly treatment. The received DI was reduced to a greater extent with weekly treatment, mainly due to hematologic toxicity.

Adult↗
PubMed1994

Comparison of 7 and 8 French guiding catheters for elective PTCA: results of a prospective randomized trial.

A prospective randomized trial was performed to detect technical and clinical differences of 7F compared to 8F guiding catheters (GC) used in elective coronary angioplasty (PTCA). One hundred and fifteen patients undergoing elective PTCA with standard balloon dilatation catheters were randomized to 7F (55 pts) or 8F (58 pts) guiding catheters. The endpoints were primarily coronary artery and peripheral vascular complications; and secondarily, technical details and quantitative and qualitative angiographic quality. There was no difference between 7F or 8F GC for development of coronary or peripheral vascular complications. With 7F GC there was less blood loss (Hct, 3.5 +/- 3.4% vs. 6.5 +/- 9.6%, P = .033), and less contrast medium (160 +/- 88 mL vs. 200 +/- 119 mL, P = .049) used. Angiographic quality was similar, although visualization of lesions in the left anterior descending coronary artery in the left anterior oblique projection was improved with the 8F GC. There is no advantage of 7F GC for the prevention of coronary or peripheral vascular complications, although there was less blood loss and contrast medium used with the 7F systems.

Aged↗
PubMed1997

Chemotherapy as an adjunct to radiation in the treatment of squamous cell carcinoma of the head and neck: results of the Yale Mitomycin Randomized Trials.

PURPOSE: Two consecutive randomized trials were run at our institution using the bioreductive alkylating agent mitomycin as an adjunct to radiation therapy in an effort to improve outcome in patients with squamous cell carcinoma of the head and neck. METHODS: Between 1980 and 1992, two consecutive randomized trials using mitomycin (trial 1) and mitomycin with dicumarol (trial 2) as an adjunct to radiation therapy in patients with squamous cell carcinoma of the head and neck were conducted at our institution. The patients were stratified by intent of therapy, extent of disease, and primary tumor site. Within each strata, patients were randomized to receive radiation therapy with or without mitomycin (trial 1) or mitomycin/dicumarol (trial 2). RESULTS: A total of 203 patients were enrolled onto both trials, 195 of whom were eligible for analysis. Patients were equally balanced with respect to sex, age, extent of disease, primary site, radiation dose, and total duration of radiation treatment. Hematologic toxicities were more frequently noted in the drug-treated arms, but were acceptable with no drug-related treatment deaths. Nonhematologic toxicities were acceptable and not significantly different between the two arms. As of September 1995, with a median follow-up of 138 months, a statistically significant benefit occurred in the mitomycin arms with respect to cause-specific survival (0.74 +/- 0.05 v 0.51 +/- 0.05; P = .005), local recurrence-free survival (0.85 +/- 0.04 v 0.66 +/- 0.05; P = .002), and local regional recurrence-free survival (0.76 +/- 0.05 v 0.54 +/- 0.05; P = .003). No statistically significant difference in overall survival was obtained (0.48 +/- 0.05 mitomycin arms v 0.42 +/- 0.05 radiation alone). CONCLUSION: The bioreductive alkylating agent mitomycin is a safe and effective adjunct to radiation therapy in the treatment of squamous cell carcinoma of the head and neck. The statistically and clinically significant improvement in local regional relapse and cause-specific survival obtained support the use of mitomycin as an adjunct to radiation therapy in the management of squamous cell carcinoma of the head and neck.

Adult↗
PubMed1987

The role of sclerotherapy in the treatment of esophageal varices: personal experience and a review of randomized trials.

Although many more randomized trials will be required to define the role of prophylactic EVS and other therapies (95-99) in the treatment of varices, EVS appears to have a place in the management of varices before they bleed. However, in view of studies recently presented in abstract form (98, 99), it must be stressed that at least in the United States, prophylactic EVS should be restricted to patients in randomized trials. Results from a VA cooperative study (98) led to the conclusion that prophylactic EVS should not be done in male patients with alcoholic cirrhosis and esophageal varices due to excess mortality in the active EVS group (p = 0.009). Although a large number of patients (n = 282) were included into this trial, on the average each of the 12 VA centers treated only 12 patients with EVS. Thus, although investigators were experienced with EVS, a single unforseen problem occurring at each VA center only once could dramatically alter the results of the study. For example, a relatively potent sclerosant solution (45) used in this study may be effective in treating variceal bleeders, but be too toxic and damaging to the esophagus for prophylactic EVS. Also, even though to enter the VA cooperative study, patients were required to have at least three variceal channels, and 89% in the study actually had "large" varices, these "large" varices may not be the same as the "ominous-looking" varices required of the patients in Paquet's study (88, 89, 99). Exactly which subgroups will benefit from each of the various treatments available will be defined as further studies of patients with a high risk of variceal bleeding are completed (95, 99).

Clinical Trials as Topic↗